SYNTAX Score Predicts Better Results With Bypass Surgery For Type II Diabetes

MedicalResearch.com Interview with:

Fumiaki Ikeno M.D. Program Director (U.S.) Japan Biodesign Stanford Biodesign Medical Director/Research Associate Experimental Interventional Laboratory Division of Cardiology Stanford University

Dr. Fumiaki Ikeno

Fumiaki Ikeno M.D.
Program Director (U.S.) Japan Biodesign
Stanford Biodesign
Medical Director/Research Associate
Experimental Interventional Laboratory
Division of Cardiology
Stanford University

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

Response: We sought to determine whether the extent of coronary disease in terms of the number of lesions and their complexity in Type 2 Diabetes patients could predict major cardiovascular events, and hypothesized that revascularization would have greater effectiveness relative to medical therapy among patients with more number of lesions and higher complexity in coronary artery disease.

Coronary bypass surgery, catheter-based treatment, and medical therapy all had similar cardiovascular outcomes among patients with less complexity of coronary artery disease who had type 2 diabetes mellitus, stable ischemic heart disease, and no prior coronary revascularization. Among patients with mid or high complexity coronary artery disease, coronary revascularization with bypass surgery significantly reduced the rate of major cardiovascular events during 5 years of follow-up.

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Novel Oral Iron Formulation Can Correct Anemia in Non-Dialysis CKD

MedicalResearch.com Interview with:

Dr. Glenn M. Chertow, MD Professor Medicine, Nephrology Stanford University School of Medicine

Dr. Glenn M. Chertow

Dr. Glenn M. Chertow, MD
Professor Medicine, Nephrology
Stanford University School of Medicine

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

Response: Iron deficiency is common in persons with moderate to advanced (non-dialysis-dependent) chronic kidney disease (CKD), for a variety of reasons. Conventional iron supplements tend to be poorly tolerated and of limited effectiveness. In earlier studies of patients treated with ferric citrate for its effect as a phosphate binder, we saw increases in transferrin saturation and ferritin (markers of iron stores) and hemoglobin and hematocrit (the “blood count”). Therefore, we thought we should test the safety and efficacy of ferric citrate specifically for the treatment of iron deficiency anemia (IDA).

With respect to the key findings, more than half (52%) of patients treated with ferric citrate experienced a sizeable (>=1 g/dL) increase in hemoglobin over the 16-week study period compared to fewer than one in five (19%) patients treated with placebo. Rates of adverse events (“side effects”) were similar to placebo; diarrhea in some patients and constipation in others were the most common. There were also favorable effects of ferric citrate on laboratory metrics of bone and mineral metabolism.

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Uterine Microbiome Plays Key Role in IVF Success

MedicalResearch.com Interview with:

Carlos Simón, M.D., Ph. D. Professor of Obstetrics & Gynecology. Valencia University, Spain Scientific Director, Igenomix SL. Adjunct Clinical Professor, Department of Ob/Gyn, Stanford University, CA Adjunct Professor, Department of Ob/Gyn, Baylor College of Medicine, TX

Dr. Carlos Simón

Carlos Simón, M.D., Ph. D.
Professor of Obstetrics & Gynecology. Valencia University, Spain
Scientific Director, Igenomix SL.
Adjunct Clinical Professor, Department of Ob/Gyn, Stanford University, CA
Adjunct Professor, Department of Ob/Gyn, Baylor College of Medicine, TX

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

Response: The main findings of this study reside in the concept that the uterine cavity, which has been classically considered as a sterile organ, possess its own microbiome and that the composition of this uterine microbiome have a functional impact on the reproductive outcome of IVF patients.

