Post hoc analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial
Language English Country England, Great Britain Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- MeSH
- Amlodipine administration & dosage adverse effects therapeutic use MeSH
- Antihypertensive Agents administration & dosage adverse effects therapeutic use MeSH
- Atorvastatin MeSH
- Drug Combinations MeSH
- Hypertension drug therapy MeSH
- Coronary Disease prevention & control MeSH
- Blood Pressure drug effects MeSH
- Heptanoic Acids administration & dosage adverse effects therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Pyrroles administration & dosage adverse effects therapeutic use MeSH
- Risk Factors MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors administration & dosage adverse effects therapeutic use MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Amlodipine MeSH
- amlodipine, atorvastatin drug combination MeSH Browser
- Antihypertensive Agents MeSH
- Atorvastatin MeSH
- Drug Combinations MeSH
- Heptanoic Acids MeSH
- Pyrroles MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors MeSH
OBJECTIVE: A proactive, multifactorial intervention strategy incorporating single-pill amlodipine/atorvastatin (SPAA) (5-10/10 mg up-titrated to 5-10/20 mg, where approved) is more effective than physician's usual care (UC) for reducing calculated 10 year coronary heart disease (CHD) risk, in patients with hypertension and additional risk factors (CRUCIAL trial: Curr Med Res Opin 2011;27:821--33). As SPAA combinations containing atorvastatin 20 mg are not approved in some countries, this post hoc analysis investigated the efficacy and safety of a proactive intervention strategy incorporating low-dose SPAA (5/10 or 10/10 mg) only (low-dose PI) versus UC. METHODS: Of 1461 CRUCIAL participants (35-79 years; hypertension and ≥3 additional risk factors; no CHD; total cholesterol ≤6.5 mmol/L), 105 were prescribed SPAA containing 20 mg atorvastatin and excluded. The primary endpoint was difference between treatment arms in Framingham 10 year CHD risk after 52 weeks; secondary assessments included difference in calculated CHD risk at Week 16; SCORE cardiovascular mortality (Week 16 and 52); blood pressure (BP)/lipid parameters; adverse events (AEs). RESULTS: Baseline BP (149.2/89.2 vs. 144.3/86.5 mmHg) and calculated CHD risk (19.6% vs. 18.1%) were higher for low-dose PI (n = 655) versus UC (n = 657) patients. Least-squares mean treatment difference (low-dose PI vs. UC) in calculated 10 year CHD risk was -26.8 (95% CI: -31.7, -22.0; p < 0.001) after 52 weeks' follow-up and -24.8 (-29.8, -19.9; p < 0.001) after 16 weeks' follow-up. Treatment difference in SCORE mortality was -20.1 (-24.7, -15.6; p < 0.001) and -22.4 (-26.8, -18.0; p < 0.001) after 16 and 52 weeks' follow-up. Risk calculations are surrogate endpoints and may not translate into actual reductions in cardiovascular events. Overall, 49.1% (low-dose PI) and 44.0% (UC) reported AEs. CONCLUSION: A proactive, multifactorial approach to cardiovascular management based on low-dose SPAA led to statistically significant improvements in calculated 10 year CHD risk versus physician's UC, comparable to that reported in the full CRUCIAL trial. These data will inform healthcare providers in countries where SPAA (5/10 or 10/10 mg) only are licensed.
References provided by Crossref.org
ClinicalTrials.gov
NCT00407537
