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

Journal of Human Hypertension volume 23, pages 196–210 (2009)Cite this article

Abstract

The Gemini-AALA (Australia, Asia, Latin America, Africa/Middle East) study evaluated the efficacy and safety of single-pill amlodipine/atorvastatin (Caduet) for the treatment of patients of diverse ethnicity with concomitant hypertension and dyslipidaemia. This was a 14-week, open-label study including patients from 27 countries across the Middle East, Asia-Pacific, Africa and Latin America. Eight dosage strengths of single-pill amlodipine/atorvastatin (5/10, 10/10, 5/20, 10/20, 5/40, 10/40, 5/80 and 10/80 mg) were titrated to improve blood pressure and lipid control. Blood pressure and lipid goals were determined according to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) and National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP ATP III) guidelines, respectively (blood pressure, <140/90 or <130/80 mm Hg; low-density lipoprotein cholesterol (LDL-C), <4.1 to <2.6 mmol l−1 (<160 to <100 mgdl−1)). Overall, 1649 patients received study medication. Most patients (91.4%) had ⩾1 cardiovascular risk factor (as defined by NCEP ATP III guidelines) in addition to hypertension/dyslipidaemia, and 61.7% had coronary heart disease/risk equivalent. At baseline, mean blood pressure was 146.6/88.3 mm Hg and LDL-C was 3.4 mmol l−1 (130.2 mgdl−1). At week 14, 55.2% of patients reached both blood pressure and lipid goals, 61.3% reached blood pressure goal and 87.1% reached lipid goal (34.0% were at lipid goal at baseline). Mean blood pressure reduction was 20.2/11.4 mm Hg. For patients who were lipid-lowering drug naive at baseline, mean reduction in LDL-C was 41.0%. Treatment-related adverse events led to the discontinuation of 3.6% of patients. Single-pill amlodipine/atorvastatin therapy was well tolerated and effective for the reduction of blood pressure and lipids to recommended goals in patients from diverse ethnic backgrounds.

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Acknowledgements

This study was funded by Pfizer Inc. We thank Jason Boland for his work in setting up the statistical output programs for this study. Editorial support was provided by Elizabeth Harvey, PhD, at Envision Pharma and funded by Pfizer Inc.

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Authors and Affiliations

  1. Cardiology Department, Istanbul University, Istanbul, Turkey

    S Erdine

  2. Sejong Medical Research Institute, Korea University, Bucheon, South Korea

    Y M Ro

  3. Department of Medicine, University of Hong Kong, Hong Kong, China

    H-F Tse

  4. Griffith and Bond University Medical Schools, Griffith and Bond Universities, Queensland, Australia

    L G Howes

  5. Department of Endocrinology and Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), Mexico City, Mexico

    C A Aguilar-Salinas

  6. Health Science Centre, Federal University of Pernambuco, Recife, Brazil

    H Chaves

  7. Faculty of Medicine, Ain Shams University, Cairo, Egypt

    R Guindy

  8. Pfizer Inc, New York, NY, USA

    P Chopra & R A Moller

  9. Pfizer Australia, Sydney, Australia

    I M Schou

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Additional information

The Gemini-AALA Study Investigators (listed by country):

Peru: Dr F Medina

South Africa: Dr H Chait, Dr NJ David, Dr G Ellis, Dr A Jacovides, Dr MT Mpe, Dr P Sareli, Dr JD Smit, Dr ZFA Vawda, Dr MC Rajput and Dr C Van Dyk

Chile: Dr J Jalil, Dr A Forero

Mexico: Dr MAT Rodríguez, Dr CA Aguilar-Salinas, Dr JL Leiva, Dr HG Alcala, Dr E Morales and Dr C Posadas

Guatemala: Dr VH Monterroso and Dr JF Molina

Thailand: Dr C Deerochanawong, Professor A Sukonthasarn and Associate P Sritara

Korea: Professor BH Oh, Professor YM Ro, Dr CG Park, Dr JE Park, Dr HJ Youn, Dr MH Jeong, Dr SC Chae, Dr YW Shin, Dr KH Ryu and Dr SK Kim

Malaysia: Dr DAA Mahayiddin, Dr KH Sim, Dr Z Yusof, Professor WAW Ahmad and Dr CL Teng

Taiwan: Dr SJ Yeh, Dr KM Chu, Dr CJ Wu, Dr CD Tsai, Dr TD Wang and Dr MJ Charng

Singapore: Dr LC Yin and Dr HK Thye

Hong Kong: Dr DWS Chu, Dr DWS Chu and Dr HF Tse

Argentina: Dr DG Starosiliz, Dr RD La Greca, Dr RH Rey, Dr J Fuselli and Dr F Botto

Brazil: Dr F Nobre, Dr G Reis, Dr H De Chaves Jr, Dr JM Ribeiro, Dr OR Coelho, Professor O Kohlmann, Dr RJ da Silva Franco and Dr FG Eliaschewitz

Philippines: Dr A Panelo, Dr FE Punzalan, Dr RG Sy, Dr RA Divinagracia, Dr JM Jaro, Dr MA Lim-Abrahan and Dr R Sevilla

Australia: Professor T Davis, Dr JH Frayne, Professor LG Howes, Professor G Jennings, Associate Professor K Kostner, Professor C Pollock and Dr P Srivastava

Indonesia: Dr LH Makmun, Dr RM Yogiarto and Dr AA Soenarta

Israel: Professor I Raz, Professor D Harats, Professor A Caspi, Dr A Rubinstein and Professor T Chajek-Shaul

India: Dr SF Padaria, Dr PK Grant, Dr KS Bhagavatula, Dr A Mathur, Dr HP Thacker, Dr KK Aggarwal, Dr JPS Sawhney, Dr SM Kumar and Dr PK Shetty

Turkey: Professor VA Vural, Associate Professor A Belgi, Dr M Demir, Professor G Akgun, Professor A Ergin, Professor N Caglar, Dr O Ergene, Dr M Bahceci, Associate Professor N Cam and Associate Professor M Aksoy

Lebanon: Dr R Azar and Dr J Hadad

United Arab Emirates: Dr WA Almahmeed, Dr ASB Brek and Dr SZ Bakir

Kuwait: Dr M Zubaid

Jordan: Dr E Al Mousa and Dr H Zuriekat

Saudi Arabia: Dr JS Alwakeel, Dr I Sulaimani and Dr A Alkhadhrah

Morocco: Dr AJ Tahiri

Tunisia: Dr MR Boujnah, H Haouala and S Kachboura

Pakistan: Dr M Hafizullah, Dr S Kureshi and Dr J Akram

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Erdine, S., Ro, Y., Tse, HF. et al. Single-pill amlodipine/atorvastatin helps patients of diverse ethnicity attain recommended goals for blood pressure and lipids (the Gemini-AALA study). J Hum Hypertens 23, 196–210 (2009). https://doi.org/10.1038/jhh.2008.114

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