Author Interviews, Heart Disease, JAMA, University of Pittsburgh / 07.01.2015

Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261MedicalResearch.com Interview with: Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261 Medical Research: What is the background for this study? What are the main findings? Response: The approval of dabigatran was considered a major contribution to the therapeutic arsenal of anticoagulants since warfarin, whose therapeutic management is complicated, was the only oral anticoagulant approved before 2011. Clinicians therefore considered dabigatran a very promising drug; however, the safety warnings released by the regulatory agencies and the reports of bleeding published in 2011 raised concerns about the safety profile of dabigatran. By the time we initiated our study, the FDA had concluded that dabigatran was associated with similar rates of bleeding than warfarin. However, the results of this observational study were not adjusted by patient characteristics. We therefore compared the risks of bleeding with dabigatran and warfarin adjusting for patient characteristics and using propensity score methods to mitigate selection biases, which observational studies are sensitive to. We found that dabigatran was associated with a higher risk of major bleeding and gastrointestinal bleeding than warfarin. However, the risk of intracranial bleeding was lower with dabigatran. In addition, we found that the increased risk of bleeding with dabigatran was specially higher for African Americans and for patients with chronic kidney disease. (more…)
Author Interviews, Depression, Heart Disease / 05.01.2015

Nancy L. Sin, Ph.D. Postdoctoral Fellow Center for Healthy Aging & Department of Biobehavioral Health The Pennsylvania State University University Park, PA 16802MedicalResearch.com Interview with: Nancy L. Sin, Ph.D. Postdoctoral Fellow Center for Healthy Aging & Department of Biobehavioral Health The Pennsylvania State University University Park, PA 16802 Medical Research: What is the background for this study? What are the main findings? Dr. Sin: Older patients with coronary heart disease often experience declines in functional status, which is the ability to perform daily activities such as bathing, walking, and doing housework. The key factors that contribute to functional status among cardiac patients are not well-understood. Previous studies have found only weak or no associations between cardiovascular disease severity and functional status. Psychological factors—such as depression—are known to increase the risk of functional impairment, but this has not been studied long-term in patients with coronary heart disease. It is unclear the extent to which long-term functional status is determined by psychological factors versus cardiovascular disease severity. The purpose of our study was to compare the contributions of depressive symptoms with those of cardiovascular disease severity (specifically, left ventricular ejection fraction, exercise capacity, and angina frequency) for predicting subsequent functional decline in 960 older adults with stable coronary heart disease. Across a 5-year period, people who had more severe depressive symptoms were at greater risk of functional decline, independent of cardiovascular disease severity, demographics, health behaviors, cognitive function, and other factors.  Low exercise capacity was also strongly related to future functional decline, but ejection fraction and angina frequency were not. These findings underscore the importance of considering both mental and physical health in determining long-term functional status. (more…)
Annals Thoracic Surgery, Author Interviews, Heart Disease, Surgical Research, Yale / 02.01.2015

Karthik Murugiah MBBS Fellow in Cardiovascular Medicine Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510MedicalResearch.com Interview with: Karthik Murugiah MBBS Fellow in Cardiovascular Medicine Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510 Medical Research: What is the background for this study? What are the main findings? Response: Aortic valve disease is common among older people and frequently requires valve replacement. 1-year survival after open surgical aortic valve replacement is high (9 in 10 survive the year after surgery). Our study focuses on the experience of these survivors in terms of the need for hospitalization during the year after surgery. Among patients >65 years of age enrolled in Medicare who underwent surgical replacement of their aortic valve and survived at least one year, 3 in 5 were free from hospitalization during that year. Both, the rates of hospitalization and the average total number of days spent in the hospital in the year following surgery have been decreasing all through the last decade (1999 to 2010). (more…)
Author Interviews, Heart Disease / 30.12.2014

MedicalResearch.com Interview with: Yan Liang, MD, PHD on behalf of co-authors Emergency and Intensive Care Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China Medical Research: What is the background for this study? What are the main findings? Response: The background of this study is mainly derived from the results of CURRENT-OASIS7 which has shown a 7-day 150 mg maintenance dose (MD) clopidogrel could reduce cardiovascular events among subgroup patients undergoing percutaneous coronary intervention (PCI) compared with the 75 mg/day regimen. We conducted a meta-analysis based on 17 randomized controlled trials to determine whether prolonging the high MD clopidogrel (≥150 mg) treatment period to at least 4 weeks could reduce major adverse cardiac events (MACEs) in the PCI patients with and without high on-clopidogrel platelet reactivity (HPR). Our study concluded that the high  maintenance dose clopidogrel was associated with a significant reduction in the risk of MACEs in PCI patients without increasing the rate of “Major/Minor bleeding” or “Any bleeding” in comparison with standard 75mg MD clopidogrel, and the “HPR Patients” subgroup were also benefited from such high MD treatment. (more…)
Author Interviews, Heart Disease, Stroke / 28.12.2014

