Matthew B. Stanbrook, MD, PhD
In patients with chronic obstructive pulmonary disease (COPD), does tiotropium increase risk for cardiovascular (CV) adverse events?
Included studies compared tiotropium with placebo in patients with COPD. Inclusion criteria for the original trials were age ≥ 40 years, ≥ 10 pack-years of smoking, and FEV1 ≤ 70% of FVC. Exclusion criteria included asthma and recent serious heart problems. Outcomes were a composite CV endpoint (fatal or nonfatal myocardial infarction or stoke, or CV death), serious and fatal cardiac and vascular events, CV death, and all-cause death.
The Boehringer Ingelheim project database was searched for randomized, double-blind, placebo-controlled trials (RCTs) ≥ 4 weeks in duration. 30 trials (n = 19 545, mean age 65 y, 76% men) met the selection criteria. Except for 1 large trial (n = 5992) that had 4 years of follow-up, duration of follow-up ranged from 20 days to 1 year. Total follow-up was 13 146 patient-years for tiotropium and 11 095 patient-years for placebo. Results from the 30 trials were pooled using individual patient data.
Risks for all-cause death, CV death, major CV events, and serious cardiac adverse events were lower in the tiotropium group than in the placebo group (Table). There was no increase in risk for any adverse event.
In patients with chronic obstructive pulmonary disease, tiotropium does not increase risk for cardiovascular adverse events.
Tiotropium vs placebo in 30 pooled trials involving 19 545 patients with chronic obstructive pulmonary disease*
*AEs = adverse events; CV = cardiovascular; other abbreviations defined in Glossary. RRR, RRI, and CI calculated from data in article.
†Fatal or nonfatal myocardial infarction or stroke, or CV death.
Stanbrook MB. Review: Tiotropium does not increase risk for cardiovascular events in chronic obstructive pulmonary disease. Ann Intern Med. ;153:JC1–2. doi: 10.7326/0003-4819-153-2-201007200-02002
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Published: Ann Intern Med. 2010;153(2):JC1-2.
Chronic Obstructive Airway Disease, Prevention/Screening, Pulmonary/Critical Care.
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