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…)
Author Interviews, Dengue, Infections, NEJM, Respiratory / 27.02.2014

Valérie D'Acremont, MD, PhD Group leader Swiss Tropical and Public Health Institute | Basel | Switzerland Médecin-adjointe, PD-MER Travel clinic | Department of Ambulatory Care and Community Medicine | University hospital of Lausanne | SwitzerlandMedicalResearch.com Interview with: Valérie D'Acremont, MD, PhD Group leader Swiss Tropical and Public Health Institute | Basel | Switzerland Médecin-adjointe, PD-MER Travel clinic | Department of Ambulatory Care and Community Medicine | University hospital of Lausanne | Switzerland MedicalResearch.com: What are the main findings of the study? Dr. D'Acremont: We discovered that, in a rural and an urban area of Tanzania, half of the children with fever (temperature >38°C) had an acute respiratory infection, mainly of the upper tract (5% only had radiological pneumonia). These infections were mostly of viral origin, in particular influenza. The other children had systemic viral infections such as HHV6, parvovirus B19, EBV or CMV. Overall viral diseases represented 71% of the cases. Only a minority (22%) had a bacterial infection such as typhoid fever, urinary tract infection or sepsis due to bacteremia. Malaria was found in only 10% of the children, even in the rural setting. (more…)
Infections, NEJM / 23.02.2014

Dr. T. M. A van Dongen, MD Univ Med Ctr Utrecht Julius Ctr Hlth Sci & Primary Care, Dept Epidemiol Utrecht, Netherlands.MedicalResearch.com Interview with: Dr. T. M. A van Dongen, MD Univ Med Ctr Utrecht Julius Ctr Hlth Sci & Primary Care, Dept Epidemiol Utrecht, Netherlands. MedicalResearch.com: What are the main findings of the study? Answer: We performed a pragmatic trial, in which we randomly assigned 230 children who had acute tympanostomy-tube otorrhea to receive antibiotic-glucocorticoid eardrops, oral antibiotics or to undergo initial observation. The primary outcome of our study was the presence of ear discharge, 2 weeks after study-group assignment. We also looked at, among others, the duration of the initial otorrhea episode and the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up. We found that antibiotic–glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, NEJM / 22.02.2014

Minesh P. Mehta, M.B., Ch.B. F.A.S.T.R.O. Professor of Radiation Oncology, University of Maryland School of Medicine Radiation oncologist, University of Maryland Marlene and Stewart Greenebaum Cancer Center, Chair, RTOG brain tumor committeeMedicalResearch.com Interview with: Minesh P. Mehta, M.B., Ch.B. F.A.S.T.R.O. Professor of Radiation Oncology, University of Maryland School of Medicine Radiation oncologist, University of Maryland Marlene and Stewart Greenebaum Cancer Center MedicalResearch.com: What are the main findings of the study? Dr. Mehta: RTOG 0825 was a clinical trial evaluating whether the addition of a novel drug that inhibits tumor vascular growth, bevacizumab, to the standard of care for glioblastoma, an aggressive brain tumor, would prolong survival. Patients were allocated randomly to one of two different treatment regimens – the standard of care, which includes radiotherapy and a drug known as temozolomide, or another regimen of radiation, temozolomide and bevacizumab. The trial design was double-blinded, and therefore, on one arm patients received the bevacizumab, whereas on the other arm they received a placebo. The survival on both arms was equivalent, and therefore it was fairly concluded that bevacizumab failed to prolong survival when given initially as part of treatment for glioblastoma. Freedom from progression, referred to as progression-free survival was also measured on this trial, and although bevacizumab appeared to lengthen progression-free survival, this level of benefit did not meet the pre-defined goals, and is therefore regarded as statistically not demonstrating an improvement. Additional endpoints included outcomes reported by the patient, including the burden of symptoms, and the impact of these on the quality of life, as well as effects on the brain, known as neurocognitive changes. Bevacizumab did not improve these endpoints either. (more…)
Author Interviews, Cancer Research, Chemotherapy, NEJM / 20.02.2014

