Single-pill amlodipine/atorvastatin helps patients of diverse ethnicity attain recommended goals for blood pressure and lipids (the Gemini-AALA study)

Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial

“…Furthermore, compared with the UC arm, patients in the proactive intervention arm were more likely to achieve the BP and LDL-C goals based on clinical guidelines including NCEP ATP III 8 , JNC 7 9 , and ESC 10 . The proportion of proactive intervention patients reaching the dual BP/LDL-C goals at week 16 (43.3%) in this study is slightly lower than that reported from the GEMINI-AALA study, which demonstrated that after 14 weeks of treatment with single-pill amlodipine/atorvastatin, 55.2% of all patients, 81.3% and 40.3% of patients in CV risk groups II and III, respectively (defined by JNC 7 and NCEP ATP III) 8,9 had achieved both their dual BP/LDL-C goals 26 . However, there are important differences in the design of GEMINI-AALA and this study that need to be considered.…”

Combining antihypertensive and antihyperlipidemic agents – optimizing cardiovascular risk factor management

“…The reductions in Framingham CHD risk and BP in patients in the proactive intervention arm vs UC were similar in those with and without diabetes. The SPAA-based treatment in the proactive intervention arm was well tolerated in patient groups, in line with previous studies 51,52. A similar evaluation assessing the proactive intervention arm resulted in a greater reduction in calculated Framingham 10-year CHD risk, BP, or LDL-C compared with continuing UC in younger (< 65 years) and older (≥ 65 years) patients.…”

“…There were no treatment-related deaths in either treatment group. The incidence of AEs in the proactive intervention arm was similar to that previously observed for SPAA52 and co-administered amlodipine and atorvastatin 42…”

“…The first of these was the GEMINI trial, which was a 14-week, open-label trial conducted in 1220 patients from the USA, which demonstrated that SPAA was well tolerated and could help patients with HTN and DYS achieve their BP and LDL-C goals 51. The subsequent GEMINI-Australia, Asia, Latin America, Africa/Middle East (AALA) study, which was a very similar study design, confirmed the findings of GEMINI among 1649 patients residing across Asia Pacific, the Middle East, Africa, and Latin America 52. The findings of these two studies were confirmed in the JEWEL study program, with JEWEL 1 conducted among 1138 patients from the UK and Canada and JEWEL 2 conducted in 1107 patients from Europe 53.…”

“…Taken as a whole, these studies demonstrate the clinical utility and good tolerability profile of SPAA across patients with HTN and DYS alone as well as those with additional CV risk factors, diabetes/metabolic syndrome,55 and symptomatic CVD 51,52,54,56. The data from GEMINI, GEMINI–AALA, JEWEL 1/2, and CAPABLE have been pooled and used to compare changes in BP when SPAA was used as first-line vs add-on antihypertensive treatment, and to investigate changes in LDL-C when SPAA was used as first-line vs replacement lipid-lowering treatment.…”