| Clinical Bottom Line: Simvastatin reduces cardiovascular morbidity and mortality (NNT = 30 for death; NNT=12 for fatal and non-fatal cardiovascular events; NNT=63 for stroke) in patients with MI or AP. |
Appraised by: Sackett; Monday, November 24, 1995
The Study:
Double-blinded randomised controlled trial without intention-to-treat.
35-70 y/o men and women at 94 Nordic centres with history of angina pectoris (21%) or myocardial infarction >6 months previously (79%) and persistent total cholesterol 5.5-8 mmol/L (triglyceride =< 2.5 mmol/L) and no planned surgery, CHF, AF, haemodynamic valvular disease, cardiomegaly, stroke, bad liver, or other serious disease. CHD onset was <1 year in a quarter and 1-5 years in 40%. A quarter had hypertension and a quarter were smokers. Had a 2-week compliance trial.
Control group (N = 2223; 2223 analysed): 2223 received placebo.
Experimental group (N = 2221; 2221 analysed): 2221 received simvastatin to bring total cholesterol to 3-5.2 mmol; 63% did it on 20 mg daily, and 37% were raised to 40 mg daily; 72% at goal at 1 year. Mean duration of follow-up was 5.4 years
The Evidence:
|
Outcome |
Time to Outcome |
CER |
EER |
RRR |
ARR |
NNT |
|
Death from any cause. |
5.4 years |
0.115 |
0.082 |
29% |
0.033 |
30 |
|
95% Confidence Intervals: |
|
|
|
13% to 44% |
0.016 to 0.050 |
20 to 64 |
|
Major Coronary events |
5.4 years |
0.280 |
0.194 |
31% |
0.086 |
12 |
|
95% Confidence Intervals: |
|
|
|
22% to 40% |
0.061 to 0.111 |
9 to 16 |
|
Any stroke |
5.4 years |
0.043 |
0.027 |
37% |
0.016 |
63 |
|
95% Confidence Intervals: |
|
|
|
12% to 62% |
0.005 to 0.027 |
37 to 192 |
Comments:
1. Total cholesterol fell by 28% (LDL by 38%; HDL rose 8%).
2. No sig. difference in non-cardiovascular deaths; suicide + trauma deaths were 7 and 6; 35 and 33 cancer deaths.
3. Women (19% of study population) had stat sig fewer secondary events.
4. no change in RRR or ARR for age >60
Expiry date: Search Updated September 1997; update again in Sept 1998.
Reference:
Scandanavian Simvastatin Survival Study Group: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-9.
 Click here to comment on this CAT |
 |