MedicalResearch.com Interview with: Torben Bjerregaard Larsen Associate professor, MD, PhD, FESC Aalborg University Hospital Department of Cardiology Aalborg Thrombosis Research Unit Denmark Medical Research: What is the background for this study? What are the main findings? Dr. Larsen: Heart failure is a major public health issue with an increasing prevalence. Heart failure is associated with an increased risk of stroke, also in patients without concomitant atrial fibrillation. However, recent prospective randomized controlled trials investigating the effect of antithrombotic therapy in heart failure patients in sinus rhythm revealed that the benefit of warfarin in reducing stroke was counterbalanced by an increased risk of bleeding. Whether subgroups within the heart failure population would benefit from antithrombotic therapy is currently unknown. Therefore, possible subgroups with a higher risk of stroke within the heart failure population must be identified. We investigated whether female sex was associated with a higher risk of stroke, since female sex has been associated with an increased stroke risk among patients with atrial fibrillation. In our study, we found an association between female sex and decreased stroke risk in heart failure patients in sinus rhythm which persisted after adjustment for concomitant cardiovascular risk factors. This association was attenuated with increasing age which could possibly be due to competing risks of death, since competing risk of death was substantial among males in the older age groups. (more…)
Author Interviews, Heart Disease, Nutrition, Salt-Sodium / 27.12.2014

Jordi Salas-Salvadó Professor of Nutrition Human Nutrition Unit Department of Biochemistry & Biotechnology IISPV School of Medicine. Rovira i Virgili University CIBERobn, Instituto Carlos IIIMedicalResearch.com Interview with: Jordi Salas-Salvadó Professor of Nutrition Human Nutrition Unit Department of Biochemistry & Biotechnology IISPV School of Medicine. Rovira i Virgili University CIBERobn, Instituto Carlos III Medical Research: What is the background for this study? What are the main findings? Response: Excess sodium intake is associated with high blood pressure, a major risk factor for cardiovascular disease (CVD). The 2010 Dietary Guidelines for Americans recommended a sodium intake below 2300 mg per day (equivalent to less than 1 teaspoon of salt per day) in the general population. However it is unknown whether decreasing sodium intake below 2300 mg/d has an effect on CVD or all-cause mortality. The recent Institute of Medicine (IOM) explicitly concluded that studies on health outcomes are inconsistent in quality and insufficient in quantity to determine that sodium intake below 2300 mg/d may increase or decrease the risk of heart disease, stroke or all cause of mortality. (more…)
Author Interviews, Heart Disease / 26.12.2014

Jiun-Ling Wang MD Associated professor at Medical school in I-Shou University infectious disease doctor at E-DA Hospital, Kaohsiung , TaiwanMedicalResearch.com Interview with: Jiun-Ling Wang MD Associated professor at Medical school in I-Shou University infectious disease doctor at E-DA Hospital, Kaohsiung , Taiwan Medical Research: What is the background for this study? What are the main findings? Dr. Wang: Some study showed increase cardiovascular death in azithromycin user. But there lacks of data in other antibiotics in the treatment for respiratory tract infections. So we used the Taiwan National Health Insurance Database to perform a nationwide, population-based study comparing the risks of ventricular arrhythmia and cardiovascular death among patients using these antibiotics. And we find azithromycin, and moxifloxacin were associated with higher risk of ventricular arrhythmia cardiovascular death than amoxicillin/clavunate. (more…)
Author Interviews, Heart Disease, Statins / 26.12.2014

