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Treating COPD early may slow progression

Patients with mild to moderate chronic obstructive pulmonary disease (COPD) are rarely prescribed medications to treat COPD because they have few signs and symptoms. Recently reported research was designed to determine if long-term use of tiotropium (Spiriva), a long-acting bronchodilator administered via inhaler, would improve lung function and slow disease progression in these patients. Researchers conducted a multicenter, randomized, double-blind, placebo-controlled study involving 841 patients with mild or moderate COPD. Patients received a once-daily inhaled dose of tiotropium (n = 419) or placebo (n = 422) for 2 years. End points included changes in forced expiratory volume in 1 second (FEV1) before bronchodilator use from baseline to 24 months.


Of the 771 patients included in the final analysis, those who received tiotropium had higher FEV1 than those who received placebo throughout the trial. In addition, the annual decline in FEV1 after bronchodilator use was "significantly less" in the tiotropium group. The incidence of adverse reactions was similar in the two groups.


The research was funded in part by Boehringer Ingelheim, the manufacturer of Spiriva.


Source: Zhou Y, Zhong NS, Li X, et al. Tiotropium in early-stage chronic obstructive pulmonary disease. N Engl J Med. 2017;377(10):923-935.



First biosimilar drug for cancer approved

A biosimilar drug is a biologic product approved based on data showing that it's highly similar in safety and effectiveness to an already-approved drug. These products are intended to spur competition, lower healthcare costs, and improve patient access to important therapies. Mvasi, the first biosimilar product approved by the FDA to treat cancer, is a vascular endothelial growth factor-specific angiogenesis inhibitor that is biosimilar to bevacizumab (Avastin). It's specifically approved to treat certain colorectal, lung, brain, kidney, and cervical cancers. Like bevacizumab, Mvasi is labeled with boxed warnings about the risk of gastrointestinal (GI) perforations; surgery and wound healing complications; and severe or fatal pulmonary, GI, central nervous system, and vaginal hemorrhage. Consult the prescribing information for details about indications, precautions, and adverse reactions.


Sources: FDA approves first biosimilar for the treatment of cancer. Food and Drug Administration. News release. September 14, 2017. Mvasi (bevacizumab-awwb) Solution for intravenous infusion. Prescribing information.



Montelukast can be a nightmare

The label for montelukast, a selective leukotriene receptor antagonist prescribed to treat asthma and allergic rhinitis in adults and children, contains a warning about possible neuropsychiatric adverse reactions. To explore the prevalence of these and other adverse reactions to montelukast, researchers studied reports of adverse reactions in a Dutch database and in a global database maintained by the World Health Organization. They found "a strong statistical relation between montelukast and nightmares. This was true for both the Dutch and worldwide population." In addition, other neuropsychiatric disorders, such as depression, aggression, suicidal ideation, and abnormal behavior, were "significantly frequently reported" in children and in adults in both databases. A high number of reports of allergic granulomatous angiitis, a very rare autoimmune disorder, was also observed.


Researchers caution that their findings don't prove a causal relationship between the drug and these adverse reactions, but clinicians should closely monitor adults and children taking montelukast for these risks.


Sources: Haarman MG, van Hunsel F, de Vries TW. Adverse drug reactions of montelukast in children and adults. Pharmacol Res Perspect. 2017;5(5). Singulair (Montelukast sodium) tablets, chewable tablets, and oral granules. Prescribing information.



Guidelines suggested for post-op opioid use

Given the risk of opioid abuse, how long should opioid-naive patients continue to use opioid analgesics after common surgical procedures? Even though overprescription of opioid analgesics is a factor in the current epidemic of opioid abuse, few specific guidelines on type or duration of opioid therapy are available to help clinicians prescribe safe and effective therapy following surgery.


To explore appropriate prescribing practices, researchers used a large Department of Defense database to study patterns of opioid prescription and opioid use by patients following surgery. The study involved 215,140 opioid-naive adults ages 18 to 64 who'd undergone one of these eight common surgical procedures between January 1, 2005, and September 30, 2014: hysterectomy, cholecystectomy, appendectomy, inguinal hernia repair, mastectomy, anterior cruciate ligament repair, rotator cuff repair, and discectomy. The main outcomes and measures were the need for an additional subsequent prescription for opioid pain medication, or a refill.


Based on their findings, researchers suggested the following guidelines for duration of opioid therapy:


* 4 to 9 days for general surgery procedures


* 4 to 13 days for women's health procedures


* 6 to 15 days for musculoskeletal procedures.



The authors write that "although a 7-day limit on initial opioid prescription appears to be adequate for many common general surgery and gynecologic procedures, for patients undergoing orthopedic and neurosurgical interventions, a 7-day limit may be inappropriately restrictive and place an undue burden on patients and clinicians."


Source: Scully RE, Schoenfeld AJ, Jiang W, et al. Defining optimal length of opioid pain medication prescription after common surgical procedures. JAMA Surg. [e-pub Sep. 27, 2017.]



Providers aren't being trained to advise patients

Although medical marijuana is legal in over half of U.S. states and the District of Columbia, a national survey of medical schools revealed that only 9% have medical marijuana documented in their curriculum. Surveys were obtained from 101 curriculum deans and 258 residents and fellows. Among the findings:


* over 66% of deans reported that their graduates were not at all prepared to prescribe medical marijuana.


* 25% of deans reported that their graduates were not at all prepared to answer questions about medical marijuana.


* over 89% of residents and fellows felt not at all prepared to prescribe medical marijuana and over 35% felt not at all prepared to answer questions about it.


* nearly 90% of residents and fellows reported having received no education in medical school or residency on medical marijuana.



The authors conclude, "With even more states on the cusp of legalizing medical marijuana, physician training should adapt to encompass this new reality of medical practice."


Source: Evanoff AB, Quan T, Dufault C, Awad M, Bierut LJ. Physicians-in-training are not prepared to prescribe medical marijuana. Drug Alcohol Depend. 2017;180:151-155.