Statin treatment reduced cardiovascular events more than hypertension drugs in intermediate-risk patients, study finds
An accompanying editorial said that the results of this trial support the benefits of statins for primary prevention and a risk-based approach to prescribing, rather than one based on LDL levels.
A recent large trial of intermediate-risk patients found reductions in cardiovascular events associated with statins but not with hypertension drugs.
The trial included 12,705 people from 21 countries who did not have cardiovascular disease and were at intermediate risk of cardiovascular events. Studied outcomes were a composite of death from cardiovascular nonfatal myocardial infarction, or nonfatal stroke (first outcome), and a composite of those events plus revascularization, heart failure, and resuscitated cardiac arrest (second outcome). In a 2-by-2 factorial process, participants were randomly assigned to 10 mg of rosuvastatin per day or placebo and 16 mg candesartan per day and 12.5 mg of hydrochlorothiazide per day or placebo. Median follow-up was 5.6 years. Results were published by the New England Journal of Medicine on April 2.
The mean blood pressure of all patients at baseline was 138.1/81.9 mm Hg. Patients who received the blood pressure medications had a 6.0/3.0-mm Hg greater drop than the placebo group. Overall, the treated group did not have a significant reduction in studied outcomes compared to the placebo group. However, those in a prespecified subgroup based on systolic blood pressure (>143.5 mm Hg) had significantly lower rates of the cardiovascular events if they were on active treatment.
An analysis of the cholesterol treatment found that mean LDL was 26.5% lower in the rosuvastatin group than the placebo group. The rosuvastatin group also had significantly reduced rates of both the first and second outcomes compared to placebo patients (3.7% vs. 4.8% and 4.4% vs. 5.7%, respectively). There was no excess diabetes or cancer associated with the statin, but patients taking it did have more cataract surgeries and muscle symptoms than those on placebo. The study authors noted that the diversity of their trial population (80% nonwhite, about 50% female) makes the findings widely applicable and supports broad use of statins for primary prevention.
Researchers also looked at the effects of the interventions combined, comparing patients who received both active treatments (n=3,180) to those who took both placebos (n=3,168). Compared to placebo patients, the active group had reductions of 33.7 mg/dL in LDL and of 6.2 mm Hg in systolic blood pressure. They also had significantly reduced rates of both composite outcomes compared to the placebo group (3.6% vs. 5.0% and 4.3% vs. 5.9%, respectively). Muscle weakness and dizziness were more common on combined therapy, but the groups had similar rates of drug discontinuation.
The results of this trial support the benefits of statins for primary prevention and a risk-based approach to prescribing, rather than one based on LDL levels, according to an accompanying editorial. The lack of benefit observed from the blood-pressure medications could be due to insufficient dosing or inclusion of lower-risk patients than are typically included in hypertension trials. The finding of benefit only in the highest-pressure subgroup “may help to define the combined threshold of systolic blood pressure (<140 mm Hg) and cardiovascular risk (<5.0%) below which the use of blood-pressure-lowering medications may not be useful in the short term,” the editorialists said. The combined analysis showed “no evidence of harm or synergy between the two interventions,” they observed.