Category Archives: Pharmacology

Trying Statins Again After Adverse Effect Linked To Lower Risk of Heart Attack

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MedicalResearch.com Interview with:

Alexander Turchin, MD,MS Director of Quality in Diabetes Associate Professor, Harvard Medical School Brigham and Women's Hospital Boston, MA

Dr. Turchin

Alexander Turchin, MD,MS
Director of Quality in Diabetes
Associate Professor, Harvard Medical School
Brigham and Women’s Hospital
Boston, MA

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

Response: Cardiovascular disease is the # 1 cause of death in the U.S. and worldwide. Statins are some of the most effective medications available for prevention of cardiovascular events.

However, many patients stop statins, frequently because of adverse reactions. In our study we aimed to assess the risk-benefit balance of trying a statin again after experiencing an adverse reaction.

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Optimistic Results From Phase 3 Study of RBP-6000 Buprenorphine Monthly Depot for Treatment of Opioid Use Disorder

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Medical Research.com Interview with:

Dr. Christian Heidbreder, PhD Chief Scientific Officer Indivior Inc. Richmond, VA 23235, USA

Dr. Heidbreder

Dr. Christian Heidbreder, PhD
Chief Scientific Officer
Indivior Inc.
Richmond, VA 23235, USA

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

Response: This pivotal Phase 3 clinical trial (RB-US-13-0001) evaluated the efficacy and safety of RBP-6000, an investigational once-monthly injectable buprenorphine in the ATRIGEL® delivery system for the treatment of adults with moderate-to-severe opioid use disorder (OUD) as part of a complete treatment plan to include counseling and psychosocial support1.

The 24-week Phase 3 study met its primary and key secondary endpoints, demonstrating statistically significant differences in percentage abstinence and treatment success across both dosage regimens of RBP-6000 versus placebo1.

The findings also showed that outcomes with RBP-6000 are consistent across other secondary clinical endpoints, including control of craving and withdrawal symptoms, as compared to placebo. These outcomes were associated with buprenorphine plasma concentrations ≥ 2 ng/mL and predicted whole brain mu-opioid receptor occupancy of ≥ 70%, and were also maintained for the one-month dosing intervals and for the entire treatment duration1.

The results were confirmed by exposure-response analyses demonstrating a relationship between buprenorphine plasma concentrations, abstinence, withdrawal symptoms and opioid craving1.

RBP-6000 was generally well tolerated and had a safety profile consistent with that of transmucosal buprenorphine. Injection site reactions were not treatment-limiting. The most common (reported in ≥ 5% of subjects) treatment-emergent adverse events (TEAEs) reported in the active total group were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzyme, fatigue and injection site pain1.

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Newer Insulin Formulation Reduces Risk of Hypoglycemia

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MedicalResearch.com Interview with:

Wendy Lane MD Director of Clinical Research Mountain Diabetes and Endocrine Center Asheville, NC 

Dr. Lane

Wendy Lane MD
Director of Clinical Research
Mountain Diabetes and Endocrine Center
Asheville, NC

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

Response: The SWITCH1 trial was the first double blinded insulin trial to compare the rate of severe, nocturnal severe and symptomatic blood glucose-confirmed hypoglycemia between two basal insulins, insulin glargine U100 and insulin degludec U100, in patients with type 1 diabetes.

The trial design (double blinded crossover treat-to-target) eliminated any bias in the results, which showed clear-cut reductions in all categories of hypoglycemia with insulin degludec compared to insulin glargine.

Severe hypoglycemia has dangerous and greatly feared consequences including cognitive impairment, seizures, coma and death, and it is the main barrier to effective use of insulin in the treatment of type 1 diabetes. Insulin degludec, which was shown to reduce the risk of hypoglycemia compared to insulin glargine in the SWITCH1 trial, should be viewed by clinicians as an advancement in insulin therapy which will increase its safety and improve the quality of life of our patients with type 1 diabetes.

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Optimization of Medication Use Critical to Success of ACOs

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MedicalResearch.com Interview with:
Kimberly Westrich, MA
Vice President, Health Services Research, National Pharmaceutical Council, and
Kristina Lunner
Principal, Leavitt Partners

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

Response: With the advent of accountable care organizations (ACOs) following passage of the Affordable Care Act in 2010, it became important to understand how success in an ACO world is different from success in a capitated environment, where the focus is only on managing costs. In an ACO, providers are responsible for the quality of care they provide for a defined population in addition to having at least some financial responsibility. We wanted to explore how an ACO can succeed in this environment of dual responsibility for costs and quality, and more specifically, how pharmaceuticals fit into this success.