Beth Taylor, PhD Director of Exercise Physiology Research Department of Preventive Cardiology Hartford Hospital Hartford, CT 06102MedicalResearch.com Interview with: Beth Taylor, PhD Director of Exercise Physiology Research Department of Preventive Cardiology Hartford Hospital Hartford, CT 06102 Medical Research: What is the background for this study? Dr. Taylor:  Statins reduce incidence of cardiac events, and thus are extremely effective drugs. However, they may cause muscle side effects such as pain, weakness and soreness (i.e., statin myalgia) in up to 10% of patients. One potential mechanism underlying statin myalgia may be the depletion of Coenzyme Q10, a mitochondrial transport element used in energy production, as statin therapy produces a 30-50% reduction in intramuscular Coenzyme Q10. Seven previous studies to date have produced conflicting results, yet CoQ10 supplementation is used by many patients and recommended by many clinicians despite the absence of definitive results. The purpose of the present study was to assess the effect of CoQ10 on muscle pain, muscle strength and aerobic performance in confirmed myalgics (i.e., patients who tested positive for  myalgia during a randomized, double-blinded cross-over trial of statin therapy vs. placebo to confirm myalgia prior to CoQ10 treatment). Medical Research: What are the main findings? Dr. Taylor:  The first main finding was that after our randomized double-blind cross-over run-in phase, only 35.8% of patients experienced myalgia on simvastatin and did not experience it on placebo, what we term true or confirmed statin myalgia, and 17.5% of patients had no symptoms on simvastatin or placebo which could have been because the dose we selected was too low.  However, 29.2% experienced pain on placebo but not on simvastatin and 17.5% experienced pain on both simvastatin and placebo during the confirmation phase. Secondly, we found that Coenzyme Q10 supplementation had no effect on the incidence and severity of myalgia, time to onset of pain, muscle strength, or aerobic performance.  Serum levels of CoQ10 went up, suggesting dosing worked, and LDL-C went down similarly in both groups, suggesting the statin was not compromised. Therefore we did not find an observable effect of CoQ10 on any muscle outcome. Finally, there were no reductions from baseline in muscle strength or aerobic performance when statins were combined with placebo in our verified statin myalgics. This is notable because while there have been observational reports of decreased muscle strength and aerobic performance in statin myalgics, there have been few rigorous assessments of muscle strength and aerobic performance with statins and myalgia. In our previous study, the The Effect of STatins On Skeletal Muscle Performance (STOMP) trial , we randomized healthy, statin-naïve patients to atorvastatin 80 mg daily or placebo for 6 months, confirming myalgia via a challenge-dechallenge protocol. In that study, we also found no significant differences in the two groups  in muscle and exercise performance, and thus the present results confirm those findings. (more…)
Author Interviews, Heart Disease, NYU / 26.12.2014

Dr. Glenn I. Fishman MD Professor; William Goldring Professor of Medicine Vice Chair Research Dept of Medicine Director of the Leon H. Charney Division of Cardiology NYU LangoneMedicalResearch.com Interview with: Dr. Glenn I. Fishman MD Professor; William Goldring Professor of Medicine Vice Chair Research Dept of Medicine Director of the Leon H. Charney Division of Cardiology NYU Langone Medical Research: What is the background for this study? What are the main findings? Dr. Fishman: Sudden cardiac arrest (SCA) due to life-threatening ventricular arrhythmias is one of the leading causes of death in the US. Conditions that predispose to SCA can be acquired, as in atherosclerotic coronary artery disease, or inherited in the form of mutated cardiac ion channels, i.e. ion channelopathies. Mutations in the SCN5A cardiac sodium channel gene have been linked to progressive cardiac conduction disorders as well as atrial and ventricular arrhythmias. Understanding the mechanistic basis for lethal arrhythmias in cardiac sodium channelopathy patients has been limited in part due to the lack of adequate model systems that replicate human physiology. To address this limitation, we have developed the first genetically modified porcine model of an inherited channelopathy. A mutation in the SCN5A gene first identified in a child with the arrhythmic condition Brugada syndrome was introduced into the pig genome. Mutant pig hearts displayed conduction abnormalities and ventricular fibrillation bearing striking resemblance to the human condition. (more…)
Heart Disease, Kidney Disease, Stem Cells / 20.12.2014

