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Author Interviews, Heart Disease, Surgical Research / 12.10.2016

MedicalResearch.com Interview with: Miguel Haime, MD VA Boston Healthcare System and Boston Medical Center Boston, MA Dr. Haime discusses an abstract about Somahlution DuraGraft during a rapid response session at the 2016 annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; 1–5 October, Barcelona, Spain) MedicalResearch.com: What is the background for this study? What are the main findings? Response: Coronary artery bypass grafting (CABG) surgery is the standard of care for multi-vessel coronary heart disease. During CABG, we use saphenous vein grafts as bypass conduits for surgical revascularization. Pathophysiological changes that occur in vein grafts during the surgical procedure can compromise the durability and patency of the graft and increase the risk of vein graft failure. At the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting, we presented results from a retrospective, non-randomized study conducted at VA Boston Healthcare System to evaluate the Real World Evidence of DuraGraft®, a vascular graft treatment designed to prevent vein graft failure after CABG. (more…)
Author Interviews, Breast Cancer, Heart Disease, JAMA / 12.10.2016

MedicalResearch.com Interview with: Husam Abdel-Qadir, MD, FRCPC, DABIM (Cardiology and Internal Medicine) Graduate student, Clinical Epidemiology and Health Care Research Elliot Philipson Clinician Scientist Training Program University of Toronto MedicalResearch.com: What is the background for this study? Response: Breast cancer is the most common malignancy among North American women. The successes of screening and treatment have led to a marked increase in the number of breast cancer survivors, whose cardiovascular health is becoming of prime concern. Many recent publications have raised alarm about the incidence of cardiovascular abnormalities after breast cancer treatment. However, there is a paucity of data about the frequency of death from cardiovascular disease rather than breast cancer. Contemporary estimates of the incidence of competing risks like cardiovascular disease are important to guide discussions about prognosis, subsequent follow-up, and survivorship plans. It is important that such incidence estimates are generated using methodology that appropriately accounts for competing risks to avoid providing results that are biased upwards. (more…)
Alcohol, Author Interviews, NIH, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Megan Ryan M.B.A. Clinical Program Director, DMD Technology Development Coordinator National Institute on Alcohol Abuse and Alcoholism National Institutes of Health Bethesda, MD MedicalResearch.com: What is the background for this study? Response: Alcohol use disorder (AUD) has been linked to the dysregulation of the brain stress systems (e.g. corticotropin-releasing factor, glucocorticoids, and vasopressin) creating a negative emotional state leading to chronic relapsing behavior. Several pre-clinical studies have shown that by blocking the V1b receptor with a V1b receptor antagonist, dependence induced compulsive-like alcohol intake is also blocked. This is the first multi-site trial to assess the efficacy of the V1b receptor antagonist novel compound (ABT-436) for the treatment of alcohol dependence. (more…)
AHA Journals, Author Interviews, Heart Disease, Occupational Health / 12.10.2016

MedicalResearch.com Interview with: Rasmus Rørth MD From Department of Cardiology Rigshospitalet University of Copenhagen, Denmark MedicalResearch.com: What is the background for this study? Response: Heart failure is considered to be one of the most common, costly, disabling and deadly medical conditions and is thus a major health care problem. The ability to maintain a full-time job addresses a vital indirect consequence and cost of heart failure, beyond the usual clinical parameters such as mortality and hospitalization. Ability to work is more than just another measure of performance status. As well as its financial importance, employment is crucial for self-esteem and quality of life in patients with chronic illness. Obtaining information on labour force inclusion should, therefore, shed light on an unstudied consequence of heart failure and provide a novel perspective on the impact of heart failure on the lives of those who, perhaps, have most to lose from this condition. (more…)
Author Interviews, Cancer Research, ESMO / 12.10.2016

MedicalResearch.com Interview with: Dr. Amanda Bobridge University of South Australia Adelaide MedicalResearch.com: What is the background for this study? Response: Despite cancer screening being demonstrated to reduce cancer morbidity and mortality, current participation in established screening programs is variable. In Australia, the participation rates range from 37% for bowel cancer (FOBT) screening to 57% for cervical cancer screening. This study aimed to determine the barriers to and enablers for cancer screening and whether the target population for screening would support the concept of combined cancer screening (all screening offered at the same time at the same location). (more…)
Author Interviews, Cost of Health Care, Dermatology, JAMA, NYU / 12.10.2016

