Reduction in cardiovascular risk using a proactive multifactorial intervention is consistent among patients residing in Pacific Asian and non-Pacific Asian regions: a CRUCIAL trial subanalysis

Abstract

Background: Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian (PA) populations. The Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL) trial demonstrated that a proactive multifactorial intervention (PMI) approach (based on single-pill amlodipine/atorvastatin) resulted in a greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) among hypertensive patients with additional risk factors. One-third of CRUCIAL patients resided in the PA region. The aim of this subanalysis was to compare two approaches to cardiovascular risk factor management (PMI versus UC) among patients residing in PA and non-PA regions.

Methods: This subanalysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions. Sensitivity analyses were conducted among men and women and those with and without diabetes.

Results: Overall, 448 patients (31.6%) resided in the PA region and 969 patients (68.4%) resided in non-PA regions. The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA (-37.1% versus -3.5%; P<0.001) and non-PA regions (-31.1% versus -4.2%; P<0.001); region interaction P=0.131. PA patients had slightly greater reductions in total cholesterol compared with non-PA patients. PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients. Treatment effects were similar in men and women and those with diabetes.

Conclusion: The PMI approach was more effective in reducing calculated Framingham 10-year CHD risk compared with UC among men and women with and without diabetes residing in the PA and non-PA region.

Keywords: anticholesteremic agents; antihypertensive agents; cardiovascular disease; clinical trial; hypertension; risk factors.

Figure 1

Flow of PA and non-PA patients through the CRUCIAL trial. Notes: ^aTreated patients with baseline and one or more postbaseline efficacy measurements. For one PMI investigator from a non-PA region, four out of 18 patients received UC during the treatment period and were analyzed in the UC arm for the safety population and in the PMI arm for the full analysis set; ^bhypertension: untreated: SBP ≥160 mmHg and/or DBP ≥100 mmHg; treated: SBP ≥140 mmHg and/or DBP ≥90 mmHg or diabetes: SBP >130 mmHg and/or DBP >80 mmHg. Abbreviations: AE, adverse event; CHD, coronary heart disease; CHF, congestive heart failure; CRUCIAL, Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk; CV, cardiovascular; DBP, diastolic blood pressure; HbA_1c, glycated hemoglobin; PA, Pacific Asian; PMI, proactive multifactorial intervention; SBP, systolic blood pressure; TC, total cholesterol; TG, triglycerides; TIA, transient ischemic attack; UC, usual care.

Figure 2

Relative percentage change in Framingham 10-year CHD risk, from baseline to week 52 for PA and non-PA patients by treatment arm. Notes: ^aP<0.001. Patients excluded for missing data: PA PMI, n=6; PA UC, n=2; non-PA PMI, n=6. Abbreviations: CHD, coronary heart disease; CI, confidence interval; LS, least square mean for difference; PA, Pacific Asian; PMI, proactive multifactorial intervention; UC, usual care.

Figure 3

Adjusted mean change from baseline to week 52 in (A) SBP and DBP (mmHg), and (B) TC and LDL-C (%) for PA and non-PA patients. Notes: ^aP<0.05; ^bP<0.001; ^cP=0.051. Patients excluded for missing LDL-C: PA PMI, n=5; PA UC, n=2; non-PA PMI, n=14; non-PA UC, n=16. Abbreviations: CI, confidence interval; DBP, diastolic blood pressure; LDL-C, low-density lipoprotein cholesterol; LS, least square mean for difference; PA, Pacific Asian; PMI, proactive multifactorial intervention; SBP, systolic blood pressure; TC, total cholesterol; UC, usual care.

Figure 4

Study-specific BP and LDL-C goal attainment at week 52 for PA and non-PA patients. Notes: ^aP=0.002; ^bP<0.001; ^cP=0.738; ^dP=0.004. Patients excluded for missing data: dual goal attainment: PA PMI, n=2; PA UC, n=0; non-PA PMI, n=4; non-PA UC, n=4; LDL-C goal attainment: PA PMI, n=4; PA UC, n=2; non-PA PMI; n=4; non-PA UC, n=4. Abbreviations: BP, blood pressure; CI, confidence interval; LDL-C, low-density lipoprotein cholesterol; OR, odds ratio; PA, Pacific Asian; PMI, proactive multifactorial intervention; UC, usual care.

Figure 5

Treatment effect on efficacy measures from baseline to week 52 for men and women in the (A) PA region, and (B) non-PA region. Note: ^aMean change from baseline to week 52 following treatment with PMI versus UC, adjusted for baseline values. Abbreviations: CHD, coronary heart disease; CI, confidence interval; LS, least square; PA, Pacific Asian; PMI, proactive multifactorial intervention; UC, usual care.

Figure 6

Treatment effect on efficacy measures from baseline to week 52 for PA and non-PA patients with (A) no diabetes, and (B) diabetes. Note: ^aMean change from baseline to week 52 following treatment with PMI versus UC, adjusted for baseline values. Abbreviations: CHD, coronary heart disease; CI, confidence interval; LS, least square; PA, Pacific Asian; SPAA, single-pill amlodipine/atorvastatin; UC, usual care.