Author Interviews, Diabetes, Pharmacology / 25.07.2016

MedicalResearch.com Interview with: Stig Ejdrup Andersen MD, PhD Clinical Pharmacology Unit Zealand University Hospital Roskilde Denmark MedicalResearch.com: What is the background for this study? Response: For decades, we have used sulphonylurea derivates in the medical treatment of type 2 diabetes. Although several newer drugs have become available, adding an SU is still a recommended and acceptable strategy when metformin monotherapy fails. The SUs are among the cheapest glucose lowering drugs on the marked but the risk of hypoglycaemia make clinicians prefer a newer oral drug such as a DPP-IV inhibitor or a SGLT-2 inhibitor to ansulphonylurea because even mild hypoglycaemia may affect the patients’ quality of life negatively. Several meta-analyses have examined the effectiveness and safety of noninsulin antidiabetic drug, all of which have considered the SUs a homogenous drug class. Pharmacologically, however, the SU agents are quite different. In 2004, a randomized controlled trial by Shernthaner et al. indicated that in comparison with glimepiride, gliclazide MR is equally effective and is associated with fewer hypoglycaemic episodes. Still, head-to-head comparisons of the SU-agents as add-on to metformin are few. In the absence of robust designed comparative trials, we decided to compare the relative risk of hypoglycaemia among the newer SU-agents in a network meta-analysis. (more…)
Author Interviews, Mental Health Research, Pharmacology, Schizophrenia / 21.07.2016

MedicalResearch.com Interview with: Glorimar Ortiz, MS Senior Researcher/Statistician NRI-National Association of State Mental Health Program Directors Research Institute Falls Church, VA 22042 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Despite the lack of empirical evidence that antipsychotic polypharmacy produces greater outcomes to antipsychotic monotherapy, and that several clinical guidelines recommend against it, patients with a diagnosis of schizophrenia continue to being discharged on polypharmacy. Over the past few years, attempts have been made to lower the rate of antipsychotic polypharmacy throughout the country. Most of the existing literature on this topic are based on Medicaid claims data which exclude data for patients discharged from state psychiatric inpatient hospitals. Our study is very important because it is the first time that data on the use of antipsychotic medications are analyzed using a large sample of discharges from state psychiatric inpatient hospitals. These hospitals now have the opportunity to benchmark their antipsychotic medication use rate with national rates more accurately, and therefore, develop and implement performance improvement activities that are more precise. The study found that 12% of all discharges were prescribed two or more antipsychotic medications. Of those patients discharged on at least one antipsychotic medication, 18% were prescribed two or more antipsychotics. The study also found that patients with a schizophrenia diagnosis and an inpatient hospital stay of 3 months or longer are more likely of being discharged on polypharmacy, and that the main reason for this was to reduce patient’s symptoms. Antipsychotic polypharmacy affects nearly 10,000 patients with schizophrenia annually in state psychiatric inpatient hospitals. (more…)
Author Interviews, Microbiome, Pharmacology / 19.07.2016

MedicalResearch.com Interview with: Mark Pimentel, MD Associate Professor, Medicine Director, GI Motility Program Director, GI Motility Laboratory Cedars-Sinai IBS-C Clinical Advisory Board (Chair) at Synthetic Biologics Los Angeles, CA MedicalResearch.com: What is the background for this study? Dr. Pimentel: The SYN-010 program is based on research from my group at Cedars-Sinai Medical Center, and other researchers and collaborators worldwide, investigating the role of intestinal methane production in functional gastrointestinal disorders. Low levels of intestinal methane are a ubiquitous by-product of normal intestinal microbial digestion; however, elevated intestinal methane levels are correlated with decreased intestinal motility and increased symptom severity in patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Methane in humans is produced almost exclusively by the intestinal microorganism Methanobrevibacter smithii (M. smithii). Highest levels of M. smithii are found in the colon; however, overgrowth of M. smithii into the small intestine has also been observed. Previous work from my laboratory demonstrated that methane production by M. smithii in stool samples from IBS-C patients is inhibited by the lactone form of lovastatin. Lovastatin lactone does not appear to eradicate microbial species in the intestine, which should reduce the risk of intestinal dysbiosis and/or the development of microbial resistance. SYN-010 is a proprietary, modified-release, oral formulation of lovastatin lactone, designed to protect lovastatin lactone from the stomach and release the active ingredient in two different locations of the intestinal tract where the M. smithii reside. SYN-010 exerts its therapeutic effect at the level of the intestinal microbiome and does not require absorption into the systemic circulation or conversion of the active ingredient (lovastatin lactone) to the cholesterol lowering β-hydroxyacid form. (more…)
Author Interviews, Diabetes, Heart Disease, JAMA, Pharmacology / 19.07.2016