MedicalResearch.com Interview with: Hao Feng, M.D., M.H.S. Resident, Department of Dermatology NYU Langone Medical Center MedicalResearch.com: What is the background for this study? Response: Recently, there has been an increased scrutiny on industry-physician interactions and emphasis on disclosures of interactions. While we know about the types of interaction between dermatologists and industry, we wanted to understand that relationship more in depth by probing the Open Payment database. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Technology / 12.10.2016

MedicalResearch.com Interview with: Ateev Mehrotra, M.D. Associate Professor Department of Health Care Policy Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prior research has highlighted that physicians make diagnostic errors roughly 10 to 15 percent of the time. Over the last two decades, computer-based checklists and other “fail-safe” digital apps have been increasingly used to reduce medication errors or streamline infection-prevention protocols. Lately, experts have wondered whether computers might also help reduce diagnostic errors. In the study, 234 internal medicine physicians were asked to evaluate 45 clinical cases, involving both common and uncommon conditions with varying degrees of severity. For each case, physicians had to identify the most likely diagnosis along with two additional possible diagnoses. Each clinical vignette was solved by at least 20 physicians. The same cases were also evaluated using 19 symptom checkers, websites or apps that use computers that help patients determine potential diagnoses for what is wrong based on their symptoms. The physicians vastly outperformed the symptom-checker apps, listing the correct diagnosis 72 percent of the time, compared with 34 percent of the time for the digital platforms. Eighty-four percent of clinicians listed the correct diagnosis in the top three possibilities, compared with 51 percent for the digital symptom-checkers. (more…)
Addiction, Alcohol, Pediatrics, Tobacco Research / 12.10.2016

MedicalResearch.com Interview with: Dr Rebecca Lacey, PhD Research Associate Epidemiology & Public Health Institute of Epidemiology & Health Faculty of Pop Health Sciences University College London MedicalResearch.com: What is the background for this study? Response: We know from previous research that children who experience parental absence, whether due to death, divorce or some other reason, are more likely, on average, to have poorer health in later life. This includes being more likely to smoke and drink as an adult. However, what we didn’t know before we conducted our study was whether children who experienced parental absence were more likely to engage in the early uptake of risky health behaviours in childhood. This is what we looked at in our study. (more…)
Author Interviews, Exercise - Fitness, OBGYNE / 12.10.2016

MedicalResearch.com Interview with: Prof. Kari Bø PhD Norwegian School of Sport Sciences Oslo, Norway MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background is that more and more female elite athletes continue to exercise into their 30s and beyond and more want to become pregnant and some to continue to compete at the same level after giving birth. MedicalResearch.com: What should readers take away from your report? Response: To date there is little scientific knowledge on elite athletes and others who perform strenuous exercise (eg women in the military) during pregnancy and after childbirth and we therefore have to be cautious when recommending intensity levels of both endurance and strength training exercise. However, given the knowledge we have now.
  • Elite athletes planning pregnancy may consider reducing high impact training routines in the week after ovulation and refraining from repetitive heavy lifting regimens during the first trimester as some evidence suggests increased miscarriage risk.
  • There is little risk of abnormal fetal heart rate response when elite athletes exercise at <90% of their maximal heart rates in the second and third trimesters.
  • Baby birthweights of exercising women are less likely to be excessively large (>4000g) and not at increased risk of being excessively small (<2500g).
  • Exercise does not increase the risk of preterm birth.
  • Exercise during pregnancy does not increase the risk of induction of labour, epidural anesthesia, episiotomy or perineal tears, forceps or vacuum deliveries.
  • There is some encouraging evidence that the first stage of labour (before full dilatation) is shorter in exercising women.
  • There is also some encouraging evidence that exercise throughout pregnancy may reduce the need for caesarean section.
(more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Dr. Sham Mailankody, MBBS Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? Response: The high price of older drugs has been increasingly criticized in part because of recent dramatic price hikes. There are some well known examples like pyrimethamine and more recently EpiPen. Whether and to what degree examples like pyrimethamine represent a common problem or exceptional cases remains unknown. Using Medicare data available for Part B, we sought to analyze the change in average sales price of cancer drugs between January 2010 and January 2015, and whether older drugs were more likely to undergo price increases than newer drugs. (more…)
Author Interviews, C. difficile, Columbia, Hospital Acquired, JAMA / 12.10.2016

