Author Interviews, Flu - Influenza, NEJM, Vaccine Studies / 15.08.2014

David P. Greenberg, M.D. Vice President, Scientific & Medical Affairs, and Chief Medical Officer Sanofi Pasteur US.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. (more…)
Author Interviews, Infections, mBio, NEJM / 07.08.2014

Claudio Soto, PhD Professor of Neurology Director Mitchell Center for Alzheimer's disease and related Brain Disorders University of Texas Medical School at HoustonMedicalResearch.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. (more…)
Author Interviews, Breast Cancer, Genetic Research, NEJM / 07.08.2014

Dr Marc Tischkowitz MD PhD University Lecturer (Associate Professor) and Honorary Consultant Physician in Medical Genetics Department of Medical Genetics, University of CambridgeMedicalResearch.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.
  • It is by far the largest study to date and provides the most accurate risk estimates for PALB2 mutation carriers.
  • It shows that the breast cancer risk is modified by the family history. (more…)
Author Interviews, Hematology, NEJM, Sloan Kettering, Transplantation / 31.07.2014

MedicalResearch.com Interview with: Richard J. O'Reilly, MD Memorial Sloan Kettering Cancer Center Medical Research: What are the main findings of the study? Dr. O'Reilly: 1.       In a comparison of the results of HLA-matched sibling transplants with other established transplant approaches, including T-cell depleted half-matched parental marrow grafts, unmodified transplants from matched unrelated donors and cord blood transplants in the current era (2000-2009), transplants from donors other than HLA-matched siblings had 5 year survival outcomes similar to those of matched siblings when applied to young infants (≤ 3.5 months of age) or infants of any age that were not infected at the time of transplants. Thus any child born with SCID can now be successfully transplanted. 2.       Active infection at the time of transplant significantly reduced chances of long-term survival for all infants except those who received transplants from HLA-matched siblings. Thus, infection is a dominant determinant of transplant outcome.  Control of treatable infections prior to transplant should be a major clinical objective. 3.       Treatment with chemotherapy containing busulfan significantly enhances the likelihood of recovering a normal ability to make antibodies and fosters better recovery of T-cells that provide cell mediated immunity, and may be an acceptable risk in uninfected infants. However, use of any chemotherapy prior to transplant in an infant who is infected, greatly decreases chances of survival. In infected patients who lack a matched sibling, T-cell depleted transplants from half matched related donors had the best outcomes. (more…)
Author Interviews, NEJM, Prostate Cancer / 27.07.2014

Tomasz M. Beer, M.D. FACP OHSU Knight Cancer Institute, Oregon Health and Science University OR 97239MedicalResearch.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. (more…)
Author Interviews, Heart Disease, Lipids, NEJM / 17.07.2014

Professor Jane Armitage Professor of Clinical Trials and Epidemiology Clinical Trial Service Unit, Oxford Cardiovascular Science Oxford, United KingdomMedicalResearch.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. (more…)
Author Interviews, Kidney Disease, NEJM, Transplantation / 15.07.2014

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 UniversityMedicalResearch.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. (more…)
Author Interviews, Breast Cancer, NEJM / 10.07.2014

Dr. Olivia Pagani Institute of Oncology of Southern Switzerland Ospedale San Giovanni, Switzerland 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. (more…)
Author Interviews, Gastrointestinal Disease, Genetic Research, NEJM, Pediatrics / 03.07.2014

Dr. Daniel AgardhMedicalResearch.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. (more…)
Author Interviews, Heart Disease, NEJM, Stroke / 01.07.2014

MedicalResearch.com Interview with: Dr. Tommaso Sanna MD Institute of Cardiology Catholic University of the Sacred Heart Rome, Italy MedicalResearch: What are the main findings of the study? Dr. Sanna: In patients with cryptogenic stroke, continuous ECG monitoring with an implantable device, called the Reveal XT Insertable Cardiac Monitor (ICM), discovered Atrial Fibrillation in 6.4 times more patients than conventional diagnostic strategies at six months, 7.3 times more patients at 12 months, and 8.8 times more patients at 36 months. In more detail, after 36 months of follow-up, 30% of patients with cryptogenic stroke had at least one episode of atrial fibrillation. (more…)
Author Interviews, NEJM, Rheumatology / 21.06.2014