MedicalResearch.com Interview with: Principal investigator A/Prof Suetonia Palmer PhD University of Otago, New Zealand Senior investigator Prof. Giovanni Strippoli MD, PhD, MPH, MM University of Sydney, Australia and Diaverum, Sweden MedicalResearch.com: What is the background for this study? Response: Network meta-analysis is a new technique that allows us to evaluate ALL medical therapies for a specific clinical problem. We wondered whether any of the usual drugs used to treat glucose levels in people with diabetes were safest or most effective. (more…)
Author Interviews, Pharmacology / 13.07.2016

MedicalResearch.com Interview with: M. N. V. Ravi Kumar PhD Professor of Pharmaceutical Sciences Texas A&M Rangel College of Pharmacy MedicalResearch.com: What is the background for this study? What are the main findings? Response: The use of ligands for receptor-mediated drug delivery offers potential for improving both the safety and efficacy of pharmaceuticals. Research to date, however, has yet to overcome some of the significant challenges of targeted drug delivery, one of which is competitive affinity with endogenous ligands. This competition for the receptor binding site can impair both natural cell processes and uptake of the drug complex across the cell wall. This article presents a unique, non-competitive active transport strategy for crossing the intestinal barrier. Gambogic acid (GA), as a ligand, was coupled with a polymer called poly(lactic-co--glycolic acid) (PLGA) that in turn can encapsulate drugs forming nanosystems to bind to transferrin receptors within the intestinal wall, which facilitated active gut barrier crossing. The study results show peak plasma concentrations of Cyclosporine A (CsA) in orally dosed rodents at 6 hours with the GA-ladened nanosystems vs 24 hours without GA. Additionally, brain concentrations of CsA are twice as high dosing with PLGA-GA NS compared with PLGA-NS (without GA). (more…)
Author Interviews, Cost of Health Care, Geriatrics, Pharmacology / 13.07.2016

MedicalResearch.com Interview with: Leigh Purvis, MPA Director of Health Services Research AARP Public Policy Institute Editors’ note: In conjunction with the AARP’s new investigative piece, 'Supplement Pills That Promise Too Much', Leigh Purvis, Director of the AARP Health Services Research program discussed the issue of the proliferation of supplements, often with labels that make extraordinary health benefit claims. MedicalResearch.com: How many Americans use nutritional supplements? How big is the business of supplements? Response: Supplements are very popular in the United States. This is particularly true for older adults. A recent study found that the proportion of older adults using supplements increased from 52 percent in 2005 to 64 percent in 2011, and the share using multiple supplements grew by nearly 50 percent. According to the National Institutes of Health, American spent an estimated $36.7 billion on dietary supplements in 2014. (more…)
Author Interviews, Heart Disease, Pharmacology / 04.07.2016