MedicalResearch.com Interview with: Dr. Daniel E. Freedberg MD MS Division of Digestive and Liver Diseases Columbia University Medical Center New York, New York MedicalResearch.com: What is the background for this study? Response: We conducted this study because previous studies indicate that the gastrointestinal microbiome is easily shared between people who co-occupy a given space (such as a hospital room).  We wondered if antibiotics might exert an effect on the local microbial environment. (more…)
Alzheimer's - Dementia, Author Interviews, Critical Care - Intensive Care - ICUs, End of Life Care, Geriatrics, JAMA / 12.10.2016

MedicalResearch.com Interview with: Joan M. Teno, MD, MS Department of Gerontology and Geriatrics, Cambia Palliative Care Center of Excellence University of Washington Medicine Seattle, Washington MedicalResearch.com: What is the background for this study? Response: An important challenge for our health care system is effectively caring for persons that high-need, high-cost — persons afflicted with advanced dementia and severe functional impairment are among these persons, with substantial need and if hospitalized in the ICU and mechanically ventilated are high cost patients, who are unlikely to benefit from this level of care and our best evidence suggest the vast majority of persons would not want this care. In a previous study, we interviewed families of advance dementia with 96% starting the goals of care are to focus comfort. Mechanical ventilation in some cases may be life saving, but in cases such as those with advanced dementia and severe functional impairment, they may result in suffering without an improvement in survival. (more…)
Alzheimer's - Dementia, Author Interviews, Genetic Research, PNAS / 12.10.2016

MedicalResearch.com Interview with: Dr. Magdalena Sastre PhD Faculty of Medicine, Department of Medicine Senior Lecturer Imperial College London MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease is the most common neurodegenerative disorder, affecting over 45 million people around the world. Currently, there are no therapies to cure or stop the progression of the disease. Here, we have developed a gene therapy approach whereby we delivered a factor called PGC-1α, which regulates the expression of genes involved in metabolism, inflammation and oxidative stress in the brain of transgenic mice. This factor is also involved in the regulation of energy in the cells, because it controls the genesis of mitochondria and in the generation of amyloid-β, the main component of the neuritic plaques present in the brains of Alzheimer’s disease patients. We have found that the animals with Alzheimer’s pathology treated with PGC-1α develop less amyloid plaques in the brain, perform memory tasks as well as healthy mice and do not have neuronal loss in the brain areas affected by the disease. (more…)
Author Interviews, Cost of Health Care / 12.10.2016

MedicalResearch.com Interview with: Daniel G. Aaron, BS Department of Community Health Sciences Boston University School of Public Health Boston MA 02118 MedicalResearch.com: What is the background for this study? Response: The study began with the co-author and me noticing a few sponsorships of health organizations by Coca-Cola and Pepsi. This drove our curiosity to find out how pervasive these sponsorships were and what they meant for public health. MedicalResearch.com: What are the main findings? Response: The main findings are the shear pervasiveness of soda company sponsorships of health organizations, as well as the anti-public health lobbying of the Coca-Cola Company and PepsiCo. (more…)
Author Interviews, Infections, JAMA, Pediatrics / 12.10.2016

MedicalResearch.com Interview with: Dr. Soren Gantt MD, PhD, MPH Investigator, BC Children's Hospital Associate Professor, Department of Infectious and Immunological Diseases (Pediatrics) Faculty of Medicine, University of British Columbia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cytomegalovirus (CMV) is a common virus that is usually transmitted through bodily fluids such as saliva, urine, blood, and breast milk, but it can also cause congenital infection (from a pregnant woman to her fetus). While it doesn’t usually cause problems for most children or adults, congenital CMV often causes serious problems. Congenital CMV causes 25 per cent of all childhood hearing loss and it’s the second most common cause of intellectual disability. Without screening, most infected newborns are not diagnosed in time to treat them with antivirals or provide other care that can make a big difference to improving their life-long outcomes. Our study showed that screening programs for congenital CMV infection are cost-effective. We found that the cost of identifying one case of congenital CMV ranges from US$2000 to US$10,000 through universal screening, or US$566 to $2833 through a targeted screening approach. Our model showed that screening programs resulted in a net savings for the health care system of approximately USD$21 to $32 per newborn for universal screening or USD$11-$27 per newborn for targeted screening by reducing lifetime costs for therapies and lost productivity due to CMV-related health problems. This finding addresses a major barrier to implementing CMV screening programs, as costs have often been viewed as an issue. (more…)
Author Interviews, Breast Cancer, ESMO / 12.10.2016

