GEMINI AALA Investigators

New Research Shows That Single Pill amlodipine besylate/atorvastatin calcium May Reduce 10-Year Risk for a Heart Attack or Stroke by More Than 50 Percent

Fukuoka, Japan (ots/PRNewswire) - - Therapy May Benefit Hypertensive Patients With Additional Risk Factors in Populations Across Asia and Latin America Single-pill amlodipine besylate/atorvastatin calcium (Caduet(R)) may reduce the 10-year risk of having a cardiovascular (CV) event - as determined by the Framingham 10-year Coronary Heart Disease (CHD) Risk Score - by 54 percent in hypertensive patients with elevated LDL-cholesterol (LDL-C, or "bad" cholesterol), according to new data from the international GEMINI AALA trial. Further, patients across participating countries who took Caduet achieved hypertension and lipid treatment targets as recommended by JNC 7(i) and NCEP ATP III(ii) guidelines. The results of the study were presented today at the annual Scientific Meeting of the International Society of Hypertension (ISH). "This is the first large-scale clinical trial to evaluate the real-world clinical effectiveness of amlodipine besylate/atorvastatin calcium therapy in patients across both Asia and Latin America," said Dr. Hung Fat Tse, GEMINI AALA Investigator, University of Hong Kong. "The results show that by taking this new fixed combination treatment with or without an existing antihypertensive regimen, these patients may achieve and maintain blood pressure and lipid goals and, more importantly, reduce their estimated 10-year risk of coronary heart disease." Cardiovascular disease (CVD) represents a growing burden in populations across Asia(1-4). The Asia-Pacific region accounts for nearly half of the global burden of CVD,(5) and in China and Malaysia, the disease has become the leading cause of death(6). In Latin America and the Caribbean, CVD accounted for more than 30 percent of all deaths in 2001, and this figure is expected to rise to 38 percent by 2020(7). "Hypertension and high cholesterol are modifiable risk factors that, together, contribute to the overall likelihood of suffering a CV event, including heart attack and stroke. As physicians, we must recognize the need to move away from treating cardiovascular risk factors in isolation and find more effective ways of treating total CV risk," added Dr. Hilton Chaves, another GEMINI AALA Investigator, Federal University of Pernambuco, Brazil. "The results of GEMINI AALA provide a compelling rationale for treating patients with hypertension and additional risk factors with amlodipine besylate/atorvastatin calcium therapy. This may be an important advance in the evolution of patient management." About the study The GEMINI AALA trial, funded by Pfizer, was a 14-week, open-label, multicentre, titration-to-goal study involving 1,649 patients in 27 countries across the Middle East, Asia, Australia, Africa, and Latin America. The study was designed to assess the real-world clinical effectiveness and safety of single-pill amlodipine besylate/atorvastatin calcium in hypertensive patients from diverse ethnic backgrounds with additional high cholesterol (dyslipidaemia). The primary efficacy endpoint was the percentage of patients reaching both blood pressure (BP) and LDL-C targets as defined by JNC 7 and NCEP ATP III guidelines. After 14 weeks of treatment, 55.2 percent of patients reached both their blood pressure (BP) and their LDL-C goals - significant because generally only 9 percent of patients with hypertension and high cholesterol are controlled for both(8). Patients' mean BP was reduced by 20.2/11.4 mmHg (approximately 13 percent), and their mean LDL-C was reduced by 1.1 mmol/L (44.2 mg/dL) [29 percent]. Further, treatment was safe and well-tolerated. A post-hoc analysis also was conducted among a subgroup of patients in Eastern Asian countries (excluding India and Pakistan). Primary and secondary efficacy measures were compared between this subgroup and a "non-Asian" subgroup of patients from all other countries. In the Asian subgroup (n=694), 56 percent of patients reached both their BP and their LDL-C therapeutic goals, and the mean Framingham 10-year CHD risk score was reduced by 56 percent. Treatment was well-tolerated in the study, with a total of 60 patients (3.6 percent) discontinuing due to adverse events (AEs). The most common AEs were peripheral oedema (9.8 percent), respiratory infection (5 percent), headache (3.3 percent), dizziness (3.1 percent), palpitations (1.5 percent) and myalgia (1.5 percent). These events are consistent with those described in the amlodipine besylate (Norvasc(R)) and atorvastatin calcium (Lipitor(R)) product information. References: (i) Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (ii) National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) 1 WHO. Integrated management of cardiovascular risk. Report of a WHO meeting. Geneva: World Health Organization; 9-12 July 2002. From Tse HF et al. Multiple-risk intervention with single-pill amlodipine/atorvastatin therapy helps patients with diverse ethnicity attain recommended therapeutic goals for blood pressure and lipids (the GEMINI-AALA study). Core poster for ISH. Poster no. P3-79. 2 Thom T et al. Heart Disease and Stroke Statistics: 2006 Update. A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2006. 3 Gaziano TA et al. Cardiovascular Disease: Disease Control Priorities in Developing Countries. Second ed. New York: Oxford University Press; 2006:645-662. 4 Murray CJL et al. Global Health Statistics: A Compendium of Incidence, Prevalence and Mortality for Over 200 Conditions. Global Burden of Disease: Harvard University Press; 1996. 5 Zhang X et al. Cholesterol, coronary heart disease, and stroke in the Asia Pacific region. Asia Pacific Cohort Studies Collaboration. International J of Epidemiology 2003;32:563-572. 6 Reynolds K et al. Geographic variations in the prevalence, awareness, treatment and control of hypertension in China. J of Hypertension 2003; 21:1273-1281. 7 Murray, C. J., and A. D. Lopez. 1994. Global Comparative Assessments in the Health Sector: Disease Burden, Expenditures, and Intervention Packages. Geneva: World Health Organization. 8 Wong ND, Lopez V, Franklin S, Tang S, Williams GR. Prevalence, Treatment, and Control of Combined Hypertension and Hypercholesterolemia in the United States. The American Journal of Cardiology 2006;98 (2):204-208. For more information, please contact Sameena Mirza, +1-212-614-4016 ots Originaltext: GEMINI AALA Investigators Im Internet recherchierbar: http://www.presseportal.ch Contact: For more information, please contact Sameena Mirza, +1-212-614-4016

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