We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Adding candesartan-HCTZ to rosuvastatin increased adverse events but not benefits in patients at intermediate CV risk.
- Authors
Eaton MD, Charles B.
- Abstract
Question In patients at intermediate cardiovascular (CV) risk, does rosuvastatin plus combination candesartan-hydrochlorothiazide (HCTZ) reduce major CV events? Methods Design Randomized, placebo-controlled, 2 x 2 factorial trial (Heart Outcomes Prevention Evaluation [HOPE]-3 trial). ClinicalTrials.gov NCT00468923. Allocation Concealed.* Blinding Blinded* (patients, clinicians, outcome assessors, and steering committee). Follow-up period Median 5.6 years. Setting 228 clinical centers in 21 countries on 6 continents. Patients 12705 men ≥55 years of age and women ≥65 years of age who had ≥1 CV risk factor (elevated waist-to-hip ratio, dysglycemia, mild renal dysfunction, recent or current use of tobacco, previous low high-density lipoprotein cholesterol level, and family history of premature coronary disease) or were ≥60 years of age with ≥2 risk factors; and adhered to a 4- week run-in phase with blood pressure and cholesterol treatments and had no unacceptable adverse events. Exclusion criteria included CVD or indications for, or contraindications to, statins, angiotensin-receptor blockers, angiotensin- converting enzyme inhibitors, or thiazide diuretics. Mean age of participants was 66 y and 54% were men. Interventions Rosuvastatin, 10 mg/d, plus candesartan-HCTZ, 16 mg/d-12.5mg/d (n =3180), rosuvastatin plus placebo (n =3181), candesartan-HCTZ plus placebo (n =3176), or placebo for both treatments (n =3168). Outcomes Coprimary outcomes were a composite of major CV events (CV death, nonfatal myocardial infarction [MI], or nonfatal stroke) and a composite of major CV events, resuscitated cardiac arrest, heart failure, or revascularization. Secondary outcomes included adverse events and permanent study treatment discontinuation. The analysis here compared individual cells in the 2 X 2 factorial study. Patient follow-up 99% for primary outcomes (intention-to-treat analysis). Main results The results for the coprimary outcomes are in the Table. The rosuvastatin plus candesartan-HCTZ group did not differ from the double placebo group for serious adverse events or permanent discontinuation of study treatment, but muscle weakness and dizziness were more common in the combined-therapy group than in the dual-placebo group. Conclusion In patients at intermediate cardiovascular risk, adding candesartan-hydrochlorothiazide to rosuvastatin did not reduce major cardiovascular events but increased adverse events.
- Subjects
CARDIAC arrest; THERAPEUTICS; CARDIOVASCULAR disease prevention; BLOOD pressure; CARDIOVASCULAR diseases risk factors; COMBINATION drug therapy; CONFIDENCE intervals; CARDIOPULMONARY resuscitation; DIURETICS; ANTIHYPERTENSIVE agents; LONGITUDINAL method; EVALUATION of medical care; MEDICAL cooperation; MYOCARDIAL revascularization; RESEARCH; RANDOMIZED controlled trials; RELATIVE medical risk; DESCRIPTIVE statistics; ROSUVASTATIN
- Publication
ACP Journal Club, 2016, Vol 165, Issue 2, p7
- ISSN
1056-8751
- Publication type
Article
- DOI
10.7326/ACPJC-2016-165-2-008