MedicalResearch.com Interview with: Judith Balmaña MD Medical Oncology Hospital Vall d’Hebron and Vall d’Hebron Institute of Oncology Barcelona, Spain MedicalResearch.com: What is the background for this study? What are the main findings? Response: Tumors  with brca1 or brca2 mutations share homologous recombination repair deficiency, which confers sensitivity to different types of dna damaging agents. An understanding of the role of brca1 and brca2 in the repair of double-stranded dna damage opened a window of opportunity for treating brca mutation–associated cancers with targeted therapies. Lurbinectedin is a trabectedin analog that specifically binds to cg-rich motifs with a selective mechanism of action: in living cells, lurbinectedin inhibits active transcription by degradation of elongating rna polymerase ii. This process occurs specifically on activated genes and is associated with the formation of double strand dna breaks and the collapse of replication forks. In addition, lurbinectedin exerts some antitumoral effect in the microenvironment by inhibiting the transcription of selected cytokines by tumor-associated macrophages, abrogating their protumoral properties. Observations that lurbinectedin was active against homologous-recombination-deficient cell lines led us to test it in patients with metastatic breast cancer having deleterious germline brca mutations. (more…)
Author Interviews, Cannabis, Cognitive Issues, Depression, Pediatrics / 12.10.2016

MedicalResearch.com Interview with: Elizabeth Osuch, M.D. Associate Professor; Rea Chair Department of Psychiatry FEMAP--London Health Sciences Centre London, ON    MedicalResearch.com: What is the background for this study? What are the main findings? Response: As a researcher and psychiatrist doing clinical work in youth aged 16-25 with mood and anxiety disorders I often see patients who are depressed and believe that using marijuana (MJ) improves their mood.  Yet they remain depressed.  This was the clinical inspiration for this brain imaging study, where we investigated emerging adults with Major Depressive Disorder (MDD).  Subject groups included patients with MDD who did and did not use MJ frequently.  Our results showed that the MDD+MJ group did not have significantly less depression than the MDD alone group, and the brain abnormalities found in MDD were not corrected by MJ use in the MDD+MJ group.  In fact, some of the brain differences were worse with the addition of MJ, while others were just different. (more…)
Author Interviews, Cancer Research, Immunotherapy / 11.10.2016

MedicalResearch.com Interview with: Bernard Vanhove, Chief Operating Officer Director of R&D and International Scientific Collaborations Ose Immunotherapeutics MedicalResearch.com: What is the background for this study? What are the main findings? Response: Myeloid suppressive cells, including tumor associated macrophages (TAM) and myeloid-derived suppressor cells (MDSC), represent an abundant immune cell type in the microenvironment of solid tumors where they promote tumor growth, metastases, angiogenesis, inhibiting anti-tumor immune responses. Myeloid cells selectively express SIRPα, an immune tyrosine associated inhibitory receptor (also named CD172a), which controls myeloid functions. We investigated the role of Effi-DEM, new generation checkpoint inhibitor specifically targeting the SIRP- α receptor on the strategic SIRP-α/CD47 pathway in human macrophages polarization and MDSC differentiation. CD47 the ligand of SIRP alpha is ubiquitously expressed in human cells and has been found to be overexpressed in many different tumor cells with a poor prognosis established. Effi-DEM is a selective antagonist of these myeloid suppressive cells as its target SIRP-α is expressed on these cells. Based on this rationale, the preclinical studies conducted with Effi-DEM have demonstrated its potential to transform suppressor myeloid and tumor associated macrophage cells in non-suppressive cells, thereby inducing a reactivation of the immune response. Effi-DEM has also shown to be effective in various aggressive cancer models with encouraging preclinical results, both in monotherapy and in therapeutic combinations with anti-PD-L1 (checkpoint inhibitors) and anti-CD137 (4-1BB) mAbs, activators of the T-cell response. Significant efficacy and survival increase data were demonstrated in models of hepatocarcinoma, melanoma and triple negative breast cancer. (more…)
Author Interviews, Dermatology / 11.10.2016

