MedicalResearch.com Interview with:
Jerry Spivak, M.D
Professor of Medicine and Oncology
Director, Center for the Chronic Myeloproliferative Disorders
John Hopkins Medicine
Medical Research: What are the main findings of the study?
Dr. Spivak: The main findings of this study are that polycythemia vera occurs in two clinical forms: an indolent form in which only phlebotomy may be necessary and a more aggressive form requiring myelosuppressive therapy and that these two forms of the disease can be distinguished genetically.
MedicalResearch.com Interview with:
John DeVincenzo, M.D.
Professor of Pediatrics
Division of Infectious Diseases
Professor of Microbiology, Immunology and Biochemistry
University of Tennessee School of Medicine.
Le Bonheur Children's Hospital Memphis, Tennessee
Medical Research: What are the main findings of the study?
Dr. DeVincenzo: The main findings are
MedicalResearch.com Interview with:
David P. Greenberg, M.D.
Vice President, Scientific & Medical Affairs, and Chief Medical Officer
Sanofi Pasteur US.
Medical Research: What are the main findings of the study?
Dr. Greenberg: The New England Journal of Medicine published positive results from a randomized, double-blind, large-scale, multi-center efficacy trial, which found that Fluzone® High-Dose (Influenza Vaccine) was more efficacious in preventing influenza illness (“the flu”) in adults 65 years of age and older compared to standard-dose Fluzone vaccine. Fluzone High-Dose vaccine was found to be 24.2 percent (95% CI, 9.7 to 36.5) more effective in preventing influenza relative to standard-dose Fluzone vaccine for the primary endpoint (laboratory-confirmed influenza associated with typical clinical symptoms occurring at least 14 days post-vaccination caused by any viral type or subtype). In other words, investigators determined that participants in the Fluzone High-Dose vaccine group were less likely to get the flu than those in the standard-dose Fluzone vaccine group. The study safety data were consistent with previous Fluzone High-Dose vaccine studies.
MedicalResearch.com Interview with:
Claudio Soto, PhD
Professor of Neurology
Director Mitchell Center for Alzheimer's disease and related Brain Disorders
University of Texas Medical School at Houston
Medical Research: What are the main findings of the study?
Dr. Soto: In this study we describe for the first time the highly sensitive detection of prions in human urine, specifically in samples from patients affected by the variant form of Creutzfeldt-Jakob disease (vCJD), which is the disease produced by infection with prions associated with bovine spongiform encephalopathy, also known as mad cow disease. For detection we used the protein misfolding cyclic amplification (PMCA) technique which amplifies the amount of abnormal prion protein in a cyclical manner conceptually analogous to the polymerize chain reaction. We detected prions in 13 of the 14 vCJD cases analyzed, and the only negative was a sample coming from a patient under treatment with a experimental drug injected directly into the brain. No false positive were observed in the more than 200 cases analyzed. The concentration of abnormal prion protein in urine was estimated at 1x10^-16 g/ml, or 3x10^-21 moles/ml, which extrapolates to ~40-100 particles per ml of urine.
MedicalResearch.com Interview with:
Dr Marc Tischkowitz MD PhD
University Lecturer (Associate Professor) and
Honorary Consultant Physician in Medical Genetics
Department of Medical Genetics, University of Cambridge
Medical Research: What are the main findings of the study?
Dr. Tischkowitz: The PALB2 gene was first identified in 2006 and linked to breast cancer in 2007 but until now we have not had good breast cancer risk estimates for women who have inherited PALB2 mutations. This study was started in 2009 by an group of research institutions (The PALB2 Interest Group) in Canada, US, Europe (UK, Belgium, Greece, Italy, Finland) and Australia. We studied 362 individuals with PALB2 mutations from 154 families. We found that awomen with a PALB2 mutation will on average have a 35% risk of developing breast cancer by the age of 70, rising to 58% if there is a strong family history. Our study will help clinicians to better advise and manage such women.
There are several new aspects.