Bethanie Wilkinson, Ph.D. Pfizer 445 Eastern Point Rd. Groton, CT 06340MedicalResearch.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.
  •  Both doses of XELJANZ met the study’s co-primary efficacy endpoints of mean change from baseline in van der Heijde modified Total Sharp Score (mtss) [0.18 and 0.04 (both P<0.001) for tofacitinib 5 and 10 mg BID, respectively, versus 0.84 for MTX], and ACR70 response rates [25.5% and 37.7% for tofacitinib 5 and 10 mg BID (both P<0.001) versus 12.0% for MTX], at Month 6.
  • These results were sustained at all measured time points up to 24 months.
(more…)
Author Interviews, Depression, Heart Disease, NEJM, OBGYNE / 19.06.2014

Dr. Krista Huybrechts MD PhD Brigham & Women’s Hospital Department of Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Boston, MA 02120MedicalResearch.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. (more…)
Author Interviews, NEJM, Obstructive Sleep Apnea, University of Pennsylvania, Weight Research / 13.06.2014

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 CenterMedicalResearch.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. (more…)
Author Interviews, Gastrointestinal Disease, NEJM, Pain Research, University of Michigan / 11.06.2014

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 SystemMedicalResearch.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. (more…)
Author Interviews, Breast Cancer, NEJM / 05.06.2014

Dr. Olivia Pagani Institute of Oncology of Southern Switzerland Ospedale San Giovanni, SwitzerlandMedicalResearch.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). (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, NEJM, Statins / 22.05.2014

Jonathon D. Truwit, MD, MBA Enterprise Chief Medical Officer Sr. Administrative Dean Froedtert-Medical College of Wisconsin Milwaukee, WI 53226MedicalResearch.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. (more…)
Author Interviews, NEJM, Pulmonary Disease, Statins / 20.05.2014

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, PAMedicalResearch 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:
  • 40 mg. of daily simvastatin (statin drug) added to usual care did not reduce exacerbation rate or prolong the time to exacerbation in patients with moderate to severe COPD.
  • Simvastatin had no effect on lung function, quality of life, severe adverse events or mortality.
  • The data do not demonstrate a therapeutic benefit from statins in patients with moderate to severe COPD.
(more…)
Author Interviews, Gastrointestinal Disease, Hepatitis - Liver Disease, NEJM / 05.05.2014

Stefan Zeuzem, M.D. Professor of Medicine, Chief Department of Medicine JW Goethe University Hospital Frankfurt GermanyMedicalResearch.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. (more…)
Author Interviews, Dengue, Ebola, Genetic Research, Infections, NEJM, NIH / 24.04.2014

Sergio D. Rosenzweig, MD, PhD Director, Primary Immunodeficiency Clinic (PID-C) LHD, NIAID, NIH 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, 20892MedicalResearch.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. (more…)
Author Interviews, Hepatitis - Liver Disease, NEJM / 12.04.2014

Kris V. Kowdley, MD Director of Research & Director of the Liver Center of Excellence Digestive Disease Institute Virginia Mason Medical Center Seattle, WA 98111MedicalResearch.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). (more…)
Author Interviews, Heart Disease, NEJM / 11.04.2014

Marc A. Pfeffer, M.D., Ph.D. Dzau Professor of Medicine Harvard Medical School Cardiovascular Division Brigham and Women's HospitalMedicalResearch.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. (more…)
Author Interviews, Heart Disease, NEJM / 04.04.2014

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 Victoria St West Auckland 1142 NEW ZEALANDMedicalResearch.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. (more…)
Author Interviews, Lipids, NEJM, Statins / 31.03.2014

Evan A. Stein, M.D., Ph.D. FRCP(C), FCAP Metabolic and Atherosclerosis Research Center Cincinnati, OH 45225,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. (more…)
Author Interviews, Duke, Lipids, NEJM, Statins / 28.03.2014

Michael J. Pencina, PhD Professor of Biostatistics and Bioinformatics Director of Biostatistics Duke Clinical Research Institute Durham, NC 27710 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. (more…)
Author Interviews, NEJM, OBGYNE / 27.03.2014