MedicalResearch.com Interview with: Robert Sheldon, MD, PhD Division of Cardiology, Department of Cardiac Sciences University of Calgary, Calgary, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vasovagal syncope is very common and more debilitating than most people appreciate. Probably up to 50% of people faint from this in their lives, making it the most common cardiovascular symptom. Around 15-20 years ago we had learned that the recurrence rates for vasovagal syncope were quite high, and that quality of life was correspondingly low. From the results of our earlier Vasovagal Pacemaker Study II and Prevention of Syncope Trial I (POST I) we knew that neither pacemakers nor beta blockers helped most patients with vasovagal syncope. However there was ample evidence that a reduction in venous return and cardiac preload were important early steps in the vasovagal cascade. Florinef is a salt-retaining mineralocorticoid that is successful in treating orthostatic hypotension with tantalizing early evidence that it might prevent vasovagal syncope induced by tilt tests. We therefore set out to test whether it prevented vasovagal syncope in a randomized placebo-controlled clinical trial. One important early part of designing a clinical trial is estimating the event rate in the untreated and treated arms. Based on our earlier work we could predict the untreated event rate but there were no data on which we could estimate the treated outcome rate. We therefore surveyed numerous colleagues for what they considered a Minimal Clinically Important Difference, and the answer was a 40% relative risk reduction. That is, to make fludrocortisone appealing to clinicians it should cause a relative risk reduction of 40%. We used this estimate to design the study. There are two main conclusions.
  • First, we studied the right population, people who would clearly be considered for active biomedical treatment. They had fainted 15-20 times in their lives and 3-4 times in the preceding year.
  • Second, we found that fludrocortisone reduced syncope by 31%, and this narrowly missed conventional statistical significance. However when we adjusted for the first two weeks that were allotted for dose adjustment we found that fludrocortisone reduced syncope by up to 50% in people who were taking 0.2 mg daily. This is quite a low dose, deliberately picked to be safe in this young and predominantly female population.
(more…)
Addiction, Author Interviews, Cancer Research, Pharmacology / 04.07.2016

MedicalResearch.com Interview with: Dr Wai Liu Senior Research Fellow St George's University of London London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Naltrexone is a drug commonly used to wean addicts off alcohol and heroin, but clinical evidence has shown that when the drug is used at lower doses, patients would exhibit alter immunity. The symptoms that patients with a number of autoimmune diseases and those associated with chronic pain would ease significantly. Additionally, a number of reports showed patients with some forms of cancer would experience therapeutic benefit. Interestingly, the doses of the drug was crucial, and the non-conventional effects of naltrexone was only achieved at doses that were lower that what was conventionally used. We set about to understand why a drug could have such different effects when used at differing doses. Our results show that the genetic profile of the drug is subtly different at the two different doses, which helped us identify novel ways in which the drug could be used to induce an anticancer effect. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Pharmacology / 29.06.2016

MedicalResearch.com Interview with: Dr Kieran Breen PhD Director of Research, Brain Tumour Research University of Portsmouth, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is evidence that aspirin (acetyl salicylic acid) can be toxic to brain tumour cells. However, its existing preparations cannot readily enter the brain because the drug is a suspension rather than being completely soluble. Furthermore, there can be significant side effects associated with the existing form of the drug including gastric bleeding. The object of this research was to develop a new formulation of aspirin which is truly soluble. When combined with two other compounds, the drug enters the brain and can therefore target the tumour cells. This study also showed that aspirin can kill tumour cells without causing any damage to the normal nerve cells. (more…)
Author Interviews, Heart Disease, JAMA, Pharmacology, UCSF / 27.06.2016

