Rationale and Design for the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial

Black, Henry R.; Elliott, W.J.; Neaton, James D.; Grandits, Gregory A; Grambsch, Patricia M.; Grimm, Richard H.; Hansson, Lennart; Lacoucière, Yves; Muller, James E.; Sleight, Peter; Weber, Michael A.; White, William Β.; Williams, Gordon H.; Wittes, Janet; Zanchetti, Alberto; Fakouhi, T

doi:10.1016/s0197-2456(98)00013-0

Cited by 89 publications

(41 citation statements)

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“…The protocol for this study includes an increase in antihypertensive medication (in either dose or number of agents) whenever the BP is not at goal (Ͻ140/90 mm Hg). 13 The CONVINCE Study therefore provides an excellent opportunity to examine the extent of BP control in a clinical trial in which forced titration of antihypertensive medication is recommended whenever the BP is Ն140/90 mm Hg.…”

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Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial

et al. 2001

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Abstract-Blood pressure (BP) control rates around the world are suboptimal. Part 2 of the National Health and Nutrition Educational Survey (NHANES) III indicates that only 27.4% of hypertensive Americans aged 18 to 74 years have a BP of Ͻ140/90 mm Hg. We wanted to assess BP control during the first 2 years and to describe the baseline characteristics of patients enrolled in the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Study, an international clinical trial that compares outcomes in hypertensive patients randomized to initial treatment with either controlled-onset extended-release verapamil or the investigator's choice of atenolol or hydrochlorothiazide. At randomization, BP was Ͻ140/90 mm Hg in only 20.3% of the 16 602 subjects (averageϮSD age 65.6Ϯ7.4 years; 56% women, 84% white/7% black/7% Hispanic). The average BP at enrollment was 148/85 mm Hg for patients taking BP medications (nϭ13 879) and 161/94 mm Hg for previously untreated patients (nϭ2723). After medication titration, with a transtelephonic computer that recommended an increase in the dose or number of antihypertensive agents whenever the BP was 140/90 mm Hg, 84.8% of the subjects attained the goal BP. During 2 years of treatment, BP control was maintained in 67% to 69% of the subjects (69% to 71% for systolic BP of Ͻ140 mm Hg and 90% for diastolic BP of Ͻ90 mm Hg). These data suggest that the control of systolic BP is more difficult than the control of diastolic BP. The US national goal of having 50% of hypertensives with a BP of Ͻ140/90 mm Hg may be achievable if a forced titration strategy is used. Interested investigators, free care and medications, and well-educated subjects may make the attainment of such a goal easier in the CONVINCE study than in the general population. (Hypertension. 2001;37:12-18.)

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Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial

et al. 2001

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“…This large-scale prospective clinical trial compared verapamil-based therapy (using a long-acting formulation) with diuretic and ␤-blocker based therapy. 26 It was concluded in early 2001, and data should be available soon.…”

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Canaday¹,

Campagna²,

Geyman³

2003

The Journal of the American Board of Family Medicine

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“…This trial intended to assess the advantage of a Covera HS ® (Searle Pharmaceutical Company, Chicago, Illinois, USA), a special formulation of verapamil designed to delay the release of medication for ∼4-5 h following the recommended bedtime ingestion, so peak blood concentrations are achieved around the time of morning awakening. The CONVINCE trial was designed to compare the degree of BP control and protection against cardiovascular events afforded by a regimen of conventional β-blocker and diuretic medications versus Covera HS ® chronotherapy (Black et al, 1998). This community-based outcomes study, however, was terminated prematurely, not because of inadequate performance of the chronotherapy, but because of a corporate business decision by the pharmaceutical company that acquired the rights to the medication.…”

Section: Bedtime Controlled-onset Verapamil Chronotherapy: the Convinmentioning

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Perspectives on the Chronotherapy of Hypertension Based on the Results of the Mapec Study

Portaluppi

Smolensky

2010

Chronobiology International

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Appreciation of chronotherapy in hypertension continues to lag, despite clear demonstrations by many studies of (i) clinically relevant dosing-time differences of the beneficial and adverse effects of most blood pressure (BP) medications and (ii) significant association between reduced sleep-time BP decline of non-dippers and their heightened risk of cardiovascular disease (CVD). The Syst-Eur and HOPE outcome trials showed evening administration of nitrendipine and ramipril in these respective studies impacts sleep-time BP, converting the 24-h BP pattern to a more dipper one and in the HOPE study decreasing CVD risk. The CONVINCE study intended to compare BP control and CVD protection afforded by conventional β-blocker and diuretic medications versus a special drug-delivery verapamil formulation as a bedtime hypertension chronotherapy; however, the trial was terminated prematurely, not based on inadequate performance of the chronotherapy but on a corporate business decision. The just completed MAPEC study is the first trial specifically designed to prospectively test the hypothesis that bedtime administration of ≥1 conventional medications exerts better BP control and CVD risk reduction than the traditional approach of scheduling all medications in the morning. The results of this 5.6-yr median follow-up study establish that bedtime chronotherapy more effectively improves BP control, better decreases prevalence of non-dipping, and, most importantly, best reduces CVD morbidity and mortality. This chronotherapeutic approach to hypertension is justified by the fact that BP is usually lowest at night as is sodium excretion, but when sodium intake is excessive or its daytime excretion hampered, nocturnal BP is adjusted higher, to a level required for compensation overnight, via the pressure/natriuresis mechanism, resulting in non-dipping 24-h BP patterning. In diurnally active persons, the entire circadian BP pattern may be reset to a lower mean level and to a "more normal" day-night variation, simply by enhancing natriuresis during the night-the time-of-day when it can be most effective. A modification as simple and inexpensive as switching ≥1 hypertension medications from morning 1652 Address correspondence to Francesco Portaluppi, MD, Hypertension Center, Department of Medicine, University Hospital "S. Anna" of Ferrara, Corso Giovecca 203, I-44100 Ferrara, Italy. Tel: +39 0532 236631; Fax: +39 0532 236622; E-mail: prf@unife.it Submitted July 10, 2010, Returned for revision July 17, 2010, Accepted July 20, 2010 Chronobiology International, 27(8): 1652-1667 Copyright © 2010 Informa Healthcare USA, Inc. ISSN 0742-0528 print/1525-6073 online DOI: 10.3109/07420528.2010.510788 to evening may be all that is needed to normalize nighttime BP, exerting an effect exactly like sodium restriction. Current clinical concepts such as "normotensive nondipper" (with higher CVD risk than a hypertensive dipper), broad recommendation of pharmacotherapy with exclusively high "smoothness index" medications (without attention to ind...

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Rationale and Design for the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial

Cited by 89 publications

References 51 publications

Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial

Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial

Editor's Note

Perspectives on the Chronotherapy of Hypertension Based on the Results of the Mapec Study

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