Madhav Swaminathan, MBBS, MD, FASE, FAHA Associate Professor with Tenure Clinical Director, Division of Cardiothoracic Anesthesiology & Critical Care Medicine Department of Anesthesiology Duke University Health System Durham, NC 27710MedicalResearch.com Interview with: Madhav Swaminathan, MBBS, MD, FASE, FAHA Associate Professor with Tenure Clinical Director, Division of Cardiothoracic Anesthesiology & Critical Care Medicine Department of Anesthesiology Duke University Health System Durham, NC 27710 Medical Research: What is the background for this study? What are the main findings? Dr. Swaminathan: The background is the need for salvage therapies for acute kidney injury (AKI,) which is a common complication in hospitalized patients. It is particularly a problem in the postoperative period after cardiac surgery. Preventive strategies have not worked well for decades. Hence the focus on strategies that target kidney recovery. Mesenchymal stem cells have been shown to be useful in enhancing kidney recovery in pre-clinical trials. We therefore hypothesized that administration of human Mesenchymal stem cells (AC607, Allocure Inc, Burlington, MA) to patients with established post-cardiac surgery AKI would result in a shorter time to kidney recovery. We conducted a phase 2, double blinded, placebo controlled, randomized clinical trial to test our hypothesis. Unfortunately we could not confirm the hypothesis and there were no significant differences in time to kidney recovery among patients that received AC607 versus placebo in 156 randomized cardiac surgery subjects. (more…)
Author Interviews, Heart Disease, JACC / 18.12.2014

MedicalResearch.com Interview with: Dexter Canoy, PhD Cancer Epidemiology Unit, Nuffield Department of Population Health University of Oxford, United Kingdom Medical Research: What is the background for this study? What are the main findings? Response: Over a million middle-aged women in the UK who took part in our study between 1996 and 2001 provided information regarding their health and lifestyle, including their reproductive history such as age when they had their first menstruation. We followed them for over 10 years and identified those who developed heart disease (and other vascular diseases) by obtaining information on hospitalizations and death records. Our study demonstrates that on average, women with menarche before age 13 or after this age have slightly increased risks of developing heart disease, stroke and hospital admissions associated with hypertension. The increased risks for these vascular diseases were highest in women with menarche at age 10 years or younger, or age 17 years or older. This U-shaped association was consistently found among lean, overweight and obese women, among never, past or current smokers, or among women in low, middle or high socioeconomic group. (more…)
Author Interviews, Cocaine, Heart Disease / 17.12.2014

MedicalResearch.com Interview with: Luis F. Callado M.D., Ph.D. Department of Pharmacology University of the Basque Country CIBERSAM Medical Research: What is the background for this study? What are the main findings? Dr. Callado: Cocaine is the most commonly used illicit stimulant drug in Europe. The use of cocaine has become a major issue for drug policy, with also important health implications, including potentially lethal cardiovascular complications. In this way, several case series have suggested a relationship between cocaine use and cardiovascular diseases in young adults. Furthermore, cocaine use has been also associated with sudden and unexpected death. Our results demonstrate that the recent use of cocaine is the main risk factor for sudden cardiovascular death in persons between 15 and 49 years old. Thus, persons that consumed cocaine recently presented a 4 times higher risk for sudden cardiovascular death than those who did not use cocaine. The morphological substrate of sudden cardiovascular death associated to cocaine use is a structural pathology not diagnosed in life. Usually, sudden death is the first manifestation of the disease. (more…)
Author Interviews, Heart Disease / 16.12.2014

Winnie Nelson PharmD, MS, MBA Director, Health Economics & Outcomes Research Janssen PharmaceuticalsMedicalResearch.com Interview with: Winnie Nelson PharmD, MS, MBA Director, Health Economics & Outcomes Research Janssen Pharmaceuticals Medical Research: What is the background for this study? What are the main findings? Dr. Nelson: Although warfarin has long served as the standard of care for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), research has shown nearly one-third of international normalized ratio (INR) levels among stabilized patients on warfarin are out-of-range. Data recently published in the International Journal of Clinical Pharmacy underscores the potential complications of out-of-range INRs, with the aim of informing patient care. The analysis of a U.S. Veterans Health Administration dataset showed out-of-range INRs were associated with a significantly increased risk of adverse clinical outcomes, including stroke and major bleeding. Of particular interest, the study also showed the magnitude of risk of thromboembolic events – such as ischemic stroke – was several folds higher in sub-therapeutic INR levels (i.e., INR <2) than risk of bleeding events when INR measures were >3. In another words, the research found more risks to patients when INRs were too low than when INRs were too high. (more…)
Author Interviews, Heart Disease, Mayo Clinic, Outcomes & Safety / 14.12.2014

