Cardiovascular Prediction Tool Underestimated Risk In Poor Socioeconomic Groups

MedicalResearch.com Interview with:

Jarrod Dalton PhD Department of Quantitative Health Sciences Cleveland Clinic , Cleveland 

Dr. Dalton

Jarrod Dalton PhD
Department of Quantitative Health Sciences
Cleveland Clinic , Cleveland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Accurate risk assessment is critical for identifying patients who are at high risk of cardiovascular events such as heart attacks and strokes.

We evaluated the performance of a widely-used risk assessment tool against the socioeconomic position of patients’ neighborhoods of residence. This tool, called the Pooled Cohort Equations Risk Model, or PCERM, was developed in 2013 jointly by the American College of Cardiology and the American Heart Association (ACC/AHA).

We found that the PCERM model accurately characterized risk among patients from affluent communities, but performed more poorly among patients from disadvantaged communities. In particular, for these patients, major cardiovascular events occurred at rates that were as much as 2-3 times than predicted from the PCERM model.

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Long Acting Local Anesthetic Reduced Need For Opioids After Knee Replacement

MedicalResearch.com Interview with:

Michael A. Mont, MD Department of Orthopaedic Surgery Cleveland Clinic Cleveland, OH

Dr. Mont

Michael A. Mont, MD
Department of Orthopaedic Surgery
Cleveland Clinic
Cleveland, OH 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Postoperative pain after total knee arthroplasty (TKA) is a major hurdle for both the patients and the orthopaedists. Many analgesic modalities are currently in use, and can be used alone or in combination in order to augment their effect. Addition of local anesthetic analgesia has been shown to improve pain control and reduce opioid consumption during postoperative period. However, the effects of this analgesia tend to dissipate with time, with the longest duration of action (bupivacaine) of approximately 12 hours. Therefore, long acting local anesthetic (liposomal bupivacaine) has been developed in order to expand the duration of effectiveness of pain relief for up to 96 hours. Many studies evaluated the effectiveness of this anesthetic and demonstrated contradictory results, however, they did not use the same methods and infiltration technique. Therefore, we conducted a prospective, randomized, double-blind, controlled study at 16 hospitals using optimal infiltration techniques. Our study demonstrated significant improvement in pain, decreased opioid consumption, increased time to first opioid rescue, more opioid free patients in liposomal bupivacaine cohort. In addition, there were no unexpected safety concerns.

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MRI Biomarkers Track Cognitive Impairment Due to Head Trauma

MedicalResearch.com Interview with:

Virendra Mishra, Ph.D. Department of Imaging Research Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas

Dr. Virendra Mishra

Virendra Mishra, Ph.D.
Department of Imaging Research
Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Repetitive head trauma has been shown to be a risk factor for various neurodegenerative disorders, mood swings, depression and chronic traumatic encephalopathy. There has been a significant amount of research into identifying an imaging biomarker of mild traumatic brain injury (mTBI) due to repetitive head trauma. Unfortunately, most of the biomarkers have not been able to find a successful translation to clinics. Additionally, the quest for the mTBI imaging biomarker especially using Magnetic Resonance Imaging (MRI) techniques has been done by looking at either the gray matter (T1-weighted) or the white matter (Diffusion Tensor Imaging) independently; and both have shown changes that are associated with repetitive head trauma.

Hence in this study, we wanted to investigate if combining gray matter and white matter information enables us to better predict the fighters who are more vulnerable to cognitive decline due to repetitive head trauma. Our method found seven imaging biomarkers that when combined together in a multivariate sense were able to predict with greater than 73% accuracy those fighters who are vulnerable to cognitive decline both at baseline and follow-up. The imaging biomarkers were indeed a combination of gray and white matter measures of regions reported previously in the literature. A key point in our study was we found the regions predicting cognitive decline without enforcing any assumptions on the regions previously reported.

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Synthetic Human Angiotensin II for the Treatment of Vasodilatory Shock

MedicalResearch.com Interview with:

Ashish Khanna, MD, FCCP Assistant Professor of Anesthesiology, Cleveland Clinic Lerner College of Medicine Staff Intensivist Center for Critical Care and Department of Outcomes Research Cleveland Clinic, Cleveland

Dr. Khanna

Ashish Khanna, MD, FCCP
Assistant Professor of Anesthesiology, Cleveland Clinic Lerner College of Medicine
Staff Intensivist
Center for Critical Care and Department of Outcomes Research
Cleveland Clinic, Cleveland

MedicalResearch.com: How did you become interested in this topic?

Response: Anesthesia forms the basis of my training but I also completed a fellowship in critical care and, at the present time, I do more work in critical care than anesthesia. About 75% of my time is spent in the Cleveland Clinic critical care units, including the Medical and surgical ICUs (Intensive Care Units).

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Elevated Kidney Biomarker Creatinine Predicts Worse Outcome in STEMI Heart Attack

MedicalResearch.com Interview with:

MedicalResearch.com Interview with: Mohamed Khayata, MD Internal Medicine Resident PGY-3 Cleveland Clinic Akron General, Akron, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies showed that patients with ST-elevation myocardial infarction (STEMI) who had elevated creatinine and/or impaired creatinine clearance on presentation had higher short- and long-term mortality independent of other cardiovascular risk factors. We used the National Cardiovascular Database Registry to investigate the impact of creatinine levels at the time of presentation on the cardiovascular outcomes in patients who presented with STEMI. Our study showed that elevated creatinine levels correlated with higher incidence of atrial fibrillation, bleeding, heart failure, and cardiogenic shock during hospital stay after the percutaneous intervention. MedicalResearch.com: What should readers take away from your report? Response: Creatinine level is being checked in almost all patients who present with STEMI within few hours of presentation. Based on previous reports and our results, creatinine is a critical marker that correlate not only with mortality, but is also with morbidity during hospital stay. This marker should be used as a predictor of worse outcomes; thus, patients with higher creatinine levels should be provided higher attention. MedicalResearch.com: What recommendations do you have for future research as a result of this study? Response: Based on our study limitations, I would encourage performing similar outcomes analysis in larger group, multi-center registries. I would also suggest extending outcomes to post-discharge status including quality of life besides cardiovascular compilcations. MedicalResearch.com: Is there anything else you would like to add? Response: MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community. Citation: Abstract presented at the 2017 National Kidney Foundation Spring Clinical Meeting https://www.kidney.org/spring-clinical The Impact of Admission Serum Creatinine on Major Adverse Clinical Events in ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions. More Medical Research Interviews on MedicalResearch.com

Dr. Khayata

Mohamed Khayata, MD
Internal Medicine Resident PGY-3
Cleveland Clinic Akron General
Akron, Ohio

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previous studies showed that patients with ST-elevation myocardial infarction (STEMI) who had elevated creatinine and/or impaired creatinine clearance on presentation had higher short- and long-term mortality independent of other cardiovascular risk factors.

We used the National Cardiovascular Database Registry to investigate the impact of creatinine levels at the time of presentation on the cardiovascular outcomes in patients who presented with STEMI.

Our study showed that elevated creatinine levels correlated with higher incidence of atrial fibrillation, bleeding, heart failure, and cardiogenic shock during hospital stay after the percutaneous intervention.

