title: Prognostic effects of rosuvastatin in patients with co-existing chronic obstructive pulmonary disease and chronic heart failure: A sub-analysis of GISSI-HF trial.
abstract: Rising evidences showed a possible protective role of statins in chronic obstructive pulmonary disease (COPD). We aimed to evaluate in a post-hoc analysis of the GISSI-HF trial the prognostic effect of the use of rosuvastatin in patients with co-existing COPD and HF, assuming that the anti-inflammatory properties of these drugs may imply a potential beneficial effect in these associated chronic inflammatory conditions.
  
  
  
  We analyzed patients with chronic HF and history of COPD deriving from the GISSI-HF study. Of all 4574 patients eligible to statin, 1060 ambulatory patients with HF and concomitant COPD were enrolled and randomly assigned to rosuvastatin 10 mg daily (538 patients) or placebo (522 patients). The primary end-point was to compare all cause death rate in patients randomized to rosuvastatin or placebo. Further, we assessed the effects of rosuvastatin (10 mg daily) on cardiovascular (CV) death, non-CV death and hospital admissions. Median follow-up was 3.9 years with an interquartile range (IQR) of 3.0-4.4.
  
  
  
  During the follow-up 438 (41.3%) patients died, 304 (28.6%) for CV death and 687 (64.8%) had at least one hospitalization. The two patient groups had similar outcome, irrespective of randomization, in terms of all-cause mortality (log-rank test p = 0.30) CV, non CV-death (p = 0.88 and 0.09 respectively) and all-cause hospitalization (p = 0.82). Cox regression analysis did not show a favorable association between the use of statin and the examined end-points both on unadjusted and adjusted models.
  
  
  
  Statin use is not associated with a beneficial effects on all cause, CV, non CV mortality and hospitalization in patients with coexistent chronic HF and history of COPD. ClinicalTrials.gov Identifier: NCT00336336.
authors.affiliation: Department of Medicine, University of Verona, Verona, Italy; AIPO Study Center, Milano, Italy. Electronic address: andrea.rossi_03@univr.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rossi
authors.affiliation: Cardiology Unit, Department of Medicine, University and General Hospital (AOUI) of Verona, Verona, Italy.
authors.forename: Riccardo M
authors.initials: RM
authors.lastname: Inciardi
authors.affiliation: Cardiology Unit, Department of Medicine, University and General Hospital (AOUI) of Verona, Verona, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rossi
authors.affiliation: Division of Cardiology, Istituti Clinici Scientifici Maugeri, Veruno, Italy.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Temporelli
authors.affiliation: ANMCO Research Center, Florence, Italy.
authors.forename: Donata
authors.initials: D
authors.lastname: Lucci
authors.affiliation: ANMCO Research Center, Florence, Italy.
authors.forename: Lucio
authors.initials: L
authors.lastname: Gonzini
authors.affiliation: Therapeutic Science & Strategy Unit (TSSU), Quintiles, Milan, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Marchioli
authors.affiliation: Department of Cardiology, Santa Maria degli Angeli Hospital, Pordenone, Italy.
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Nicolosi
authors.affiliation: Maria Cecilia Hospital, GVM Care & Research, Ettore Sansavini Health Science Foundation, Cotignola, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D000068718:Rosuvastatin Calcium / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000068718:Rosuvastatin Calcium
keywords: Chronic heart failure; Chronic obstructive pulmonary disease; Pleiotropic effects; Statin