From Aker Hospital, Oslo, Norway (T.R.P.); Linköping University
Hospital, Sweden (A.G.O.); Århus Hospital, Denmark (O.F.);
Rikshospitalet, University of Oslo, Norway (J.K., B.C.); Sahlgrenska
University Hospital, Göteborg, Sweden (H.W., L.W.); Institute of Medical
Genetics, University of Oslo, Norway (K.B.); Odense Hospital, Denmark (T.H.);
Landspitalinn University Hospital, Reykjavik, Iceland (G.T.); Kuopio
University Hospital, Finland (K.P., T.M.); and Merck Research Laboratories,
Rahway, NJ (J.A.T., T.A.M., T.J.C.).
Correspondence to Dr Terje R. Pedersen, Cardiology Department, Medical Clinic, Aker Hospital, N 0514, Oslo, Norway.
Background—The Scandinavian
Simvastatin Survival Study (4S) randomized 4444 patients
with coronary heart disease (CHD) and serum
cholesterol 5.5 to 8.0 mmol/L (213 to 310 mg/dL) with
triglycerides
Methods and Results—The Cox proportional hazards model was used
to assess the relationship between lipid values (baseline, year 1, and
percent change from baseline at year 1) and MCEs. The reduction in MCEs
within the simvastatin group was highly correlated with
on-treatment levels and changes from baseline in total and LDL
cholesterol, apolipoprotein B, and less so with HDL
cholesterol, but there was no clear relationship with
triglycerides. We estimate that each additional 1%
reduction in LDL cholesterol reduces MCE risk by 1.7%
(95% CI, 1.0% to 2.4%; P<.00001).
Conclusions—These analyses suggest that the beneficial
effect of simvastatin in individual patients in 4S was
determined mainly by the magnitude of the change in LDL
cholesterol, and they are consistent with current
guidelines that emphasize aggressive reduction of this lipid in CHD
patients.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Lipoprotein Changes and Reduction in the Incidence of Major Coronary Heart Disease Events in the Scandinavian Simvastatin Survival Study (4S)
2.5 mmol/L (220 mg/dL) to
simvastatin 20 to 40 mg or placebo once daily. Over the
median follow-up period of 5.4 years, one or more major
coronary events (MCEs) occurred in 622 (28%) of the 2223
patients in the placebo group and 431 (19%) of the 2221 patients in
the simvastatin group (34% risk reduction,
P<.00001). Simvastatin produced substantial
changes in several lipoprotein components, which we have attempted to
relate to the beneficial effects observed.
Key Words: coronary disease • lipoproteins • cholesterol • simvastatin
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