MedicalResearch.com Interview with:
Tomasz M. Beer, M.D. FACP
OHSU Knight Cancer Institute
Oregon Health and Science University
OR 97239
Medical Research: What are the main findings of the study?
Dr. Beer: In the study, we found that compared to placebo, enzalutamide improves overall survival, progression-free survival, quality of life, and delays the need for chemotherapy. Enzalutamide is superior to placebo with respect to all planned endpoints, across all subsets of the patient population in the study. Enzalutamide treatment is associated with an excellent safety profile.
MedicalResearch.com Interview with:
Professor Jane Armitage
Professor of Clinical Trials and Epidemiology
Clinical Trial Service Unit, Oxford Cardiovascular Science
Oxford, United Kingdom
Medical Research: What are the main findings of the study?
Prof. Armitage: The study showed that adding extended release niacin with laropiprant (to reduce the flushing) to standard treatment including statins in people with heart disease or strokes did not improve their outcome or reduce the risk of recurrent heart attacks or strokes.
MedicalResearch.com Interview with:
Paul Kimmel, M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health
Professor Division of Renal Diseases and Hypertension
The George Washington University
Medical Research: What are the main findings of the review?
Dr. Kimmel: AKI (Acute Kidney Injury) and CKD (Chronic Kidney Disease), two syndromes approached separately in medical school curricula as well as in the clinical arena are inextricably intertwined. They should be taught as a combined entity, culminating in progressive loss of renal function necessitating renal replacement therapy (dialysis or transplantation).
The two syndromes increase risk for cardiovascular disease and diminished quality of life as well. Preventive and therapeutic strategies should be directed at the combined entity.
MedicalResearch.com Interview with:
Dr. Olivia Pagani
Clinical Director of the Breast Unit of Southern Switzerland
Ospedale San Giovanni, Switzerland
Medical Research: What are the main findings of the study?
Dr. Pagani: The study showed that the aromatase inhibitor Exemestane is superior to Tamoxifen (both given together with ovarian function suppression) in preventing breast cancer recurrence in premenopausal women with oestrogen receptor positive early breast cancer.
MedicalResearch.com Interview with:
Dr. Daniel Agardh M.D., Ph.D
Department of Pediatrics
Diabetes and Celiac Disease Unit
Skåne University Hospital
Malmo, Sweden,
MedicalResearch: What are the main findings of the study?
Dr. Agardh: In this study, we stratify the risk of celiac disease among children according to their HLA genotype and country of residence. We confirm that HLA-DQ2/2 genotype is the major risk factor for early celiac disease, but also show how the risk differs between the participating countries despite of sharing similar HLA risk. This points to the direction of an interaction between HLA and the environment that eventually lead to an autoimmune response in genetic susceptible children.
MedicalResearch.com Interview with
Bethanie Wilkinson, Ph.D.
Pfizer
445 Eastern Point Rd.
Groton, CT 06340
MedicalResearch: What are the main findings of the study?
Dr. Wilkinson: ORAL Start showed that XELJANZ (tofacitinib citrate) 5 and 10 mg twice daily (BID), taken by itself without methotrexate (MX), inhibited the progression of structural damage and reduced the signs and symptoms of rheumatoid arthritis (RA), and was statistically significantly superior to methotrexate on these measures at Month 6 (primary endpoint) and at all measured time points up to 24 months in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate. XELJANZ is not indicated in patients who had not previously received methotrexate.
MedicalResearch.com Interview Invitation
Dr. Krista Huybrechts MD PhD
Brigham & Women’s Hospital
Department of Medicine
Division of Pharmacoepidemiology & Pharmacoeconomics
Boston, MA 02120
MedicalResearch: What are the main findings of the study?
