Author Interviews, Pharmacology, Schizophrenia / 31.10.2018

MedicalResearch.com Interview with: Jelena Kunovac, M.D., M.S. Founder and Chief Executive Chief Medical Officer Altea Research Las Vegas, Nevada MedicalResearch.com: What is the background for this study? Response: We conducted the study to confirm that the addition of samidorphan to olanzapine does not have an effect on the antipsychotic efficacy of olanzapine in subjects with an acute exacerbation of schizophrenia. (more…)
Author Interviews, Kidney Disease, Mineral Metabolism, Pharmacology / 29.10.2018

MedicalResearch.com Interview with: Dr Mattias Ivarsson PhD CEO, Inositec, co-author of data MedicalResearch.com: What is the background for this study? Response: When control of factors in the blood that regulate mineral balance in the body is lost, the subsequent build-up of calcium deposits in the arterial walls and cardiac valves lead to an increase in cardiac events, particularly in patients with chronic kidney disease or diabetes, as well as all-cause mortality. There is a significant unmet need for therapeutic agents capable of reducing pathological mineral accumulation regardless of their root cause. To date, there is no approved therapy for treating calcification-dependent cardiovascular disease.  (more…)
Author Interviews, Geriatrics, JAMA, Pharmacology / 17.10.2018

MedicalResearch.com Interview with: Dr. Emily Reeve BPharm(Hons) PhD NHMRC-ARC Dementia Research Fellow Northern Clinical School University of Sydney MedicalResearch.com: What is the background for this study? What are the main findings? Response: Older adults commonly take multiple medications. All medications carry the potential for both benefit and harm. When a medication is started a decision has been made between the healthcare professional and the patient that the likely benefits outweigh the potential risks. But over time the potential benefits and harms can change. So, part of good clinical care is discontinuation of medications when the benefit no longer outweighs the risks – for example when it is no longer needed or high risk. This is called “deprescribing”. Previously we knew that older adults could have mixed feelings about their medications, that is, they believe that all their medications are necessary but also feel that they are a burden to them. Qualitative research has explored this further, finding that there are a number of barriers and enablers to deprescribing from the patient perspective. For example, someone might have fear of deprescribing because they are worried that their symptoms may come back. But if they know that deprescribing is a trial and they will be monitored and supported by their physician or other healthcare professional they might be more open to deprescribing. From the physician perspective, there were concerns that older adults and their families were resistant to deprescribing and so there was fear that discussing possible medication discontinuation could damage the doctor-patient relationship. In this study of almost 2000 older adults in the United States, we found that over 90% were willing to stop one of more of their medications if their doctor said it was possible. Additionally, one third of participants wanted to reduce the number of medications that they were taking.  (more…)
Author Interviews, JAMA, Neurology, Outcomes & Safety, Parkinson's, Pharmacology, University of Pennsylvania / 04.10.2018

MedicalResearch.com Interview with: Allison W. Willis, MD, MS Assistant Professor of Neurology Assistant Professor of Biostatistics and Epidemiology Senior Fellow, Leonard Davis Institute Senior Scholar, Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study was motivated by my own experiences as a neurologist-neuroscientist. I care for Parkinson disease patients, and over the year, have had numerous instances in which a person was taking a medication that could interact with their Parkinson disease medications, or could worsen their PD symptoms. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA, Pharmacology / 17.08.2018

MedicalResearch.com Interview with: Dr Ruth Webster PhD, BMedSc(hons), MBBS(hons), MIPH(hons) Head, Research Programs, Office of the Chief Scientist Senior Lecturer, Faculty of Medicine UNSW Sydney The George Institute for Global Health Australia MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We know from previous research that 80% of the blood pressure lowering efficacy of any medication occurs in the first half of the dose whilst most side effects occur at higher doses. We also know that most people will require at least 2 blood pressure lowering medications to reach their target blood pressure and that combining multiple pills into one combination medication helps patients take their medication more reliably. There was therefore good evidence to believe that using three half strength doses in one pill would be better than usual care in helping patients to achieve their blood pressure targets. We showed that, compared with patients receiving usual care, a significantly higher proportion of patients receiving the Triple Pill achieved their target blood pressure of 140/90 or less (with lower targets of 130/80 for patients with diabetes or chronic kidney disease). It's estimated more than a billion people globally suffer from high blood pressure with the vast majority having poorly controlled blood pressure. Our results could help millions of people globally reduce their blood pressure and reduce their risk of heart attack or stroke. (more…)
Alzheimer's - Dementia, Author Interviews, Pharmacology / 16.08.2018

