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Tiotropium Cut Exacerbations in Poorly Controlled Asthma

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Studies Miss Noncompliance, CV Risk

These studies’ findings cannot be generalized to all patients with uncontrolled asthma, because both studies selectively enrolled patients who had persistent airflow limitation – thus skewing the study populations to resemble the COPD patients who are already known to benefit from tiotropium, said Dr. Elisabeth H. Bel.

Both studies also excluded patients with heart disease, which may have masked the fact that soft-mist inhaler delivery of tiotropium "may impose a substantial risk in patients with a history of [cardiovascular] events," Dr. Bel cautioned.

In addition, the researchers failed to verify whether subjects were fully compliant with background asthma therapy at enrollment. Because it is known that more than 80% of patients with poorly controlled asthma have poor treatment adherence, the patients’ relative undertreatment at baseline "might have left room for additional bronchodilation by tiotropium," she noted.

Dr. Bel is in the department of pulmonology at the Academic Medical Center, Amsterdam. She reported ties to Actelion, GlaxoSmithKline, Merck, Novartis, Nycomed, and Schering Plough. These remarks were taken from her editorial accompanying Dr. Kerstjens’ report (N. Engl. J. Med. 2012 Sept. 3 [doi:10.1056/NEJMe1209381]).


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

Cardiac events occurred in less than 2% of both study groups; they were considered drug related in 0.4% of patients in the tiotropium group and 0.2% of those in the placebo group. Adverse changes in blood pressure, pulse rate, laboratory measures, and electrocardiograms were balanced between the two study groups.

Less than 2% of all patients experienced dry mouth – a typical adverse event with anticholinergic agents – but it was reported more frequently in the tiotropium group (eight patients vs. three patients), Dr. Kerstjens and his associates said.

Dr. Kerstjens reported additional associations with Almirall, Chiesi, Novartis, and Nycomed, and his associates reported ties to numerous industry sources.

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