Category Archives: Pharmacology

Peppermint Oil Based IBgard® Found Efficacious In Some Patients With Irritable Bowel Syndrome with Mixed Bowel Habits

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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

Dr. Cash

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]  Continue reading →

Efficacy of SSRIs for Anxiety Influenced By Patient’s Expectations

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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.

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Adulterated Proprietary Chinese Medicines Pose Serious Health Hazards

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“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.

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IPF: Combination of Nintedanib and Pirfenidone May Have Added Benefit With Manageable Side Effects

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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.

Prof. Vancheri

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.

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Study Evaluates Pediatric Outcomes of Antidepressant Use During Pregnancy

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MedicalResearch.com Interview with:

Xiaoqin Liu, PhD Department of Economics and Business Economics Aarhus University

Dr. Xiaoqin Liu

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.

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Victoza® Receives FDA Approval To Reduce Heart Attack and Stroke in Patients With Type 2 Diabetes and Heart Disease

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MedicalResearch.com Interview with:

Todd Hobbs, MD Vice President and Chief Medical Officer Novo Nordisk North America

Dr. Hobbs

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.

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New Approach Could Lead To Osteoporosis Drugs With Fewer Side Effects

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MedicalResearch.com Interview with:

Dieter Bromme, Ph.D. Professor and Canada Research Chair The University of British Columbia Faculty of Dentistry  Vancouver, BC

Dr. Bromme

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.

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Serotonin Receptors Tied To Weight Gain From Atypical Antipsychotic Medications

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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

Dr. Chen Liu

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.

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Evidence Does Not Support Gabapentinoids in Non-Specific Chronic Low Back Pain

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MedicalResearch.com Interview with:

Harsha Shanthanna MBBS, MD, MSc Associate Professor, Anesthesiology Chronic Pain Physician St Joseph's Healthcare,McMaster University Hamilton, Canada Diplomate in National Board, Anesthesiology (India) Fellow in Interventional Pain Practice (WIP) European Diplomate in Regional Anesthesia and Pain (ESRA)

Dr. Shanthanna

Harsha Shanthanna MBBS, MD, MSc
Associate Professor, Anesthesiology
Chronic Pain Physician
St Joseph’s Healthcare,McMaster University
Hamilton, Canada
Diplomate in National Board, Anesthesiology (India)
Fellow in Interventional Pain Practice (WIP)
European Diplomate in Regional Anesthesia and Pain

MedicalResearch.com: What is the background for this study?

Response: Pregabalin (PG) and gabapentin (GB) are increasingly used for nonspecific Chronic Low Back Pain (CLBP) despite a lack of evidence. There have been concerns expressed over their increased prescribing for various non cancer pain indications in recent years. Their use requires slow titration to therapeutic doses and establishing maintenance on a long-term basis. With prolonged treatment, the potential gain over possible adverse effects and risks could become unclear.

We searched Cochrane, MEDLINE and EMBASE databases for randomized control trials reporting the use of gabapentinoids for chronic lower back pain treatment of 3 months or more in adult patients.

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Risk of Suicide Attempts With Methylphenidate Treatment for ADHD

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MedicalResearch.com Interview with:
Professor Ian Chi Kei Wong and
Kenneth KC Man, Senior Research Assistant
Department of Social Work and Social Administration, Faculty of Social Science
Department of Pharmacology and Pharmacy, LKS Faculty of Medicine
The University of Hong Kong

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients with attention-deficit/hyperactivity disorder (ADHD) are at higher risk of various mental health problems. Previous studies suggested that individuals with ADHD are having a higher chance of both attempted and completed suicide. Methylphenidate is a psychostimulant that is recommended for the treatment of ADHD. With the increasing usage of methylphenidate over the past decade, there are concerns about the safety of the medication, in particular, psychiatric adverse effects such as suicide attempt.

The current study looked into over 25,000 patients aged 6 to 25 years in Hong Kong who were receiving methylphenidate in 2001 to 2015. Using the self-controlled case series design, in which the patients act as their own control, we found that the risk of suicide attempt was 6.5 fold higher during a 90-day period before methylphenidate was initiated, remained elevated 4-fold during the first 90 days of treatment, and returned to the normal level during ongoing treatment.

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