MedicalResearch.com Interview with: MedicalResearch.comVesa Tapiainen, MD School of Pharmacy, University of Eastern Finland Research Centre for Comparative Effectiveness and Patient Safety University of Eastern Finland Kuopio, Finland  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alzheimer’s disease is a non-curable dementing disease and a major health concern and thus, identification of potential modifiable risk factors, such as benzodiazepines, is important. Benzodiazepines and related drugs are commonly used among older people as every fourth older people use them. Benzodiazepines and related drugs were associated with modestly increased risk of Alzheimer’s disease. A dose-response relationship was observed with higher cumulative dose and longer use periods being associated with higher risk of Alzheimer’s disease. The risk associated with larger cumulative doses was partly explained by more common use of other psychotropics among these persons.  (more…)
Addiction, Author Interviews, Opiods, Pharmacology / 06.08.2018

MedicalResearch.com Interview with: Mark Pirner, MD, PhD Senior Medical Director Clinical Research and Medical Affairs US WorldMeds MedicalResearch.com: What is the background for this announcement? How does lofexidine differ from other opioid withdrawal medications? Response: LUCEMYRA™ (lofexidine) was FDA-approved on May 16 as the first and only non-opioid, non-addictive medication for the management of opioid withdrawal in adults. LUCEMYRA mitigates the acute and painful symptoms of opioid withdrawal by suppressing the neurochemical surge in the brain that occurs when opioids are abruptly discontinued. In clinical studies, patients receiving treatment with LUCEMYRA experienced greater symptom relief and were significantly more likely to complete their withdrawal. LUCEMYRA is not an opioid drug and is not a treatment for opioid use disorder; it should be used as part of a longer-term treatment plan. (more…)
Author Interviews, Eli Lilly, Lancet, Pharmacology, Rheumatology, UCLA / 26.07.2018

MedicalResearch.com Interview with: Daniel J. Wallace M.D., FACP, MACR Associate Director, Rheumatology Fellowship Program Board of Governors, Cedars-Sinai Medical Center Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA In affiliation with Attune Health Beverly Hills, Ca 90211 MedicalResearch.com: What is the background for this study? What are the main findings?   Response: This is the first positive study of systemic lupus erythematosus (SLE) using baricitinib,  a small oral molecule that blocks the JAK system. The human kinome consists of 500 genes and helps regulate cell surface receptor interaction. While agents that inhibit certain pathways are approved for rheumatoid arthritis and certain malignancies, this is the first study of its kind in SLE. (more…)
Author Interviews, BMJ, Boehringer Ingelheim, McGill, Pharmacology / 19.07.2018

MedicalResearch.com Interview with: Samy Suissa, PhD Director, Centre for Clinical Epidemiology, Lady Davis Institute Professor, Departments of Epidemiology and Biostatistics and of Medicine McGill University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sulfonylureas are widely used oral antidiabetic drugs that are recommended as second-line treatments after first-line metformin to treat patients with type 2 diabetes. While their safety has been studied extensively, studies in patients with poorly controlled diabetes in need of pharmacotherapy escalation have been sparse and limited. Our study evaluated whether adding or switching to sulfonylureas after initiating metformin treatment is associated with increased cardiovascular or hypoglycaemic risks, compared with remaining on metformin monotherapy. Using a large cohort of over 77,000 patients initiating treatment with metformin monotherapy, we found that adding or switching to sulfonylureas is associated with modest increases of 26% in the risk of myocardial infarction and 28% in the risk of death, as well as an over 7-fold major increase in the risk of severe hypoglycaemia leading to hospitalisation. In particular, we found that switching from metformin to sulfonylureas was associated with higher risks of myocardial infarction and death, compared with adding sulfonylureas to metformin.  (more…)
Author Interviews, Education, Mental Health Research, Pharmacology / 28.06.2018

