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Titolo:
Principal results from the international nifedipine GITS study: Intervention as a goal in hypertension treatment (INSIGHT)
Autore:
Brown, MJ; Palmer, CR; Castaigne, A; de Leeuw, PW; Mancia, G; Rosenthal, T; Ruilope, LM;
Indirizzi:
Univ Cambridge, Clin Pharmacol Unit, Cambridge, England Univ Cambridge Cambridge England lin Pharmacol Unit, Cambridge, England Univ Cambridge, Ctr Appl Med Stat, Cambridge, England Univ Cambridge Cambridge England Ctr Appl Med Stat, Cambridge, England Univ Paris, Hop Henri Mondor, Serv Cardiol, F-75252 Paris, France Univ Paris Paris France F-75252 dor, Serv Cardiol, F-75252 Paris, France Univ Maastricht, Maastricht, Netherlands Univ Maastricht Maastricht Netherlands stricht, Maastricht, Netherlands Univ Milan, Cattedra Med Interna, Milan, Italy Univ Milan Milan ItalyUniv Milan, Cattedra Med Interna, Milan, Italy Tel Aviv Univ, Chaim Sheba Med Ctr, Hypertens Unit, IL-69978 Tel Aviv, Israel Tel Aviv Univ Tel Aviv Israel IL-69978 s Unit, IL-69978 Tel Aviv, Israel Univ Madrid, Hosp 12 Octobre, Dept Nephrol, Madrid 3, Spain Univ Madrid Madrid Spain 3 osp 12 Octobre, Dept Nephrol, Madrid 3, Spain
Titolo Testata:
EUROPEAN HEART JOURNAL SUPPLEMENTS
fascicolo: B, volume: 3, anno: 2001,
pagine: B20 - B26
SICI:
1520-765X(200105)3:B<B20:PRFTIN>2.0.ZU;2-U
Fonte:
ISI
Lingua:
ENG
Soggetto:
ISOLATED SYSTOLIC HYPERTENSION; CALCIUM-CHANNEL BLOCKADE; CORONARY HEART-DISEASE; BLOOD-PRESSURE; ACTIVE TREATMENT; OLDER PATIENTS; MORTALITY; PLACEBO; TRIALS; RISK;
Keywords:
hypertension; nifedipine GITS; thiazide-amilozide; INSIGHT;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
21
Recensione:
Indirizzi per estratti:
Indirizzo: Brown, MJ Addenbrookes Hosp, Clin Pharmacol Unit, Hills Rd,Level 6,ACCI,Box 110, Cambridge CB2 2QQ, England Addenbrookes Hosp Hills Rd,Level 6,ACCI,Box 110 Cambridge England CB2 2QQ
Citazione:
M.J. Brown et al., "Principal results from the international nifedipine GITS study: Intervention as a goal in hypertension treatment (INSIGHT)", EUR H J SUP, 3(B), 2001, pp. B20-B26

Abstract

Background We compared the effects of a long-acting calcium-channel blocker with a thiazide-amiloride combination on cardiovascular mortality and morbidity in patients with additional cardiovascular risk factors. The primaryobjective was to demonstrate 25% superiority of nifedipine GITS. A secondary objective was to establish non-inferiority compared with co-amilozide. Methods A prospective, randomized, double-masked trial was carried out in Europe and Israel, involving 6321 patients of 55-80 years of age with hypertension (blood pressure greater than or equal to 150/95 mmHg or systolic greater than or equal to 160 mmHg). Patients were also required to have at least one out of ten additional cardiovascular risk factors, such as diabetesor hypercholesterolaemia. Patients were assigned randomly to initial treatment with either nifedipine GITS (N), 30 mg, or co-amilozide (C) (hydrochlorothiazide, 25 mg, and amiloride, 2.5 mg), so that similar numbers of patients with each risk factor could be compared between the two drugs. Dose titration was principally by dose doubling, and addition of atenolol, 25-50 mg, or enalapril, 5-10 mg. Patients were followed for a mean period of 3 years. The primary outcome was a composite of death from cardiovascular causes,myocardial infarction, heart failure or stroke. Secondary outcome variables included death from any cause. Superiority analysis was of time to first event, by intention-to-treat. Non-inferiority analysis required the difference (Delta) in event-rate, and the 95% CI around Delta, to be <2% in patients remaining on randomized treatment. Findings Mean blood pressure was decreased similarly in both treatment groups, from 173/99 (14/8) mmHg to 138/82 (12/7) mmHg; 72% of patients were controlled on monotherapy. There were more withdrawals from the N group than from the C group, because of peripheral oedema in 8% and because of more serious adverse events (880 vs 776, P=0.02) in the C group. A primary end-point occurred in 200 (6.3%) of 3157 patients in the N group (182 events per 1000 patient-years) and in 182 (5.8%) of 3164 patients in the C group (16.5 events per 1000 patient-years; relative risk 1.1 [95% CI 0.90-1.3], P=0.35). Adding secondary variables, there were end-points in 383 (12.1%) of the Ngroup (35.1 per 1000 patient-years), and 397 (12.7%) of the C group (36.5 per 1000 patient-years; relative risk 0.97 [95% CI 0.84-1.11], P=0.32). Deaths were predominantly non-vascular (N, 176 vs C, 172; P=0.81). Interpretation The INSIGHT treatment regimens achieve optimal blood pressure control in most high-risk patients. This appears to be more important than choice of individual drugs in determining outcome in hypertension. Against a previous 'gold standard', nifedipine GITS was found to be effective inpreventing cardiovascular or cerebrovascular complications, and may be regarded as appropriate first-line therapy in hypertension.

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Documento generato il 25/01/20 alle ore 06:27:19