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.

Keywords::

• Amlodipine
• Atorvastatin
• Cardiovascular Risk
• Dyslipidemia
• Hypertension
• Latin America

Transparency

Declaration of funding

This study was sponsored by Pfizer Inc.

Declaration of financial/other relationships

A.P. and J.Z. have served as consultants or received travel expenses, payment for speaking at meetings, or funding for research from one or more pharmaceutical companies (including Pfizer Inc. who sponsored this study) that market blood-pressure-lowering or lipid-lowering drugs. C.Y. and S.S. are employees of Pfizer Inc.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

Medical writing support was provided by Sarah Partridge of UBC Scientific Solutions, and funded by Pfizer Inc.