To address these questions, the National Pharmaceutical Council worked with the American Medical Group Association (AMGA), Premier, Inc., and a group of seven leading ACOs to develop a conceptual framework for considering the role of pharmaceuticals in ACOs. This framework shows how optimizing medication use in a value-based healthcare environment, such as an ACO, can help the organization achieve its cost and quality benchmarks.

We evaluated ACO readiness to optimize medication use in 2014 and again with our most recent study, published in June 2017 online ahead of print in the Journal of Managed Care & Specialty Pharmacy. For our 2017 study, we worked with Leavitt Partners to survey and interview ACOs to understand how they optimize medication use, determine if there is an association between efforts to optimize medication use and achievement on financial and quality metrics, ascertain organizational factors that correlate with optimized medication use, and identify barriers to optimized medication use.
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Brexanolone Shows Promise in PostPartum Depression

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MedicalResearch.com Interview with:

Samantha Meltzer-Brody, MD, MPH Associate Professor and Associate Chair for Faculty Development Director, Perinatal Psychiatry Program Director, Taking Care of Our Own Program Department of Psychiatry Chapel Hill, NC 2759

Dr. Meltzer-Brody

Samantha Meltzer-Brody, MD, MPH
Associate Professor and Associate Chair for Faculty Development
Director, Perinatal Psychiatry Program
Director, Taking Care of Our Own Program
Department of Psychiatry
Chapel Hill, NC 2759 

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

Response: The Lancet published results from a randomized, placebo-controlled, phase 2 clinical trial with the investigational medication, brexanolone, for women with severe postpartum depression (PPD). During the study, which was conducted at multiple sites across the country, physician researchers administered brexanolone in 21 women, 10 of whom were administered a 60-hour infusion of brexanolone. The other 11 women were given a placebo. Results from the trial showed that 70 percent of participants who received the drug saw remission of their PPD symptoms within 60 hours of treatment, an effect that was maintained until the 30-day follow up.

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Letermovir Found Highly Effective In Preventing CMV Infection

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MedicalResearch.com Interview with:

Roy F Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A Professor, Department of Infectious Diseases, Director, Infection Control and Employee Health, Division of Internal Medicine Director of the clinical virology research program,Department of infectious diseases Infection control and employee health The University of Texas MD Anderson

Dr. Chemaly

Roy F Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A
Professor, Department of Infectious Diseases,
Director, Infection Control and Employee Health, Division of Internal Medicine
Director of the clinical virology research program,Department of infectious diseases
Infection control and employee health
The University of Texas MD Anderson

MedicalResearch.com: Would you briefly explain the significance of CMV infections? What is the background for this study?

Response: Cytomegalovirus (CMV) is one of the most important causes of infectious complications following organ transplantation and is a significant cause of illness and death in patients who have undergone allogeneic hematopoietic cell transplantation (allo-HCT). For more than 20 years, we have been managing this infection and trying to develop effective strategies to control it, but to no one’s satisfaction; CMV infection is still associated with significant morbidity and mortality in this high-risk population.

Most transplant centers have adopted preemptive antiviral therapy as the strategy of choice for HCT patients.1 While anti-CMV drugs have decreased the incidence of CMV diseases, their use for prophylaxis has not been associated with improved outcomes.1

Demographic and transplant trends heighten the need for new anti-CMV agents. In the U.S, 83% of people aged 60 and older are CMV seropositive. These older patients received 8% of all hematopoietic-cell transplants in 2000-2006, a figure that jumped to 22% in 2007-2013. As Baby Boomers age, many more allogeneic transplant patients will be CMV seropositive.

Therefore, prophylactic antiviral compounds that could effectively control viral replication, and restrict some pathologic processes of CMV diseases, could potentially lessen the complications associated with CMV infection and possibly reduce all-cause mortality.