MedicalResearch.com Interview with: Dr. Gregory M. Marcus MD Gregory M Marcus, MD, MAS, FACC, FAHA, FHRS Director of Clinical Research Division of Cardiology Endowed Professor of Atrial Fibrillation Research  University of California, San Francisco MedicalResearch.com: What is the background for this study? What are the main findings? Response: Conduction system disease, or blockages in the electrically system (as opposed to blockages in the blood vessels, of which most are well-aware), is a common condition responsible for both heart failure in many patients as well as the need for pacemaker implantation. Although treatments for the disease are available, there are no known means to prevent it. This is important as the primary treatment, a pacemaker, can itself cause problems (including procedural complications, a long-term risk of infection with repeated battery changes, and even a greater risk of heart failure). In addition, predictors of what types of individuals are at risk for developing conduction disease has largely remained unknown. Based on the fact that the majority of conduction disease is due to fibrosis, or scarring, of the conduction system, we sought to test the hypothesis that a common drug for high blood pressure with anti-fibrotic properties, Lisinopril, might reduce the risk of new conduction system disease. We took advantage of the fact that more than 20,000 patients with hypertension were randomized to three common high blood pressure drugs that work via different mechanisms in the ALLHAT trial: Lisinopril, amlodipine, and chlorthalidone. We found that participants randomly assigned to Lisinopril were statistically significantly less likely to develop conduction disease. In addition, our analyses revealed several risk factors for the development of conduction disease: older age, male sex, diabetes, smoking, a thicker heart, and white race (compared to black race). (more…)
Author Interviews, Infections, Pharmacology, Urinary Tract Infections / 25.06.2016

MedicalResearch.com Interview with: Amanda Paschke, MD Director, Infectious Disease Clinical Research Merck Research Laboratories MedicalResearch.com: What is the background for this study? What are the main findings? Response: Relebactam is an investigational beta-lactamase inhibitor being developed as a fixed-dose combination with imipenem/cilastatin, which is a broad-spectrum antibiotic in the carbapenem class. In preclinical studies, this combination demonstrated antibacterial activity against a broad range of multidrug-resistant Gram-negative pathogens, including those producing extended-spectrum beta-lactamases such as Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae and AmpC-producing Pseudomonas aeruginosa. Many of the most concerning infections caused by “superbugs” are caused by Gram-negative bacteria. These bacteria have evolved to be resistant to commonly used antibacterials, and even to antibacterials used as “last resort” treatment, which is why finding ways to treat them has become urgent. The addition of relebactam to imipenem is designed to restore activity of imipenem against certain imipenem-resistant strains of Gram-negative bacteria known to cause serious infections among people who often have other underlying medical conditions, which complicates treatment. This was a Phase 2, multicenter, randomized, double-blind, non-inferiority study. The study looked at the use of relebactam plus imipenem versus imipenem alone for the treatment of adult patients with complicated urinary tract infections. The primary endpoint for the trial was microbiological response at the completion of IV study therapy. The study met its primary endpoint, demonstrating that the combination of relebactam with imipenem was as at least as effective as imipenem alone for the treatment of complicated urinary tract infections. The trial also demonstrated that the combination of relebactam plus imipenem is well-tolerated, with a safety profile similar to that of imipenem alone in this patient. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, JAMA, Pharmacology / 22.06.2016

MedicalResearch.com Interview with: Thomas Andrew Gaziano, MD, MSc Department of Cardiology Assistant Professor Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Heart failure (HF) is the leading cause of admissions to hospitals in the United States and the associated costs run between $24-47 billion annually. Targeting neurohormonal pathways that aggravate the disease has the potential to reduce admissions. Enalapril, an angiotensin converting enzyme-inhibitor (ACEI), is more commonly prescribed to treat HF than Sacubitril/Valsartan, an angiotensin-receptor/neprilysin inhibitor (ARNI). The latter was shown to reduce cardiovascular death and hospitalizations due to heart failure in a multi-country, randomized clinical (PARADIGM-HF), compared to Enalapril. In order to assess the cost-effectiveness of Sacubitril/Valsartan, compared to Enalapril, in the United States, we created a model population with population characteristics equivalent to the population in the PARADIGM-HF trial. Using a 2-state Markov model we simulated HF death and hospitalizations for patients with a left ventricular ejection fraction (LVEF) of 40% or less. (more…)
Author Interviews, Heart Disease, JAMA, Pharmacology, UCLA / 22.06.2016

