Effects of rosuvastatin on atrial fibrillation occurrence: ancillary results of the GISSI-HF trial

Eur Heart J. 2009 Oct;30(19):2327-36. doi: 10.1093/eurheartj/ehp357. Epub 2009 Aug 30.


Aims: This ancillary analysis of the GISSI-HF database aims at assessing the effect of rosuvastatin on the occurrence of atrial fibrillation (AF) in patients with chronic heart failure (HF) who were not in AF at study entry.

Methods and results: GISSI-HF was a double-blind, placebo-controlled trial testing n-3 PUFA and rosuvastatin vs. corresponding placebos in patients with chronic HF. Atrial fibrillation occurrence was defined as the presence of AF in the electrocardiogram (ECG) performed at each visit during the trial or AF as a cause of worsening HF or hospital admission or as an event during hospitalization. Among the 3690 patients (80.7%) without AF on their baseline ECG, 15.0% developed AF during a median follow-up period of 3.7 years, 258 randomized to rosuvastatin (13.9%) vs. 294 allocated to placebo (16.0%). Although the difference was not significant at unadjusted analysis (P = 0.097) and multivariable analysis adjusting for clinical variables (P = 0.067), it became significant after adjustment for clinical variables and laboratory examinations (P = 0.039), and for clinical variables, laboratory examinations, and background therapies (P = 0.038).

Conclusion: This study shows that there is some evidence of a beneficial effect of rosuvastatin in terms of reduction of AF occurrence in patients with HF. Larger populations are needed to provide a definite answer to the question. ClinicalTrials.gov Identifier: NCT00336336.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anti-Arrhythmia Agents / therapeutic use*
  • Atrial Fibrillation / drug therapy*
  • Chronic Disease
  • Double-Blind Method
  • Drug Therapy, Combination
  • Fatty Acids, Omega-3 / therapeutic use*
  • Female
  • Fluorobenzenes / therapeutic use*
  • Heart Failure / drug therapy*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Pyrimidines / therapeutic use*
  • Risk Factors
  • Rosuvastatin Calcium
  • Sulfonamides / therapeutic use*
  • Treatment Outcome


  • Anti-Arrhythmia Agents
  • Fatty Acids, Omega-3
  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium

Associated data

  • ClinicalTrials.gov/NCT00336336