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

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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Even After Rebates, Use of PCSK9 Inhibitor Would Still Cost Over $5 Million To Prevent One Stroke

MedicalResearch.com Interview with:

Inmaculada Hernandez, PharmD, PhD Assistant Professor of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Pittsburgh, PA 1526

Dr. Hernandez

Inmaculada Hernandez, PharmD, PhD
Assistant Professor of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy
Pittsburgh, PA 1526

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

Response: A few months ago, the results of the FOURIER trial were published. This trial was the first one to evaluate the efficacy of PCSK9 inhibitors in the prevention of cardiovascular events, since the approval of these agents was based on trials that evaluated their efficacy in reducing levels of LDL-C. The results of the FOURIER trial did not meet the expectations generated by prior studies that had simulated how much the risk of cardiovascular events should decrease based on the observed reduction in LDL-C levels. A few hours after the publication of the results of the FOURIER trial, Amgen (evolocumab´s manufacturer) announced that it would be willing to engage in contracts where the cost of evolocumab would be refunded for those patients who suffer a heart attack or a stroke while using the drug.

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Proton Pump Inhibitors Linked To Increased Risk of Adverse Effects and and Death

MedicalResearch.com Interview with:

Ziyad Al-Aly MD FASN Assistant Professor of Medicine Co-director for Clinical Epidemiology Center Department of Medicine, Washington University School of Medicine Saint Louis, Missouri

Dr. Ziyad Al-Aly

Ziyad Al-Aly MD FASN
Assistant Professor of Medicine
Co-director for Clinical Epidemiology Center
Department of Medicine, Washington University School of Medicine
Saint Louis, Missouri
Associate Chief of Staff for Research and Education
Veterans Affairs Saint Louis Health Care System

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

Response: Proton Pump Inhibitors (PPI) are commonly used, and they are associated with adverse events including kidney disease, dementia, fractures, cardiovascular disease, and pneumonia. We asked the question of whether this translates to increased risk of death.

We conducted this large cohort study to specifically examine the association between PPI use and risk of death. The results consistently showed an association between use of PPI and increased mortality risk. Moreover, there was a graded relationship between duration of PPI use and risk of death in that longer duration of use was associated with incrementally higher risk of death.

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Physicians Should Be Critical of Adverse Event Reporting in Clinical Trials

MedicalResearch.com Interview with:

Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department  IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy

Dr. Paolo Bossi

Paolo Bossi MD
Medical Oncologist
Head and Neck Cancer Department
IRCCS Istituto Nazionale dei Tumori Foundation
Milan, Italy

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

Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs.

It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs.
However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities.

This line of reasoning is particularly true for new or “relatively new” drugs, such as immunotherapy (IT) and targeted agents (TT).

So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database.

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Many Leading Oncologists Have Pharmaceutical Ties

MedicalResearch.com Interview with:

Dr. Aaron Mitchell MD Hematology/Oncology Fellow University North Carolina

Dr. Aaron Mitchell

Dr. Aaron Mitchell MD
Hematology/Oncology Fellow
University North Carolina

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

Response: It is well known that many physicians work with the pharmaceutical industry. In some cases, this can create conflicts of interest with physicians’ other responsibilities. The Open Payments law, passed as part of the Affordable Care Act, recently made these relationships public, which now allows us to study them more systematically.

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Acetaminophen During Pregnancy Linked to Childhood Behavioral Problems

MedicalResearch.com Interview with:

Dr Evie Stergiakouli Lecturer in Genetic Epidemiology and Statistical Genetics MRC Integrative Epidemiology Unit at the University of Bristol University of Bristol Bristol UK

Dr. Evie Stergiakouli

Dr Evie Stergiakouli
Lecturer in Genetic Epidemiology and Statistical Genetics
MRC Integrative Epidemiology Unit
University of Bristol
Bristol UK

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

Response: Acetaminophen is considered safe to use during pregnancy. However, research suggests that acetaminophen use in pregnancy is associated with abnormal neurodevelopment. It is possible that this association might be confounded by unmeasured behavioural factors linked to acetaminophen use. We compared acetaminophen use during pregnancy to postnatal acetaminophen use and partner’s acetaminophen use. Only acetaminophen use during pregnancy has the potential to cause behavioural problems in the offspring. Any associations with postnatal acetaminophen use and partner’s acetaminophen use would be due to confounding. Behavioural problems in the offspring were only associated with acetaminophen use during pregnancy.

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Counterfeit Xanax Contained Toxic Amounts of Opioid Fentanyl

MedicalResearch.com Interview with:
Ann M. Arens, MD
California Poison Control Center
San Francisco, CA 94110

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

Response: Prescription opioid abuse is a significant public health threat that has garnered the attention of health care providers throughout medicine. With efforts to curb the number of prescriptions for opioid pain medications, users may begin to purchase prescription medications from illegal sources.

