Proactive multifactorial intervention strategy reduces the risk of cardiovascular disease estimated with region-specific risk assessment models in Pacific Asian patients participating in the CRUCIAL trial

Abstract

Despite race, ethnic, and regional differences in cardiovascular disease risk, many worldwide hypertension management guidelines recommend the use of the Framingham coronary heart disease (CHD) risk equation to guide treatment decisions. This subanalysis of the recently published CRUCIAL trial compared the treatment-related reductions in calculated CHD and stroke risk among Pacific Asian (PA) patients using a variety of region-specific risk assessment models. As a result, greater reductions in systolic and diastolic blood pressure, low-density lipoprotein cholesterol, and triglycerides were observed in the proactive multifactorial intervention (PMI) arm compared with the usual care arm at Week 52 for PA patients. The relative percentage change in 10-yr CHD risk between baseline and Week 52 in the PMI versus usual care arms was greatest using the NIPPON DATA80 fatal CHD model (LS [least square] mean difference -42.6%), and similar in the SCORE fatal CHD and Framingham total CHD models (LS mean difference -29.4% and -30.8%, respectively). The single-pill based PMI approach is consistently effective in reducing cardiovascular disease risk, evaluated using a variety of risk assessment models. (ClinicalTrials.gov registration number: NCT00407537).

Keywords: Anticholesteremic Agents; Antihypertensive Agents; Cardiovascular Diseases; Clinical Trial; Hypertension; Risk Factors.

Conflict of interest statement

EJ Cho and JH Kim have served as consultants, received travel expenses or payment for speaking at meetings, or received funding for research from one or more pharmaceutical companies (including Pfizer Inc, who sponsored this study) that market BP-lowering or lipid-lowering drugs. C Yunis is an employee of Pfizer Inc. S Sutradhar and M Westergaard were employees of Pfizer Inc at the time that this study was conducted. All authors provided input for this sub-analysis, interpreted the results and drafted/reviewed the paper and approved the final version but objectively conducted with fairness.

Figures

Fig. 1

Flow of PA patients through the CRUCIAL trial. *Treated patients with baseline and 1 or more post-baseline efficacy measurements. CRUCIAL, Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-Term Risk; PA, Pacific Asian; PMI, proactive multifactorial intervention; UC usual care.

Fig. 2

Absolute percentage change in 10-yr CHD risk from baseline to Week 52 in each treatment arm among PA patients. *P < 0.001. CHD, coronary heart disease; CI, confidence interval; LS, least square mean for difference; NIPPON DATA80, National Integrated Project for Prospective Observation of Non-Communicable Disease and its Trends in the Aged, 1980; PMI, proactive multifactorial intervention; SCORE, Systematic Coronary Risk Evaluation; UC, usual care.

Fig. 3

Relative percentage change in 10-yr CHD risk from baseline to Week 52 by treatment arm among PA patients. *P < 0.001. CHD, coronary heart disease; CI, confidence interval; LS, least square mean for difference; NIPPON DATA80, National Integrated Project for Prospective Observation of Non-Communicable Disease and its Trends in the Aged, 1980; PMI, proactive multifactorial intervention; SCORE, Systematic Coronary Risk Evaluation; UC, usual care.

Fig. 4

Relative change in 10-yr fatal non-CHD risk from baseline to Week 52 by treatment arm among PA patients. *P = 0.283; †P < 0.001. CHD, coronary heart disease; CI, confidence interval; CVD, cardiovascular disease; LS, least square mean for difference; NIPPON DATA80, National Integrated Project for Prospective Observation of Non-Communicable Disease and its Trends in the Aged, 1980; PMI, proactive multifactorial intervention; SCORE, Systematic Coronary Risk Evaluation; UC, usual care.

Fig. 5

Adjusted mean change from baseline in SBP and DBP (mmHg), and TC and LDL-C (%), from baseline to Week 52 by treatment arm among PA patients. *P < 0.05, †P = 0.051, ‡P < 0.001. CI, confidence interval; DBP, diastolic blood pressure; LDL-C, low-density lipoprotein cholesterol; LS, least square mean for difference; SBP, systolic blood pressure; TC, total cholesterol; PMI, proactive multifactorial intervention; UC, usual care.