amlodipine--atorvastatin-drug-combination and Coronary-Disease

To compare the reduction in calculated Framingham 10 year coronary heart disease (CHD) risk after 52 weeks' intervention with a proactive multifactorial intervention (PMI) strategy (based on single-pill amlodipine/atorvastatin [SPAA]) versus continuing usual care (UC) (based on investigators' best clinical judgment) among younger (<65 years) and older (≥ 65 years) patients.. Sub-analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial. Eligible patients had hypertension and ≥ 3 cardiovascular risk factors.. Treatment-related reduction in calculated Framingham 10 year CHD risk between baseline and Week 52 in younger and older patients.. Nine hundred patients (63.5%) were <65 years (mean age 54.2 years, 57.4% men) and 517 patients (36.5%) were ≥ 65 years (mean age 70.5 years, 42.7% men). Younger patients had lower mean baseline CHD risk versus older patients (17.1% vs. 22.6%). A greater reduction in calculated CHD risk at Week 52 was observed in the PMI versus the UC arm in both younger (-33.2% vs. -2.9%, p < 0.001) and older (-32.7% vs. -5.7%, p < 0.001) patients. Least-squares mean treatment differences (PMI vs. UC) in percentage change from baseline in calculated CHD risk were similar in younger and older patients (-26.3% vs. -25.7%, age interaction p = 0.887). CHD risk reduction was slightly greater among younger men than younger women (-29.3 vs. -23.9, gender interaction p = 0.062). A low proportion of patients discontinued the PMI strategy due to adverse events in both age groups (5.8% vs. 6.1%, respectively). Study limitations included ad-hoc (not pre-specified) sub-group analysis and short duration of follow-up.. The PMI strategy based on the inclusion of SPAA in the treatment regimen is more effective than UC in reducing calculated CHD risk. This strategy may be considered as the treatment of choice in younger and older hypertensive patients with additional cardiovascular risk factors.

Topics: Age Factors; Aged; Amlodipine; Coronary Disease; Drug Combinations; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Prospective Studies; Pyrroles; Risk Factors; Sex Factors; Time Factors

A proactive, multifactorial intervention strategy incorporating single-pill amlodipine/atorvastatin (SPAA) (5-10/10 mg up-titrated to 5-10/20 mg, where approved) is more effective than physician's usual care (UC) for reducing calculated 10 year coronary heart disease (CHD) risk, in patients with hypertension and additional risk factors (CRUCIAL trial: Curr Med Res Opin 2011;27:821--33). As SPAA combinations containing atorvastatin 20 mg are not approved in some countries, this post hoc analysis investigated the efficacy and safety of a proactive intervention strategy incorporating low-dose SPAA (5/10 or 10/10 mg) only (low-dose PI) versus UC.. Of 1461 CRUCIAL participants (35-79 years; hypertension and ≥3 additional risk factors; no CHD; total cholesterol ≤6.5 mmol/L), 105 were prescribed SPAA containing 20 mg atorvastatin and excluded. The primary endpoint was difference between treatment arms in Framingham 10 year CHD risk after 52 weeks; secondary assessments included difference in calculated CHD risk at Week 16; SCORE cardiovascular mortality (Week 16 and 52); blood pressure (BP)/lipid parameters; adverse events (AEs).. Baseline BP (149.2/89.2 vs. 144.3/86.5 mmHg) and calculated CHD risk (19.6% vs. 18.1%) were higher for low-dose PI (n = 655) versus UC (n = 657) patients. Least-squares mean treatment difference (low-dose PI vs. UC) in calculated 10 year CHD risk was -26.8 (95% CI: -31.7, -22.0; p < 0.001) after 52 weeks' follow-up and -24.8 (-29.8, -19.9; p < 0.001) after 16 weeks' follow-up. Treatment difference in SCORE mortality was -20.1 (-24.7, -15.6; p < 0.001) and -22.4 (-26.8, -18.0; p < 0.001) after 16 and 52 weeks' follow-up. Risk calculations are surrogate endpoints and may not translate into actual reductions in cardiovascular events. Overall, 49.1% (low-dose PI) and 44.0% (UC) reported AEs.. A proactive, multifactorial approach to cardiovascular management based on low-dose SPAA led to statistically significant improvements in calculated 10 year CHD risk versus physician's UC, comparable to that reported in the full CRUCIAL trial. These data will inform healthcare providers in countries where SPAA (5/10 or 10/10 mg) only are licensed.

Topics: Amlodipine; Antihypertensive Agents; Atorvastatin; Blood Pressure; Coronary Disease; Drug Combinations; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Male; Middle Aged; Pyrroles; Risk Factors

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.. 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.. Treatment-related change in calculated Framingham 10-year CHD risk between baseline and Week 52 in the LA and non-LA regions.. 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%).. 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.

Topics: Adult; Aged; Amlodipine; Anticholesteremic Agents; Cholesterol; Coronary Disease; Drug Combinations; Female; Follow-Up Studies; Heptanoic Acids; Hispanic or Latino; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Pyrroles; Risk Factors