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Customized Briefing for Dr. Jarir Nakouzi Wednesday, September 24, 2008


Study indicates drugs for lung disease may increase risk of strokes, heart attacks.

USA Today (9/24, Rubin) reports that "widely prescribed drugs recommended as first-line therapy for chronic obstructive pulmonary disease, or COPD -- the USA's fourth-leading killer -- raise the risk of heart attacks, strokes, and death from heart disease," according to a study published in the Sept. 24 issue of the Journal of the American Medical Association. COPD comprises "two incurable lung ailments, chronic bronchitis and emphysema. Most COPD patients have both. The most common cause is cigarette smoking."

        The study focuses on "a class of medications known as inhaled anticholinergics that are used to treat" COPD, the Wall Street Journal (9/24, B2, Dooren) adds. For instance, Spiriva (tiotropium), co-marketed by Boehringer Ingelheim GmbH and Pfizer, Inc., "is the dominant anticholinergic medication," which "works by blocking a chemical involved with airway restriction. The analysis also looked at ipratropium, an older medication also marketed by Boehringer Ingelheim under the brand name Atrovent."

        According to the AP (9/24, Tanner), Sonal Singh, M.D., M.P.H., of the Wake Forest University School of Medicine in Winston-Salem, N.C., and colleagues, conducted a meta-analysis of "17 randomized studies comparing mostly older patients on either of the drugs with those on different medicine or dummy drugs." The researchers found that "using either drug for more than one month appeared to increase chances for fatal and nonfatal heart problems, including heart attacks, by more than 50 percent." In addition, of "7,400 patients on either inhaled drug, 1.8 percent or 135 people developed fatal or nonfatal heart problems over a period of several weeks to several years." Conversely, "among about 7,300 patients on other drugs or dummy medicine, 1.2 percent or 86 had those problems."

        The authors pointed out that "a larger clinical trial is needed to validate the findings," Bloomberg News (9/24, Ostrow) reports. Still, in light of these findings, "patients with prior heart attacks and strokes, or those who have high blood pressure, may want to consider stopping these medicines, said Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York, who wasn't involved in the study."

        HealthDay (9/23, Gardner) noted that "there have been previous scattered reports of an increased risk of cardiovascular events in people using Spiriva, resulting in an 'early communication' from the U.S. Food and Drug Administration earlier this year warning of a possible increased risk of stroke with use of the drug."

        A recent study conducted by Veterans Affairs researchers also "found a 34 percent increase in risk of cardiovascular death for newly diagnosed COPD patients using ipratropium," MedPage Today (9/23, Peck) added. Meanwhile, the authors of the current study "said the precise mechanism by which inhaled anticholinergics increase risk was uncertain, but they noted that the Lung Health Study found 'an increase in the incidence of supraventricular tachycardia with inhaled ipratropium consistent with the vagolytic nature of the drug.'" The researchers also acknowledged that "the study was limited by quality of the reported data, much of which came from small, short-term trials. Moreover, they said the reporting of cardiovascular outcomes might have been incomplete, because these were not the focus of those studies."

        In response to the results, "pharmaceutical industry spokespeople issued a statement strongly disagreeing with the conclusions of the study," and presented "their own new analysis that they say confirms the safety of Spiriva," WebMD (9/23, Doheny) reported.

        The BBC (9/23), AHN (9/23), the U.K.'s Telegraph (9/23, Devlin), HeartWire (9/23, Stiles), the CBC (9/24), and the U.K.'s Press Association (9/24) also cover the story.