Simvastatin for the prevention of exacerbations in moderate-to-severe COPD.

TitleSimvastatin for the prevention of exacerbations in moderate-to-severe COPD.
Publication TypeJournal Article
Year of Publication2014
AuthorsCriner, GJ, Connett, JE, Aaron, SD, Albert, RK, Bailey, WC, Casaburi, R, J Cooper, AD, Curtis, JL, Dransfield, MT, Han, MLK, Make, B, Marchetti, N, Martinez, FJ, Niewoehner, DE, Scanlon, PD, Sciurba, FC, Scharf, SM, Sin, DD, Voelker, H, Washko, GR, Woodruff, PG, Lazarus, SC
Corporate AuthorsCOPD Clinical Research Network, Canadian Institutes of Health Research
JournalN Engl J Med
Date Published2014 Jun 5
KeywordsAdult, Aged, Female, Forced Expiratory Volume, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Lipids, Male, Middle Aged, Prospective Studies, Pulmonary Disease, Chronic Obstructive, Quality of Life, Severity of Illness Index, Simvastatin, Treatment Failure, Vital Capacity

BACKGROUND: Retrospective studies have shown that statins decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD). We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large, multicenter, randomized trial.

METHODS: We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations (STATCOPE) as a randomized, controlled trial of simvastatin (at a daily dose of 40 mg) versus placebo, with annual exacerbation rates as the primary outcome. Patients were eligible if they were 40 to 80 years of age, had COPD (defined by a forced expiratory volume in 1 second [FEV1] of less than 80% and a ratio of FEV1 to forced vital capacity of less than 70%), and had a smoking history of 10 or more pack-years, were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents, or had had an emergency department visit or hospitalization for COPD within the past year. Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded. Participants were treated from 12 to 36 months at 45 centers.

RESULTS: A total of 885 participants with COPD were enrolled for approximately 641 days; 44% of the patients were women. The patients had a mean (±SD) age of 62.2±8.4 years, an FEV1 that was 41.6±17.7% of the predicted value, and a smoking history of 50.6±27.4 pack-years. At the time of study closeout, the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo. The mean number of exacerbations per person-year was similar in the simvastatin and placebo groups: 1.36±1.61 exacerbations and 1.39±1.73 exacerbations, respectively (P=0.54). The median number of days to the first exacerbation was also similar: 223 days (95% confidence interval [CI], 195 to 275) and 231 days (95% CI, 193 to 303), respectively (P=0.34). The number of nonfatal serious adverse events per person-year was similar, as well: 0.63 events with simvastatin and 0.62 events with placebo. There were 30 deaths in the placebo group and 28 in the simvastatin group (P=0.89).

CONCLUSIONS: Simvastatin at a daily dose of 40 mg did not affect exacerbation rates or the time to a first exacerbation in patients with COPD who were at high risk for exacerbations. (Funded by the National Heart, Lung, and Blood Institute and the Canadian Institutes of Health Research; STATCOPE number, NCT01061671.).

Alternate JournalN. Engl. J. Med.
PubMed ID24836125
Grant List115074 / / Canadian Institutes of Health Research / Canada
U10 HL074407 / HL / NHLBI NIH HHS / United States
U10 HL074408 / HL / NHLBI NIH HHS / United States
U10 HL074416 / HL / NHLBI NIH HHS / United States
U10 HL074418 / HL / NHLBI NIH HHS / United States
U10 HL074422 / HL / NHLBI NIH HHS / United States
U10 HL074424 / HL / NHLBI NIH HHS / United States
U10 HL074428 / HL / NHLBI NIH HHS / United States
U10 HL074431 / HL / NHLBI NIH HHS / United States
U10 HL074439 / HL / NHLBI NIH HHS / United States
U10 HL074441 / HL / NHLBI NIH HHS / United States
U10HL074409 / HL / NHLBI NIH HHS / United States