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Drugs Receiving Accelerated FDA Approval Often Have Flaws In Their Evidence Base

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MedicalResearch.com Interview with:

Huseyin Naci, PhD Assistant Professor of Health Policy LSE Health Department of Social Policy London School of Economics and Political Science London, United Kingdom

Dr. Naci

Huseyin Naci, PhD
Assistant Professor of Health Policy
LSE Health
Department of Social Policy
London School of Economics and Political Science
London, United Kingdom 

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

Response: An increasing proportion of novel therapeutic agents are entering the market on the basis of expedited development and approval programs. The Food and Drug Administration’s (FDA) Accelerated Approval pathway is one such expedited approval program. In our study, we examined the dynamics of research on drugs receiving accelerated approvals. We were particularly interested in the timing and characteristics of research studies including drugs with accelerated approvals.

Our primary findings are the following:

  • First, there is an abundance of research on drugs receiving accelerated approvals. Yet, the majority of this research (about 70%) is of poor quality. Ideally, these drugs are evaluated in so-called randomised controlled trials to establish their efficacy and safety. However, only about a third of all existing studies are randomised controlled trials.
  • Second, a substantial share (about 30%) of the existing research on these drugs is in areas not approved by the FDA. This may be indicative of industry research practices in trying to prioritise identification of new uses for drugs receiving accelerated approvals instead of strengthening their evidence base.
  • Third, when focusing on well-designed studies, only about a half actually evaluate the effectiveness of the accelerated approval drugs. The rest appears to use the accelerated approval drug as background therapy. Interestingly, these two types of studies are conducted concurrently. In other words, while one research group is trying to find out if an accelerated approval drug is effective, other research groups are already using it as part of a background regimen when testing the effectiveness of another, potentially newer drug

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New Simultaneous Antidepressant and Benzodiazepine Use Relatively Common

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MedicalResearch.com Interview with:

Greta A Bushnell, MSPH Doctoral Candidate, Department of Epidemiology UNC, Gillings School of Global Public Health

Greta Bushnell

Greta A Bushnell, MSPH
Doctoral Candidate, Department of Epidemiology
UNC, Gillings School of Global Public Health

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

Response: Patients with depression may be co-prescribed a benzodiazepine at antidepressant initiation for a short period for a variety of reasons. Reasons include reducing concurrent anxiety and insomnia, reducing depression severity more quickly, and improved antidepressant continuation. However, there are concerns with benzodiazepines including dependency. As such, benzodiazepines are usually recommended for only short-term treatment.

Prior to our study, little was known about a) how often new simultaneous antidepressant and benzodiazepine prescribing occurred among patients initiating antidepressant treatment for depression or b) whether new simultaneous users became long-term benzodiazepine users.

In a large commercial insurance database, we identified adults aged 18-64 years with depression who initiated an antidepressant from 2001 to 2014. We found that 11% of adults simultaneously initiated benzodiazepine treatment, which increased from 6% in 2001 to a peak at 12% in 2012. We observed similar antidepressant treatment length at six months in simultaneous new users and among patients initiating antidepressants only. The majority of simultaneous new users had only one benzodiazepine prescription fill before benzodiazepine discontinuation; however, 12% were identified as long-term benzodiazepine users.

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Long-acting Injectable Medications Reduce Relapse and Rehospitalizations in Schizophrenia

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MedicalResearch.com Interview with:

Jari Tiihonen, MD, PhD Professor, Department of Clinical Neuroscience Karolinska Institutet Stockholm, Sweden

Prof. Tiihonen

Jari Tiihonen, MD, PhD
Professor, Department of Clinical Neuroscience
Karolinska Institutet
Stockholm, Sweden 

MedicalResearch.com: What are the limitations of existing analyses of the comparative effectiveness of antipsychotics?

Response: It has remained unclear if there are clinically meaningful differences between antipsychotic treatments in relapse prevention of schizophrenia, due to the impossibility of including large unselected patient populations in randomized controlled trials, and due to residual confounding from selection biases in observational studies.

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IPF Patients Treated With Nintedanib (Ofev) More Likely To Have Stable Lung Function

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MedicalResearch.com Interview with:

Kevin R. Flaherty

Dr. Flaherty

Kevin R. Flaherty, M.D., M.S.
Professor, Department of Internal Medicine
Associate Director, T32 Multidisciplinary Training Program in Lung Diseases
Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee
University of Michigan Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease.

IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans.

The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted.

These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%.

In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup.

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