Statins are at least as effective in patients with low levels of inflammation as they are in other patients, according to a study from the Heart Protection Study Collaborative Group published online Jan. 27 in the Lancet. These findings refute the suggestion that a person's level of systemic inflammation, as measured by levels of C-reactive protein (CRP), could modify their response to statin therapy.
The group, which is based at the clinical trial service unit at the University of Oxford in England, published the main results of the Heart Protection Study in Lancet in 2002.
For this study, Jonathan R. Emberson, PhD, from the cardiovascular sciences department at Oxford, and colleagues analyzed more than 20,000 patients who took part in the original Heart Protection Study between 1994 and 2001. The participants were aged 40 to 80 years and at high risk of vascular events, and from 69 hospitals in the U.K.
The patients were assigned to receive either simvastatin 40 mg daily or matching placebo for a mean of five years. The researchers monitored them for occurrence of coronary-related death, heart attack, stroke or intervention for revascularization.
Overall, patients assigned to simvastatin had a highly significant 24 percent reduction in the risk of a major vascular event, with no evidence that CRP had any significant effect on this reduction, the researchers reported. Even in patients with the lowest CRP levels, statins reduced major vascular events by the same amount of about one quarter.
Indeed, the authors noted that any combination of low or high CRP with low or high LDL cholesterol appeared to have little impact on the benefits of the statin.
"The results do not lend support to the suggestion that the beneficial effects of statin therapy are affected by baseline CRP concentration or, more generally, by inflammation status,” Emberson and colleagues concluded. “The results could be applicable to all statins (not only simvastatin) and are likely to be applicable to a wide range of people with and without pre-existing vascular disease."
In an accompanying Lancet commentary, Jean-Pierre Després, PhD, from Université Laval in Québec City, Québec, pointed out that LDL cholesterol and CRP concentrations assessed at baseline were both associated with the absolute vascular event rate.
"[A]lthough the highest event rate was recorded in patients with both high LDL-cholesterol and CRP concentrations, patients given simvastatin who had low baseline CRP concentrations had the lowest rate of vascular events irrespective of their baseline LDL-cholesterol values,” Després wrote “Thus, although all subgroups benefited from statin therapy, both LDL-cholesterol and CRP concentrations were clearly associated with major vascular event rates.”
Yet, Després complimented this “landmark” trial for bringing “more fuel to a healthy debate.”
The study received funding from the U.K. Medical Research Council, the British Heart Foundation, Merck, Roche Vitamins and GlaxoSmithKline.