Calcium Channel Blockade and Cardiovascular Prognosis in the European Trial on Isolated Systolic Hypertension

Staessen, Jan A.; Thijs, Lutgarde; Fagard, Robert; Birkenhäger, W. H.; Арабидзе, Г Г; Babeanu, Speranta; Gil‐Extremera, Blas; Bulpitt, Christopher J.; Davidson, Christopher; Leeuw, Peter W. de; Efstratopoulos, A.; Fletcher, Astrid; Fogari, Roberto; Jääskivi, Matti; Kawecka−Jaszcz, Kalina; Nachev, C; Petrie, J C; Seux, Marie-Laure; Tuomilehto, Jaakko; Webster, J.; Yodfat, Y

doi:10.1161/01.hyp.32.3.410

Cited by 64 publications

(26 citation statements)

References 18 publications

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“…Benefit was also noticed in patients who remained on monotherapy with active nitrendipine. 20 Nitrendipine-based treatment was particularly effective in diabetic patients, in whom active treatment was estimated to prevent 178 severe cardiovascular complications as opposed to only 22 in the non-diabetic group. 21 The per-protocol analysis 12 considered only the end-points which had occurred during double-blind treatment and confirmed the results by intention-totreat.…”

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confidence: 99%

Overview of the outcome trials in older patients with isolated systolic hypertension

et al. 1999

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Aims: Isolated systolic hypertension affects over 8 to 15% of all subjects older than 60 years. In the elderly, systolic hypertension is the major modifiable cardiovascular risk factor. Three placebo-controlled outcome trials on antihypertensive drug treatment of this disorder have been published. The aim of this article was to shortly review each of these three trials and to present the pooled estimates of benefit of antihypertensive drug treatment in isolated systolic hypertension in the elderly. Methods and results: The Systolic Hypertension in the Elderly Program (SHEP) in the United

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confidence: 99%

Overview of the outcome trials in older patients with isolated systolic hypertension

et al. 1999

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“…Active treatment reduced total mortality (P = 0.04), cardiovascular mortality (P = 0.02) and all cardiovascular endpoints (P = 0.01) significantly more in the diabetic than the non-diabetic Syst-Eur patients. 29 In spite of the evidence produced by the Syst-Eur trial 3,9,27,29 and other placebo-controlled outcome studies in hypertension, 10,11 the controversy about the use of calcium-channel blockers as first-line drugs for the treatment of hypertension is still alive. Several arguments fuel the debate.…”

Section: Discussionmentioning

confidence: 99%

“…3 Cardiovascular benefit was equally observed in the patients remaining on monotherapy with nitrendipine as in those pro-gressing to combined treatment with nitrendipine plus enalapril, hydrochlorothiazide, or both drugs. 9 At the risk observed in the placebo group (intentionto-treat analysis), treating 1000 patients for 5 years could prevent 29 strokes or 53 major cardiovascular events. 3 Similar findings were obtained in two placebo-controlled trials in China, in which antihypertensive treatment was also started with a dihydropyridine.…”

Section: Rationale and Objective Of Syst-eurmentioning

confidence: 99%

“…With regard to Syst-Eur 2, it is important to note that the cardiovascular benefit in the Syst-Eur trial was equally observed in the patients remaining on monotherapy with nitrendipine as in those progressing to combined treatment with nitrendipine plus enalapril, hydrochlorothiazide, or both drugs. 9 In 1995, a case-control study raised the possibility that calcium-channel blockers prescribed to patients with hypertension may increase the risk of myocardial infarction. 15 In a quantitative review of 16 randomised secondary prevention trials, the use of short-acting nifedipine in patients with coronary heart disease was found to be associated with a 16% (95% CI: 1 to 33%) higher mortality.…”

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confidence: 99%

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Systolic Hypertension in Europe (Syst-Eur) Trial Phase 2: objectives, protocol, and initial progress