Dr. Huybrechts: In this cohort study including 949,504 pregnant women enrolled in Medicaid, we examined whether the use of selective serotonin reuptake inhibitors (SSRIs) and other antidepressants during the first trimester of pregnancy is associated with increased risks for congenital cardiac defects. In order to control for potential confounding by depression and associated factors, we restricted the cohort to women with a depression diagnosis and used propensity score adjustment to control for depression severity and other potential confounders. We found no substantial increased risk of cardiac malformations attributable to SSRIs. Relative risks for any cardiac defect were 1.25 (95%CI, 1.13-1.38) unadjusted, 1.12 (1.00-1.26) depression-restricted, and 1.06 (0.93-1.22) depression-restricted and fully-adjusted. We found no significant associations between the use of paroxetine and right ventricular outflow tract obstruction (1.07, 0.59-1.93), or the use of sertraline and ventricular septal defects (1.04, 0.76-1.41); two potential associations that had been of particular concern based on previous research findings.
MedicalResearch.com Interview with:
Julio A. Chirinos, MD, PhD
Assistant Professor of Medicine
Director, CTRC Cardiovascular Phenotyping Unit
Perelman School of Medicine, University of Pennsylvania
Director of Non-Invasive Imaging
Philadelphia VA Medical Center
MedicalResearch: What are the main findings of the study?
Dr. Chirinos: The main findings of the study is that, among patients with obesity and moderate to severe obstructive sleep apnea, obesity, rather than OSA, appears to be the primary cause of inflammation, insulin resistance and dyslipidemia. However, both obesity and obstructive sleep apnea appear to be causally related to hypertension. In this population, weight loss, but not CPAP, can be expected to reduce the burden of inflammation, insulin resistance and dyslipidemia. However, CPAP, among patients who comply with therapy, can be expected to provide a significant incremental benefit on blood pressure. The latter is an important potential benefit of CPAP and should not be disregarded.
MedicalResearch.com Interview with:
William D. Chey, MD, AGAF, FACG, FACP, RFF
Professor of Medicine
Director, GI Physiology Laboratory
Co-director, Michigan Bowel Control Program
University of Michigan Health System
MedicalResearch: What are the main findings of the study?
Dr. Chey: Opiate analgesics are the most commonly prescribed medications in the US. GI side effects are common in patients who opiates. Constipation is the most common and most bothersome GI side effect of opiates. Peripherally acting mu opioid antagonists have been shown to benefit a subset of patients with opiate induced constipation. In 2 large, randomized, placebo controlled phase III trials, the peripherally acting, mu-opioid antagonist naloxegol was found to improve constipation in patients taking opioid analgesics for noncancer pain. Response rates were significantly higher with 25 mg of naloxegol than with placebo (intention-to-treat population: study 04, 44.4% vs. 29.4%, P = 0.001; study 05, 39.7% vs. 29.3%, P = 0.02) in both studies. Benefits were seen with the lower 12.5 mg dose in one of the studies (intention-to-treat population, 40.8% vs. 29.4%, P = 0.02). An interesting aspect of this study was the a priori inclusion of patients who had tried and failed to respond to other laxatives prior to enrollment. Response rates in this population were similar to the overall population (patients with an inadequate response to laxatives: study 04, 48.7% vs. 28.8%, P = 0.002; study 05, 46.8% vs. 31.4%, P = 0.01). Pain scores and daily opioid dosing were similar among the three groups before and after treatment.
MedicalResearch.com Interview with:
Dr. Olivia Pagani
Institute of Oncology of Southern Switzerland
Ospedale San Giovanni, Switzerland
MedicalResearch: What are the main findings of the study?
Dr. Pagani: The studies show that also in premenopausal women (as already proven in postmenopausal women), aromatase inhibitors (AIs) (in this case Exemestane) given as adjuvant treatment are more effective than Tamoxifen in women with hormone receptor positive early breast cancer who are given concomitantly ovarian suppression to lower estrogen production. The 28% improvement in disease free survival is comparable to that seen in postmenopausal women. In particular, outcomes in women who did not receive chemotherapy (43% of the entire population, 29% of whom with node positive disease) were strikingly good (<97% were breast cancer free at 5 years).
