The FEVER (Felodipine EVEnt Reduction) trial; a randomised, double-blind, placebo-controlled trial in Chinese hypertensive patients
Authors:
M. Souček; M. Plachý
Authors place of work:
II. interní klinika Lékařské fakulty MU a FN u sv. Anny, Brno, přednosta doc. MUDr. Miroslav Souček, CSc.
Published in the journal:
Vnitř Lék 2007; 53(1): 63-70
Category:
Reviews
Summary
The FEVER trial observed the difference between intense and less intense treatment of hypertension by comparing combination therapy consisting of a low diuretic dose (12.5 mg of hydrochlorothiazide) and a low calcium antagonist dose (5 mg of felodipine) with monotherapy based on a low diuretic dose (12.5 mg of hydrochlorothiazide) in Chinese hypertensive patients. The trial enrolled 9,711 hypertonics (of which 4,841 on hydrochlorothiazide + felodipine combination and 4,870 on hydrochlorothiazide + placebo combination). Blood pressure decreased from 158.7/92.4 to 138.1/82.3 mmHg and from 158.0/92.7 to 141.6/83.9 mmHg in the combination therapy group and monotherapy group, respectively. The average difference throughout the trial was 4.2/2.1 mmHg. The primary endpoint – fatal and non-fatal stroke (CVA) – was reduced by 27 % in the combination therapy group. Among secondary endpoints, the success ratio of combination therapy was expressed by 27 % reduction of all cardiovascular events, 35 % reduction of all cardiac events, 32 % reduction of coronary events and 31 % reduction of deaths. The minor difference between systolic and diastolic blood pressure of approximately 4/2 mmHg was related to a decrease in the incidence of CVA and cardiovascular events in Chinese hypertonics.
Key words:
hypertension – hydrochlorothiazide – felodipine – combination therapy – monotherapy – cerebrovascular accident
Zdroje
1. Liu L, Zhang Y, Liu G et al. for the FEVER Study Group. The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo-controlled trial in Chinese hypertensive patients. J Hypertens 2005; 23: 2157-2172.
2. Wang L. 2002 National nutrition and health survey: report I General Report. Beijing: People’s Medical Publishing House 2005 (v čínštině).
3. Kerney PM, Whelton M, Reynolds K et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365: 217-223.
4. Annals of Health of China Committee. 1999 Annals of Health of China. Beijing (China): People’s Health Press 2000 (v čínštině).
5. Asia Pacific Cohort Studies Collaboration. Blood pressure and cardiovascular disease in the Asia Pacific Region. J Hypertens 2003; 21: 707-716.
6. Gong L, Zhang W, Zhu Y et al. Shanghai trial of nifedipine in the elderly (STONE). J Hypertens 1996; 14: 1237-1245.
7. Liu L, Wang JG, Gong L et al. Comparison of active treatment and placebo in older Chinese patients with isolated systolic hypertension (Syst-China). J Hypertens 1998; 16: 1823-1829.
8. Chobanian AV, Bakris GL, Black HR 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.
9. Guidelines Committee 2003. European Society of Hypertension - European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003; 21: 1011-1059.
10. World Health Organization - International Society of Hypertension, Writing Group. World Health Organization - International Society of Hypertension statement on management of hypertension. J Hypertens 2003; 21: 1983-1992.
11. Chinese Hypertension Guidelines Committee. Chinese Hypertensiom Guidelines. Chin J Hypertens 2004; 12: 487-489.
12. The Heart Outcomes Prevention Evaluation Study Investigators. Effects of angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med 2000; 342: 145-153.
13. PROGRESS Collaboration Study Group. Randomised trial of perindopril based blood pressure-lowering regimen among 6108 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358: 1033-1041.
14. Lithell H, Hansson L, Skogg I et al. for the SCOPE Study Group. The Study on Cognition and Prognosis in the Elderly (SCOPE). Principal results of a randomised double-blind intervention trial. J Hypertens 2003; 21: 875-886.
15. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomised to doxazosin vs chlorthalidone: the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2000; 283: 1967-1975.
16. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomised to angiotensin-converting enzyme inhibitor or calcium channel blockers vs diuretic: The Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981-2997.
17. Hansson L, Zanchetti A, Carruthers SG et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet 1998; 351: 1755-1762.
18. Zanchetti A, Hansson L, Clement D et al. on behalf of the HOT Study Group. Benefits and risks of more intensive blood pressure lowering in hypertensive patients of the HOT Study with different risk profiles: does a J-shaped curve exist in smokers? J Hypertens 2003; 21: 797-804.
19. Pepine CJ, Handberg EM, Cooper-De Hoff RM et al. A calcium antagonist versus a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial. JAMA 2003; 290: 2805-2819.
20. Julius S, Kjeldsen SE, Weber M 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.
21. The European trial on reduction of cardiac events with perindopril in stable coronary artery disease investigators. Efficacy of perindropil in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet 2003; 362: 782-788.
22. Lubsen J, Wagener G, Kirwan B-A et al. Effects of long-acting nifedipine on mortality and cardiovascular morbidity in patients with symptomatic stable angina and hypertension: the ACTION trial. J Hypertens 2005; 23: 641-648.
23. PATS Collaboration Group. Post-stroke antihyperytensive treatment study: a preliminary result. Chinese Med J 1995; 108: 710-717.
24. Staessen JA, Fagard R, Thijs L et al. for the Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. Lancet 1997; 350: 757-764.
25. Dahlöf B, Devereux RB, Kjeldsen SE et al. Cardiovascular morbidity and mortality in the Losartan Intervention Endpoint reduction in hypertension study. (LIFE): a randomised trial against atenolol. Lancet 2002; 359: 995-1003.
26. Brown MJ, Palmer CR, Castaigne A et al. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet 2000; 356: 366-372.
27. Black HR, Elliot WJ, Grandist G et al. for the CONVINCE Research Group. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular Endpoints (CONVINCE) trial. JAMA 2003; 289: 2073-2082.
28. Zanchetti A. Calcium channel blockers for hypertension. In: Black H, Elliot W (eds). Clinical hypertension. A companion of Braunwald’s heart disease. Philadelphia: Elsevier 2005: kap 21 (v tisku).
29. Wassertheil-Smoller S, Psaty B, Greenland P et al. Association between cardiovascular outcomes and antihypertensive drug treatment in older women. JAMA 2004; 292: 2849-2859.
30. Psaty B, Heckbert S, Koepsell T et al. The risk of myocardial infarction associated with antihypertensive drug therapies. JAMA 1995; 274: 620-625.
31. Pahor M, Guralnik J, Ferrucci L et al. Calcium channel blockade and incidence of cancer in aged populations. Lancet 1996; 348: 493-497.
32. Pahor M, Guralnik J, Corti M et al. Long-term survival and use of antihypertensive medications in older persons. J Am Geriatr Soc 1995; 43: 1191-1197.
33. Blood Pressure Lowering Treatment Trialists’ Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomized trials. Lancet 2003; 362: 1527-1535.
34. Zanchetti A Evidence-based medicine in hypertension: what type of evidence? J Hypertens 2005; 23: 1113-1120.
Štítky
Diabetology Endocrinology Internal medicineČlánok vyšiel v časopise
Internal Medicine
2007 Číslo 1
Najčítanejšie v tomto čísle
- The FEVER (Felodipine EVEnt Reduction) trial; a randomised, double-blind, placebo-controlled trial in Chinese hypertensive patients
- Guidelines for pharmacotherapy of acute and chronic non-oncological pain
- The importance of determination of Nt-proBNP and big endothelin in diagnosing chronic heart failure in patients on regular haemodialysis treatment
- Epilepsy and disorders of reproduction