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Clinical Question
In men with a low-density lipoprotein cholesterol level of 190 mg/dL or higher, are statins effective as primary prevention?
Bottom line
These results confirm that the use of statins for men with a low-density lipoprotein (LDL) cholesterol level of at least 190 mg/dL, regardless of calculated risk, is associated with a clinically and statistically significant reduction in cardiovascular events and probably cardiovascular and all-cause mortality. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (any)
Synopsis
The most recent American College of Cardiology / American Heart Association lipid guidelines recommend a statin for any patient with an LDL cholesterol level of 190 mg/dL or higher. However, the evidence supporting this recommendation is limited. The West of Scotland Coronary Prevention Study (WOSCOPS), originally published in 1995, was one of the first studies of statins for primary prevention. It enrolled men aged 45 years to 64 years with an LDL level of at least 155 mg/dL and randomized them to receive pravastatin 40 mg or placebo. The mean age of the study population was 55 years, mean body mass index was 26 kg/m2, and the mean LDL cholesterol level was 192 mg/dL. These authors re-analyzed the data, limiting their analysis only to primary prevention by excluding anyone with any possible evidence of vascular disease, and adding a 20-year observational follow-up. They stratified the results by LDL cholesterol level of 190 mg/dL or higher (n = 2560) versus LDL level of less than 190 mg/dL (n = 2969). The researchers found a fairly consistent relative reduction in cardiac events with the use of statins, regardless of the initial LDL level. For the combined outcome of cardiovascular death, myocardial infarction, and stroke, the relative risk reduction was 25% for those with an initial LDL level of at least 190 mg/dL. There were favorable trends (not statistically significant) regarding all-cause mortality and cardiovascular death with the use of statins. For the combined outcome of nonfatal myocardial infarction and coronary heart disease death, there was a significant benefit for those with an initial LDL level of less than 190 mg/dL (hazard ratio 0.58; 95% CI 0.41 - 0.81), but not for those with an initial LDL level of 190 mg/dL or more. Results were generally consistent during the 20-year follow-up period, although this time the reductions in all-cause mortality and cardiovascular death were statistically significant for the group with an initial LDL of 190 mg/dL or higher. The results from a subgroup analysis of patients without diabetes and a less than 7.5% 10-year event risk were similar. A limitation of this study is generalizability to a contemporary US population: The WOSCOPS participants were all men, 44% smoked, and less than 2% had type 2 diabetes mellitus.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
good poem
Reassuring of current practice
Number needed to treat
I calculate an NNT of 50 for CAD and 40 for preventing MI. I had to find the article to look at ARR. By presenting only relative risk reduction in this POEM the numbers will always look more impressive.
population vs individual benefit
This is a tough issue. There's pretty good evidence that if we just gave statins to EVERYONE we'd reduce the overall rate of cardiac events by a rather significant degree. On the other hand the benefit to any particular patient is vanishingly small. The harms to that patient (even if only being labeled as ill) are not addressed.
NNT
I find it hard to reconcile these numbers in the Number needed to treat comment when I look at this web page
http://www.thennt.com/nnt/statins-persons-low-risk-cardiovascular-disea…
Reporting this study as a Poem, without including critical reports of this study, is disappointing. 1) it was a posthoc analysis with an absolute risk reduction of 2.3%. 2) for the 15 years after the original five-year trial most patients in the treatment arm stopped taking the statin, and approximately a 3rd of patients in the placebo arm took a statin.
It would be better if there is a clear causal relationship between lowering LDL and decreased IHD.
NNT
Where's the NNT??
WHATS WITH THE US UNITS!!!!!
LDL conversion
190 mg/dl is 5.0 mmol/l-wish for Canadian Consumption it be converted.
We all use < 2.0 mmol/l (about 75 mg/dl) as target for high risk, (Framingham >20) post cardiac patients
American cholesterol unit values should have shown the corresponding Canadian / European unit values in a Canadian educational evidence summary.