MedicalResearch.com Interview with:
Jonathon D. Truwit, MD, MBA
Enterprise Chief Medical Officer
Sr. Administrative Dean
Froedtert-Medical College of Wisconsin
Milwaukee, WI 53226
MedicalResearch.com: What are the main findings of the study?
Dr. Truwit: Rosuvastatin did not reduce mortality, nor days free of the breathing machine, in patients with sepsis-associated acute respiratory distress syndrome (ARDS). One in four patients with ARDS die.
MedicalResearch Interview with:
Dr. Gerard J. Criner MD, FACP, FACCP
Professor, Medicine
Director, Medical Intensive Care Unit and Ventilator Rehabilitation Unit
Co-Director, Center for Inflammation, Translational and Clinical Lung Research, Temple University Hospital in Philadelphia, PA
MedicalResearch: What are the main findings of the study?
Dr. Criner: The STATCOPE Trial (Simvastatin in the Prevention of COPD Exacerbations) found that a statin drug commonly used to lower cholesterol is not effective in reducing the number and severity of flare ups from chronic obstructive pulmonary disease (COPD). The study rigorously tested the hypothesis that statin drugs may be beneficial to persons with COPD because of the drugs’ purported anti-inflammatory effect. However, researchers found that:
MedicalResearch.com Interview with:
Stefan Zeuzem, M.D.
Professor of Medicine, Chief Department of Medicine
JW Goethe University Hospital
Frankfurt Germany
MedicalResearch.com: What are the main findings of the study?
Dr. Zeuzem: Main finding is that also patients infected with HCV 3 can be cured with an IFN-free regimen. However, duration of therapy must be prolonged to 24 weeks.
MedicalResearch.com Interview with:
Sergio D. Rosenzweig, MD, PhD
Director, Primary Immunodeficiency Clinic (PID-C)
Head of the Infectious Diseases Susceptibility Unit at the Laboratory of Host Defenses, National Institutes of Allergy and Infectious Diseases National Institutes of Health
Bethesda, MD, 20892
MedicalResearch.com: What are the main findings of the study?
Dr. Rosenzweig: We diagnosed a disease called CDG-IIb in two siblings with severe development issues and very low levels of immunoglobulins, which include infection-fighting antibodies. These children were referred to the NIAID Primary Immunodeficiency Clinic through the NIH Undiagnosed Diseases Program. CDG-IIb is an extremely rare congenital disorder of glycosylation (CDG), with only one other case reported. The genetic defect of the disease disrupts glycosylation, the process for attaching and trimming sugars from proteins. Almost 50% of our proteins have sugars attached, and these are called glycoproteins. They include immunoglobulins and also some viral glycoproteins that are made when cells are infected by a virus. The spread of some viruses, including HIV and influenza, depend on viral glycoproteins in order to infect additional cells and form viral protective shields. We found that this type of virus was less able to replicate, infect other cells, or create adequate protective shields in CDG-IIb patient cells because of the glycosylation defect. In comparison, adenovirus, poliovirus, and vaccinia virus, which either do not rely on glycosylation or do not form protective glycoprotein shields, replicated normally when added to both CDG-IIb and healthy cells.
MedicalResearch.com Interview with:
Kris V. Kowdley, MD
Director of Research & Director of the Liver Center of Excellence
Digestive Disease Institute
Virginia Mason Medical Center
Seattle, WA 98111
MedicalResearch.com: What are the main findings of the study?
Dr. Kowdley: A fixed-dose combination of ledipasvir and sofosbuvir in chronic Hepatitis C (HCV) genotype 1 patients without cirrhosis for 8 weeks without ribavirin was equally effective as the same combination with ribavirin added and also a 12 week combination of ledipasvir-sofosbuvir (without ribavirin).
MedicalResearch.com Interview with:
Marc A. Pfeffer, M.D., Ph.D.
Dzau Professor of Medicine
Harvard Medical School
Cardiovascular Division
Brigham and Women's Hospital
MedicalResearch.com: What are the main findings of the study?