MedicalResearch.com Interview with: Kiyohito Iigaya PhD Gatsby Computational Neuroscience Unit and Max Planck UCL Centre for Computational Psychiatry and Ageing Research University College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Serotonin (5-HT) is believed to play many important roles in cognitive processing, and past experiments have not crisply parsed them. We developed a novel computational model of mice behavior that follows reinforcement learning principles, which are widely used in machine learning and AI research. By applying this model to experimental data, we found that optogenetic 5-HT stimulation speeds up the learning rate in mice, but the effect was only apparent on select subset of choices. (more…)
Author Interviews, Dermatology, Environmental Risks, Pharmacology / 28.06.2018

MedicalResearch.com Interview with: Sidsel Arnspang Pedersen MD Department of Public Health, Clinical Pharmacology and Pharmacy Anton Pottegård PhD Associate professor, Clinical Pharmacy Odense University Hospital University of Southern Denmark, The following is based on results from three published papers in JAAD and JAMA Internal Medicine. (1–3)   MedicalResearch.com: What is the background for this study? Response: Hydrochlorothiazide is one of the most frequently used diuretic and antihypertensive drugs in the United States and Western Europe. The drug is known to be photosensitizing and has previously been linked to lip cancer.4–6 Based on these previous findings, the International Agency for Research on Cancer (IARC) has classified hydrochlorothiazide as ‘possibly carcinogenic to humans’ (class 2B). This prompted us to investigate whether use of hydrochlorothiazide was associated to other UV dependent skin cancers, including non-melanoma skin cancer (i.e. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)), cutaneous melanoma, as well as the more rare non-melanoma skin cancers Merkel cell carcinoma and malignant adnexal skin tumours. (more…)
Addiction, Author Interviews, Opiods, Pharmacology / 30.04.2018

MedicalResearch.com Interview with: Maria Sullivan, M.D., Ph.D Senior Medical Director of Clinical Research and Development Alkermes MedicalResearch.com: What is the background for this study? Response: Extended release injectable naltrexone is approved for the prevention of relapse to opioid dependence after detoxification and when used with counseling. It is recommended that patients abstain from opioids for a minimum of seven to 10 days prior to induction onto XR-naltrexone to avoid precipitating opioid withdrawal. This requirement of detoxification represents a substantial clinical challenge, particularly in the outpatient setting. There is currently no single recognized best method for opioid detoxification prior to first dose of extended-release naltrexone (XR-naltrexone). A number of induction regimens have been explored, including the use of low doses of oral naltrexone to shorten the transition period from dependence on opioids to XR-naltrexone treatment. The goal of the study was to help establish an outpatient regimen to transition subjects from physiological opioid dependence to XR-naltrexone treatment and mitigate the severity of opioid withdrawal symptoms. We hypothesized that low-dose oral naltrexone, combined with buprenorphine and psychoeducational counseling, would assist with the transition of patients with opioid use disorder onto XR-naltrexone. In this 3-arm trial, we examined the utility of oral naltrexone, buprenorphine, and a fixed regimen of ancillary medications (oral naltrexone + buprenorphine vs. oral naltrexone + placebo buprenorphine vs. placebo +placebo), to determine whether any of these regimens was associated with higher rates of induction onto XR-naltrexone. (more…)
Author Interviews, Diabetes, Gastrointestinal Disease, Pharmacology / 22.03.2018