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The Capillary Index Score as a Marker of Viable Cerebral Tissue in Stroke

MedicalResearch.com Interview with:

Firas Al-Ali, MD Departments of Neuro Interventional Surgery Cleveland Clinic Akron General, Akron, OH

Dr. Firas Al-Ali

Firas Al-Ali, MD
Departments of Neuro-Interventional Surgery
Cleveland Clinic Akron General, Akron, OH

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Capillary Index Score (CIS) is based on the simple following assumption: “ the presence of capillary blush on diagnostic cerebral angiography, in an ischemic area, is an indicator of ischemic BUT viable cerebral tissue, while its absence indicate NONE- no viable tissue”

In previous publication we demonstrated that the CIS is a strong predictor of clinical outcome (CO) in patients presented acute ischemic stroke (AIS) . In previous studies AIS patients presented with Poor CIS (pCIS) did not have a good clinical outcome despite timely and full recanalization, while when patients presented with favorable CIS (fCIS) had 80-90% good clinical outcome when achieved good recanalization.

In this latest paper we tried to test our original assumption mentioned above. i.e. If the absence of capillary blush in a certain vascular cerebral territory signify no viable cerebral tissue then when an area on diagnostic cerebral cerebral angiogram (DCA) lack capillary blush BEFORE endovascular treatment, it will progress to infarcted tissue despite timely and full recanalization, seen as an area of hypodensity on the POST treatment Cat-Scan (CT).

While an area with Capillary blush in an ischemic area seen on the pre treatment DCA, will not show infarction on POST treatment CT if we obtain successful and timely recanalization.

In this paper we matched areas on the Pre and post -treatment CT to its corresponding location on the Pre-treatment DCA, and we demonstrated that when an area lacked capillary blush on the pre-treatment DCA had a very high chance to progress from normal on the Pre-treatment CT to hypodensity on the post treatment CT (infarcted cerebral tissue). while the areas with capillary blush on the rep treatment CT stayed normal on the post treatment CT when we achieve timely recanalization of the occluded vessel.

MedicalResearch.com: What should readers take away from your report?

Response: The Capillary Index Score is a powerful tool to assess residual viable tissue in a ischemic area, and has a great prognostic value for clinical outcome.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: We are now enrolling patient in a multi-center prospective trial, the Capillary Index Score Trial, phase I, to prove the value of CIS prospectively, and to demonstrate that:
1- CIS is a powerful indicator of clinical outcome
2- Treatment patients with pCIS could harmful by demonstrating that most complications happen in the pCIS group.

In The CIS Trial, phase II, we will try to demonstrate that treating patients with pCIS is futile by randomizing them into two groups:
One offered endovascular treatment plus usual medical management and the second group offered only usual medical management.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

The Capillary Index Score as a Marker of Viable Cerebral Tissue
Proof of Concept—The Capillary Index Score in the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Trial
Firas Al-Ali, Olvert A. Berkhemer, Wina P. Yousman, John J. Elias, Evin N. Bender, Hester F. Lingsma, Aad van der Lugt, Diederik W.J. Dippel,Yvo B.W.E.M. Roos, Robert J. van Oostenbrugge, Wim H. van Zwam, William P. Dillon and Charles B.L.M. Majoie
Stroke: http://dx.doi.org/10.1161/STROKEAHA.116.013513
Published: September 1, 2016

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Activating Scavenger System May Treat Blocked Blood Vessels Without Surgery

MedicalResearch.com Interview with:

MedicalResearch.com Interview with: Qing Kenneth Wang PhD, MBA Huazhong University of Science and Technology Wuhan, P. R. China and Department of Molecular Cardiology The Cleveland Clinic Cleveland, Ohio

Dr. Qing Kenneth Wang

Qing Kenneth Wang PhD, MBA
Huazhong University of Science and Technology
Wuhan, P. R. China and
Department of Molecular Cardiology
The Cleveland Clinic
Cleveland, Ohio

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Coronary Artery Disease (CAD) and its complication myocardial infarction (MI or so called heart attacks) are the most common causes of deaths in the US and other parts of the world. Based on the American Heart Association statistics, 620,000 Americans have a new MI each year in the United States alone, 295 000 have a recurrent MI, and nearly 400,000 of them will die from it suddenly. Moreover, an estimated 150,000 silent first MI occur each year.

CAD and MI are caused by an occlusion or blockage of a coronary artery, which disrupts blood flow to the heart region, leading to damage or death of cardiac cells, impairment of cardiac function and sudden death. Current treatment of CAD and MI relies on reperfusion therapy with reopening of the occluded coronary artery with percutaneous coronary intervention (PCA) and coronary artery bypass surgery (CABG). However, 12% of patients are not candidates for PCA or CABG due to an unfavorable occlusive pattern, diffuse coronary atherosclerosis, small distant vessels and co-morbidities. An alternative revascularization strategy has to be developed to benefit these patients.

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Study Addresses Appropriate Treatment Setting for Hypertensive Urgency

MedicalResearch.com Interview with:
Krishna Patel, MD, PG Y3 Resident
Internal Medicine Residency Program
Cleveland Clinic
Cleveland, OH 44195

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Patel: In our outpatient resident clinic practice, we found that patients with poorly controlled hypertension presenting with blood pressures in the hypertensive urgency range (SBP>=180mmHg or DBP >=110 mmHg) but with no symptoms of end-organ damage were common, however there was no clear cut manner in which these patient’s blood pressures were treated. According to the comfort level of the physician, these patients were managed in the office and on serial outpatient visits and some of the patients would be referred to the emergency department for management of these elevated blood pressures. Given there was not much prior literature on this topic, we decided to study the prevalence and short term cardiovascular outcomes for this population of patients.

We found that hypertensive urgency is quite common in the office setting (4.6% in our study). In absence of symptoms of end organ damage, the short term risk of major cardiovascular events was very low around 1%, and patients who were referred to the ED for management of blood pressures had a lot of unnecessary testing and more hospital admissions than those who were managed as an outpatient.

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Intestinal Metabolite Associated With Diffuse Atherosclerosis

MedicalResearch.com Interview with:

Dr. W.H. Wilson Tang M.D. Department of Cellular and Molecular Medicine (NC10) Cleveland Clinic Lerner Research Institute Cleveland, Ohio 44195

Dr. W.H.Wilson Tang

Dr. W.H. Wilson Tang M.D.
Department of Cellular and Molecular Medicine (NC10)
Cleveland Clinic Lerner Research Institute
Cleveland, Ohio 44195

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our group has recently described the mechanistic link between intestinal microbe-generated phosphatidylcholine metabolite, trimethylamine N-oxide (TMAO), and the pathogenesis of atherosclerotic coronary artery disease (CAD) and its adverse clinical outcomes. Here in a separate, independent, contemporary cohort of patients undergoing coronary angiography, we demonstrated the association between elevated fasting TMAO levels and quantitative atherosclerotic burden (as measured by SYNTAX and SYNTAX II scores) in stable cardiac patients and is an independent predictor for the presence of diffuse (but not focal) lesion characteristics.