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High Intensity Statins Increase For High Risk Atherosclerotic Patients, But Lagging in Women and Minorities

MedicalResearch.com Interview with:

Fatima Rodriguez, MD, MPH Division of Cardiovascular Medicine and Cardiovascular Institute Stanford University Stanford, CA

Dr. Fatima Rodriguez

Fatima Rodriguez, MD, MPH
Division of Cardiovascular Medicine and Cardiovascular Institute
Stanford University
Stanford, CA

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

Response: The 2013 ACC/AHA cholesterol management guidelines emphasized that high-risk patients with atherosclerotic disease should be on high-intensity statins. We sought to determine how these guidelines are being adopted at the Veterans Affairs (VA) Health System and to identify treatment gaps.

Our main findings were that the use of high-intensity statins increased from 23 to 35% following the guideline release for these high-risk patients. However, high-intensity statin use was lowest in Hispanics and Native Americans. Women, older adults, and patients with peripheral arterial and cerebrovascular disease were also less likely to undergo statin intensification after the release of the guideline. We also noted geographic and institutional differences across VA hospitals in rates of high-intensity statin use for secondary prevention.

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Post-Op Radiotherapy Improved Survival In Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

MedicalResearch.com Interview with:

Michelle M. Chen, MD/MHS Department of Otolaryngology- Head and Neck Surgery Stanford University

Dr. Michelle Chen

Michelle M. Chen, MD/MHS
Department of Otolaryngology- Head and Neck Surgery
Stanford University 

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

Response: The benefit of post-operative radiotherapy (PORT) for patients with T1-T2 N1 oral cavity and oropharyngeal cancer without adverse pathologic features is unclear. Starting in 2014, the national guidelines no longer recommended consideration of post-operative radiotherapy for N1 oropharyngeal cancer patients, but left it as a consideration for N1 oral cavity cancer patients. We found that post-operative radiotherapy was associated with improved survival in both oral cavity and oropharyngeal cancers, particularly in patients younger than 70 years of age and those with T2 disease.

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Intensive Blood Pressure Management Found To Be Cost Effective

MedicalResearch.com Interview with:

Ilana B. Richman, MD Palo Alto VA Health Care System, Palo Alto, California Center for Primary Care and Outcomes Research/Center for Health Policy Department of Medicine Stanford University School of Medicine Stanford, California

Dr. Ilana B. Richman

Ilana B. Richman, MD
Palo Alto VA Health Care System, Palo Alto, California
Center for Primary Care and Outcomes Research/Center for Health Policy
Department of Medicine
Stanford University School of Medicine
Stanford, California

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

Response: In November of 2015, researchers published results from the Systolic Blood Pressure Intervention Trial (SPRINT). This large, NIH-funded study compared a systolic blood pressure target of 120 mm Hg vs 140 mm Hg among hypertensive, nondiabetic patients at elevated risk for cardiovascular disease. SPRINT reported a 25% reduction in the rate of cardiovascular disease and death among those treated to a lower target. Those treated to a lower target blood pressure, though, experienced certain adverse events more frequently.

Our cost effectiveness analysis asked two questions: given the potential risks and benefits described in SPRINT, does achieving a lower systolic blood pressure result in net benefit over the course of a lifetime? And if it does, how much would it cost, compared to standard treatment? We found that achieving a lower blood pressure target does result in a net benefit, with a gain of about 0.9 years of life (quality adjusted) among those treated to a lower target compared to those treated to a standard target. This gain, though, required some investment. We found that treating to a lower blood pressure target cost $23,777 per quality-adjusted life year gained. Compared to other commonly used interventions here in the US, this would be considered an excellent value.

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Do Dysplastic Nevi Need Re-excision?

MedicalResearch.com Interview with:

Susan M. Swetter, MD Professor of Dermatology Director, Pigmented Lesion & Melanoma Program Physician Leader, Cancer Care Program in Cutaneous Oncology Stanford University Medical Center and Cancer Institute

Dr. Susan Swetter

Susan M. Swetter, MD
Professor of Dermatology
Director, Pigmented Lesion & Melanoma Program
Physician Leader, Cancer Care Program in Cutaneous Oncology
Stanford University Medical Center and Cancer Institute

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

Response: Dysplastic nevi (DN) are frequently re-excised following initial biopsy due to concerns for malignant transformation; however, the long-term risk of melanoma developing in mildly or moderately dysplastic nevi with positive histologic margins is unknown. In this cohort study of 590 histologic DN that were followed over 20 years, 6 cases of melanoma (5 in situ) arose in the 304 DN with positive margins that were clinically observed, only 1 of which developed from an excisionally-biopsied dysplastic nevus. One melanoma in situ arose in the 170 cases that underwent complete excision at the outset. The risk of new primary melanoma at other sites of the body was over 9% in both groups.

