International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: The JEWEL programme

European Journal of Cardiovascular Prevention and Rehabilitation

Volumn 16, Issue 4, 2009, Pages 472-480

  Richard Hobbs, Frederick D ^a   Gensini, Gianfranco ^c   John Mancini, Giovanni B ^f   Manolis, Athanasios J ^d,e   Bauer, Beverly ^g   Genest, Jacques ^h   Feldman, Ross D ⁱ   Harvey, Peter ^b   Jenssen, Trond G ^j,k   Da Silva, Pedro Marques ^l  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b Crouch Oak Family Practice   (United Kingdom)

^c UNIVERSITY OF FLORENCE   (Italy)

^d Asklepeion General Hospital   (Greece)

^e EMORY UNIVERSITY   (United States)

^f UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^g Pfizer Canada Inc   (Canada)

^h MCGILL UNIVERSITY HEALTH CENTRE   (Canada)

ⁱ UNIVERSITY OF WESTERN ONTARIO   (Canada)

^j UNIVERSITY OF TROMSØ   (Norway)

^k UNIVERSITY OF OSLO   (Norway)

^l HOSPITAL DE SANTA MARTA   (Portugal)

more..

Author keywords

Amlodipine; Atorvastatin; Calcium channel blocker; Cardiovascular; Dyslipidaemia; Hypertension

Indexed keywords

AMLODIPINE PLUS ATORVASTATIN; CHOLESTEROL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIHYPERTENSIVE THERAPY; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BLOOD PRESSURE REGULATION; CANADA; CHOLESTEROL BLOOD LEVEL; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DIZZINESS; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FATIGUE; FEMALE; HEADACHE; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; INFLUENZA; JOINT SWELLING; LIFESTYLE MODIFICATION; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; OUTCOME ASSESSMENT; PAIN; PERIPHERAL EDEMA; PILL; PRACTICE GUIDELINE; PRIORITY JOURNAL; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; UNITED KINGDOM; UPPER RESPIRATORY TRACT INFECTION;

EID: 70349224192     PISSN: 17418267     EISSN: None     Source Type: Journal    
DOI: 10.1097/HJR.0b013e32832b63f5     Document Type: Article

References (48)