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Decipher Genomic Testing Moves Prostate Cancer Prognosis into Precision Medicine Era

MedicalResearch.com Interview with:

Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic

Dr. Eric Klein

Eric A. Klein, MD
Chairman, Glickman Urological and Kidney Institute
Cleveland Clinic

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Klein: Prostate cancer is an enigma. While this tumor is the second leading cause of cancer death among American men, most newly diagnosed disease detected by PSA screening is biologically indolent and does not require immediate therapy. Currently, the main clinical challenge in these men is to distinguish between those who can be managed by active surveillance from those who require curative intervention. Current clinical and pathological tools used for risk stratification are limited in accuracy for distinguishing between these scenarios.

An abundance of research in the last decade has provided evidence that genomics can offer meaningful and clinically actionable biological information to help inform decision making, and current National Comprehensive Cancer Network (NCCN) guidelines on prostate cancer endorse the use of commercially available genomic tools for men considering active surveillance.[1] It has been previously shown that the 22-gene genomic classifier, Decipher, accurately predicts the likelihood of metastasis and prostate cancer specific mortality when measured on tissue from radical prostatectomy specimens.[2] In multiple validation studies, it performed with higher accuracy and discrimination compared to clinical risk factors alone.

The current study[3] is the first to examine whether the use of Decipher might aid decision making when measured on biopsy tissue at the time of diagnosis. Men with available needle biopsy samples were identified from a study cohort that previously had Decipher performed on their matched radical prostatectomy tissue. In this cohort of mixed low, intermediate and high risk men, Biopsy Decipher predicted the risk of metastasis 10 years post RP with high accuracy, outperforming NCCN clinical risk categorization, biopsy Gleason score and pre-operative PSA. Furthermore, this study showed that Decipher reclassified 46% of patients into lower or higher risk classification compared to NCCN classification alone. The study also showed that Biopsy Decipher can identify men that are at high risk for adverse pathology as defined by the presence of primary Gleason pattern 4 or greater.

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Immune Modulator Ozanimod Shows Promise in Multiple Sclerosis

MedicalResearch.com Interview with:

Dr Jeffrey A Cohen MD Neurological Institute Cleveland Clinic, Cleveland OH 44195, USA

Dr. Jeffrey Cohen

Dr Jeffrey A Cohen MD
Mellen Center, Neurological Institute
Cleveland Clinic, Cleveland
OH 44195, USA

Medical Research: What is the background for this study? What are the main findings?

Dr. Cohen: Fingolimod, a non-selective sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral medication approved to treat relapsing multiple sclerosis.  Though generally well tolerated, fingolimod’s first dose cardiac effects and other potential adverse effects complicate its use.  Ozanimod is a selective S1PR modulator with several other potentially advantageous pharmacologic properties.

The results of phase 2 RADIANCE trial were recently published.  In this trial, participants were randomized to placebo (n=88), ozanimod 0.5 mg (n=87), or ozanimod 1 mg (n=83) PO once daily for 24 weeks.  The mean cumulative number of gadolinium-enhancing lesions on monthly MRI scans at weeks 12-24, the primary endpoint, was reduced from 11.1 +/- 29.9 with placebo to 1.5 +/- 3.7 with ozanimod 0.5 mg and 1.5 +/- 3.4 with ozanimod 1 mg (both p<0.0001).  Other MRI endpoints supported the primary endpoint.  Ozanimod was well tolerated with good safety.  Importantly, the dose up-titration protocol effectively mitigated first dose cardiac effects.

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Very Early Preterm Births More Common In Black Mothers

More on Racial Disparities in Health Care on MedicalResearch.com

Emily A. DeFranco, D.O., M.S. Associate Professor Maternal-Fetal Medicine Center for Prevention of Preterm Birth, Perinatal Institute Cincinnati Children's Hospital Medical Center University of Cincinnati College of Medicine Department of Obstetrics and Gynecology Medical Sciences Building, Room 4553B Cincinnati, OH

Dr. Emily DeFranco

MedicalResearch.com Interview with:
Emily A. DeFranco, D.O., M.S
.
Associate Professor Maternal-Fetal Medicine
Center for Prevention of Preterm Birth, Perinatal Institute
Cincinnati Children’s Hospital Medical Center
University of Cincinnati College of Medicine
Department of Obstetrics and Gynecology
Medical Sciences Building, Room 4553B
Cincinnati, OH

Medical Research: What is the background for this study?

Dr. DeFranco: The Infant Mortality Rate in the state of Ohio is higher than many other states.  Additionally, there is a large disparity in the IMR with black infants impacted to a higher degree compared to white infants. For this reason, we are particularly interested in identifying factors that contribute to this disparity in order to identify potential areas where public health efforts can be focused.

We know that preterm birth is a major contributor to infant mortality, and that all babies born alive prior to 23 weeks of gestational age, i.e. “previable”, die after birth and contribute to the infant mortality rate.  In this study, we wanted to assess whether black women are more likely to have early preterm births at less than 23 weeks, and if so whether that may be part of the explanation of why black mothers are at higher risk of experiencing an infant mortality.

Medical Research: What are the main findings?

Dr. DeFranco: In this study, we found that black mothers were more likely to deliver than white mothers  at very early preterm gestational ages, less than 23 weeks.  We also found that the earlier the delivery, the larger the disparity with black mothers being at higher risk for the earliest deliveries compared to white mothers.  From this data, we estimated that in Ohio, 44% of all infant mortality in black mothers is caused by previable preterm birth, whereas only 28% of infant mortality in white mothers is attributed to the same cause.  We concluded that very early preterm birth in black mothers is a large contributor to the racial disparity observed in the infant mortality dilemma here in Ohio.

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Telemedicine Can Support Rapid Stroke Treatment in Ambulances

Ken Uchino, MD FAHA FANA Director, Vascular Neurology Fellowship Research Director, Cerebrovascular Center, Cleveland Clinic Associate Professor of Medicine (Neurology) Cleveland Clinic Lerner College of Medicine of CWRU Cleveland, OH 44195

Dr. Ken Uchino

MedicalResearch.com Interview with:
Ken Uchino, MD FAHA FANA

Director, Vascular Neurology Fellowship
Research Director, Cerebrovascular Center, Cleveland Clinic
Associate Professor of Medicine (Neurology)
Cleveland Clinic
Lerner College of Medicine of CWRU
Cleveland, OH 44195

Medical Research: What is the background for this study? What are the main findings?

Dr. Uchino: Treatment for acute ischemic stroke is time dependent. Multiple studies have reported strategies to improve time to treatment after arrival in the hospital. Mimicking pre-hospital thrombolysis of acute myocardial infarction pioneered 30 years ago, two groups in Germany have implemented pre-hospital ischemic stroke thrombolysis using mobile stroke unit (“stroke ambulance”) that includes CT scan and laboratory capabilities. These units have been demonstrated to provide stroke treatment earlier than bringing patients to the emergency departments.

Our report extends the concept mobile stroke unit further by using telemedicine for remote physician presence. The other mobile stroke units were designed to have at least one physician on board. This allows potential multiple or geographically distant units to be supported by stroke specialists.