MedicalResearch.com Interview with: Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA, 90095-1679 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Fonarow: Angiotensin receptor neprilysin inhibitors (ARNI) have been demonstrated to reduce mortality in patients with heart failure with reduced ejection fraction. However, to date, the population level impact of optimal implementation of this therapy in the United States has not been evaluated. This new analysis estimates that as many 28,484 deaths in heart failure with reduced ejection fraction patients annually could be prevented or postponed with optimal use of angiotensin receptor neprilysin inhibitors (with sensitivity analyses demonstrating a range of 18,230 to 41,017). (more…)
Annals Internal Medicine, Author Interviews, Diabetes, Hepatitis - Liver Disease, Pharmacology / 22.06.2016

MedicalResearch.com Interview with: Kenneth Cusi, M.D., F.A.C.P., F.A.C.E. Professor of Medicine VAMC staff Chief, Division of Endocrinology, Diabetes and Metabolism The University of Florida Gainesville, FL 32610-0226 MedicalResearch.com: What is the background for this study? Dr. Cusi: Many patients with prediabetes or Type 2 Diabetes Mellitus (T2DM) are not diagnosed with Nonalcoholic steatohepatitis (NASH), a disease that is the second cause of liver transplantation in the United States. It is also associated with worse cardiovascular disease and harder to control T2DM. We had done in this population a proof-of-concept study published in Nov 2006 in the NEJM. But we lacked a larger, long-term study for definitive proof. This is the largest SINGLE center study, and the longest ever (3 years). NASH is an overlooked problem for perhaps as many as one-third of patients with Type 2 Diabetes Mellitus. There is now a safe and effective treatment option for patients with T2DM and NASH – pioglitazone will become for NASH what metformin is to the treatment of T2DM: a safe, effective, the “backbone therapy" to which other treatments will be added. (more…)
Author Interviews, Education, JAMA, Pharmacology, UCSF / 21.06.2016

MedicalResearch.com Interview with: Colette DeJong Medical student at UCSF and Research Fellow at the UCSF Center for Healthcare Value. MedicalResearch.com: What is the background for this study? Response: Data released under the U.S. Sunshine Act reveals that in the last five months of 2013, over half of American physicians received free meals, gifts, or payments from the pharmaceutical industry. Recent studies have shown that doctors who receive large payments from drug companies—such as speaking fees and royalties—are more likely to prescribe expensive brand-name drugs, even when generics are available. Our findings, however, suggest that physicians’ prescribing decisions may be associated with much smaller industry payments than previously thought. We found that doctors who receive a single industry-sponsored meal—with an average value under $20—are up to twice as likely to prescribe the brand-name drug being promoted. (more…)
Annals Internal Medicine, Author Interviews, Pharmacology / 17.06.2016

MedicalResearch.com Interview with: Steven Woloshin, MD Professor of The Dartmouth Institute Professor of Medicine Professor of Community and Family Medicine New Hamphsire MedicalResearch.com: What is the background for this study? Dr. Woloshin: Drug companies are required by law to post results of trials used to support drug applications to the FDA on the clinicaltrials.gov website - but it is not clear whether posted results are complete and accurate. Recent studies attempting to validate posted results by comparing them to corresponding peer reviewed medical journal publications suggest that discrepancies are relatively common. But it is which source is more likely to be correct. We tried to validate posted results against an arguably better gold standard, the drug approval packages from the FDA (ie, the medical and statistical reviews posted on the [email protected] website). FDA reviews have an advantage over peer reviewed publications: unlike medical journal editors and peer reviewers, FDA has access to the individual participant data from the trials. This means FDA can see all the trials and all the outcomes (avoiding sleective publication) and it means FDA can independently reanalyze according to what they believe to be the best statistical practices (data can be analyzed in many ways - and different decisions, for example, how to account for missing data, can yield very different results). (more…)
Author Interviews, Diabetes, Pharmacology / 15.06.2016

