Abstract 4024: 15 Year Follow-Up of the West of Scotland Coronary Prevention Study
Introduction: West of Scotland Coronary Prevention Study (WOSCOPS), a double blind placebo controlled trial of pravastatin (40mg) in 6595 men aged 45– 64 with no history of MI, demonstrated after an average of 4.9 years that pravastatin reduced CHD death or non-fatal MI by 31% (P<0.001) with no increase in non-CV deaths or in incident cancers. Overall mortality was reduced from 4.1% to 3.2% (P=0.051). Despite the positive findings there was significant interest in studying the long-term safety and benefits after study closedown.
Hypothesis: WOSCOPS subjects would obtain long-term CHD benefit from randomized treatment with pravastatin with no increase in non-CV mortality or in cancer incidence.
Methods: Subjects’ medical records were followed up for a period of 5 years post-trial to review their statin treatment status. Electronic record linkage with the Scottish Record Linkage System captured all hospital admissions and deaths until December 2004 and all incident cancers until June 2003. Hazard ratios for the impact of treatment on outcomes were calculated from Cox regression models.
Results: The numbers of subjects on statin treatment post trial were similar in the two groups with (27% at 1 year and 37% at 5 years). Hazard ratios for CHD events are given below within-trial, post-trial and overall. There was no excess of non-CV deaths (377 placebo vs 367 pravastatin) or in cancer deaths (266 placebo vs 266 pravastatin) or incident cancers (404 placebo vs 431 pravastatin) in the average 15 years of follow-up.
Conclusions: Long-term follow-up of the WOSCOPS randomized subjects confirmed the safety of pravastatin treatment and strongly suggests ongoing benefit in reducing CHD events over a period of 10 years after the trial.