The study demonstrates that after patient arrival in the ambulance, the time to evaluation (CT scanning and blood testing) and to thrombolytic treatment is as quick or better as patient arrival in emergency department door. We are reporting the overall time efficiency after emergency medical service notification (911 call) in a separate paper.

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Cancer Patients Should Be Screened For Heart Disease

Sadeer G Al-Kindi, MD Fellow, Harrington Heart and Vascular Institute Onco-Cardiology Program, Advanced Heart Failure and Transplant Center, Harrington Heart and Vascular Institute, University Hospitals Case Medical Center Cleveland, OH

Dr. Al-Kindi

MedicalResearch.com Interview with:
Sadeer G Al-Kindi, MD
Fellow, Harrington Heart and Vascular Institute
Onco-Cardiology Program, Advanced Heart Failure and Transplant Center, Harrington Heart and Vascular Institute,
University Hospitals Case Medical Center
Cleveland, OH

Medical Research: What is the background for this study?

Dr. Al-Kindi: Cardiovascular disease and cancer are the most common causes of death in the United States. They often have the same risk factors (for example, smoking, advancing age, obesity). Many cancers are treated with drugs that can have detrimental effect on the heart thus limiting their use. Some studies have suggested that cardiovascular diseases can worsen outcomes in patients with cancer. The emergence of onco-cardiology programs led to multidisciplinary care of patients with cancer and heart disease. Given this tight relationship between cancers and cardiovascular disease, we hypothesized that heart disease and its risk factors are very common in patients diagnosed with cancer.

Medical Research: What are the main findings?

Dr. Al-Kindi: Using a very large clinical database of 1/8th of the US population, we identified patients with most common cancers that are treated with cardiotoxic medications and identified the prevalence of cardiovascular diseases. Overall, prevalence was 33% for hematologic malignancies (leukemia and lymphoma), 43% for lung cancers, 17% for breast cancers, 26% for colon cancers, 35% for renal cancers, and 26% for head and neck cancers. Peripheral artery disease, coronary artery disease and cerebrovascular diseases were the most common, followed by heart failure, and carotid artery disease. Despite the high prevalence, only about a half of these patients were on the cardiovascular medicines and half were referred to cardiologists.

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Generic Multiple Sclerosis Drug Found Equivalent To Brand Medication

Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main CampusMedicalResearch.com Interview with:
Dr. Jeffrey Cohen MD
Director
Mellen Center for Multiple Sclerosis Treatment and Research
Director of the Experimental Therapeutics Program
Cleveland Clinic Main Campus

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Cohen: Medications are a major contributor to the high cost of Multiple Sclerosis (MS) care.  As medications go off patent, there is the opportunity to develop generic versions with lower cost.  This trial was conducted after extensive in vitro and animal studies supported the equivalence of a generic glatiramer acetate to the brand drug Copaxone. The trial showed that generic and brand glatiramer acetate have equivalent efficacy as measured by MRI and clinical endpoints, safety, and tolerability.

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ESRD Patients May Experience Cardiac Improvement After Transplant

W.H. Wilson Tang, MD, FACC Assistant Professor in Medicine, Cleveland Clinic Lerner College of Medicine Staff, Section of Heart Failure & Cardiac Transplant Medicine Assistant Program Director, General Clinical Research Center (GCRC) The Cleveland Clinic Cleveland, OHMedicalResearch.com Interview with:
W.H. Wilson Tang, MD, FACC 

Assistant Professor in Medicine,
Cleveland Clinic Lerner College of Medicine
Staff, Section of Heart Failure & Cardiac Transplant Medicine
Assistant Program Director, General Clinical Research Center
The Cleveland Clinic  Cleveland, OH

Medical Research: What is the background for this study? What are the main findings?

Dr. Tang: Cardiac function is a key determinant of outcomes after surgery, especially transplantation. End-stage renal disease (ESRD) poses a unique scenario, as the metabolic and uremic derangements that result from this condition lead to adverse cardiac remodeling, and kidney transplantation offers a potential for reverse remodeling. We studied patients who underwent kidney transplantation and found that echocardiogram following transplantation demonstrated consistent and significant improvement in cardiac structure and function. Post-transplant improvement in anemia was a vital factor that independently predicted such positive changes, whereas post-transplant changes in blood pressure, renal function at 12 months, and dialysis duration duration did not. Moreover, patients that demonstrated reverse remodeling had outcomes comparable to those with normal baseline cardiac function.

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Biomarker Identifies Kidney Injury In Heart Failure Patients

Dr. Wilson Tang MD Professor of Medicine Cleveland Clinic Lerner College of Medicine Case Western Reserve University Director of the Center for Clinical Genomics Cleveland ClinicMedicalResearch.com Interview with:
Dr. Wilson Tang MD
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Case Western Reserve University
Director of the Center for Clinical Genomics
Cleveland Clinic 

Medical Research: What is the background for this study? What are the main findings?

Dr. Tang: Renal impairment has long been associated with worse outcomes in acute heart failure. Administration of diuretic therapy often obscures accurate assessment of renal function by urine output.  Despite extensive literature suggesting the poor outcomes in those with a rise in creatinine following treatment, recent data has suggested that in the presence of effective diuresis, this phenomenon likely represents hemoconcentration and azotemia rather than acute kidney injury.  We observed that using a novel and sensitive biomarker that identified acute kidney injury, specific to tubular injury, we can identify those at higher risk of adverse outcomes in patents admitted for acute heart failure.   However, after adjusting for standard risk factors, the prognostic value was clearly attenuated.

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Herpes Zoster/Shingles Vaccine Not Found Cost Effective In Patients Under 60

Phuc Le, Ph.D., M.P.H. Center for Value-Based Care Research, Medicine Institute Cleveland, OHMedicalResearch.com Interview with:
Phuc Le, Ph.D., M.P.H.
Center for Value-Based Care Research, Medicine Institute
Cleveland, OH 

Medical Research: What is the background for this study? What are the main findings?

Dr. Phuc Le: The live attenuated herpes zoster vaccine is approved by the FDA for persons aged 50 years and above. However, the Advisory Committee on Immunization Practices recommends it for only persons aged 60 years and older. Therefore, we aimed to analyze the vaccine’s cost-effectiveness among persons aged 50-59 years to see if ACIP’s recommendation is reasonable. We found that the vaccine is not cost-effective among people at aged 50 years, having an incremental costs of $323,000 per QALY gained, which is 3 times more than a commonly accepted threshold ($100,000/QALY).

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New Drug Combination Studied To Treat Agitation in Alzheimer’s Disease

Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic Las Vegas, NV 89106MedicalResearch.com Interview with:
Jeffrey L. Cummings, M.D., Sc.D.
Director, Lou Ruvo Center for Brain Health
Camille and Larry Ruvo Chair for Brain Health
Cleveland Clinic  Las Vegas, NV 89106 

Medical Research: What is the background for this study? What are the main findings?

Dr. Cummings: Agitation is a common problem in Alzheimer’s disease (AD); approximately 70% of patients with AD will experience periods of agitation.  This difficult behavior challenges patients and caregivers, adversely affects quality of life, and may precipitate institutionalization.  There are not drugs approved for treatment of agitation in Alzheimer’s disease.

