2006-10-18

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 RiskFactors 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 elevatedLDL-cholesterol (LDL-C, or "bad" cholesterol), according to new datafrom the international GEMINI AALA trial. Further, patients acrossparticipating countries who took Caduet achieved hypertension andlipid treatment targets as recommended by JNC 7(i) and NCEP ATPIII(ii) guidelines. The results of the study were presented today atthe annual Scientific Meeting of the International Society ofHypertension (ISH).

"This is the first large-scale clinical trial to evaluate thereal-world clinical effectiveness of amlodipine besylate/atorvastatincalcium therapy in patients across both Asia and Latin America," saidDr. Hung Fat Tse, GEMINI AALA Investigator, University of Hong Kong."The results show that by taking this new fixed combination treatmentwith or without an existing antihypertensive regimen, these patientsmay achieve and maintain blood pressure and lipid goals and, moreimportantly, reduce their estimated 10-year risk of coronary heartdisease."

Cardiovascular disease (CVD) represents a growing burden inpopulations across Asia(1-4). The Asia-Pacific region accounts fornearly half of the global burden of CVD,(5) and in China andMalaysia, the disease has become the leading cause of death(6). InLatin America and the Caribbean, CVD accounted for more than 30percent of all deaths in 2001, and this figure is expected to riseto 38 percent by 2020(7).

"Hypertension and high cholesterol are modifiable risk factorsthat, together, contribute to the overall likelihood of suffering aCV event, including heart attack and stroke. As physicians, we mustrecognize the need to move away from treating cardiovascular riskfactors in isolation and find more effective ways of treating totalCV risk," added Dr. Hilton Chaves, another GEMINI AALA Investigator,Federal University of Pernambuco, Brazil. "The results of GEMINI AALAprovide a compelling rationale for treating patients withhypertension and additional risk factors with amlodipinebesylate/atorvastatin calcium therapy. This may be an importantadvance 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 1,649patients in 27 countries across the Middle East, Asia, Australia,Africa, and Latin America. The study was designed to assess thereal-world clinical effectiveness and safety of single-pillamlodipine besylate/atorvastatin calcium in hypertensive patientsfrom diverse ethnic backgrounds with additional high cholesterol(dyslipidaemia). The primary efficacy endpoint was the percentage ofpatients reaching both blood pressure (BP) and LDL-C targets asdefined by JNC 7 and NCEP ATP III guidelines. After 14 weeks oftreatment, 55.2 percent of patients reached both their blood pressure(BP) and their LDL-C goals - significant because generally only 9percent of patients with hypertension and high cholesterol arecontrolled for both(8). Patients' mean BP was reduced by 20.2/11.4mmHg (approximately 13 percent), and their mean LDL-C was reduced by1.1 mmol/L (44.2 mg/dL) [29 percent]. Further, treatment was safeand well-tolerated.

A post-hoc analysis also was conducted among a subgroup ofpatients in Eastern Asian countries (excluding India and Pakistan).Primary and secondary efficacy measures were compared between thissubgroup and a "non-Asian" subgroup of patients from all othercountries. In the Asian subgroup (n=694), 56 percent of patientsreached both their BP and their LDL-C therapeutic goals, and the meanFramingham 10-year CHD risk score was reduced by 56 percent.

Treatment was well-tolerated in the study, with a total of 60patients (3.6 percent) discontinuing due to adverse events (AEs). Themost common AEs were peripheral oedema (9.8 percent), respiratoryinfection (5 percent), headache (3.3 percent), dizziness (3.1percent), palpitations (1.5 percent) and myalgia (1.5 percent). Theseevents are consistent with those described in the amlodipine besylate(Norvasc(R)) and atorvastatin calcium (Lipitor(R)) productinformation.

References:

(i) Joint National Committee on Prevention, Detection, Evaluation,and Treatment of High Blood Pressure

(ii) National Cholesterol Education Program (NCEP) Adult TreatmentPanel III (ATP III)

1 WHO. Integrated management of cardiovascular risk. Report of aWHO meeting. Geneva: World Health Organization; 9-12 July 2002. FromTse HF et al. Multiple-risk intervention with single-pillamlodipine/atorvastatin therapy helps patients with diverse ethnicityattain 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 andStroke Statistics Subcommittee. Circulation 2006.

3 Gaziano TA et al. Cardiovascular Disease: Disease ControlPriorities in Developing Countries. Second ed. New York: OxfordUniversity Press; 2006:645-662.

4 Murray CJL et al. Global Health Statistics: A Compendium ofIncidence, Prevalence and Mortality for Over 200 Conditions. GlobalBurden of Disease: Harvard University Press; 1996.

5 Zhang X et al. Cholesterol, coronary heart disease, and strokein the Asia Pacific region. Asia Pacific Cohort StudiesCollaboration. 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 ofHypertension 2003; 21:1273-1281.

7 Murray, C. J., and A. D. Lopez. 1994. Global ComparativeAssessments in the Health Sector: Disease Burden, Expenditures, andIntervention Packages. Geneva: World Health Organization.

8 Wong ND, Lopez V, Franklin S, Tang S, Williams GR. Prevalence,Treatment, and Control of Combined Hypertension andHypercholesterolemia in the United States. The American Journal ofCardiology 2006;98 (2):204-208.

For more information, please contact Sameena Mirza,+1-212-614-4016

ots Originaltext: GEMINI AALA InvestigatorsIm Internet recherchierbar: http://www.presseportal.de

Contact:For more information, please contact Sameena Mirza, +1-212-614-4016

GEMINI AALA Investigators

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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

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