MedicalResearch.com Interview with: Devin Abrahami, graduate student Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal Department of Epidemiology, Biostatistics, and Occupational Health McGill University, Montreal, QC, Canada MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The goal of our study was to assess whether a class of antidiabetic drugs, the dipeptidyl peptidase-4 (DPP-4) inhibitors, is associated with the risk of inflammatory bowel disease (IBD). While these drugs control blood sugar levels in patients with type 2 diabetes, there is some evidence that they may also be involved in immune function, and possibly in conditions such as IBD. In our study, we found that the use of DPP-4 inhibitors was associated with a 75% increased risk of IBD, with the highest risk observed after three to four years of use. (more…)
Author Interviews, Pharmacology, Schizophrenia / 04.02.2018

MedicalResearch.com Interview with: Hsien-Yuan Lane, MD,PhD Distinguished Professor, Director, Graduate Institute of Biomedical Sciences China Medical University, Taichung, Taiwan Director, Brain Diseases Research Center (BDRC), Addiction Research Center, and Department of Psychiatry, China Medical University and Hospital, Taichung, Taiwan PI, Taiwan Clinical Trial Consortium for Mental Disorders  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Schizophrenia is a chronic and severe mental illness affecting more than 21 million people worldwide. Clozapine has been regarded as the last-line antipsychotic agent for patients with refractory schizophrenia. However, an estimated 40–70% of patients with refractory schizophrenia fail to improve even with clozapine , referred to as “clozapine-resistant”. To date, there is no convincing evidence for augmentation on clozapine. Activation of N-methyl-D-aspartate (NMDA) receptors, including inhibition of D-amino acid oxidase (DAAO) that may metabolize D-amino acids, has been reported to be beneficial for patients receiving antipsychotics other than clozapine. Sodium benzoate is a DAAO inhibitor. A recent randomized, double-blind, placebo-controlled clinical trial found that add-on sodium benzoate improved the clinical symptoms in patients with clozapine-resistant schizophrenia, possibly through DAAO inhibition and antioxidation as well. (more…)
Author Interviews, Pharmacology / 26.01.2018

MedicalResearch.com Interview with: “#Headache situation #ibuprofen” by Khairil Zhafri is licensed under CC BY 2.0David Kaufman, ScD Director, Slone Epidemiology Center, Boston Universit Professor of Epidemiolog Boston University School of Public Health  MedicalResearch.com: What is the background for this study?   Response: Ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most-used medicines in the US, but, if too much is taken, can cause harm. This was an internet-based diary study.  1326 individuals who reported taking an ibuprofen medication in the preceding month completed a daily diary of their NSAID use for one week.  The daily dosage ingested was computed from the diary, which allowed us to determine whether a user exceed the recommended daily maximum dose. (more…)
Author Interviews, Parkinson's, Pharmacology / 14.12.2017

MedicalResearch.com Interview with: Dr. Youcef Mehellou PhD Lecturer in Medicinal Chemistry Cardiff School of Pharmacy and Pharmaceutical Sciences Cardiff University MedicalResearch.com: What is the background for this study? Response: Over the last decade or two, there has been many reports linking genetic mutations to the pathogenesis of Parkinson’s disease (PD). Among the proteins that have been found to be mutated in PD is a protein called PINK1. Indeed, PINK1 mutations that disturb its function in cells were found to be causal of PD in humans. Subsequent studies showed that PINK1 is a major player in maintaining healthy neurons. This is because it is one of the components involved in controlling the quality of the mitochondria, an organelle within the cell, and it does this by triggering the disposal of unhealthy mitochondria. Overall, studies into PINK1 indicated that the activation of PINK1 as a plausible strategy for maintaining health neurons and hence slowing down the development and progress of Parkinson’s disease. (more…)
Abuse and Neglect, Dermatology, Pharmacology / 11.12.2017