1. Khan NA, Hemmelgarn B, Herman RJ, Rabkin SW, McAlister FA, Bell CM, et al. The 2008 Canadian Hypertension Education Program recommendations for the management of hypertension: part 2-therapy. Can J Cardiol 2008; 24:465-475.
2. Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, et al. 2007 Guidelines for the Management of Arterial Hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007; 25:1105-1187. (Pubitemid 46924065)
3. Williams B, Poulter NR, Brown MJ, Davis M, McInnes GT, Potter JF, et al. Guidelines for management of hypertension: report of the fourth working party of the British Hypertension Society, 2004-BHS IV. J Hum Hypertens 2004; 18:139-185.
4. British Cardiac Society; British Hypertension Society; Diabetes UK; HEART UK; Primary Care Cardiovascular Society; Stroke Association. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005; 91 (Suppl 5):v1-v52.
5. Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, et al. European guidelines on cardiovascular disease prevention in clinical practice. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil 2007; 14 (Suppl 2):S1-S113.
6. Chapman RH, Benner JS, Petrilla AA, Tierce JC, Collins SR, Battleman DS, Schwartz JS. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med 2005; 165:1147-1152.
7. O'Connor PJ. Improving medication adherence: challenges for physicians, payers, and policy makers. Arch Intern Med 2006; 166:1802-1804.
8. Chapman RH, Petrilla AA, Benner JS, Schwartz JS, Tang SS. Predictors of adherence to concomitant antihypertensive and lipid-lowering medications in older adults: a retrospective, cohort study. Drugs Aging 2008; 25: 885-892.
9. Wong ND, Pio JR, Franklin SS, L'Italien GJ, Kamath TV, Williams GR. Preventing coronary events by optimal control of blood pressure and lipids in patients with the metabolic syndrome. Am J Cardiol 2003; 91:1421-1426.
10. Jackson R, Lawes CM, Bennett DA, Milne RJ, Rodgers A. Treatment with drugs to lower blood pressure and blood cholesterol based on an individual's absolute cardiovascular risk. Lancet 2005; 365:434-441.
11. Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003; 326:1423-1429.
12. Turnbull F. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet 2003; 362:1527-1535.
13. Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 2005; 366:1267-1278.
14. Mills EJ, Rachlis B, Wu P, Devereaux PJ, Arora P, Perri D. Primary prevention of cardiovascular mortality and events with statin treatments: a network meta-analysis involving more than 65 000 patients. J Am Coll Cardiol 2008; 52 :1769-1781.
15. Steinberg BA, Bhatt DL, Mehta S, Poole-Wilson PA, O'Hagan P, Montalescot G, et al. Nine-year trends in achievement of risk factor goals in the US and European outpatients with cardiovascular disease. Am Heart J 2008; 156:719-727.
16. Wolf-Maier K, Cooper RS, Kramer H, Banegas JR, Giampaoli S, Joffres MR, et al. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension 2004; 43:10-17.
17. O'Meara JG, Kardia SL, Armon JJ, Brown CA, Boerwinkle E, Turner ST. Ethnic and sex differences in the prevalence, treatment, and control of dyslipidemia among hypertensive adults in the GENOA study. Arch Intern Med 2004; 164:1313-1318.
18. Johnson ML, Pietz K, Battleman DS, Beyth RJ. Therapeutic goal attainment in patients with hypertension and dyslipidemia. Med Care 2006; 44:39-46.
19. Hansson L, Lloyd A, Anderson P, Kopp Z. Excess morbidity and cost of failure to achieve targets for blood pressure control in Europe. Blood Press 2002; 11:35-45.
20. Lloyd A, Schmieder C, Marchant N. Financial and health costs of uncontrolled blood pressure in the United Kingdom. Pharmacoeconomics 2003; 21:33-41.
21. Blank R, LaSalle J, Reeves R, Maroni J, Tarasenko L, Sun F. Single-pill therapy in the treatment of concomitant hypertension and dyslipidemia (the amlodipine/atorvastatin Gemini study). J Clin Hypertens 2005; 7:264-273.
22. Erdine S, Ro YM, Tse H-F, Howes LG, Aguilar-Salinas CA, Chaves H, 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 2008; 23:196-210.
23. Flack JM, Victor R, Watson K, Ferdinand KC, Saunders E, Tarasenko L, et al. Improved attainment of blood pressure and cholesterol goals using single-pill amlodipine/atorvastatin in African Americans: the CAPABLE trial. Mayo Clin Proc 2008; 83:35-45.
24. Sever PS, Dahlöf B, Poulter NR, Wedel H, Beevers G, Caulfield M, et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003; 361:1149-1158. (Pubitemid 36398384)
25. Dahlöf B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 2005; 366:895-906.
26. Preston RA, Harvey P, Herfert O, Dykstra G, Jukema JW, Sun F, Gillen D. A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the Respond trial. J Clin Pharmacol 2007; 47:1555-1569.
27. Sever P, Dahlöf B, Poulter N, Wedel H, Beevers G, Caulfield M, et al. Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial. Eur Heart J 2006; 27: 2982-2988.
28. Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363:2022-2031.
29. Messerli FH, Bakris GL, Ferrera D, Houston MC, Petrella RJ, Flack JM, et al. Efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia: Results of the AVALON trial. J Clin Hypertens (Greenwich) 2006; 8:571-581.
30. Patel BV, Leslie RS, Thiebaud P, Nichol MB, Tang SSK, Solomon H, et al. Adherence with single-pill amlodipine/atorvastatin vs a two-pill regimen. Vasc Health Risk Manag 2008; 4:673-681.
31. Hobbs FD, Gensini G, Mancini GB, Manolis AJ, Bauer B, Bohler S, et al. 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). Int J Cardiol 2006; 110:242-250.
32. Khan NA, McAlister FA, Lewanczuk RZ, Touyz RM, Padwal R, Rabkin SW, et al. The 2005 Canadian Hypertension Education Program recommendations for the management of hypertension: part II-therapy. Can J Cardiol 2005; 21:657-672. (Pubitemid 41030491)
33. European Society of Hypertension-European Society of Cardiology Guidelines Committee. 2003 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003; 21:1011-1053.
34. Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA 2001; 285:2486-2497.
35. Conroy RM, Pyörälä K, Fitzgerald AP, Sans S, Menotti A, De Backer G, et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003; 24:987-1003.
36. Gómez-Belda A, Rodilla E, González C, Costa JA, Serra B, Pascual JM. [Lipid lowering goals in high risk and very high cardiovascular risk patients: a reasonable challenge?]. Rev Clin Esp 2006; 206:417-421.
37. Diamantopoulos EJ, Athyros VG, Yfanti GK, Migdalis EN, Elisaf M, Vardas PE, et al. The control of dyslipidemia in outpatient clinics in Greece (OLYMPIC) Study. Angiology 2005; 56:731-741.
38. Joffres MR, Ghadirian P, Fodor JG, Petrasovits A, Chockalingam A, Hamet P. Awareness, treatment, and control of hypertension in Canada. Am J Hypertens 1997; 10:1097-1102.
39. Petrella RJ, Merikle E, Jones J. Prevalence and treatment of dyslipidemia in Canadian primary care: a retrospective cohort analysis. Clin Ther 2007; 29 :742-750.
40. McPherson R, Frohlich J, Fodor G, Genest J. Canadian Cardiovascular Society position statement-recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease. Can J Cardiol 2006; 22:913-927.
41. Goldberg KC, Melnyk SD, Simel DL. Overcoming inertia: improvement in achieving target low-density lipoprotein cholesterol. Am J Manag Care 2007; 13:530-534.
42. Schmittdiel JA, Uratsu CS, Karter AJ, Heisler M, Subramanian U, Mangione CM, Selby JV. Why don't diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med 2008; 23:588-594.
43. Rodondi N, Peng T, Karter AJ, Bauer DC, Vittinghoff E, Tang S, et al. Therapy modifications in response to poorly controlled hypertension, dyslipidemia, and diabetes mellitus. Ann Intern Med 2006; 144:475-484.
44. Newman C, Tsai J, Szarek M, Luo D, Gibson E. Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14 236 patients. Am J Cardiol 2006; 97:61-67.
45. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report. JAMA 2003; 289:2560-2572.
46. Hobbs FDR, Erhardt L. Acceptance of guideline recommendations and perceived implementation of coronary heart disease prevention among primary care physicians in five European countries: the Reassessing European Attitudes about Cardiovascular Treatment (REACT) survey. Fam Pract 2002; 19:596-604.
47. Bangalore S, Shahane A, Parkar S, Messerli FH. Compliance and Fixed-dose Combination Therapy. Curr Hypertens Rep 2007; 9: 184-189.
48. Sleight P, Pouleur H, Zannad F. Benefits, challenges, and registerability of the polypill. Eur Heart J 2006; 27:1651-1656.