Statins may benefit intermediate-risk patients without CVD
Statins can be more widely used in patients considered to be intermediate risk for cardiovascular disease.
Blood pressure and cholesterol-lowering effects were studied in patients without the presence of cardiovascular (CV) disease but who were considered “immediate risk” for disease in the HOPE-3 (Heart Outcomes Prevention Evaluation) clinical trial.
The findings were presented by study investigators Eva Lonn, MD, MSc, FRCPC, FACC; Jackie Bosch, MD; and Salim Yusuf, MD, DPhil at the 2016 American College of Cardiology Scientific Sessions & Expo (ACC) in Chicago and simultaneously published in the New England Journal of Medicine.
A total of 12 705 patients were enrolled in the trial with a 2-by-2 factorial design. Patients were recruited from 228 centers in 21 countries and were followed-up for a median of 5.6 years. Dr Eva Lonn, professor of medicine at McMaster University in Hamilton, Canada, pointed out that the ethnically diverse population allowed the research team to conduct multiple subanalyses, including stroke risk, low-density lipoprotein cholesterol (LDL-C) levels, and systolic blood pressure (SBP) values at baseline.
The first coprimary outcome was composite death from CV causes, nonfatal myocardial infarction (MI), or nonfatal stroke. The second coprimary outcome included resuscitated cardiac arrest, heart failure, and revascularization.
The mean blood pressure was 138.1/81.9 mm Hg at baseline. In addition, the mean SBP was 138.2 ± 14.7 mm Hg in the active-treatment group and 137.9 ± 14.8 mm Hg in the placebo group. The decrease was 6.0/3.0 mm Hg greater in the treatment group vs the placebo group.
The mean total cholesterol level was 201.4 mg/dL at baseline. In patients who received rosuvastatin 10 mg/day, the mean LDL-C was 26.5% lower in the treatment group compared with placebo.
Antihypertensive therapy with candesartan (16 mg/day) plus hydrochlorothiazide (HCTZ; 12.5 mg/day) was not associated with lower rates of major CV events compared with placebo. However, researchers did observe significantly lower rates of the first and second coprimary outcomes in the upper third SBP group (>143.5 mm Hg). In the middle and lower thirds, the effects were neutral (P=.02 and P=.009, respectively, for trend in the 2 outcomes).
“The pattern for stroke differed, with no heterogeneity in the 3 subgroups that were defined according to baseline [SBP],” the researchers wrote in 1 of their published reports. “Blood-pressure differences between the trial groups were similar across the 3 subgroups of baseline SBP. Therefore, the observed subgroup findings are not related to differences in the magnitude of blood-pressuring lowering but rather to a differential effect in participants at different baseline blood-pressure levels.”
At the ACC press conference, Dr Lonn commented that both the JNC-8 and European guidelines still debate over the BP entry level for patients with “uncomplicated hypertension,” but the results from HOPE-3 may help better define those values.