The study reported in JAMA showed that a drug based on a combination of dextromethorphan and quinidine (DM/Q) produced statistically significant and clinically meaningful reduction in agitation in Alzheimer’s disease patients.  The study met its primary outcome (decline in the Neuropsychiatric Inventory agitation scale in drug compared to placebo) and many of its secondary outcomes (e.g, decreases in caregiver stress).  The agent was safe and well tolerated.

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Routine Nuclear Stress Testing in Asymptomatic Atrial Fibrillation Has Low Yield

Wael A. Jaber, MD FACC, FAHA Professor of Medicine Cleveland Clinic Lerner College of Medicine Fuad Jubran Endowed Chair in Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Cleveland, OH

MedicalResearch.com Interview with:
Wael A. Jaber, MD FACC, FAHA
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Fuad Jubran Endowed Chair in Cardiovascular Medicine
Heart and Vascular Institute
Cleveland Clinic  Cleveland, OH

Medical Research: What is the background for this study? What are the main findings?

Prof. Jaber: Risk stratification of patients presenting with atrial fibrillation often includes a non-invasive evaluation for coronary artery disease. However, the yield of such testing in patients without angina or anginal-equivalent symptoms is uncertain. That is, how often do we find silent myocardial ischemia?

In our cohort of 1700 consecutive patients with atrial fibrillation, less than 5% had ischemia on nuclear stress testing, even though comorbidities were prevalent. Moreover, in patients with ischemia that had invasive coronary angiography, less than half had obstructive coronary artery disease.

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Elders Also Benefit When Young Adults Get Flu Vaccine

Dr. Glen Taksler, PhD Medicine Institute Cleveland Clinic Main CampusMedicalResearch.com Interview with:
Dr. Glen Taksler, PhD
Medicine Institute
Cleveland Clinic Main Campus

Medical Research: What is the background for this study? What are the main findings?

Dr. Taksler: Although young, healthy adults who develop influenza are usually able to recover, they may spread the flu to other people in the community who have a higher risk of hospitalization or other serious complications. These higher-risk people have a limited ability to protect themselves from influenza, because flu vaccines are less effective in the elderly and in people with weakened immune systems.

To better understand whether young, healthy adults could help the community-at-large by getting a flu vaccine, we looked at data on more than 3 million Medicare beneficiaries across 8 influenza seasons.

We found that the elderly had 21% lower odds of developing influenza if they lived in areas where more nonelderly adults (people aged 18-64 years old) got a flu vaccine.

Importantly, we found these benefits even in elderly adults who obtained an influenza vaccine, perhaps because flu vaccines are less effective in the elderly.  This means that elderly adults who were proactive to try to prevent influenza still benefited from communitywide vaccination.

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Active Surveillance Utilization For Prostate Cancer Remains Low

Hui Zhu, MD, ScD Section Chief, Urology Section Louis Stokes Cleveland Veterans Affairs Medical Center and Staff, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation Cleveland, Ohio MedicalResearch.com Interview with:
Hui Zhu, MD, ScD
Section Chief, Urology Section
Louis Stokes Cleveland Veterans Affairs Medical Center
and Staff, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation
Cleveland, Ohio

MedicalResearch: Tell me a little bit about the impetus for this study. What gap in knowledge were you trying to fill? 

Dr. Zhu: Prostate cancer is a very challenging disease to understand and manage. For the minority of men, prostate cancer is a lethal disease, and in fact, it is the second leading cause of cancer death in American men, behind only lung cancer. However, for the majority of men, prostate cancer poses little risk of death. In fact, about 1 man in 7 will be diagnosed with prostate cancer during his lifetime, but only 1 man in 38 will die from prostate cancer.

In an effort to avoid suffering and death from prostate cancer for those men with the lethal form, the early detection of prostate cancer (before the disease has reached a stage when it is no longer curable) through widespread prostate cancer screening was instituted in the late 1980s and early 1990s. As a result, prostate cancer diagnosis increased substantially, and most prostate cancers were detected at an early, treatable stage. Screening successfully reduced the risk of death from prostate cancer by 20%.

Unfortunately, our best available screening tests, i.e. prostate-specific antigen (PSA) testing and the digital rectal exam, do not differentiate well between lethal and nonlethal prostate cancer. Consequently, screening is associated with a high risk of overdiagnosis of nonlethal prostate cancer. As a result, about 800 men must be screened and about 30 men must be diagnosed and treated to avoid one death from the prostate cancer, according to recent results from the largest prostate cancer screening trial.

Since the natural history of newly diagnosed screen-detected prostate cancer is difficult to predict (i.e. lethal or nonlethal), most prostate cancers have been treated aggressively, leading to overtreatment of many nonlethal cancers. Aside from receiving unnecessary treatment, these men are exposed to the potential side effects and complications of treatment, including erectile dysfunction and urinary incontinence.

In response to the harms associated with screening and treatment, the US Preventative Services Task Force issued a statement in 2011 (formalized in 2012) recommending against prostate cancer screening in all men. Unfortunately, while minimizing the risks of overdiagnosis and overtreatment for men with nonlethal prostate cancer, this solution eliminates any of the potential benefits of screening for those men with the lethal form of the disease.

As urologists, our solution is different. Rather than throw the baby out with the bathwater, we prefer to preserve PSA screening and its benefits by addressing and hopefully minimizing its associated risks. To achieve this, our goal is to better distinguish between those men who have lethal vs. nonlethal prostate cancer, limiting treatment only to those men who have the lethal form of the disease at an early stage when it is still curable. The dilemma is that our currently available diagnostic tests are unable to accurately differentiate lethal from nonlethal prostate cancer with 100% certainty at the time of initial diagnosis.

The solution, or at least part of the solution, is active surveillance. In men who appear to have nonlethal (“low risk”) cancer at the time of diagnosis, it now appears to be safe to observe these cancers, at least initially. This is the concept behind active surveillance. Active surveillance entails carefully monitoring men with low-risk prostate cancer using serial testing and reserving the option of treatment for those men with prostate cancers that exhibit lethal characteristics. In this way, active surveillance preserves the benefits of screening while minimizing the harms of overdiagnosis and overtreatment.

Active surveillance was first introduced in the early 2000s, but its efficacy and safety have only been elucidated recently over the last 5 years. Given that active surveillance may be one solution to the screening dilemma, we wanted to evaluate contemporary active surveillance utilization, which is the impetus for our study. Based on the most recent data available to us, we chose the years 2010-2011, which coincide to the time immediately before and during the release of the US Preventative Services Task Force statement against PSA screening.

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States With Stroke Legislation Have More Certified Stroke Centers

Dr. Ken Uchino, MD Cleveland Clinic Main Campus Cleveland, OH 44195MedicalResearch.com Interview with:
Dr. Ken Uchino, MD
Cleveland Clinic Main Campus
Cleveland, OH 44195

Medical Research: What is the background for this study? What are the main findings?

Dr. Uchino: Stroke center designation started in 2003 and more hospitals have been certified as primary stroke centers over time. We asked the question how many are certified now? What are the characteristics of the hospitals that are certified?