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois MedicalResearch.com: What is the background for this study? What are the main findings? Response: Systemic corticosteroids are commonly used as systemic treatments for atopic dermatitis. However, few studies assessed the efficacy and safety of systemic corticosteroids in atopic dermatitis. This systematic review sought to summarize the available evidence for their use in atopic dermatitis. Overall, 52 reviews and 12 studies were included in this systematic review. Most studies suffered from small sample size, low quality. In one of the only randomized-controlled trials performed, systemic corticosteroids were less effective than cyclosporine and led to more rebound flares. There were numerous safety and tolerability concerns with both short and long-term treatment with systemic corticosteroids. One study found that even short-term use of systemic corticosteroids was associated with increased sepsis, venous thromboembolism and fractures. (more…)
Author Interviews, Cancer Research, Orthopedics, Pharmacology / 13.11.2017

MedicalResearch.com Interview with: Charles L.Shapiro MD Professor of Medicine Director of Translational Breast Cancer Research Director of Cancer Survivorship Division of Hematology/Oncology Tisch Cancer Institute New York, NY MedicalResearch.com: What is the background for this study? What are the main findings? Response: The new 2017 ASCO guidelines for the use bone-modifying in individuals with bone metastases recently endorsed every 3-month zoledronic, because of high level evidence from three randomized trials, including our trial (published in Jama in Jan 2017, first author Himelstein et al) that giving zoledronic acid every 3-months was non-inferior to the standard of monthly zoledronic. The guidelines also concluded that there was not one preferred bone modifying agent of the other, despite the fact the comparing monthly zoledronic to monthly denosumab in women with bone metastases, denosumab delayed the time to first skeletal-related event (pathological fractures, necessity for radiation or surgery, and spinal cord compression) and subsequent events by 23% (or in absolute terms about 3 months) . Zoledronic acid became generic in 2013, whereas monthly denosumab is still patented until 2022-25. (more…)
Author Interviews, Autism, Pharmacology / 07.11.2017

MedicalResearch.com Interview with: Dr. Mark E. Gurney, PhD MBA Chairman & CEO, Tetra Discovery Partners Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Fragile X is a genetic condition. Affected patients display a range of behavioral and other symptoms, including seizures, sleep disorders, anxiety, irritability, hyperactivity, autism, mild-to-severe cognitive impairment and intellectual disability. BPN14770 is a novel therapeutic agent that selectively inhibits phosphodiesterase-4D (PDE4D). Inhibition of PDE4 has been validated as a treatment strategy by many research groups in the Fragile X field, but non-selective PDE4 inhibitors have been associated with significant GI side-effects that have limited those drugs’ use. As a selective inhibitor, such side-effects were not seen for BPN14770 in a Phase 1 clinical trial in healthy young and elderly adults. In the current study, daily treatment of Fragile X knock-out (FXS) mice with BPN14770 showed a reduction in hyperarousal, improved social interactions and natural behaviors, and changes in nerve structure in the prefrontal cortex of the brain, the portion of that brain associated with cognition. Moreover, the drug’s benefit persisted for two weeks after all drug was cleared from the mice. At the same time, the behavior of normal mice treated with the drug remained unchanged. Examination of neurons from the prefrontal cortex of the treated FXS mice showed an improvement in dendritic spine morphology. (more…)
AstraZeneca, Author Interviews, Boehringer Ingelheim, Diabetes, Eli Lilly, J&J-Janssen, Merck, Pharmacology / 18.10.2017

MedicalResearch.com Interview with: Melanie J Davies CBE MB ChB MD FRCP FRCGP Professor of Diabetes Medicine NIHR Senior Investigator Emeritus Diabetes Research Centre Leicester Diabetes Centre – Bloom University of Leicester MedicalResearch.com: What is the background for this study? What are the main findings? Response:  This was the first study to test the effectiveness of an oral GLP-1 in patients with type 2 diabetes. The main findings were that compared to both placebo and a GLP-1, Semaglutide, delivered by sub-cutaneous injection weekly, the oral therapy delivered once a day produced better results than placebo and similar results to injectable GLP-1 with regard to reductions in HbA1c and weight loss. (more…)
Author Interviews, Depression, Diabetes, JAMA, Pediatrics, Pharmacology / 17.10.2017

