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Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and
José Zamorano1, Serap Erdine, Abel Pavia
1Hospital Clinico San Carlos, Madrid, Spain. zamorano@secardiologia.es
Insights
A proactive intervention using amlodipine/atorvastatin significantly reduced 10-year coronary heart disease (CHD) risk compared to usual care in hypertensive patients. This multifactorial strategy effectively lowered both blood pressure and cholesterol levels.
Area of Science:
- Cardiovascular Medicine
- Pharmacotherapy
- Preventive Cardiology
Background:
- Hypertension and elevated cholesterol are major risk factors for coronary heart disease (CHD).
- Effective management of multiple cardiovascular risk factors is crucial for preventing CHD events.
- ClinicalTrials.gov identifier: NCT00407537.
Purpose of the Study:
- To evaluate a proactive multifactorial intervention strategy for reducing calculated 10-year CHD risk.
- To compare the efficacy of single-pill amlodipine/atorvastatin plus tailored therapy against usual care (UC).
- To assess the impact on blood pressure (BP) and cholesterol levels in hypertensive patients with additional risk factors.
Main Methods:
- Prospective, multinational, open-label, cluster randomized trial involving 1461 hypertensive patients (35-79 years) with ≥3 cardiovascular risk factors.
- Intervention group received amlodipine/atorvastatin (5/10 or 10/10 mg) plus other therapies as needed; control group received usual care (UC).
- Primary endpoint: calculated Framingham 10-year CHD risk at 52 weeks.
Main Results:
- The proactive intervention group showed a significantly greater reduction in 52-week CHD risk (12.5%) compared to UC (16.3%) (p < 0.001).
- This risk reduction was driven by significant improvements in systolic BP and total cholesterol (TC) in the intervention arm.
- Adverse events were comparable between groups, with the intervention arm's profile consistent with known medication safety.
Conclusions:
- A proactive multifactorial intervention simultaneously addressing BP and cholesterol is more effective than UC for reducing CHD risk.
- This strategy is beneficial for hypertensive patients with additional cardiovascular risk factors.
- The use of single-pill amlodipine/atorvastatin facilitates effective risk factor management.
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 < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication.
Conclusions:
A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.
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