MedicalResearch.com Interview with: Professor Philip Home D.M., D.Phil Professor of Diabetes Medicine Newcastle University MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Home: MK1293 is a biosimilar insulin designed with the same amino acid sequence, manufacturing process and formulation as originator insulin glargine (Lantus). This is the clinical proving study in type 1 diabetes, being a 24-week randomized study in 508 participants between MK1293 and Lantus. The primary efficacy endpoint of non-inferiority of HbA1c was met, as was a secondary of equivalence (difference in change from baseline 0.04 (95% CI -0.11, 0.19) %-units), with other measures including hypoglycaemia, insulin antibodies and adverse events also consistent with similarity. (more…)
Author Interviews, JAMA, Pharmacology, UCSD, Weight Research / 15.06.2016

MedicalResearch.com Interview with: Siddharth Singh, MD, MS Postdoctoral Fellow, NLM/NIH Clinical Informatics Fellowship Division of Biomedical Informatics Clinical Assistant Professor of Medicine, Division of Gastroenterology, Department of Internal Medicine, University of California San Diego, La Jolla MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Singh: Over the last 4 years, four new medications have been approved for long-term use for weight loss by the FDA. We sought to evaluate the comparative effectiveness and tolerability of these medications through a systematic review and network meta-analysis. Based on 28 trials in over 29,000 overweight or obese patients, we observed that magnitude of weight loss achieved with these agents is variable, ranging from 2.6kg with orlistat to 8.8kg with phentermine-topiramate. Over 44-75% of patients are estimated to lose at least 5% body weight, and 20-54% may lose more than 10% of body weight; phentermine-topiramate was the most efficacious, whereas lorcaserin was the best tolerated. (more…)
Author Interviews, Pharmacology, Sleep Disorders / 14.06.2016

MedicalResearch.com Interview with: Anna-Therese Lehnich Zentrum für Klinische Epidemiologie (ZKE) c/o Institut für Medizinische Informatik Biometrie undEpidemiologie (IMIBE) MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sleep disturbances and their consequences are often underestimated but they are of high importance with respect to public health. We were interested in the question whether drugs labeled as sleep disturbing in the summary of product characteristics actually lead to more sleep disorders like difficulties falling asleep, difficulties maintaining sleep, and early morning arousal. To answer this question, we analyzed data of 4,221 persons from Germany. (more…)
Author Interviews, Diabetes, Kidney Disease, Pharmacology / 13.06.2016

MedicalResearch.com Interview with: Doctor Hiddo Lambers Heerspink Department of Clinical Pharmacy and Pharmacology University Medical Center Groningen the Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: SGLT2 inhibitors, including canagliflozin, have beneficial effects on multiple cardiovascular and renal risk parameters. This suggests that SGLT2 inhibitors may confer cardiovascular and renal protection. A recent large clinical trial with the SGLT2 inhibitor empagliflozin demonstrated marked reductions in cardiovascular morbidity and mortality and suggested possible renoprotective effects. Whether SGLT2 inhibition slows the progression of kidney function decline independent of its glucose-lowering effect, however, is unknown. We therefore assessed whether canagliflozin slows the progression of kidney function decline by comparing the effects of canagliflozin versus glimepiride on eGFR and albuminuria. (more…)
ASCO, Author Interviews, Cancer Research, Geriatrics, Lymphoma, NYU, Pharmacology / 07.06.2016

MedicalResearch.com Interview with: Dr. Catherine S. M. Diefenbach MD Assistant Professor of Medicine NYU Cancer Center New York, NY 10016 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Diefenbach: It is well known that age is important prognostic factor in non-Hodgkin’s lymphoma (NHL). Multiple studies have illustrated that elderly lymphoma patients have inferior survival outcomes as compared to their younger counterpart. While the tumor biology is often different in these two groups, and may play a role in this discordancy, elderly patients are often frail or have multiple medical comorbidities. These include geriatric syndromes, such as: cognitive impairment, falls, polypharmacy, and potentially inappropriate medication (PIM) use. All of these may contribute to poor outcomes for elderly patients. In addition, elderly patients are often under-treated for their aggressive lymphoma out of concern for toxicity or side effects, even though the data clearly demonstrates that elderly patients can still benefit from curative intent chemotherapy. (more…)
Author Interviews, Pharmacology / 02.06.2016