MedicalResearch.com Interview with: Mehmet Burcu, PhD, MS Department of Pharmaceutical Health Services Research University of Maryland, Baltimore  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antidepressants are one of the most commonly used psychotropic medication classes in U.S. youth, with serotonin reuptake inhibitors representing a large majority of total antidepressant use in youth. The most interesting finding was that the current use of serotonin reuptake inhibitors in youth was associated with an increased risk of type 2 diabetes mellitus, and this increased risk intensified further with the increasing duration of use and with the increasing dose. A secondary analysis also revealed that the risk of incident type 2 diabetes was most apparent in youth who used serotonin reuptake inhibitors for longer durations AND in greater daily doses. (more…)
Author Interviews, Gastrointestinal Disease, Pharmacology / 15.10.2017

MedicalResearch.com Interview with: Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.S.G.E. Professor of Medicine and Chief of the USA Gastroenterology Division Director, Motility and Physiology Service University of South Alabama Mobile, Alabama  MedicalResearch.com: What is the background for this study? Response: Irritable Bowel Syndrome (IBS) among patients with IBS-M (mixed diarrhea and constipation) is a challenging and difficult to diagnose and treat sub-type of IBS. Patients with IBS-M represent a dissatisfied group of IBS patients due to the lack of proven therapies. It is an area of high unmet medical need. Among adult patients with IBS, a sizeable proportion suffers from IBS-M with prevalence rates estimated to be between 44 to 66 percent of IBS sufferers[1],[2],[3]. IBS-M patients carry a heavy burden, characterized by bouts of constipation interrupted by diarrhea and vice versa. Physicians find IBS-M challenging to manage because of the difficulty in avoiding ‘overshoots’ when diarrhea management can turn into constipation and vice versa.[4]  (more…)
Author Interviews, Mental Health Research, Pharmacology, Psychological Science / 10.10.2017

MedicalResearch.com Interview with: Vanda Faria PhD Department of Psychology Uppsala, Sweden  MedicalResearch.com: What is the background for this study? What are the main findings? Response: It has been debated whether selective serotonin reuptake inhibitors (SSRIs), which are commonly prescribed for depression and anxiety, are more effective than placebo. Concerns have been raised that the beneficial effects of SSRIs, as measured in double-blind clinical trials, may be explained by expectancies (a crucial placebo mechanism) rather than the biochemical compound. But no study has tested experimentally the extent to which the SSRI treatment effect can be influenced by expectancies induced by verbal suggestions. We compared the efficacy of overt vs. covert administration of an SSRI (escitalopram) in patients with social anxiety disorder. Rather than comparing the SSRI with placebo, we compared it with itself while manipulating the patients’ expectations of improvement. This was achieved by informing one group correctly about the SSRI and its effectiveness (overt group) whereas the comparison (covert) group received incorrect information. By use of a cover story, the covert group was led to believe they were treated with a so called “active placebo”, an ineffective neurokinin-1 antagonist yielding similar side effects as the SSRI but lacking anxiety-reducing properties. But the treatment, dosage and duration was in fact identical in both groups. Results showed that overt outperformed covert SSRI treatment, as the number of treatment responders was more than three times higher on the main clinical outcome measure when correct information was given. Using neuroimaging (fMRI) we also noted differences between the overt and covert SSRI groups on objective brain activity measures. There were differences between the groups e.g. with regard to activation of the posterior cingulate cortex with treatment, and the functional coupling between this region and the amygdala which is a brain region crucially involved in fear and anxiety. The fMRI  results may reflect the interaction between cognition and emotion as the brain changes differently with treatment pending on the expectations of improvement. (more…)
Author Interviews, Pharmacology, Toxin Research / 04.10.2017

