Question: How well does rosuvastatin (Crestor®) 10 mg/d protect against cardiovascular events in patients at intermediate cardiovascular risk?
Background: Previous studies have extensively addressed the reduction of cardiovascular events by statins in those already suffering from cardiovascular disease (secondary prevention). The HOPE 3 trial now investigated the role of LDL cholesterol lowering in patients without cardiovascular disease (primary prevention).
PATIENTS AND METHODS: The HOPE 3 (Heart Outcomes Prevention Evaluation) is a double-blind, randomized, placebo-controlled trial with 228 participating centers in 21 countries on six continents. Women aged 65 years and older and men aged 55 years and older without cardiovascular disease but with an intermediate risk-defined as approximately 1% per year-of a major cardiovascular event were included. For this, at least one of the following risk factors had to be present: increased waist-to-hip ratio, low HDL cholesterol level, persistent nicotine use or nicotine use that had stopped in the previous years, dysglycemia, incipient renal dysfunction, or positive family history for coronary heart disease. In addition, women aged 60 years and older with at least two risk factors were included. One group received rosuvastatin 10 mg/d (n=6361), the other placebo (n=6344) over a median observation period of 5.6 years.
Results: The first co-primary end point (cerebrovascular accident/heart attack or death from cardiovascular event) occurred in 235 participants (3.7%) in the rosuvastatin group and 304 (4.8%) in the placebo group. Thus, the hazard ratio was 0.76 (CI 0.64-0.91), the p-value was 0.002, and the number needed to treat (NNT) was 91 patients. Fewer ischemic (41 vs. 77) but slightly more hemorrhagic cerebral infarctions (11 vs. 8) occurred in the rosuvastatin group than in the placebo group. 367 participants (5.8%) on rosuvastatin reported muscle pain or weakness compared with 296 (4.7%) on placebo; p=0.005. Further information on side effects can be found in the study publication. With a mean LDL cholesterol level of 3.31 mmol/l at baseline, there was an overall mean difference of 0.90 mmol/l (26.5%; p<0.001) between the rosuvastatin and placebo groups at the end of the study.
Authors’ Conclusions: Daily use of 10 mg rosuvastatin results in a significantly lower risk of cardiovascular events (compared with placebo) in an ethnically diverse, “intermediate-risk” population without cardiovascular disease.
Comment: On the one hand, from a therapeutic point of view, the HOPE 3 trial provides us with interesting results on effective primary prevention of cardiovascular events. Due to the high prevalence and the resulting financial burden on the health care system, prevention is of great importance. However, statins medicinally reduce a risk that has been created and is maintained by factors that can often be influenced. Recommendations on healthy eating, striving for a normal weight, abstinence from nicotine, physical activity and avoiding alcohol overconsumption seem trivial and negligible compared to a “pill”. However, the primary preventive effect of lifestyle modifications has been repeatedly investigated in good studies and showed impressive reductions in the risk of cerebral infarction of 30-80%, depending on the type and number of optimized factors. Accordingly, the recommendation must primarily go in this direction, although an additional cholesterol reduction as an effective primary prophylactic measure must also always be considered.
InFo NEUROLOGY & PSYCHIATRY 2016; 14(4): 33.