MedicalResearch.com Interview with: Professor Neil Carragher Principal Investigator Drug Discovery Institute of Genetics and Molecular Medicine University of Edinburgh MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Carragher: The aim of the study was to generate novel small molecule inhibitors that target breast cancers using a strategy which we named: "dual ligand based phenotypic screening". From initial derivation of a small chemical library based on a promiscuous kinase inhibitor PP1, iterative screening across a suite of breast cancer phenotypic assays guided chemical design towards the novel compound eCF506. eCF506 is a highly potent, orally bioavailable and specific inhibitor of Src Kinase. (more…)
Author Interviews, Emory, PAD, Pharmacology / 15.05.2016

MedicalResearch.com Interview with: Shipra Arya MD, SM Assistant Professor, Division of Vascular Surgery Emory University School of Medicine Assistant Professor of Epidemiology (Adjunct) Rollins School of Public Health Staff Physician, Atlanta VA Medical Center Director, AVAMC Vascular Lab and Endovascular Therapy  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Arya: Peripheral Arterial Disease is the next cardiovascular epidemic. It is poorly recognized and not adequately treated compared to heart disease – and research is lacking on the optimal use of statins for PAD patients. Very few randomized clinical trials have been done specifically in PAD patients to assess the impact of statins on cardiovascular outcomes and none on limb related outcomes. The 2013 ACC/AHA guidelines for cholesterol lowering medications recommends high intensity statins for PAD patients extrapolated from the level 2 and 3 evidence and empirically based on CAD and stroke data. In this study we looked at the amputation and mortality risk based on statin dosage in a large cohort of patients from the VA population and found that high intensity statins are associated with a significant reduction in limb loss (~30%) and mortality (~25%) in PAD patients followed by a smaller risk reduction [~23% for amputation risk reduction and 20% reduction in mortality risk] by low-moderate intensity statins as compared to no statin therapy. (more…)
Author Interviews, Geriatrics, Pharmacology / 13.05.2016

MedicalResearch.com Interview with: Leigh Purvis, MPA Director of Health Services Research AARP Public Policy Institute MedicalResearch.com Editor’s Note: The May AARP Bulletin has a important article “Black Market Meds Are Flooding the Nation’s Pharmacies And Hospitals” by Joe Eaton, discussing the growing problem of counterfeit medications entering the US pharmaceutical supply chain. Ms. Leigh Purvis of the AARP Policy Institute discussed this important issue for the readers of MedicalResearch.com. Ms. Purvis’ areas of expertise include prescription drug pricing, biologic drugs, and Medicare prescription drug coverage.  MedicalResearch.com: Is pharmaceutical theft and fraud a new or growing problem? Ms. Purvis: I think it’s safe to say that pharmaceutical theft is a growing problem. Skyrocketing prices have made pharmaceuticals a lucrative target for criminals. Trucks transporting pharmaceuticals are a common target, although some thieves have stolen prescription drugs directly from manufacturers’ warehouses. Pharmaceutical fraud is also a growing concern. FDA does a great deal to ensure the safety of US pharmaceuticals. However, problems can still arise, particularly when people purchase drugs online. (more…)
Abuse and Neglect, Author Interviews, NYU, Pharmacology, Urology / 11.05.2016