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Sickle Cell Trait Not Associated With Increased Mortality in Military Population

MedicalResearch.com Interview with:
D. Alan Nelson, MPAS, PhD
Postdoctoral research fellow
Stanford Medicine

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

Response: The study was inspired by the uncertainty surrounding sickle cell trait (SCT) and its association with serious exertional collapse events and mortality in active populations. I conducted initial, exploratory analyses on these topics in 2014-15 while examining a range of military readiness predictors and outcomes. The early work indicated that the risk of mortality, rhabdomyolysis and other exertional events arising from SCT might be substantially lower than that suggested by prior work in the research literature.

Dr. Lianne Kurina and I decided to conduct further, focused study at the Stanford University School of Medicine to confirm or refute these findings. In considering best approaches, we noted that there was an absence of prior research in which the  sickle cell trait status of an entire, large, physically-active study population was known. This limitation could introduce bias to inflate the apparent impact of a theorized predictive factor.

Aside from the challenges in studying the impact of SCT on exertional outcomes, with respect to prevention, a further concern is that  sickle cell trait is a non-modifiable trait. If it were a serious risk factor for rhabdomyolysis and/or mortality, despite careful exertional injury precautions such as those employed by the Army, this might present great challenges for prevention efforts. To maximize the potential for new research to provide actionable prevention information, our interests included examining a range of modifiable risk factors for rhabdomyolysis.

Dr. Kurina and I have employed large, longitudinal military datasets for about five years to examine critical military health outcomes, making this study a natural progression of our joint work. The research proceeded with the support of the Uniformed Services University of the Health Sciences, and in cooperation with a distinguished group of experts who co-authored the paper and advised the project. The study was conducted using de-identified records of all SCT-tested African American US Army soldiers on active duty during 2011 – 2014 (N = 47,944).

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Pathway That May Grow New Blood Vessels After Heart Attack Discovered

MedicalResearch.com Interview with:

Mark Mercola, Ph.D. Professor, Development, Aging and Regeneration Program, Sanford-Burnham-Prebys Medical Discovery Institute Professor, Stanford Cardiovascular Institute and Stanford University School of Medicine La Jolla, California 92037

Dr. Mark Mercola

Mark Mercola, Ph.D.
Professor, Development, Aging and Regeneration Program, Sanford-Burnham-Prebys Medical Discovery Institute
La Jolla, California 92037
Professor, Stanford Cardiovascular Institute and Stanford University School of Medicine
Stanford, CA, 94305,

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

Response: Heart disease, especially after heart attack (myocardial infarction) is a major cause of death worldwide, accounting for over 13% of all human mortality. There is a major search for ways to treat the immediate cause or lessen the effect of a heart attack. One way researchers have considered is to boost the blood vessels that nourish the heart muscle. The heart muscle is nourished by many small blood vessels. We found a normal protein that acts as a high level regulator of blood vessel formation in the heart. This protein, known as RBPJ, suppresses the factors that make vessels grow. Therefore, we found that inhibiting this protein made more vessels, and consequently protected the hearts from the damage of a heart attack.