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, Tel: 86-731-84373557(O)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

MedicalResearch.com: What are the main findings of the study? Dr. Xiao:  The study presents the first cases of human primary infertility due to mutation in a zona pellucida gene. We have identified a homozygous frameshift mutation in ZP1 ( GenBank accession number, KJ489454) resulting in the aberrant ZP1, which affects the formation of zona pellucida. We detected an autosomal-recessive pattern of inherited infertility. (more…)
Author Interviews, CDC, Hand Washing, Hospital Acquired, Infections, NEJM / 26.03.2014

MedicalResearch.com Interview with: Shelley S. Magill, M.D., Ph.D. From the Centers for Disease Control and Prevention Emory University School of Medicine Atlanta, Georgia MedicalResearch.com: What are the main findings of the study? Dr. Magill: The results of this survey show that healthcare-associated infections continue to be a threat to patient safety in U.S. acute care hospitals. Among the more than 11,000 patients included in the survey, approximately 4% (or 1 in 25) had at least one healthcare-associated infection at the time of the survey. We used these results to develop national estimates of healthcare-associated infections. We estimated that in 2011, there were approximately 721,800 healthcare-associated infections in U.S. acute care hospitals. The most common types of infections were surgical site infections (SSIs), pneumonias, and gastrointestinal infections. (more…)
Autism, Genetic Research, NEJM, UCSD / 26.03.2014

MedicalResearch.com Interview with: Dr. Erik Courchesne PhD Professor, Department of Neurosciences UC San Diego School of Medicine MedicalResearch.com: What are the main findings of the study? Dr. Courchesne: “Building a baby’s brain during pregnancy involves creating a cortex that contains six layers,” Courchesne said. “We discovered focal patches of disrupted development of these cortical layers in the majority of children with autism.” The authors created the first three-dimensional model visualizing brain locations where patches of cortex had failed to develop the normal cell-layering pattern. The study found that in the brains of children with autism key genetic markers were absent in brain cells in multiple layers. “This defect,” Courchesne said, “indicates that the crucial early developmental step of creating six distinct layers with specific types of brain cells – something that begins in prenatal life – had been disrupted.”  The study gives clear and direct new evidence that autism begins during pregnancy. (more…)
Author Interviews, Biomarkers, Colon Cancer, NEJM / 19.03.2014

Dr. Thomas Imperiale MD Professor of Medicine, Indiana University School of Medicine Research Scientist, Indiana University Center for Health Services and Outcomes Research Research Scientist, Center for Health Services Research, Regenstrief Institute, Inc. Core Investigator, VA HSR&D Center for Health Information and CommunicationMedicalResearch.com Interview Invitation with: Dr. Thomas Imperiale MD Professor of Medicine, Indiana University School of Medicine Research Scientist, Indiana University Center for Health Services and Outcomes Research Research Scientist, Center for Health Services Research, Regenstrief Institute, Inc. Core Investigator, VA HSR&D Center for Health Information and Communication MedicalResearch.com: What are the main findings of the study? Dr. Imperiale: The main findings are the performance characteristics of the multi-target test (sensitivity of 92.3%, specificity of 86.6%) and its performance as compared with the commercial FIT: more sensitive for colorectal cancer and advanced precancerous polyps, but less specific. (more…)
Author Interviews, NEJM, Outcomes & Safety, Surgical Research / 13.03.2014

David R. Urbach, M.D From the Institute for Clinical Evaluative Sciences Department of Surgery Institute of Health Policy, Management and Evaluation University of Toronto, the University Health Network Toronto, ON M5G 2C4, CanadaMedicalResearch.com Interview with: David R. Urbach, M.D From the Institute for Clinical Evaluative Sciences Department of Surgery Institute of Health Policy, Management and Evaluation University of Toronto, the University Health Network Toronto, ON M5G 2C4, Canada MedicalResearch.com: What are the main findings of the study? Dr. Urbach: After surgical safety checklists were adopted by hospitals in Ontario, surgical outcomes—death after surgery, complications, length of stay, readmissions—did not improve substantially. (more…)