In 2013, nearly a third (23%) of acute short-term adult general hospitals with emergency departments were certified as stroke centers. 74% of the stroke centers were certified by the Joint Commission, a non-profit organization that certifies health care facilities and programs. 20% were certified by state health departments. States varied in percentages of hospitals that were certified, ranging from 4% in Wyoming to 100% in Delaware.

Not unexpectedly larger hospitals and hospitals in urban locations were more likely to be certified as stroke centers.

But a hospital being located in a state with so-called “stroke legislation” more than tripled the chance of being a certified stroke centers, even accounting for other factors. These states passed legislation to promote stroke centers and mandated stroke patients to be preferentially transported to qualified hospitals.

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TAVR Bests Standard Therapy For Sick, Elderly Patients With Severe AS

Prof Samir R Kapadia MD
Director, Sones Cardiac Catheterization Laboratories
Cleveland Clinic Cleveland, OH

For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).

In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.

According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.

“This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.

Superior survival benefit with TAVR

PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.

The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.

The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.

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Goserelin Protects Ovarian Function During Breast Cancer Chemotherapy

Halle C.F. Moore, M.D. Cleveland Clinic Foundation Taussig Cancer Institute Cleveland, OH 44195MedicalResearch.com Interview with:
Halle C.F. Moore, M.D.
Cleveland Clinic Foundation
Taussig Cancer Institute
Cleveland, OH 44195

Medical Research: What is the background for this study? What are the main findings?

Dr. Moore: Ovarian failure is a common long-term side effect of chemotherapy. Previous studies investigating whether suppressing ovarian function during chemotherapy treatment will preserve ovarian function following chemotherapy have had mixed results. Our study found that suppressing the ovaries with the GnRH analog goserelin during chemotherapy treatment for early stage ER-negative breast cancer resulted in a reduced risk of ovarian failure two years after initiation of treatment.

Also, more women who received the goserelin with chemotherapy became pregnant than women who received chemotherapy without goserelin.

In addition, there was an apparent improvement in survival among the goserelin group, confirming the safety of this approach in this patient population.
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Gut Bacteria Link Between Heart and Kidney Disease Strengthened

MedicalResearch.com Interview with: W. H .Wilson Tang, M.D., F.A.C.C., F.A.H.A. Professor in Medicine, Cleveland Clinic Lerner College of Medicine Cleveland Clinic, Cleveland, OH 44195MedicalResearch.com Interview with:
W. H .Wilson Tang, M.D., F.A.C.C., F.A.H.A.
Professor in Medicine, Cleveland Clinic Lerner College of Medicine
Cleveland Clinic, Cleveland, OH 44195.

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Tang: Our group has previously demonstrated that TMAO is linked to future cardiac risks in both humans and in animal models.  We now show that long-term exposure to higher levels of TMAO promotes renal functional impairment and fibrosis in animal studies.  We also show that in humans, as the kidneys lose function, TMAO isn’t eliminated as easily, and their blood levels further rise, thereby increasing cardiovascular and kidney disease risks further.  This newly discovered TMAO link offers further insight into the relationship between cardiovascular disease and chronic kidney disease.

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Tool Helps Chronic Kidney Disease Patients Make Dialysis Decisions

MedicalResearch.com Interview with:
Suma Prakash MD, MSc, FRCPC

Department of Medicine, Division of Nephrology
Case Western Reserve University
MetroHealth Medical Center Cleveland, Ohio

Medical Research: What is the background for this study? What are the main findings?

Dr. Prakash: Patients with advanced chronic kidney disease are often faced with difficult decisions of having to choose between options to replace their kidney function. Many patients may not be ready to make treatment decisions since most people don’t want to need a chronic medical treatment.

The behavioural stage of change model originally used to help people with smoking cessation has been used to help patients make decisions about self-care with diabetes and undergo cancer screening. It has not been studied in patients with chronic kidney disease. As patients progress through the stages, they are more ready to make decisions. Focusing on better understanding the decision making process from patients’ perspectives allows us as medical professionals to help patients make timely decision about their options.

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Gut Bacteria Linked To Heart Failure and Mortality Risk

Professor of Medicine, Cleveland Clinic Lerner College of Medicine at CWRU Director, Cardiomyopathy Program, Kaufman Center for Heart Failure Research Director, Section of Heart Failure and Cardiac Transplantation Medicine Heart and Vascular Institute, Cleveland Clinic Cleveland, OH 44195MedicalResearch.com Interview with:
W. H. Wilson Tang, MD FACC FAHA

Professor of Medicine,
Cleveland Clinic Lerner College of Medicine at CWRU
Director, Cardiomyopathy Program, Kaufman Center for Heart Failure
Research Director, Section of Heart Failure and Cardiac Transplantation Medicine
Heart and Vascular Institute, Cleveland Clinic Cleveland, OH 44195

Medical Research: What are the main findings of the study?

Dr. Tang: A chemical byproduct of gut bacteria-dependent digestion, TMAO (trimethylamine N-oxide), was previously shown to contribute to heart disease development. In this study, blood levels of TMAO for the first time are linked to heart failure development and mortality risk.
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Multiple Sclerosis: Generic Copaxone Demonstrates Equivalent Safety and Efficacy

Jeffrey Cohen MD Department of Neurology Cleveland ClinicMedicalResearch.com: Interview with:
Jeffrey A. Cohen, MD
Hazel Prior Hostetler Endowed Chair
Professor, Cleveland Clinic Lerner College of Medicine
Director, Mellen Center for MS Treatment and Research
Neurological Institute
Cleveland Clinic Cleveland, OH  44195

Medical Research: What are the main findings of the study?

Dr. Cohen: The primary objective of the GATE trial was to compare the efficacy and safety of generic glatiramer acetate to the approved form (Copaxone) in relapsing-remitting multiple sclerosis.  The study demonstrated equivalent efficacy of generic glatiramer acetate and Copaxone measured by gadolinium enhancing brain MRI lesions at months 7, 8, and 9 and a number of additional measures of MRI lesion activity.  The study also showed comparable safety (measured by adverse events) and injection site tolerability.

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Lung Cancer: Free Fatty Acids as Potential Biomarkers

Daniel I. Sessler, M.D. Michael Cudahy Professor and Chair, Department of Outcomes Research Cleveland Clinic, Cleveland,MedicalResearch.com Interview with:
Daniel I. Sessler, M.D.
Michael Cudahy Professor and Chair, Department of Outcomes Research
Cleveland Clinic, Cleveland, OH


MedicalResearch.com: What are the main findings of the study?

Dr. Sessler: Free fatty acids, arachidonic acid and linoleic acid, and their metabolites hydroxyeicosatetraenoic acids (5-HETE, 11-HETE, 12-HETE, and 15-HETE) were 1.8 to 5.7-fold greater in 37 patients with adenocarcinoma versus 111 patients without cancer (all P<0.001). Areas under the receiver operating characteristics (ROC) curve were significantly greater than 0.50 discriminating lung cancer patients and controls for all biomarkers and phospholipids, and ranged between 0.69 and 0.82 (all P<0.001) for lung cancer patients versus controls. Arachidonic acid, linoleic acid, and 15-HETE showed sensitivity and specificity >0.70 at the best cutpoint. Concentrations of free fatty acids and their metabolites were similar in 18 squamous-cell carcinoma patients and 54 non-cancer controls.