Atsushi Sorita, MD, MPH Mayo Clinic, Division of Preventive Medicine Rochester, MN 55905.MedicalResearch.com Interview with: Atsushi Sorita, MD, MPH Mayo Clinic, Division of Preventive Medicine Rochester, MN 55905.   Medical Research: What is the background for this study? What are the main findings? Dr. Sorita: Prior studies have suggested that patients with heart attack who are admitted during off-hours (weekends, nights and holidays) have higher risk of death when compared with patients admitted during regular hours. In our study, we found that patients undergoing percutaneous coronary interventions for heart attack who were admitted during off-hours did not have higher mortality or readmission rates as compared with ones admitted during regular hours at a highly-integrated academic center in the United States. (more…)
Author Interviews, BMJ, Heart Disease, Nutrition, Sugar, Weight Research / 13.12.2014

Dr James J DiNicolantonio PharmD Ithaca, New YorkMedicalResearch.com Interview with: James J. DiNicolantonio, PharmD Associate Editor BMJ Open Heart Cardiovascular Research Scientist Saint Luke's Mid America Heart Institute Medical Research: What is the background for this study? What are the main findings? Dr. DiNicolantonio: Cardiovascular disease is the leading cause of premature mortality in the developed world, and hypertension is its most important risk factor. Controlling hypertension is a major focus of public health initiatives, and dietary approaches have historically focused on sodium. A reduction in the intake of added sugars, particularly fructose, and specifically in the quantities and context of industrially-manufactured consumables, would help not only curb hypertension rates, but would also help address broader problems related to cardiometabolic disease. (more…)
Author Interviews, Biomarkers, Heart Disease / 13.12.2014

MedicalResearch.com Interview with: Mette Bjerre, Associate Professor, PhD Medical Research Laboratory Aarhus University Hospital & Aarhus University Aarhus C Denmark Medical Research: What is the background for this study? What are the main findings? Dr.Bjerre: Recently, a connection between bone regulatory proteins and vascular biology has attracted attention, suggesting osteoprotegerin (OPG), a secreted glycoprotein that regulates bone resorption, as a possible mediator of vascular calcification. Indeed, we and others has shown that high levels of circulating OPG predicts long-term outcome in patients with cardiovascular disease (CVD). However, the mechanism remains poorly understood. In order to elucidate the role of OPG in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), our study aimed to evaluate the progression of OPG levels, in four consecutive blood-samples obtained pre-PCI, post-PCI, day 1 and day 2. OPG levels did indeed change during treatment. OPG levels peaked post-PCI and then decreased; mean concentrations (95% confidence interval) pre-PCI 2650ng/L (2315-3036ng/L), post-PCI 2778ng/L (2442-3363ng/L), day 1 2024ng/L (1775-2306ng/L) and day 2 1808ng/L (1551-2106), (repeated measures ANOVA, F=33.192, p<0.001). Additional, high OPG level is independently associated with impaired LVEF (LVEF < 40%). Adjustment for BMI and traditional cardiovascular risk factors (hypertension, hypercholesterolemia, diabetes and current smoking) did not significantly impact the association between OPG response and reduced LVEF. (more…)
Author Interviews, Heart Disease, Imperial College, JACC / 13.12.2014

MedicalResearch.com Interview with: Dr. Jane A. Mitchell National Heart and Lung Institute Imperial College, London, UK Medical Research: What is the background for this study? What are the main findings? Dr. Mitchell: Anti-inflammatory drugs (NSAIDs) work by inhibiting the enzyme COX-2. COX-2 selective anti-inflammatory drugs, like Vioxx, were introduced to reduce gastrointestinal side effects associated with these drugs. However, COX-2 inhibitors as well as most older NSAIDs are associated with increased risk of heart attacks although the precise mechanisms underlying these side effects are not completely understood. The main findings of this study are: 1) COX-2 is highly expressed in the kidney where its genetic deletion leads to changes in more than 1000 genes. 2) Analysis of these genes revealed changes in 2-3 specific genes that regulate levels of ADMA, an endogenous inhibitor of the nitric oxide released by vessels, that can be reversed by giving more of the substrate for NO, L-arginine. 3) Further studies showed that ADMA was indeed increased in the plasma of mice where COX-2 gene was knocked out or in normal mice given a COX-2 inhibitor. 4) In mice where COX-2 was knocked out the release of nitric oxide from vessels was reduced and this could be reversed by supply L-arginine. 5) ADMA was also increased in human volunteers taking a COX-2 inhibitor (more…)
Author Interviews, Heart Disease, Lipids, PLoS / 11.12.2014