Krishnansu S. Tewari, MD, FACOG, FACS| Professor & Director of Research Principal Investigator - The Gynecologic Oncology Group at UC Irvine The Division of Gynecologic Oncology University of California, Irvine Medical Center Orange, CA 92868MedicalResearch.com Interview with: Krishnansu S. Tewari, MD, FACOG, FACS| Professor & Director of Research Principal Investigator - The Gynecologic Oncology Group at UC Irvine, Division of Gynecologic Oncology University of California, Irvine Medical Center Orange, CA 92868 MedicalResearch.com: What are the main findings of the study? Dr. Tewari: The main findings of this study were that the addition of bevacizumab to chemotherapy resulted in a significantly improved survival of 3.7 months in a population of patients that have very limited options. This improvement in overall survival was not accompanied by any significant deterioration in quality of life and serious side effects were limited to 3% to 8% of the study population. (more…)
Author Interviews, Johns Hopkins, NEJM / 13.02.2014

MedicalResearch.com Interview with: Dr. Richard P. Allen Department of Neurology Johns Hopkins University Baltimore, MD 21224, MedicalResearch.com: What are the main findings of the study? Dr. Allen:  This study should serve to change medical practice by reducing use of pramipexole and ropinirole to avoid the insidious worsening of restless legs syndrome that occurs for many on these drugs. Pramipexole (Mirapex) a medication that mimics dopamine in the brain  in usual therapeutic doses for treatment of restless legs syndrome (RLS) works at first but over time one year makes the disease worse for up to 9% of the patients on 0.5 mg a day. Pregabalin (Lyrica) an anti-convulsant and pain drug  that works on a calcium channel in the brain in therapeutic dose for RLS (300 mg a day) does not make the disease worse  (There is some natural progression of the disease shown to occur fro 1 - 2% or patients over a year.. seen in this study). Pregabalin is in the short run as effective as pramipexole (over 12 weeks) and in the long run over 52 weeks more effective. These results confirm what had been expected that the dopamine drug pramipexole makes worse Restless Legs Syndrome while a drug not directly acting on the dopamine system does NOT make restless legs syndrome worse. (more…)
Alzheimer's - Dementia, Author Interviews, Baylor College of Medicine Houston, NEJM / 02.02.2014

Rachelle S. Doody, M.D.,Ph.D. Effie Marie Cain Chair in Alzheimer's Disease Research Director, Alzheimer's Disease and Memory Disorders Center Baylor College of Medicine-Department of Neurology Houston, Texas 77030: MedicalResearch.com MedicalResearch.com Interview with: Rachelle S. Doody, M.D.,Ph.D. Effie Marie Cain Chair in Alzheimer's Disease Research Director, Alzheimer's Disease and Memory Disorders Center Baylor College of Medicine-Department of Neurology Houston, Texas 77030: MedicalResearch.com MedicalResearch.com: What are the main findings of the study?  Dr. Doody: The study set out to see whether the antibody infusion treatment, Solanezumab, would improve the course of mild to moderate Alzheimer's disease in the ways necessary to gain drug approval.  Unfortunately, the results did not support an approvable treatment for this purpose. (more…)
Author Interviews, Gastrointestinal Disease, NEJM, Pediatrics, Vaccine Studies / 15.01.2014

W. Katherine Yih Ph.D., M.P.H Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care InstituteMedicalResearch.com Interview with: W. Katherine Yih Ph.D., M.P.H Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute MedicalResearch.com:  What are the main findings of the study? Dr. Yih: The main findings are that vaccination with the first dose of RotaTeq is associated with a small increase in the risk of intussusception, which is concentrated in the first week after vaccination.  The estimated risk is about 1.5 excess cases per 100,000 first doses administered.  This risk is fairly small, amounting to roughly 1/10 of the risk seen after the original rotavirus vaccine (called Rotashield) that was used in 1998-1999, before it was withdrawn from the market. We also found evidence that Rotarix increases the risk of intussusception.  However, the number of infants receiving Rotarix and the number getting intussusception after Rotarix were too small to allow us to estimate the risk after Rotarix with any precision. (more…)
Author Interviews, Gastrointestinal Disease, Infections, NEJM, Vaccine Studies / 15.01.2014

MedicalResearch.com Interview with Eric S. Weintraub, M.P.H. Epidemiologist at Centers for Disease Control and Prevention MedicalResearch.com: What are the main findings of the study? Mr. Weintraub: While current rotavirus vaccines were not associated with intussusception in large pre-licensure trials, recent post-licensure data (from international settings) suggest the possibility of a low risk of intussusception occurrence after receipt of monovalent rotavirus vaccination (RV1).  We examined the risk of intussusception following RV1 vaccination in a U.S. population.  In this study of more than 200,000 doses of RV1, a slight increased risk of intussusception was observed after vaccination, which should be considered in light of the benefits of preventing rotavirus associated illness. (more…)