Our study reports a series of patients in the San Francisco Bay Area who were exposed to counterfeit alprazolam (Xanax®) tablets found to contain large amounts of fentanyl, an opioid 100 times more potent than morphine, and in some cases etizolam, a benzodiazepine. The California Poison Control System – San Francisco division identified eight patients with unexpected serious health effects after exposure to the tablets including respiratory depression requiring mechanical ventilation, pulmonary edema, cardiac arrest, and one fatality. Patients reportedly purchased the tablets from drug dealers, and were unaware of their true contents. In one case, a 7 month-old infant accidentally ingested a counterfeit tablet dropped on the floor by a family member.

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Drugs Labeled as ‘Sleep Disturbing’ May Not Contribute to Significant Sleep Disruption

MedicalResearch.com Interview with:

Anna-Therese Lehnich Zentrum für Klinische Epidemiologie (ZKE) c/o Institut für Medizinische Informatik Biometrie undEpidemiologie (IMIBE)

Anna Therese Lehnich

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.

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Potentially Inappropriate Medications Linked to Decreased Survival in Elderly Lymphoma Patients

MedicalResearch.com Interview with:

Dr. Catherine S. M. Diefenbach MD Assistant Professor of Medicine NYU Cancer Center New York, NY 10016

Dr. Catherine Diefenbach

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.

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Counterfeit and Stolen Pharmaceuticals Pose Growing Threat, Especially To Seniors

MedicalResearch.com Interview with:

Leigh Purvis, MPA Director of Health Services Research AARP Public Policy Institute

Ms. Leigh Purvis

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.

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ACA Enrollees More Likely To Use Medicines For Hepatitis and HIV

Julie M. Donohue, Ph.D. Associate professor and Vice Chair for Research Graduate School of Public Health Department of Health Policy and Management University of PittsburghMedicalResearch.com Interview with:
Julie M. Donohue, Ph.D.

Associate professor and Vice Chair for Research
Graduate School of Public Health Department of Health Policy and Management
University of Pittsburgh

Medical Research: What is the background for this study? What are the main findings?

Dr. Donohue: We looked at data on medication use from January through September 2014 on 1 million Affordable Care Act-established marketplace insurance plan enrollees. Our analysis found that among people who enrolled in individual marketplaces, those who enrolled earlier were older and used more medication than later enrollees. Marketplace enrollees, as a whole, had lower average drug spending per person and were less likely to use most medication classes than patients enrolled in employer-sponsored health insurance. However, marketplace enrollees were much more likely to use medicines for hepatitis C and for HIV, which is particularly important given the general concerns about the rising costs of these medications for consumers.

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Single Step Process May Speed Production of Statins

Professor Andrew W. Munro FRSC FSB Professor of Molecular Enzymology Manchester Institute of Biotechnology Faculty of Life Sciences University of Manchester Manchester UKMedicalResearch.com Interview with:
Professor Andrew W. Munro FRSC FSB
Professor of Molecular Enzymology
Manchester Institute of Biotechnology
Faculty of Life Sciences University of Manchester
Manchester UK

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

Dr. Munro: Statins are blockbuster drugs that inhibit the key enzyme in cholesterol synthesis: 3-beta-hydroxymethylglutaryl CoA reductase (HMG-CoA reductase), which catalyzes the rate-limiting step in the biosynthesis of cholesterol. As a consequence, statin drugs reduce levels of low-density lipoprotein (LDL-) cholesterol, are effective against hypercholesterolemia and reduce the risk of atherosclerosis and heart attack. One of the major statin drugs is pravastatin, which is derived from a fungal natural product called compactin. The process of conversion of compactin into pravastatin involves the use of an oxygen-inserting enzyme called a cytochrome P450 (or P450), which catalyzes the hydroxylation of compactin to form pravastatin. In order to produce a more cost-efficient and streamlined route to pravastatin production, our teams from the University of Manchester (UK) and DSM (Delft, The Netherlands) developed a single-step process for pravastatin production. This process involved harnessing the productive efficiency of an industrial strain of the beta-lactam (penicillin-type) antibiotic producing fungus Penicillium chrysogenum. The beta-lactam antibiotic genes were deleted from this organism, and replaced by those encoding for compactin biosynthesis (transferred from a different Penicillium species). This led to high level production of compactin, but also to substantial formation of a partially degraded (deacylated) form. To get around this problem and in order to further improve compactin production, the enzyme responsible for the deacylation (an esterase) was identified and the gene encoding this activity was deleted from the production strain. The final stages of development of the novel, one-step pravastatin production process involved the identification of a suitable P450 enzyme that could catalyze the required hydroxylation of compactin. A bacterial P450 was identified that catalyzed hydroxylation at the correct position on the compactin molecule. However, the stereoselectivity of the reaction was in favour of the incorrect isomer – forming predominantly epi-pravastatin over the desired pravastatin. This was addressed by mutagenesis of the P450 – ultimately leading to a variant (named P450Prava) that hydroxylated compactin with the required stereoselectivity to make pravastatin in large amounts. Determination of the structure of P450Prava in both the substrate-free and compactin-bound forms revealed the conformational changes that underpinned the conversion of the P450 enzyme to a pravastatin synthase. The expression of P450Prava in a compactin-producing strain of P. chrysogenum enabled pravastatin production at over 6 g/L in a fed-batch fermentation process, facilitating an efficient, single-step route to high yield generation of pravastatin.

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