A large, long-term project by the Heart Protection Study Collaborative Group showed that statin therapy increasingly reduced heart attack, stroke, and other vascular disease as treatment continued, and that these benefits persisted for several years after treatment had stopped. In addition, no increases in cancer incidence or other nonvascular morbidity or mortality were seen over 11 years of follow-up.
Trials have shown that lowering LDL with statins quickly reduces vascular morbidity and mortality, but evidence of long-term efficacy and safety has been limited. In addition, in observational epidemiologic studies, prolonged follow-up has shown lower blood cholesterol concentrations to be associated with higher rates of particular types of cancer as well as other nonvascular morbidity and mortality.
The Heart Protection Study group evaluated these issues and reported their findings online ahead of print in The Lancet. A total of 20,536 patients at high risk of vascular and nonvascular outcomes received either 40 mg simvastatin (Zocor) daily or placebo.
During the in-trial period, allocation to simvastatin resulted in an average reduction in LDL of 1.0 mmol/L and a proportional decrease in major vascular events of 23%. The absolute benefits increased as treatment continued during the five-year trial period. Post-trial, when statin use and lipid concentrations were similar in both groups, no further significant reductions were noted in either major vascular events or vascular mortality.
During the combined in-trial and post-trial periods, no significant differences were recorded in cancer incidence at all sites or at any particular site, or in mortality attributed to cancer.
The results “provide considerable assurance — both to prescribers and to patients — about the long-term safety of lowering LDL cholesterol substantially for about five years.”
In another study featuring statin use, the SATURN trial recently demonstrated that maximum doses of rosuvastatin (Crestor) or atorvastatin (Lipitor) are similarly very effective in reversing atherosclerosis after 24 months of treatment, with few adverse events occurring among the 1,039 participants. Rosuvastatin was associated with a 1.22% decrease in plaque burden and atorvastatin with a 0.99% decrease (N Engl J Med. 2011;365:2078-2087).