Dr. Pfeffer: We randomized 3445 patients with symptomatic heart failure and a left ventricular ejection fraction greater than or equal to 45% (heart failure with preserved ejection fraction or diastolic heart failure) to spironolactone or placebo and followed them for over 3 years. Our primary outcome the composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for management of heart failure was not significantly reduced in the group randomized to spironolactone. We did, however, observe that fewer patients in the spironolactone group were hospitalized for the management of heart failure following randomization. Spironolactone therapy was associated with higher incidence of hyperkalemia and rises in serum creatinine.
MedicalResearch.com Interview with:
Professor Harvey White
MB ChB DSc FRACP FACC FESC FAHA FHKCC (Hon) FCSANZ FRSNZ La'auli (matai); Prince Mahidol Laureate; John Neutze Scholar, Director of Coronary Care & Green Lane Cardiovascular Research Unit, Green Lane Cardiovascular Service
Auckland City Hospital NEW ZEALAND
MedicalResearch.com: What are the main findings of the study?
Prof. White: During follow-up (median 3.7 years), the composite primary end point (cardiovascular death, myocardial infarction or stroke) occurred in 9.7% of the 7,924 patients randomly assigned to darapladib and 10.4% of the 7,904 patients in the placebo group (HR 0.94, 95% CI 0.85-1.03 p=0.199).
In the first prespecified secondary endpoint of major coronary events (CHD death, MI or urgent revascularization) compared with placebo, darapladib reduced the rate (9.3% vs. 10.3%; HR=0.9; 95% CI, 0.82-1 p=0.045). Total coronary events (14.6% vs. 16.1%; HR = 0.91; 95% CI, 0.84-0.98,p=0.019). (CHD death, MI, any coronary revascularization, hospitalization for unstable angina) were also reduced. No major safety concerns arose during the trial.
MedicalResearch.com Interview with:
Evan A. Stein, M.D., Ph.D. FRCP(C), FCAP
Metabolic and Atherosclerosis Research Center
Cincinnati, OH 45225,
MedicalResearch.com: What are the main findings of the study?
Dr. Stein: The study which is the first 52 week randomized double blind trial of a PCSK9 to report results (all others have been 12 weeks) demonstrated that the excellent LDL-C reductions of 55-60% seen at 12 weeks are maintained through 52 weeks, with no fall off in patient compliance, tolerability of efficacy. It also demonstrated that with longer treatment no new or unexpected side effects.
The study also had a unique design in that prior to randomization to the PCSK9 inhibitor (evolocumab) or placebo patients had a run in period during which time they were assigned, based on NCEP-ATP III criteria, to appropriated background therapy which ranged from diet only, to atorvastatin 10 mg a day, to atorvatatin 80 mg a day or atorvastatin 80 mg a day plus ezetimibe - reflecting how these patients are treated in practice. Only then if their LDL-C was still above 75 mg/dL were they randomized into the treatment part of the study with the new drug. The study showed that irrespective of background therapy the reduction with evolocumab was consistent.
MedicalResearch.com Interview with:
Michael J. Pencina, PhD
Professor of Biostatistics and Bioinformatics
Director of Biostatistics
Duke Clinical Research Institute
Durham, NC 27710
MedicalResearch.com: What motivated your research?
Dr. Pencina: After the new guidelines were issued last November, we were intrigued by the change in treatment philosophy from that based on cholesterol levels (used by the “old guidelines” known as NCEP ATPIII) to one based on 10-year risk of cardiovascular disease (used by the new AHA-ACC guidelines). We were curious what the practical consequences of this shift would be.
Furthermore, the media quoted a lot of experts making educated guesses on the impact. We realized that this question can be answered much more precisely based on the NHANES data.
MedicalResearch.com Interview with:
Dr. Hong-Mei Xiao M.D.,Ph.D.
Cognition Section
Professor of Gynecology,Reproductive Medicine
The Institute of Reproduction and Stem Cell Engineering
Xiangya School of Medicine, Central South University
Vice director, Reproduction and Genetics Hospital of CITIC-Xiangya
China, Changsha