SESSION TITLE: COPD Exacerbation Risk
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Wednesday, October 29, 2014 at 02:45 PM - 04:15 PM
PURPOSE: To investigate the annualized rate of comorbidities in patients with moderate to severe chronic obstructive pulmonary disease (COPD) enrolled in the Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT®) trial (NCT00144339).
METHODS: UPLIFT® was a 4-year, randomized, double-blind, placebo-controlled, parallel-group trial of tiotropium HandiHaler® 18 μg or placebo once daily, involving 5993 patients with moderate to very severe COPD.1 The use of all COPD medications except for inhaled anticholinergics was permitted. The Medical Dictionary for Regulatory Activities (MedDRA) version 13.1 was used to code relevant medical history/concomitant diagnoses (within the past 5 years) as reported by the Investigator at baseline and throughout the 4-year trial period; specific terms (preferred terms [PTs]), standardized MedDRA queries [SMQs] were categorized under system organ classes within MedDRA. For conditions that are known to have a high prevalence in patients with COPD, MedDRA PTs denoting similar conditions and SMQs were pooled.
RESULTS: At baseline 87.8% of patients had documented comorbidities compared with 98.2% at the end of the 4-year study (95.4%, 97.2% and 97.9% patients after years 1, 2 and 3). The cumulative increase in nine comorbidities most frequently observed in patients with COPD, at baseline and years 1 to 4 were: SOC cardiac disease (26.0, 29.6, 32.5, 34.9, and 37.0%); myocardial infarction (SMQ broad; 2.8, 3.8, 4.4, 5.1, and 5.5%); SMQ other ischaemic heart disease (broad; 15.4, 16.4, 17.7, 18.4, and 19.1%); SMQ cardiac arrhythmias (6.4, 8.1, 9.5, 10.8, and 11.8%); SMQ cardiac arrhythmias sub-SMQ tachyarrhythmias (4.4, 5.8, 7.0, 8.0, and 8.9%); PT hypertension (39.6, 42.2, 43.8, 45.4, 46.6%); stroke (2.3, 3.0, 3.8, 4.3, 4.7%); PT diabetes mellitus (5.6, 6.2, 6.7, 7.3, 7.8%); SMQ depression (8.8, 9.6, 10.6, 11.3, 11.9%). There were no notable differences in the incidences of comorbidities between the active treatment and placebo at baseline and during the trial.
CONCLUSIONS: The incidence of comorbidities increased considerably (11.8%) during the 4-year duration of the study.
CLINICAL IMPLICATIONS: Large-scale, long-term studies like UPLIFT® may illustrate how patients with COPD are likely to develop comorbidities over time, by mirroring what happens in daily clinical practice. Reference1Tashkin DP, et al. N Engl J Med. 2008;359:1543-1554. Funded by Boehringer Ingelheim and Pfizer
DISCLOSURE: Donald Tashkin: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Marc Miravitlles: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim David Price: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Norbert Metzdorf: Employee: Boehringer Ingelheim Katrin Kupas: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Bartolome Celli: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim
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