MedicalResearch.com Interview with: Prof. Erik Ingelsson, MD, PhD, FAHA Professor of Molecular Epidemiology and Andrea Ganna PhD student Uppsala University Medical Research: What is the background for this study? What are the main findings? Response: Coronary heart disease (CHD) comprises a major cause of morbidity and mortality throughout the world. Measurement of metabolites, small molecules, in the blood could allow earlier diagnosis and inform about mechanisms leading to CHD. We examined the metabolic profiles (including thousands of metabolites) of blood samples from more than 3,600 individuals from Sweden that had been followed-up for up to 10 years, and found two lipid-related metabolites, lysophosphatidylcholine and sphingomyelin that reduced the risk of developing coronary heart disease and another lipid metabolite, monoglycerides, that was instead associated with increased risk. (more…)
Author Interviews, Heart Disease, Kidney Disease / 11.12.2014

Anders Nissen Bonde MBs Department of Cardiology Copenhagen University Hospital Gentofte, Gentofte, Denmark MedicalResearch.com Interview with: Anders Nissen Bonde MBs Department of Cardiology Copenhagen University Hospital Gentofte, Gentofte, Denmark Medical Research: What is the background for this study? What are the main findings? Response: Patients with severe chronic kidney disease have been excluded from randomized trials of antithrombotic therapy in atrial fibrillation.They represent a very fragile group as they are both at increased risk of stroke/thromboembolism and major bleedings, and previous observational studies have had conflicting conclusions regarding the safety and benefits of the treatment. A previous study from our department reported both increased risk of bleeding and reduced risk of stroke with warfarin. We wanted to assess the net clinical benefit of aspirin and warfarin in these patients, balancing stroke and major bleeding associated with the treatment. (more…)
Author Interviews, Heart Disease, JAMA, Johns Hopkins, Outcomes & Safety / 09.12.2014

Dr. Amit Navin Vora MD, MPH Third Year Cardiovascular Fellow John Hopkins UniversityMedicalResearch.com Interview with: Dr. Amit Navin Vora MD, MPH Third Year Cardiovascular Fellow John Hopkins University   Medical Research: What is the background for this study? What are the main findings? Response: Current guidelines recommend timely reperfusion in patients presenting with ST-elevation myocardial infarction, with primary PCI being the preferred method if delivered in an expedient fashion. Otherwise, guidelines recommend that eligible patients should be treated with fibrinolysis prior to transfer to a PCI capable hospital. In our study, we used Google Maps to estimate drive times between the initial presenting hospital and the PCI-capable hospital looked at the association between estimated drive time and reperfusion strategy (primary PCI or fibrinolysis) selection. We found that less than half of eligible patients with an estimated drive time of more than 30 minutes received primary PCI in time, and only half of patients with more than an hour’s drive received lytics before transfer. This suggests that neither primary PCI nor pre-transfer fibrinolytic therapy is being used optimally. Among eligible patients with a drive time of 30-120 minutes, we found no significant mortality difference but higher bleeding risk among patients receiving lytics prior to transfer; this increased bleeding risk was focused in patients that required rescue PCI. (more…)
Author Interviews, Diabetes, Heart Disease / 07.12.2014

Simin Liu, MD, ScD, Professor of Epidemiology School of Public Health, Professor of Medicine The Warren Alpert School of Medicine Director, Molecular Epidemiology and Nutrition Brown UniversityMedicalResearch.com Interview with: Simin Liu, MD, ScD, Professor of Epidemiology School of Public Health, Professor of Medicine The Warren Alpert School of Medicine Director, Molecular Epidemiology and Nutrition Brown University MedicalResearch: What is the background for this study? What are the main findings? Dr. Liu: Cardiovascular Disease (CVD) and type 2 diabetes (T2D) are highly heritable and share many risk factors and show ethnic-specific prevalence. Nevertheless, a comprehensive molecular-level understanding of these observations is lacking. We conducted a comprehensive assessment of whole genome assessment using network-based analysis in >15,000 women and identified eight molecular pathways share in both diseases as well as several “key driver” genes that appear to form the gene networks in which these pathways connect and interact. (more…)
Heart Disease / 04.12.2014