“Pills” by Victor is licensed under CC BY 2.0MedicalResearch.com Interview with: Tony Wing Lai Mak , MBChB, MBA, FRCPath, FRCPA, FHKCPath, FHKAM(Path  Hospital Authority Toxicology Reference Laboratory Princess Margaret Hospital, Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Proprietary Chinese medicines (pCMs) and health products are generally believed to be natural and safe. However, the safety of pCMs and health products has been compromised by the illicit practice of adulteration with undeclared drugs. Such adulteration can have serious and even fatal consequences. Previous reports of pCM and health product adulteration were mainly routine surveillance data or case reports/series with a small number of affected patients. The present study in Hong Kong, to our knowledge, is the largest case series that reports an overview of the use of various adulterated Proprietary Chinese medicine and health products and the resulting adverse effects. From 2005 to 2015, we have identified 404 cases involving the use of 487 adulterated pCMs or health products with a total of 1234 adulterants detected. The adulterants consisted of approved drugs, banned drugs, drug analogues and animal thyroid tissue. The six most common categories of adulterants detected were nonsteroidal ant-inflammatory drugs (18%), anorectics (15%), corticosteroids (14%), diuretics and laxatives (11%), oral antidiabetic agents (10%), and erectile dysfunction drugs (6%). Sibutramine, an anorectic that has been withdrawn from the market owing to its association with increased cardiovascular events and strokes, was the most common adulterant identified. A significant proportion of patients (65.1%) had adverse effects that were attributable to these illicit products, including 14 severe and two fatal cases. These illicit Proprietary Chinese medicine and health products pose severe health hazards to the public. (more…)
Author Interviews, Boehringer Ingelheim, Pharmacology, Pulmonary Disease / 02.10.2017

MedicalResearch.com Interview with: Professor Carlo Vancheri Professor of Respiratory Medicine, University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine. MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The aim of Boehringer Ingelheim’s INJOURNEY trial was to investigate the safety profile of Ofev (nintedanib) in combination with pirfenidone in treating patients with idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone, the only two FDA-approved drugs for the treatment of IPF, are able to slow down the progression of the disease, reducing the forced vital capacity (FVC) decline of about 50%, but this is not a cure. The target for the future is to have even more effective treatments. In the meanwhile, it is necessary to optimize the use of the available drugs. The medical treatment of other pulmonary diseases such as COPD, asthma or pulmonary hypertension is already based on different combinations of drugs. This 12-week, open-label, randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone, compared with nintedanib alone in patients with IPF. Change in FVC, the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint. The primary endpoint of the INJOURNEY trial was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12 of randomized treatment, and the results showed that the combination of nintedanib and add-on pirfenidone resulted in a manageable safety and tolerability profile, similar to the profile of each drug individually in the majority of patients. Results also indicated there may be a slower decline in FVC in patients treated with pirfenidone along with nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination. However, further research will be necessary to fully evaluate the efficacy of the combination. (more…)
Author Interviews, BMJ, Mental Health Research, OBGYNE, Pharmacology / 10.09.2017

MedicalResearch.com Interview with: Xiaoqin Liu, PhD Department of Economics and Business Economics Aarhus University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous research on the long-term neurodevelopmental outcomes of serotonin-reuptake inhibitor (SSRI) use during pregnancy has primarily focused on offspring risk of autism spectrum disorder. Given SSRIs cross the placental barrier and affect the fetal brain, in-utero SSRI exposure may increase risks of other psychiatric disorders as well as autism spectrum disorder. We conducted a population-based study to look at a range of diagnostic groups of psychiatric disorders in children whose mothers used antidepressants during pregnancy. This was possible because of the nature of information available in Danish population registers, allowing us to follow children for many years. We found increased risks of various diagnostic groups of psychiatric disorders in children whose mothers continued antidepressant treatment during pregnancy, in comparison to children whose mothers stopped antidepressant treatment before pregnancy. (more…)
Author Interviews, Diabetes, Heart Disease, Pharmacology / 31.08.2017