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Multikinase Inhibitor Midostaurin Improved Symptoms and Survival in Most Advanced Forms of Blood Cancer Mastocytosis

MedicalResearch.com Interview with:

Jason R. Gotlib, MD The Clinical Investigator Pathway Hematology Division at Stanford University Medical Cent

Dr. Jason R. Gotlib

Jason R. Gotlib, MD
The Clinical Investigator Pathway
Hematology Division
Stanford University Medical Center

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

Response: The background is that advanced forms of systemic mastocytosis, which are blood cancers characterized by accumulation of abnormal mast cells in the bone marrow and additional organs, represent a group of orphan diseases with a large unmet need. Approximately 90% of patients harbor the acquired KIT D816V mutation, a mutated receptor tyrosine kinase on the surface of mast cells which a primary driver of disease pathogenesis. Only 1 drug is approved for patients with one form of advanced systemic mastocytosis, termed ‘aggressive systemic mastocytosis, or ‘ASM’. This therapy is imatinib (Gleevec), but it is only approved for patients without the KIT D816V mutation, or with KIT mutation status unknown because the KIT D816V mutation is resistant to imatinib. Therefore, this drug may only be useful for approximately 10% of patients. Other drugs that have been used off-label for systemic mastocytosis (but are not approved for this indication) include interferon-alpha or cladribine, which show some activity, but their evaluation to date has been primarily limited to small case series which are usually retrospective in nature, and include mixed populations of systemic mastocytosis patients who have both early stage disease without organ damage (e.g. indolent systemic mastocytosis) and and advanced stage patients, as included in this trial, who have one or more findings of organ damage. Also, those trials employed differing response criteria and no central adjudication of eligibility and response assessments was undertaken.

Midostaurin is a multikinase inhibitor with activity against both wild-type KIT, but most importantly, KIT D816V (in contrast to imatinib). Prior work demonstrated that cell lines transformed with the KIT D816V mutation can be inhibited at relatively low concentrations of midostaurin. These concentrations could also be achieved in vivo (e.g. at concentrations achievable in the blood of patients). Cell lines transformed by KIT D816V could not be inhibited by imatinib.

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Monitoring Circulating Tumor Cells May Further Personalized Cancer Treatment

MedicalResearch.com Interview with:

Dr. Elodie Sollier
Chief Scientific Officer at Vortex Biosciences

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

Response: Circulating Tumor Cell (CTC) burden may be a useful biomarker of response to targeted therapy in PDX (Patient Derived Xenograft) mouse models. Vortex Biosciences’ technology has been proven to enrich CTCs from human blood, but use of the technology with mouse blood had not yet been explored. In this poster, human CTCs are isolated with both high efficiency and purity from xenograft model of breast cancer using Vortex’s technology. Circulating Tumor Cell enumeration increased as the tumor burden increased in the mouse demonstrating its utility as a biomarker for drug treatment response.

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Artificial Outdoor Nighttime Lights Really Do Keep People Up At Night

MedicalResearch.com Interview with:

Maurice M. Ohayon, MD, DSc, PhD Chief of the Division of Public Mental Health and Population Sciences Director of the Stanford Sleep Epidemiology Research Centre (SSERC) John-Arrillaga PI & Professor of Psychiatry and Behavioral Sciences School of Medicine, Stanford University Palo Alto, CA 94303

Dr. Maurice Ohayon

Maurice M. Ohayon, MD, DSc, PhD
Chief of the Division of Public Mental Health and Population Sciences
Director of the Stanford Sleep Epidemiology Research Centre (SSERC)
John-Arrillaga PI & Professor of Psychiatry and Behavioral Sciences
School of Medicine, Stanford University
Palo Alto, CA 94303 

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

Dr. Ohayon: Artificial Lights at night are known to be powerful disruptors of the normal sleep/wake cycle. Light exposure at night acts on suppressing and delaying melatonin secretion and exciting the central nervous system.

In this study we focused on the effects of the outdoor lights at night, (such as street lights and lights, outdoor light fixtures and advertising boards) as measured at nighttime by satellite observations.

We analyzed the sleep habits of a representative sample of the American general population that had been interviewed with the artificial intelligence system Sleep-EVAL.

We found that individuals living in areas at high level of radiance, such as can be found in the downtowns of metropolitan areas, have a delayed bedtime, delayed wake up time and, overall, shorter sleep duration, than people living in areas with low nighttime radiance.

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