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-...

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Bibliographic Details
Published in:Current medical research and opinion 2011-04, Vol.27 (4), p.821-833
Main Authors: Zamorano, José, Erdine, Serap, Pavia, Abel, Kim, Jae-Hyung, Al-Khadra, Ayman, Westergaard, Mogens, Sutradhar, Santosh, Yunis, Carla
Format: Article
Language:English
Subjects:
Adult
Aged
Amlodipine
Amlodipine - administration & dosage
Amlodipine - adverse effects
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - adverse effects
Atorvastatin
Atorvastatin Calcium
Cardiovascular Diseases - etiology
Cardiovascular Diseases - prevention & control
Cardiovascular risk
Drug Combinations
Dyslipidemia
Female
Follow-Up Studies
Global risk
Heptanoic Acids - administration & dosage
Heptanoic Acids - adverse effects
Humans
Hypertension
Hypertension - complications
Hypertension - therapy
Hypolipidemic Agents - administration & dosage
Hypolipidemic Agents - adverse effects
Male
Middle Aged
Preventive Health Services - methods
Preventive Health Services - utilization
Pyrroles - administration & dosage
Pyrroles - adverse effects
Risk Factors
Standard of Care - utilization
Usual care
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Summary: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 
ISSN:0300-7995
1473-4877
DOI:10.1185/03007995.2011.555754