MedicalResearch.com Interview with: Dr. Kristian Reich Professor of Dermatology at the Georg-August-University Göttingen and inflammation specialist Dermatologikum Hamburg in Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: While there is ongoing research into the causes and triggers of psoriasis, recent studies have identified IL-23 as a main driver of the IL-23/IL-17 pathway which is now thought to be the predominant pathway in the psoriasis inflammatory cascade. Selective Inhibition of IL-23 may present a new targeted strategy for treating patients with the condition. The hope for molecules selectively targeting IL-23, specifically the p19 component of the cytokine, is that newer therapies, like tildrakizumab, can more selectively control the disease allowing more patients to achieve higher and even more durable clinical responses. The two pivotal Phase-3 studies (reSURFACE 1 and 2) evaluated the efficacy and safety of the IL-23 inhibitor tildrakizumab in adult patients with moderate-to-severe plaque psoriasis, and results through week 28 were presented for the first time as part of the Late Breaking News Session at EADV. In the reSURFACE 1 and 2 pivotal Phase-3 studies, tildrakizumab, a selective IL-23p19 inhibitor, was evaluated against placebo and etanercept to assess efficacy, safety and tolerability. The co-primary efficacy endpoint of the two placebo-controlled studies was a) the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician’s Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The reSURFACE 2 also included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoints of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28. (more…)
Author Interviews, JAMA, Supplements / 11.10.2016

MedicalResearch.com Interview with: Elizabeth D. Kantor, PhD MPH Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center NY, NY MedicalResearch.com: What is the background for this study? Response: Prior studies show that use of supplements increased between the 1980s and mid-2000s, and despite much research conducted on the health effects of supplements, we know little about recent trends in use. Given this gap, we decided to create an up-to-date, comprehensive resource on the prevalence and trends of supplement use among US adults using nationally representative data from the National Health and Nutrition Examination Survey (NHANES). Data were collected over seven continuous cycles (from 1999-2000 to 2011-2012). (more…)
Author Interviews, Outcomes & Safety / 11.10.2016

MedicalResearch.com Interview with: Bala N. Hota, MD Department of Internal Medicine Rush Medical College Chicago, IL MedicalResearch.com: What is the background for this study? Response: There has been a proliferation of online ranking systems that seek to rate the quality of health care systems. Rush University Medical Center (RUMC) has consistently scored highly on patient safety measurement systems. For example, RUMC has received nine consecutive “A” grades for safety from the Leapfrog Group, and was recently ranked “4 stars” in the CMS 2016 star ranking system. In the 2015-2016 US News and World Report Ranking System, however, Rush received a low score for quality, a 1 out of 5 possible points, which was a surprise. To understand these results, the RUMC quality team began a process to validate the data and methods of the US News hospital ranking system. What was found was a surprise – the data backing the ranking system produced by US News had flaws, leading to the low score. Specifically, data were missing from the data set used for the US News analysis, including whether a condition was present on admission in 10% of cases; dates of service were also missing from all cases. The quality team at RUMC then conducted an analysis using national data, and simulated the impact of these data flaws on national rankings. (more…)
Author Interviews, Cost of Health Care, Hospital Readmissions / 10.10.2016

MedicalResearch.com Interview with: Kathleen Carey, Ph.D. Professor, Department of Health Law, Policy and Management School of Public Health Boston University Boston MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: The ACA’s Hospital Readmissions Reduction Program (HRRP) imposes Medicare reimbursement penalties on hospitals with readmission rates for certain conditions if they exceed national averages. A number of observers have expressed serious concern over the program’s impact on safety-net hospitals, which serve a high proportion of low income patients who are more likely to be readmitted – often for reasons outside hospital control. Many have argued that the HRRP should adjust for socio-economic status. However, Medicare does not want to lower the standard of quality for these hospitals. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Outcomes & Safety / 10.10.2016

MedicalResearch.com Interview with: Jared Conley, MD, PhD, MPH Department of Emergency Medicine Massachusetts General Hospital Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Response: As the U.S. healthcare system seeks to improve the health of populations and individual patients, there is increasing interest to better align healthcare needs of patients with the most appropriate setting of care—particularly as it relates to hospital-based care (accounting for 1/3 of total U.S. healthcare costs). Avoiding hospitalization—as long as safety and quality are not compromised—is often preferred by patients and the added benefit of potentially making care more affordable further promotes such care redesign efforts. There is a growing body of research studying alternative management strategies to hospitalization; we sought to comprehensively review and analyze this work. Alternative management strategies reviewed include outpatient management, quick diagnostic units, observation units, and hospital-at-home. (more…)
Author Interviews / 10.10.2016