Gąsowski¹,

Staessen²,

Celis³

et al. 1999

J Hum Hypertens

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on behalf of the Systolic Hypertension in Europe InvestigatorsThe Systolic Hypertension in Europe (Syst-Eur) trial proved that blood pressure (BP) lowering therapy starting with nitrendipine reduces the risk of cardiovascular complications in older (у60 years) patients with isolated systolic hypertension (systolic BP у160 mm Hg and diastolic BP Ͻ95 mm Hg). After the completion of the Syst-Eur trial on 14 February 1997, 3506 consenting patients (93.0% of those eligible) were enrolled in phase 2 of the Syst-Eur trial. This open follow-up study aims to confirm the safety of long-term antihypertensive therapy based on a dihydropyridine. To lower the sitting systolic BP below 150 mm Hg (target BP), the first-line agent nitrendipine (10-40 mg/day) may be associated with enalapril (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), both add-on study drugs, or if required any other antihypertensive agent. On 1 November 1998, 3248 patients were still being followed, 86 patients had proceeded to non-supervised follow-up, and 43 had died. The median follow-up in Syst-Eur 2 was 14.3 months. At Keywords: calcium-channel blockade; elderly; dihydropyridine; isolated systolic hypertension IntroductionIn 1989 the European Working Party on High Blood Pressure in the Elderly started the placebo-controlled double-blind Systolic Hypertension in Europe trial (Syst-Eur). 1 Active treatment was initiated with the dihydropyridine calcium-channel blocker nitrendipine 2 with the possible addition of enalapril, hydrochlorothiazide or both drugs. The Syst-Eur trial stopped on 14 February 1997 according to predefined rules, 3 because the second of four planned interim analyses had shown a significant benefit for stroke, the primary end-point. 1 At the Syst-Eur investigators meeting in March 1997, the decision was taken to keep the Syst-Eur patients in followup. This article summarizes the rationale and protocol of this study, named Systolic Hypertension in Correspondence: Dr Jan A Staessen, Klinisch Laboratorium Hypertensie, Inwendige Geneeskunde-Cardiologie, UZ Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium Received 14 October 1998; accepted 21 October 1998 the last available visit, systolic/diastolic BP in the patients formerly randomised to placebo (n = 1682) or active treatment (n = 1824), had decreased by 13.2/5.2 mm Hg and by 4.6/1.6 mm Hg, respectively, so that the between-group BP difference was 1.7 mm Hg systolic (95% Cl: 0.8 to 2.6 mm Hg; P Ͻ 0.001) and 0.9 mm Hg diastolic (95% Cl: 0.4 to 1.5 mm mm Hg; P Ͻ 0.001). At the beginning of Syst-Eur 2, the goal BP was reached by 25.4% and 50.6% of the former placebo and activetreatment groups; at the last visit these proportions were 55.9% and 63.1%, respectively. At that moment, 45.9% of the patients were on monotherapy with nitrendipine, 29.3% took nitrendipine in combination with other study drugs. Until the end of 2001, BP control of the Syst-Eur 2 patients will be further improved. Cardiovascular complications and adverse events, such as cancer or gastro-intestinal bleeding, wi...

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“…8 Staessen et al 11 showed the usefulness of treatment with calcium antagonist monotherapy in the Syst-Eur study reanalysis. These studies used twice-daily long-acting calcium antagonists and demonstrated that calcium antagonists and diuretic treatment have a similar preventive effect against cardiovascular events; there was greater protection against stroke than against myocardial infarction.…”

Section: Nics-eh Study Group Calcium Antagonist and Diuretic In The Ementioning

confidence: 99%

Randomized Double-Blind Comparison of a Calcium Antagonist and a Diuretic in Elderly Hypertensives

1999

Hypertension

137

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Abstract-Although diuretics are recommended for the treatment of hypertension, decreased diuretic use and increased calcium antagonist use necessitate a comparison of the efficacy of these drugs in preventing cardiovascular events. Patients Ն60 years of age with systolic blood pressure of 160 to 220 mm Hg and diastolic blood pressure Ͻ115 mm Hg were enrolled. Patients were randomly assigned to 20 mg of sustained-release nicardipine hydrochloride twice daily or 2 mg of trichlormethiazide once daily by the double-dummy method and followed up for 5 years. A total of 414 patients were analyzed: 204 in the nicardipine group and 210 in the diuretic group. Blood pressure at entry was 172/94 mm Hg and 173/93 mm Hg, respectively, and decreased to 147/81 mm Hg and 147/79 mm Hg, respectively. Cardiovascular morbidity rates per 1000 persons per year were similar in the nicardipine and diuretic groups (27.8 and 26.8, respectively; Pϭ0.923

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Calcium Channel Blockade and Cardiovascular Prognosis in the European Trial on Isolated Systolic Hypertension

Cited by 64 publications

References 18 publications

Overview of the outcome trials in older patients with isolated systolic hypertension

Overview of the outcome trials in older patients with isolated systolic hypertension

Systolic Hypertension in Europe (Syst-Eur) Trial Phase 2: objectives, protocol, and initial progress

Randomized Double-Blind Comparison of a Calcium Antagonist and a Diuretic in Elderly Hypertensives

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