MedicalResearch.com Interview with: Dr. Joanne van Ryn, PhD Department of CardioMetabolic Disease Research Boehringer Ingelheim GmbH & Co., Germany MedicalResearch: What is the background for this study? What are the main findings? Response: Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific antidote to reverse the anticoagulant effect of dabigatran. Currently, there are no specific antidotes available for any of the newer oral anticoagulants, or NOACs, to complement the existing range of bleed management options during critical care situations. Idarucizumab is being developed to provide physicians with an additional therapeutic option they could consider should a patient require emergency intervention or if a patient experiences uncontrolled bleeding. Pre-clinical studies indicated idarucizumab binds specifically to and inhibits dabigatran. Phase I data with idarucizumab in healthy volunteers demonstrated the potential of idarucizumab to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation. In that placebo-controlled study, idarucizumab did not cause any clinically relevant side effects. This phase I sub-study in 35 healthy volunteers showed that idarucizumab restores dabigatran-induced inhibition of fibrin formation at a small wound site. Fibrin, the main component of a blood clot, was assessed by measuring levels of fibrinopeptide A (FPA), a substance that is released when fibrin is formed. Fibrin formation was assessed after a small scratch, similar to a paper cut, was made. Measurements were conducted at baseline, after administration of dabigatran, and after subsequent administration of idarucizumab or placebo. The results showed that dabigatran almost completely inhibited the production of FPA at the wound site, and that idarucizumab restored FPA production:
  • At baseline, before the volunteers took dabigatran, the average level of FPA was 3981 ng/mL.
  • On day three, 2.5 hours after the volunteers took dabigatran, the average level of FPA was 208 ng/mL, an approximate 95 percent decrease compared to baseline.
  • On day four, 2.5 hours after the volunteers took dabigatran and 30 minutes after they were infused with 1 g, 2 g or 4 g of idarucizumab, FPA levels were 24 percent, 45 percent and 95 percent, respectively, of the average baseline level.
The restored fibrin production at the wound site after idarucizumab dosing with 2g or 4g also correlated with reversal of the dabigatran-anticoagulation activity in circulating blood. (more…)
Heart Disease / 04.12.2014

dr_John-SeegerMedicalResearch.com Interview with: Dr. John Seeger, PharmD, DrPH Department of Medicine, Brigham and Women’s Hospital Dr. Seeger: What is the background for this study? What are the main findings? Response: This study is part of an ongoing research program initiated in 2013 to assess prescribing patterns and real-world safety and effectiveness of oral anticoagulants, including dabigatran, for the reduction of stroke risk. The study program is expected to run through the end of 2016. Boehringer Ingelheim and Brigham and Women’s Hospital are aiming to gather data from more than 100,000 U.S. NVAF patients. Using a sequential matched cohort design, the safety and effectiveness of dabigatran compared to warfarin among patients with non-valvular atrial fibrillation (NVAF) receiving these medications in routine care settings can be assessed periodically. The interim findings at this stage come from 38,378 non-valvular atrial fibrillation patients in two health insurance databases, MarketScan (31,058 patients) and UnitedHealth (7,320 patients). The primary analysis follows patients from start of therapy until a switch or discontinuation of the anticoagulant, an outcome event, or disenrollment. The average follow-up was five months for patients in the dabigatran group and four months for those taking warfarin. The primary outcomes measured in the analysis are stroke and major hemorrhage. Interim findings from the combined databases showed a 25 percent reduction in the rate of major hemorrhage (hazard ratio [HR] 0.75, 95 percent confidence interval [CI] 0.65-0.87, 354 vs. 395 events) and a 23 percent reduction in strokes (HR 0.77, CI 0.54-1.09, 62 vs 69 events) for dabigatran compared to warfarin among these patients with NVAF. The database-specific results indicate a reduction in the rate of major hemorrhage with dabigatran (MarketScan: HR 0.78, CI 0.67- 0.91; UnitedHealth: HR 0.56, CI 0.36-0.86). In the larger MarketScan database, dabigatran reduced the stroke rate by 36 percent (HR 0.64, CI 0.44-0.95), while in the smaller UnitedHealth database, stroke rates were not different between the two anticoagulants, as there were only 26 strokes in total which led to wide confidence intervals (HR=1.62, CI 0.72-3.66). (more…)
Author Interviews, General Medicine, Heart Disease, JAMA, Kidney Disease / 30.11.2014

