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Cardiovascular safety of tiotropium in patients with COPD.
- Source :
-
Chest [Chest] 2010 Jan; Vol. 137 (1), pp. 20-30. Date of Electronic Publication: 2009 Jul 10. - Publication Year :
- 2010
-
Abstract
- Background: The clinical trial safety database for tiotropium has been augmented with a 4-year trial in patients with COPD, which provides an opportunity to better evaluate the cardiovascular (CV) profile of tiotropium.<br />Methods: Trials with the following criteria were considered: > or = 4 weeks, randomized, double-blind, parallel-group, placebo-controlled. Inclusion/exclusion criteria were similar, including spirometry-confirmed COPD, > or = 10 pack-year smoking, and age > or = 40 years. Adverse events were collected throughout each trial using standardized case report forms. Incidence rates (IRs) were determined from the total number of patients with an event divided by total time at risk. Rate ratios (RRs) and 95% CI for tiotropium/placebo were calculated. IRs were determined for all-cause mortality and selected CV events, including a composite CV end point encompassing CV deaths, nonfatal myocardial infarction (MI), nonfatal stroke, and the terms sudden death, sudden cardiac death, and cardiac death.<br />Results: There were 19,545 patients randomized: 10,846 (tiotropium) and 8,699 (placebo) from 30 trials. Mean FEV(1) = 1.15 +/- 0.46 L (41 +/- 14% predicted), 76% men, mean age = 65 +/- 9 years. Cumulative exposure to study drug was 13,146 (tiotropium) and 11,095 (placebo) patient-years. For all-cause mortality, the IR was 3.44 (tiotropium) and 4.10 (placebo) per 100 patient-years (RR [95% CI] = 0.88 [0.77-0.999]). IR for the CV end point was 2.15 (tiotropium) and 2.67 (placebo) per 100 patient-years (RR [95% CI] = 0.83 (0.71-0.98]). The IR for the CV mortality excluding nonfatal MI and stroke was 0.91 (tiotropium) and 1.24 (placebo) per 100 patient-years (RR [95% CI] = 0.77 [0.60-0.98]). For total MI, cardiac failure, and stroke the RRs (95% CI) were 0.78 (0.59-1.02), 0.82 (0.69-0.98), and 1.03 (0.79-1.35), respectively.<br />Conclusion: Tiotropium was associated with a reduction in the risk of all-cause mortality, CV mortality, and CV events.
- Subjects :
- Administration, Inhalation
Aged
Cardiovascular Diseases complications
Cause of Death
Cholinergic Antagonists administration & dosage
Cholinergic Antagonists adverse effects
Dose-Response Relationship, Drug
Double-Blind Method
Female
Follow-Up Studies
Forced Expiratory Volume drug effects
Humans
Incidence
Male
Pulmonary Disease, Chronic Obstructive complications
Pulmonary Disease, Chronic Obstructive physiopathology
Retrospective Studies
Scopolamine Derivatives administration & dosage
Scopolamine Derivatives adverse effects
Spirometry
Survival Rate
Tiotropium Bromide
Treatment Outcome
United States epidemiology
Cardiovascular Diseases epidemiology
Cholinergic Antagonists therapeutic use
Pulmonary Disease, Chronic Obstructive drug therapy
Scopolamine Derivatives therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1931-3543
- Volume :
- 137
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Chest
- Publication Type :
- Academic Journal
- Accession number :
- 19592475
- Full Text :
- https://doi.org/10.1378/chest.09-0011