MedicalResearch.com Interview with: Todd Hobbs, MD Vice President and Chief Medical Officer Novo Nordisk North America  MedicalResearch.com: Would you tell us a little about liraglutide? How does it work to control diabetes/blood sugar?  Response: Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration (FDA) in 2010 to help lower blood sugar in adults with type 2 diabetes. Victoza® is the #1 prescribed (GLP-1) receptor agonist. Victoza® is a non-insulin, once-a-day medication that helps lower blood sugar levels in adults with type 2 diabetes by increasing glucose-dependent insulin release, inhibiting glucagon secretion, and slowing gastric emptying. On August 25, the FDA approved a new indication for Victoza®, making it the only type 2 diabetes treatment approved to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. (more…)
Author Interviews, Osteoporosis, Pharmacology / 30.08.2017

MedicalResearch.com Interview with: Dieter Bromme, Ph.D. Professor and Canada Research Chair The University of British Columbia Faculty of Dentistry Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Every three seconds somebody will fracture a bone because of osteoporosis. Several treatments are available to slow down bone loss but all of them have shortcomings ranging from poor bone quality to various side effects. Thus new treatment strategies and novel drug targets are needed that promise efficacy without significant adverse reactions. One of the novel promising targets was cathepsin K, a protease solely responsible for the degradation of our organic bone matrix. Major efforts and funds were spent by the pharmaceutical industry to develop potent and selective cathepsin K inhibitors. These inhibitors were highly effective in preserving bone in clinical trials. Despite the good news, cathepsin K inhibitors were never approved because of various non-skeletal side effects. We hypothesized that these side effects are not caused by off-target effects (drugs react with undesired targets) but by on-target effects. Most drugs that target enzymes are active site-directed compounds and thus will stop the entire activity of the target enzyme. If the target is a multifunctional enzyme, safety problems are preprogrammed. Based on our studies to understand the molecular mechanism of collagen degradation by cathepsin K, we developed the concept of ectosteric enzyme inhibition, which allowed us to identify highly selective collagenase inhibitors of this protease. In our study, we used a red sage-derived small molecule that selectively blocked the collagenase activity of cathepsin K and thus consequently bone degradation in an osteoporosis mouse model without affecting other known functions of the protease. The crucial difference might be that the red sage inhibitor did not block the cathepsin K-mediated degradation of TGF-ß1, a growth factor involved in fibrotic pathologies described in the clinical trials. TGF-ß1 degradation is blocked by these inhibitors and thus accumulates in tissues, causing fibrosis. (more…)
Author Interviews, JNCI, Mental Health Research, Pharmacology, UT Southwestern, Weight Research / 23.08.2017

MedicalResearch.com Interview with: Chen Liu, Ph.D. Assistant Professor Departments of Internal Medicine and Neuroscience Division of Hypothalamic Research The University of Texas Southwestern Medical Center Dallas, Texas 75390-9077  MedicalResearch.com: What is the background for this study? Response: Atypical antipsychotics are second-generation antipsychotics (SGAs) that have been increasingly used to treat a variety of neuropsychiatric conditions such as schizophrenia, depression, and autism. Many patients taking these medications, however, are left in an agonizing dilemma. On one hand, they rely on these drugs’ psychotropic effect for normal functioning in daily life. On the other, many SGAs, including the most widely prescribed olanzapine and clozapine, can cause a metabolic syndrome that is known for excessive weight gain, dyslipidemia, and type-2 diabetes_ENREF_2. Notably, while full-blown type 2 diabetes and morbid obesity typically take years to unfold in the general population, these conditions progress at a much faster pace (within months) following second-generation antipsychotics treatment. Other factors such as ethnicity, age, and sex can also aggravate SGA-induced metabolic syndrome. Together, these peculiar features strongly suggest a distinct etiology underlying SGA-induced metabolic syndrome that has yet been fully elucidated. Currently, there is no medication specifically targeting SGA-induced metabolic syndrome. For many youths and adults taking second-generation antipsychotics, metabolic complications are difficult to manage as lifestyle changes, nutritional consulting, and commonly used anti-diabetic medications only provide limited relief. (more…)