Giovanni Landoni, M.D. Head of Research,Department of Anesthesiology and Intensive Care Associate Professor at Università Vita-Salute San Raffaele, MilanMedicalResearch.com Interview with: Giovanni Landoni, M.D. Head of Research,Department of Anesthesiology and Intensive Care Associate Professor at Università Vita-Salute San Raffaele, Milan Medical Research: What is the background for this study? Dr. Landoni: The prevention and treatment of acute kidney injury after cardiac surgery is a major therapeutic goal, but no effective agents have yet been identified. Meta-analyses suggested that fenoldopam might be effective. Medical Research: What are the main findings? Dr. Landoni: We found that in cardiac surgery patients with early acute kidney injury (defined as a ≥50% increase of serum creatinine from baseline or oliguria for ≥6 hours), fenoldopam had no impact on the need for renal replacement therapy or 30-day mortality, while increasing the rate of hypotension. (more…)
Heart Disease / 28.11.2014

Concetta Crivera MPH, Pharm.D Associate Director, Outcomes Research Ortho-McNeil Janssen Scientific Affairs, LLCMedicalResearch.com Interview with: Concetta Crivera MPH, Pharm.D Associate Director, Outcomes Research Ortho-McNeil Janssen Scientific Affairs, LLC   Medical Research: What is the background for this study? What are the main findings? Response: Findings from the study presented at the American Heart Association (AHA) 2014 Scientific Sessions showed once-daily XARELTO® (rivaroxaban) is associated with significantly fewer hospitalization days and outpatient visits compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). Corresponding hospitalization and outpatient healthcare costs were also significantly lower for XARELTO® compared to warfarin in NVAF patients, according to longitudinal, real-world findings from this observational study. (more…)
Author Interviews, Heart Disease / 28.11.2014

Dr. Roberta Williams MD Professor and Chair, Department of Pediatrics, Keck School of Medicine VP for Pediatrics and Academic Affairs, Childrens Hospital Los AngelesMedicalResearch.com Interview with: Dr. Roberta Williams MD Professor of Pediatrics Keck School of Medicine at the University of Southern California MedicalResearch.com: What is the background for this study? Dr. Williams: Although a large number of children with chronic disease are surviving into adulthood, the extent and type of health resource needs remains a mystery. Patients with congenital heart disease (CHD) require lifelong care, so it is important to understand present resource utilization both as a foundation for planning services and as a reference point to assess the changes that occur with presumed improved access to care due to health care reform. (more…)
Author Interviews, Heart Disease / 28.11.2014

MedicalResearch.com Interview with: Siobhan Brown, Ph.D. Biostatistician, ROC Clinical Trials Center University of Washington Medical Research: What is the background for this study? What are the main findings? Dr. Brown: There are several observational studies suggesting that patients with out-of-hospital cardiac arrest may be more likely to survive to hospital discharge when emergency medical service provides do not pause for ventilations while performing CPR (i.e., give continuous compressions); however, the American Heart Association recommends that rescuers pause after each 30 compression to give two ventilations (interrupted compressions). We designed and are conducting a randomized clinical trial comparing the two approaches to see which results in better survival. The trial is still ongoing, so watch for results in late 2015! (more…)
Author Interviews, Heart Disease, JAMA / 26.11.2014

Dr. Mary T. Hawn Center for Surgical, Medical Acute Care Research, and Transitions, Birmingham Veterans Affairs Medical Center University of Alabama at Birmingham, BirminghamMedicalResearch.com Interview with Dr. Mary T.  Hawn MD Center for Surgical, Medical Acute Care Research, and Transitions, Birmingham Veterans Affairs Medical Center University of Alabama at Birmingham, Birmingham Medical Research: What are the main findings? Dr. Hawn: The main findings of the study are that the recommendations made in the guidelines published by the American College of Cardiology / American Heart Association in 2007 were effective at reducing postoperative major adverse cardiac events following noncardiac surgery in patients with a cardiac stent.1  These guidelines recommended the delay of noncardiac surgeries in patients with a drug-eluting stent for 365 days if the surgery was not emergent or the delay of surgery for 4 to 6 weeks among patients with a bare metal stent.  In addition to a 26% reduction in postoperative major adverse cardiac events, we also found an increase in the time between drug-eluting stent placement and non-cardiac surgery consistent with the guideline recommendations. (more…)