MedicalResearch.com Interview with: Dr. Jed Kaminetsky MD Clinical Assistant Professor Department of Urology NYU Langone Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kaminetsky: Nocturia is a voiding disorder not well treated by available drugs for overactive bladder and benign prostatic hypertrophy. Desmopressin stimulates the kidneys to concentrate the urine which results in a greatly reduced volume of urine formation for a period of time. Serenity Pharmaceuticals has spent many years developing a low dose nasal spray version of desmopressin called Noctiva specifically for nocturia. The study reported now is a large, placebo controlled phase 3 trial to confirm the statistical efficacy and clinical benefit of this treatment for nocturia. (more…)
Author Interviews, OBGYNE, Pharmacology, Science / 11.05.2016

MedicalResearch.com Interview with: Lynda Harris PhD Lecturer in Pharmaceutics University of Manchester Manchester Pharmacy School Maternal and Fetal Health Research Centre Manchester MedicalResearch.com: What is the background for this study? Dr. Harris: Pregnancy complications such as pre-eclampsia and fetal growth restriction remain a problem despite advances in antenatal care, and impact heavily on future health: small size at birth is associated with an increased risk of cardiovascular disease and diabetes in later life. Drugs to improve pregnancy outcome are severely lacking, as pregnant women are considered a high risk cohort by drug companies, who fear expensive lawsuits associated with side effects and teratogenicity. The majority of pregnancy complications are caused by a poorly growing or poorly functioning placenta. A number of potential drugs have been identified that enhance placental function in vitro, and improve fetal growth in animal models; however, there is currently no means of restricting their actions to the placenta, and systemic administration of these drugs to pregnant women is not feasible due to the risk of adverse effects in other tissues. To address this issue, we have identified a series of placental “homing peptides” which we have used to create nanocarriers for targeted delivery of drugs to the placenta. (more…)
Author Interviews, Lipids, Pharmacology / 06.05.2016

MedicalResearch.com Interview with: Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA Associate Professor, Social, Behavioral & Administrative Pharmacy Touro College of Pharmacy New York, NY 10027 & Of Counsel Sorell, Lenna, & Schmidt, LLP MedicalResearch.com: What is the background for this study? Dr. Rumore: The management of lipid therapy is only one component that affects overall cardiovascular outcomes.This study is one of the first to look at the benefits of dose titration versus intensity-based statin therapy.  To evaluate whether patients titrated on statin therapy using ATPIII algorithm with an LDL goal of <100mg/dL also met the 2013 ACC/AHA Guideline for Management of Blood Cholesterol goal of ≥40% LDL reduction from baseline compared to inpatients initiated on high-moderate intensity statin (HIS).  Other objectives included comparison of algorithms to lower LDL ≥40%, final dose, adverse drug events (ADEs), clinic visits to goal, and cardiovascular event occurrence. MedicalResearch.com: What are the main findings? Dr. Rumore: 981 patients were included- 43% were titrated and 57% achieved LDL<100; 38% achieved both LDL <100mg/dL and LDL ≥40% reduction; 58% received HIS and 53% achieved LDL <100; 43% achieved both LDL <100mg/dL and LDL ≥40% reduction. Initiating patients on  High Intensity statins was not more effective than dose titration in achieving <100mg/dL and ≥40% LDL reduction;X2=0.006,N=159,p=0.938. A 50% LDL reduction in patients that also achieved an LDL <100 was 54% and 48%, in titration and HIS groups, respectively; X2=0.611,N=159,p=0.434.  The titration group required an average of 4.3 clinic visits to achieve goal, compared to 3.1 visits for HIS; p=0.309; 95% CI(-1.36,1.06). (more…)
Author Interviews, Outcomes & Safety, Pharmacology / 06.05.2016

MedicalResearch.com Interview with: Serene I. Chen MD Dr. Chen is an emergency medicine resident at Highland Hospital, in Oakland, California. She was a student at the Yale School of Medicine when this research was conducted. MedicalResearch.com: What is the background for this study? Dr. Chen: To address the rise in U.S. drug shortages, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012—and early evidence does suggest that the overall number of new shortages have decreased. However, we found that drugs that are frequently used emergency departments and other acute settings are still affected by more frequent and increasingly prolonged shortages. (more…)