MedicalResearch.com Interview with: Susan P. Y. Wong, MD Acting Instructor Division of Nephrology University of Washington Seattle VA Puget Sound Health Care System MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is not known what proportion of US patients with advanced chronic kidney disease (CKD) go on to receive renal replacement therapy (RRT) with maintenance dialysis or kidney transplantation. Most of what is known about treatment practices for advanced CKD in the US comes from the United States Renal Data System (USRDS), our national registry of RRT. However, the USRDS does not collect information on patients who reach the advanced stages of CKD but do not receive RRT. To address this knowledge gap, we conducted a retrospective study of a national cohort of 28,568 adults with advanced CKD (a sustained estimated glomerular filtration rate <6.8% among similarly aged patients described in these other countries. Despite the fact that age is strongly associated with limited survival and quality of life after dialysis initiation, our findings suggest that dialysis initiation practices were far more liberal among older patients in our study cohort than reported for other developed countries. (more…)
Author Interviews, Breast Cancer, ESMO, Immunotherapy / 10.10.2016

MedicalResearch.com Interview with: Gabriel N. Hortobagyi, MD, FACP, F.A.S.C.O. Professor of Medicine Nellie B. Connally Chair in Breast Cancer Department of Breast Oncology Co-Director, Multidisciplinary Breast Cancer Research Program University of Texas MD Anderson Cancer Center Houston, Texas MedicalResearch.com: What is the background for this study? What are the main findings? Response: MONALEESA-2 is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer. The primary efficacy results from the pivotal MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS) compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (HR= 0.556; 95% CI: 0.429-0.720; p=0.00000329)1. The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone, significantly extending PFS across all patient subgroups. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% during treatment (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028)1. (more…)
Author Interviews, Gastrointestinal Disease, Infections, PLoS / 10.10.2016

MedicalResearch.com Interview with: Brian K. Coombes, PhD Professor & University Scholar Associate Chair, Graduate Education Department of Biochemistry & Biomedical Sciences Assistant Dean, Biochemistry Graduate Program Canada Research Chair in Infectious Disease Pathogenesis MedicalResearch.com: What is the background for this study? Response: North Americans have among the highest reported prevalence and incidence of inflammatory bowel disease (IBD) in the world. This is a lifelong disease that often strikes people in their early years, leading to decades of suffering, increased risk of colorectal cancer, and 50% increased risk of premature death. Compared to the general population, quality of life for those with Crohn’s disease is low across all dimensions of health. The need to understand the root origins of this disease and to use this information to invigorate a new pipeline of treatments and preventions has never been more pressing. (more…)
Author Interviews, Pharmacology, Schizophrenia / 10.10.2016

Antony Loebel, M.D. Executive Vice President and Chief Medical Officer, Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma GroupAntony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion Head of Global Clinical Development Sumitomo Dainippon Pharma Group MedicalResearch.com: What is the background for this study? Response: Lurasidone hydrochloride (HCl) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia in 2010. There are a number of publications on lurasidone studies, pooled data that were included in a network meta-analysis of RCTs in schizophrenia. The meta-analysis compares lurasidone with other antipsychotics using RCTs where both medications were studied at the same time. Such approach (meta-analysis of similarly designed trials) allows for a state of the art review of efficacy, safety and tolerability of medications where direct head-to-head trials are not available. (more…)
Alzheimer's - Dementia, Author Interviews, Genetic Research, JAMA, Race/Ethnic Diversity / 10.10.2016

MedicalResearch.com Interview with: Dr Tamara Shiner MD PhD Specialist in Neurology Neurology Division Tel Aviv Sourasky Medical Centre MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although in the past believed to be sporadic, there is much emerging evidence for a significant genetic contribution to Dementia with Lewy bodies (DLB). Hetrozygosity for common mutations in the GBA gene have been shown to be more frequent among DLB patients and Parkinson's disease patients than in the general population. We found that GBA mutations are in fact exceptionally frequent among Ashkenazi Jewish (AJ) patients with Dementia with Lewy bodies. Our results indicate that one in three of all Ashkenazi DLB patients carry mutations in this specific gene (compared to approximately 6% in the general Ashkenazi Jewish population). We also found that those who carry these mutations have a more severe disease phenotype. (more…)
Author Interviews, Infections, NEJM / 10.10.2016

MedicalResearch.com Interview with: Simon I. Hay, BSc, DPhil, DSc Professor of Global Health University of Washington Director of Geospatial Science Institute for Health Metrics and Evaluation (IHME). MedicalResearch.com: Why did you undertake this study? Response: As malaria control has not been routinely informed by subnational variation of malaria burden, we undertook the study to highlight the potential for high-resolution maps of disease burden to better understand the epidemiology of malaria as well as the contribution of recent control efforts as well as to better inform future malaria control efforts. (more…)