Can combining different risk interventions into a single formulation contribute to improved cardiovascular disease risk reduction? Rationale and design for an international, open-label program to assess the effectiveness of a single pill (amlodipine/atorvastatin) to attain recommended target levels for blood pressure and lipids (The JEWEL Program)

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

“…14 However, the impact of different guideline recommendations on the reductions in BP and LDL-C achieved with amlodipine/atorvastatin appears to be minimal, with comparable results between Gemini-AALA and the Jewel 1/2 studies, which used countryspecific targets for the United Kingdom, Canada and Europe. 25,26 Mean BP was lowered by 20.2/ 11.4 mm Hg in the Gemini-AALA study as compared with 20.4/10.7 mm Hg in Jewel 1 (United Kingdom/ Canada) and 21.8/12.6 mm Hg in Jewel 2 (Europe) studies. 25 The mean reduction in LDL-C was 1.1 mmol l À1 (43.7 mgdl À1 ) for the Gemini-AALA study, 0.90 mmol l À1 (34.8 mgdl À1 ) for the Jewel 1 study and 1.1 mmol l À1 (42.2 mgdl À1 ) for the Jewel 2 study.…”

“…Levels of goal attainment were also comparable with those achieved in the US Gemini study (57.7%, using JNC 6 BP goals 31 ), 24 the Clinical Utility of Caduet in Simultaneously Achieving Blood Pressure and Lipid Endpoints (CAPABLE) study, which evaluated single-pill amlodipine/atorvastatin in African-American patients (48.3%, using JNC 7 BP goals 29 ) 27 and the Jewel programme in Canadian and European patients (55.5%, using country-specific goals). 25,26 Together, the results of these studies indicate that single-pill amlodipine/atorvastatin therapy aids BP and LDL-C goal attainment among patients from a wide range of countries and ethnic backgrounds.…”

“…[17][18][19][20][21][22] Furthermore, both coadministered amlodipine and atorvastatin, or singlepill amlodipine/atorvastatin, are an effective and safe means of helping patients attain recommended BP and lipid targets. [23][24][25][26][27][28] Limited data are currently available concerning the treatment patterns for patients with hypertension and dyslipidaemia in countries across the Middle East, Asia-Pacific, Africa and Latin America; to date, no large-scale clinical trial has been undertaken to study the treatment of more than one CV risk factor in hypertensive patients across these regions. The utility of single-pill amlodipine/atorvastatin has previously been assessed in studies in the United States, Europe and Canada.…”

“…The utility of single-pill amlodipine/atorvastatin has previously been assessed in studies in the United States, Europe and Canada. [24][25][26][27] The Gemini-AALA (Australia, Asia, Latin America, Africa/Middle East) study was designed to complement these trials by assessing the clinical utility of single-pill amlodipine/atorvastatin in patients from the Middle East, Asia-Pacific, Africa and Latin America. The primary objective of the Gemini-AALA study was to assess the efficacy and safety of single-pill amlodipine/atorvastatin in patients of diverse ethnicity with hypertension and dyslipidaemia and to gain clinical experience in these regions of dosing and titrating a single pill containing these two agents.…”

Fixed-dose combination orally disintegrating tablets to treat cardiovascular disease: formulation, in vitro characterization and physiologically based pharmacokinetic modeling to assess bioavailability

“…Several clinical studies have examined the efficacy and safety of amlodipine and atorvastatin combination therapy in patients with concurrent hypertension and dyslipidemia. Combination therapy has been shown to achieve blood pressure and LDL goals 21,22. The RESPOND study, which compared combination therapy with amlodipine or atorvastatin, alone showed no difference in efficacy,23 whereas the AVALON study reported an increased efficacy with combination therapy over either drug alone 24.…”