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Autism: Autistic Brains Create More Information at Rest

Roberto Fernández Galán, PhD Department of Neurosciences, School of Medicine Case Western Reserve University Cleveland, OH, USAMedicalResearch.com Interview with:
Roberto Fernández Galán, PhD
Department of Neurosciences, School of Medicine
Case Western Reserve University
Cleveland, OH, USA
MedicalResearch.com: What are the main findings of the study?

Dr. Galán: The main finding is that autistic brains create more information at rest than non-autistic brains. This is consistent with the classical view on autism as withdrawal into self. It is also consistent with a recent theory on autism, the “Intense World Theory”, which claims that autism results from hyper-functioning neural circuitry, leading to a state of excessive arousal. From both perspectives, the classical and the IWT, communication and social deficits associated with autism result from having a more intense inner life and a higher level of introspection.
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Dabigatran: Comparison Mini-Sentinel Clinical Trials and GI Bleeding

Ilke Sipahi, MD Department of Cardiology Acibadem University Medical School, Istanbul, Turkey Harrington Heart and Vascular Institute, University Hospitals Case Medical Cente  Case Western Reserve University School of Medicine, Cleveland, OhioMedicalResearch.com Interview with:
Ilke Sipahi, MD
Department of Cardiology
Acibadem University Medical School, Istanbul, Turkey
Harrington Heart and Vascular Institute, University Hospitals Case Medical Cente, Case Western Reserve University School of Medicine, Cleveland, Ohio

MedicalResearch.com: Were you surprised at the extreme difference between these 2 analyses?

Answer: I was surprised. However, it is not unusual to find completely
contradictory results in medical studies. I was more surprised at the
fact that FDA paid more attention to it administrative observational
dataset rather than the huge large randomized clinical trials, all
showing excess GI bleeds with dabigatran (Pradaxa). Anyone who is even
slightly familiar with the medical literature knows that randomized trials are the gold standard in medical studies.
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Lung Cancer: Breath Test Detection

Dr. Peter Mazzone MD, MPH Pulmonary, Allergy and Critical Care Medicine Cleveland Clinic Main Campus Cleveland, OH 44195MedicalResearch.com Interview with:
Dr. Peter Mazzone MD, MPH
Pulmonary, Allergy and Critical Care Medicine
Cleveland Clinic Main Campus
Cleveland, OH 44195

MedicalResearch.com: What are the main findings of this study?

Dr. Mazzone: There were 2 parts to this study:

In the first part we looked at how the breath collection instrument and sensor were performing and made adjustments to both in order to optimize its performance. In the second part we used the improved device and sensor to see if we could accurately separate a sensor signal of our patients with lung cancer from those without lung cancer. We found good separation of lung cancer from non-cancer breath signals, and very good separation of signals of one type of lung cancer from another.

We have concluded that a colorimetric sensor array based breath test is capable of separating those with lung cancer from those without.

We learned about ways that we can enhance the sensor and breath collection instrument, and showed enough promise that this can be an accurate test, that we plan to design a larger study with an improved system in hopes that this will be the final step towards having a clinically useful test.

Citation:

The Analysis of Volatile Organic Compound Profiles in the Breath as a Biomarker of Lung Cancer

Peter Mazzone, MD; Xiaofeng Wang, PhD; Paul Rhodes, PhD; Ray Martino, PhD; Sung Lim, PhD; Mary Beukeman; Meredith Seeley; Humberto Choi, MD; James Jett, MD

Chest. 2013;144(4_MeetingAbstracts):645A. doi:10.1378/chest.1703380

 

 
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URI: Safety and Effectiveness of an Oral CPC Spray

Pranab K. Mukherjee, Ph.D. Assistant Professor Center for Medical Mycology Department of Dermatology University Hospitals Case Medical Center Case Western Reserve University Cleveland, OH 44106-5028MedicalResearch.com Interview with:
Pranab K. Mukherjee, Ph.D.
Assistant Professor
Center for Medical Mycology
Department of Dermatology
University Hospitals Case Medical Center
Case Western Reserve University
Cleveland, OH 44106-5028

MedicalResearch.com: What are the main findings of the study?

Answer: We performed a randomized double-blinded placebo-controlled pilot clinical trial to assess the safety, tolerability and effectiveness of a cetylpyridinium chloride (CPC)-based oral spray in the prevention of acute upper respiratory tract infections (URIs).

  • The tested CPC spray (ARMS-I, developed by Arms Pharmaceutical LLC, Cleveland, OH) was safe and exhibited high tolerability and acceptability among study participants
  • The product exhibited a trend to protect against URIs (55% relative reduction compared to the placebo), based on confirmed URIs, post-medication exit interviews, and daily electronic diaries completed by study participants
  • There was statistically significant reduction in frequency of cough and sore throat in the active group
  • The number of days (duration) of cough was significantly reduced in the active group compared to placebo arm
  • URI-associated viruses (influenza, rhinovirus and coronavirus) were detected in three individuals, all in the placebo arm. No virus was detected in the active arm/
  • No drug-related adverse events or oral lesions were observed
  • Previous vaccination status of the study participants did not affect the study outcome.

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Nerve Block after Surgery Reduced Narcotic Usage, Shortened Hospital Stays

MedicalResearch.com Interview with:

Conor P. Delaney, MD MCh PhD FRCSI FACS FASCRS

The Jeffrey L. Ponsky Professor of Surgical Education | Chief, Division of Colorectal Surgery | Vice-Chair, Department of Surgery | Director, CWRU Center for Skills and Simulation | Surgical Director, Digestive Health Institute | University Hospitals Case Medical Center | Case Western Reserve University | 11100 Euclid Avenue Cleveland, OH 44106-5047

MedicalResearch.com: What are the main findings of the study?

Answer: Our goal was to see whether the transversus abdominis plane (TAP) block reduced complications and shortened the hospital stay of patients undergoing colorectal operations.  The TAP block is a nerve block injection given at the conclusion of the operation which reduces pain in the operative area.  Results showed that the mean hospital stay dropped to less than 2.5 days after the surgical procedure, significantly lower than the 3.7 days which the University Hospitals Case Medical Center Care pathway had already described for more than 1,000 consecutive patients. In our new study, we employed the TAP block and the Enhanced Recovery Pathway (ERP) on 100 patients.  We found that 27 patients went home the next day and another 35 went home 48 hours after their operations. That is considerably better than the five or six days patients usually stay in the hospital after laparoscopic colorectal procedures, and certainly better than nine days often seen after an open operation.  With a third of patients leaving the day after colorectal resection, we feel these results are significant.
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Aortic Dissection Repair: Does the Lunar Cycle Affect Outcomes?

MedicalResearch.com Interview with Dr. Frank Sellke, MD

Chief of cardiothoracic surgery and co-director of the Cardiovascular Institute at Rhode Island, The Miriam and Newport hospitals

MedicalResearch.com: What are the main findings of the study?

