title: Risk of nonlower respiratory serious adverse events following COPD exacerbations in the 4-year UPLIFT® trial.
abstract: BACKGROUND
  Chronic obstructive pulmonary disease (COPD) exacerbations are associated with systemic consequences. Data from a 4-year trial (Understanding Potential Long-term Impacts on Function with Tiotropium [UPLIFT(®)], n = 5,992) were used to determine risk for nonlower respiratory serious adverse events (NRSAEs) following an exacerbation.
  
  
  METHODS
  Patients with ≥ 1 exacerbation were analyzed. NRSAE incidence rates (incidence rate [IR], per 100 patient-years) were calculated for the 30 and 180 days before and after the first exacerbation. NRSAEs were classified by diagnostic terms and organ classes. Maentel-Haenszel rate ratios (RR) (pre- and postexacerbation onset) along with 95% confidence intervals (CI) were computed.
  
  
  RESULTS
  A total of 3,960 patients had an exacerbation. The mean age was 65 years, forced expiratory volume in 1 s (FEV(1)) was 38% predicted, and 74% were men. For all NRSAEs, the IRs 30 days before and after an exacerbation were 20.2 and 65.2 with RR (95% CI) = 3.22 (2.40-4.33). The IRs for the 180-day periods were 13.2 and 31.0 with RR (95% CI) = 2.36 (1.93-2.87). The most common NRSAEs by organ class for both time periods were cardiac, respiratory system (other), and gastrointestinal. All NRSAEs as well as cardiac events were more common after the first exacerbation, irrespective of whether the patient had cardiac disease at baseline.
  
  
  CONCLUSIONS
  The findings confirm that, after exacerbations, serious adverse events in other organ systems are more frequent, particularly those that are cardiac in nature.
authors.affiliation: Royal Devon & Exeter Hospital, Barrack Road, Exeter, EX2 5DW, UK. David.Halpin@rdeft.nhs.uk
authors.forename: David M G
authors.initials: DM
authors.lastname: Halpin
authors.forename: Marc
authors.initials: M
authors.lastname: Decramer
authors.forename: Bartolome
authors.initials: B
authors.lastname: Celli
authors.forename: Steven
authors.initials: S
authors.lastname: Kesten
authors.forename: Inge
authors.initials: I
authors.lastname: Leimer
authors.forename: Donald P
authors.initials: DP
authors.lastname: Tashkin
mesh_terms: D000368:Aged; D001993:Bronchodilator Agents / Q000009:adverse effects* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D005541:Forced Expiratory Volume; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012140:Respiratory Tract Diseases / Q000139:chemically induced; D012306:Risk; D012602:Scopolamine Derivatives / Q000009:adverse effects* / Q000627:therapeutic use; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide