Statin evidence sparse for heart disease prevention
Results of a Cochrane Systematic Review reveal the drugs that are widely used to lower cholesterol may be of no benefit for those with no history of cardiovascular disease and may even cause more harm than good for some patients.
Fiona Taylor, from the Cochrane Heart Group at the London School of Hygiene and Tropical Medicine in London, UK says, "This review highlights important shortcomings in our knowledge about the effects of statins in people who have no previous history of CVD. The decision to prescribe statins in this group should not be taken lightly."
The researchers cite evidence that low cholesterol can cause death from all causes and there is little evidence that statins can prevent heart disease for individuals no history of cardiovascular disease (CVD).
Given the potential for harm, and outcomes found in trial reviews, the researchers concluded there is not enough evidence to recommend cholesterol lowering drugs for prevention in low risk individuals, though the benefits of statins for those with existing heart disease are well established.
Taylor says, "It is not as simple as just extrapolating the effects from studies in people who have a history of heart disease."
The researchers reviewed outcomes of patients given statins or placebo and usual care in 14 trials involving 34,272 patients. They found the drugs reduced the chances of each year from 9 to 8 per 1000 people treated with cholesterol lowering drugs, found in eight trials involving 28,161 patients.
They also found trials showing the benefits of statins were mostly sponsored by drugs companies, with the exception of one.
"We know that industry-sponsored trials are more likely to report favourable results for drugs versus placebos, so we have to be cautious about interpreting these results," said Taylor. "The numbers eligible for treatment with statins are potentially great so there might be motivations, for instance, to stop trials earlier if interim results support their use."
Even using combined approaches to curb heart disease, including lifestyle changes through education and counseling had little effect on reducing the rates of heart disease, making the findings unclear. In an accompanying editorial, Carl Heneghan, University of Oxford, said, "Although various multiple prevention strategies exist, the most effective and cost-effective intervention for primary prevention in adults at low risk currently remains unclear."
The review suggests statin benefits for preventing heart disease for those at low risk are sparse, but the Cochrane reviewers note limitations from potentially biased, selective and limited reporting from studies. They recommend careful consideration regarding statin use, given limited information that the drugs can prevent heart disease for those with no history of disease and at low risk.
"Statins: Benefits Questionable in Low-Risk Patients"