Changes in calculated coronary heart disease risk using proactive multifactorial intervention versus continued usual care in Latin-American and non-Latin-American patients enrolled in the CRUCIAL trial

Abstract

Objective: To compare the change in calculated coronary heart disease (CHD) risk using a proactive multifactorial intervention (PMI) versus usual care (UC), among Latin-American (LA) and non-LA patients enrolled in the CRUCIAL trial.

Research design and methods: This is a sub-analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL) trial. CRUCIAL was a prospective, multinational, open-label, cluster-randomized trial. Eligible patients had hypertension and ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol ≤6.5 mmol/l (250 mg/dl). The PMI strategy was implemented by the inclusion of single-pill amlodipine/atorvastatin (SPAA) in the patients' treatment regimen. Overall, 20% of patients resided in the LA region.

Main outcome measure: Treatment-related change in calculated Framingham 10-year CHD risk between baseline and Week 52 in the LA and non-LA regions.

Results: A greater relative reduction in calculated CHD risk after 52 weeks' follow-up was observed for patients in the PMI arm compared with UC arm in both LA (-32.8% vs. -7.5%, p = 0.003) and non-LA regions (-33.1% vs. -3.3%, p < 0.001), region interaction p = 0.316. The proportion of patients discontinuing treatment in the PMI arm due to adverse events (AEs) was low in both regions (both 5.9%).

Conclusions: The PMI approach based on the inclusion of SPAA in the patients' treatment regimen may improve the management of CHD risk among patients residing in LA and non-LA regions. Clinicians may be reassured by the low rate of AEs leading to discontinuation of SPAA in both regions.