The Clinical Trial Service Unit at the University of Oxford have announced the summary results (PDF) of the SEARCH study. Publication of the full results is expected in 2009.
The study aimed to assess the impact of intensive lipid lowering with simvastatin 80mg versus standard therapy with simvastatin 20mg and folic acid supplementation in patients who have had a heart attack.
The study recruited 12,000 participants with 6,000 being randomly assigned to treatment with intensive or standard statin therapy. The study ran for an average of 6.7 years. The intensive treatment produced a reduced level of low-density lipoprotein cholesterol (LDL-C) by 0.35mmol/L. This reduction was associated with a 6% reduction in heart attacks, stroke and revascularisation procedures although this was not statistically significant. The study also found that there was no benefit from folic acid or vitamin B12 supplementation in the prevention of heart attacks or strokes.
The press release states that the study results, although not statistically significant, are consistent with data from meta-analysis showing a 0.35mmol/L reduction in LDL-C is associated with a relative risk reduction of 6-7% and therefore supports the assertion at lower LDL-C is better.
However, it is also notable that during the study 3 patients treated with simvastatin 20mg developed myopathy while 53 developed this adverse drug reaction while taking simvastatin 80mg.
This is a relative risk increase of 1767%.
Hat tip: http://www.prescriber.org.uk/
1 comment:
With statins as a class of medications:
A.E.s are often under-reported with high doses of potent statins in particular. Additionally, there is no reduction in mortality or increase in the lifespan of one on statin therapy.
Several risk factors should determine if one is placed on statin therapy, and not just one variable.
Statins do decrease CV events and risks significantly. The meds. increase endothelial function, stabilize coronary plaque build up, and decrease thrombus formation. Maximum reduction in LDL is evaluated after about a month of therapy.
There is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP), those with dementia or Parkinson's disease, and some forms of Cancer and cataracts.
It appears those statins produced by fermentation, such as Zocor and Pravachol, have less myopathy than the other synthetic statins, possibly due to being more hydrophyllic.
Yet overall, the existing cholesterol lowering recommendation should be re-evaluated, as they may be over-exaggerated, and likely are embellished.
With children, diet should be the focus with them so they do not develop the arteries of one who is middle-aged so they avoid statin therapy.
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