Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial.

Abstract

OBJECTIVE:

To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin (5/10, 10/10 mg) in addition to other antihypertensive and lipid-lowering therapy, as required, resulted in greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) after 52-weeks treatment.

RESEARCH DESIGN AND METHODS:

Prospective, multinational, open-label, cluster randomized trial, with the investigator as the unit of randomization. Eligible hypertensive patients were 35-79 years of age, with ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol (TC) ≤6.5 mmol/l.

CLINICAL TRIAL REGISTRATION:

www.ClinicalTrials.gov ; trial identifier NCT00407537.

MAIN OUTCOME MEASURE:

The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks.

RESULTS:

Of the 140 randomized sites, 136 sites contributed 1461 patients. Mean baseline age and low-density lipoprotein cholesterol (LDL-C) were comparable between treatment arms. Mean baseline BP (150.3/89.7 vs. 144.3/86.5 mmHg) and Framingham CHD risk (20.0 vs. 18.1%) were higher in the proactive intervention versus the UC arm (p < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication.

CONCLUSIONS:

A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.

• Authors: José Zamorano, Serap Erdine, Abel Pavia, Jae-Hyung Kim, Ayman Al-Khadra, Mogens Westergaard, Santosh Sutradhar, Carla Yunis, CRUCIAL Investigators
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 27 Issue 4 Pg. 821-33 (Apr 2011) ISSN: 1473-4877 [Electronic] England
• PMID: 21306285 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Drug Combinations
• Heptanoic Acids
• Hypolipidemic Agents
• Pyrroles
• Amlodipine
• Atorvastatin

Topics

• Adult
• Aged
• Amlodipine (administration & dosage, adverse effects)
• Antihypertensive Agents (administration & dosage, adverse effects)
• Atorvastatin
• Cardiovascular Diseases (etiology, prevention & control)
• Drug Combinations
• Female
• Follow-Up Studies
• Heptanoic Acids (administration & dosage, adverse effects)
• Humans
• Hypertension (complications, therapy)
• Hypolipidemic Agents (administration & dosage, adverse effects)
• Male
• Middle Aged
• Preventive Health Services (methods, statistics & numerical data)
• Pyrroles (administration & dosage, adverse effects)
• Risk Factors
• Standard of Care (statistics & numerical data)