Dr. Sellke: The main findings of the study are that outcomes of repair of an ascending aortic dissection are improved under a full moon compared to other phases of the moon. This was with regard to both mortality and length of hospital stay. Interestingly, there was no correlation with season of the year.
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Analyzing excess mortality from cancer among individuals with mental illness

MedicalResearch.com: eInterview with Siran M. Koroukian, Ph.D.
Population Health and Outcomes Research Core,
Clinical & Translational Science Collaborative
Associate Professor Department of Epidemiology and Biostatistics
School of Medicine Case Western Reserve University
Cleveland, OH 44106-7281

MedicalResearch.com: What are the main findings of the study?

Dr. Koroukian: Among individuals who died of cancer, those with mental illness (MI) died an average of 10 years earlier than those without MI.

Overall, there was excess mortality from cancer associated with having mental illness in all the race/sex strata: SMR, 2.16 (95% CI, 1.85-2.50) for black men; 2.63 (2.31-2.98) for black women; 3.89 (3.61-4.19) for nonblack men; and 3.34 (3.13-3.57) for nonblack women.

We note statistically significant higher SMRs for every anatomic cancer site in nonblack men and women and for most cancer sites in black men and women.
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Study shows increased prostate cancer risk from vitamin E supplements

Men who took 400 international units (I.U.) of vitamin E daily had more prostate cancers compared to men who took a placebo, according to an updated review of data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT). The findings showed that, per 1,000 men, there were 76 prostate cancers in men who took only vitamin E supplements, vs. 65 in men on placebo over a seven-year period, or 11 more cases of prostate cancer per 1,000 men. This represents a 17 percent increase in prostate cancers relative to those who took a placebo. This difference was statistically significant and therefore is not likely due to chance. The results of this update appeared Oct. 12, 2011, in the Journal of the American Medical Association.

SWOG, an international network of research institutions, carried out SELECT at more than 400 clinical sites in the United States, Puerto Rico, and Canada. SELECT was funded by the National Cancer Institute (NCI) and other institutes that comprise the National Institutes of Health.

“Based on these results and the results of large cardiovascular studies using vitamin E, there is no reason for men in the general population to take the dose of vitamin E used in SELECT as the supplements have shown no benefit and some very real risks,” said Eric Klein, M.D., a study co-chair for SELECT, and a physician at the Cleveland Clinic. “For now, men who were part of SELECT should continue to see their primary care physician or urologist and bring these results to their attention for further consideration.”

The SELECT study began in 2001 and included over 35,000 men. It was started because earlier research had suggested that selenium or vitamin E might reduce the risk of developing prostate cancer. However, based on an independent safety monitoring review in autumn 2008, participants were told to stop taking their study supplements because it had become clear that the trial would never produce the 25 percent reduction in prostate cancer the study was designed to show with the use of these supplements. In 2010, the study sites were closed and over half of the participants consented to have their health monitored via mail questionnaires. Now, because of this latest finding, researchers are encouraging all participants to consider taking part in long-term study follow-up so investigators can continue to track outcomes.

SELECT was undertaken to substantiate earlier, separate findings from studies in which prostate cancer risk was not the primary outcome. A 1998 study of male smokers in Finland who took 50 I.U. of vitamin E daily to prevent lung cancer, showed 32 percent fewer prostate cancers in men who took the supplement. A 1996 study of men and women with a history of skin cancer who took selenium for prevention of disease recurrence showed that men who took the supplement had 52 percent fewer prostate cancers than men who did not take the supplement.

Based on these and other findings, men were recruited to participate in SELECT. They were randomly assigned to take one of four sets of supplements or placebos, with more than 8,000 men in each group. One group took both selenium and vitamin E; one took selenium and a placebo that looked similar to vitamin E; one took vitamin E and a placebo that looked similar to selenium; and the final group received placebos of both supplements. Men who took selenium alone or vitamin E and selenium together were also more likely to develop prostate cancer than men who took a placebo, but those increases were small and possibly due to chance.

“SELECT has definitively shown a lack of benefit from vitamin E and selenium supplements in the prevention of prostate cancer and has shown there is the potential for harm,” said Lori Minasian, M.D., study co-author and acting director of NCI’s Division of Cancer Prevention. “Nevertheless, this type of research has been critically important to understanding the potential benefits and risks from supplements.”

SELECT researchers are now measuring the amount of vitamin E, selenium, and other nutrients in the blood of participants when they joined the trial, to see if the effect of the supplements depended upon this baseline level of micronutrient. Other researchers are looking at single nucleotide polymorphisms, which are DNA changes known as SNPs, to see if a change in one or more genes could affect cancer risk or perhaps increase a man’s risk of developing prostate cancer while taking vitamin E.

The participant samples come from the study biorepository of blood and toe nail clippings which, when coupled with the extensive clinical information on participants, is a vital resource for further study. “SWOG is soliciting proposals from researchers nationwide to use the SELECT biorepository to help answer the biological question of why vitamin E increased risk instead of decreasing it,” said Laurence Baker, D.O., study co-author and chairman of SWOG. “There are many more questions raised by these study results than we have answers for, and thus the need for further investigation.”

Except for skin cancer, prostate cancer is the most common type of cancer in men in the United States. The current lifetime risk of prostate cancer for American men is 16 percent. In 2011, there will be an estimated 240,890 new cases of prostate cancer and 33,720 deaths from this disease in the United States.

Reference: EA Klein, IM Thompson, CM Tangen, JJ Crowley, MS Lucia, PJ Goodman, L Minasian, LG Ford, HL Parnes, JM Gaziano, DD Karp, MM Lieber, PJ Walther, L Klotz, JK Parsons, JL Chin, A Darke, SM Lippman, GE Goodman, FL Meyskens, and LH Baker. Vitamin E and the Risk of Prostate Cancer: Results of The Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. October 12, 2011. 306(14) 1549-1556.

Tyk2 protein potential new Breast Cancer Therapy Target

New Rochelle, NY, October 5, 2011 — A possible new target for breast cancer therapy comes from the discovery that the Tyk2 protein helps suppress the growth and metastasis of breast tumors, as reported in Journal of Interferon & Cytokine Research, a peer-reviewed journal published by Mary Ann Liebert, Inc.

Qifang Zhang and Andrew Larner, Virginia Commonwealth University (Richmond, VA), and colleagues from VCU, Temple University School of Medicine (Philadelphia, PA), Jagiellonian University (Krakow, Poland), and Miyazaki University (Japan), present data demonstrating that mice lacking Tyk2 tyrosine kinase that are injected with breast cancer cells exhibit enhanced breast tumor growth and metastasis compared to mice with normal Tyk2 protein expression.

The authors conclude that altered Tyk2 expression affects the ability of the animals’ immune systems to respond to the tumor challenge. They present the evidence in the article entitled, “The Role of Tyk2 in Regulation of Breast Cancer Growth,” and they describe the role of Tyk2 in immunity-related biochemical signaling pathways.

“This study suggests that boosting Tyk2 activity may be beneficial for arresting breast tumor growth,” says Ganes C. Sen, PhD, Chairman, Department of Molecular Genetics, Cleveland Clinic Foundation and Co-Editor-in-Chief of Journal of Interferon & Cytokine Research.