Nifedipine gastrointestinal therapeutic system (GITS) for hypertensive patients in a primary care setting: results of the Extended Release Adalat Canadian Trial (EXACT)

Toal, Corey B.; Mahon, W. A.; Barnes, Colin C.; Burelle, Denis

doi:10.1016/s0149-2918(97)80046-x

Cited by 16 publications

(13 citation statements)

References 6 publications

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“…Furthermore, no clear relationship between oedema incidence/severity and dose of nifedipine was observed; low doses of nifedipine were associated with oedema rates similar to those for candesartan monotherapy, although a trend for a greater incidence of moderate oedema with 60 mg doses of nifedipine (monotherapy or in combination) was indicated. Such an increase in incidence of peripheral oedema has previously been noted when up-titrating from 30 to 60 mg nifedipine GITS [38]; however, this side effect appears to be largely ameliorated when nifedipine GITS is taken at bedtime rather than in the morning [39]. As the data from this study indicate similar efficacy in BP control with N30C32 and N60C32, further research is warranted into the clinical potential of these dose combinations and their tolerability profiles.…”

Section: Discussionsupporting

confidence: 56%

Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile

Kjeldsen

Sica

Haller

et al. 2014

Journal of Hypertension

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Objectives:DISTINCT (reDefining Intervention with Studies Testing Innovative Nifedipine GITS – Candesartan Therapy) aimed to determine the dose–response and tolerability of nifedipine GITS and/or candesartan cilexetil therapy in participants with hypertension.Methods:In this 8-week, multinational, multicentre, randomized, double-blind, placebo-controlled study, adults with mean seated DBP of at least 95 to less than 110 mmHg received combination or monotherapy with nifedipine GITS (N) 20, 30 or 60 mg and candesartan cilexetil (C) 4, 8, 16 or 32 mg, or placebo. The primary endpoint, change in DBP from baseline to Week 8, was analysed using the response surface model (RSM); this analysis was repeated for mean seated SBP.Results:Overall, 1381 participants (mean baseline SBP/DBP: 156.5/99.6 mmHg) were randomized. Both N and C contributed independently to SBP/DBP reductions [P < 0.0001 (RSM)]. A positive dose–response was observed, with all combinations providing statistically better blood pressure (BP) reductions from baseline versus respective monotherapies (P < 0.05) and N60C32 achieving the greatest reduction [–23.8/–16.5 mmHg; P < 0.01 versus placebo (–5.3/–6.7 mmHg) and component monotherapies]. Even very low-dose (N20 and C4) therapy provided significant BP-lowering, and combination therapy was similarly effective in different racial groups. N/C combination demonstrated a lower incidence of vasodilatory adverse events than N monotherapy (18.3 versus 23.6%), including headache (5.5 versus 11.0%; P = 0.003, chi-square test) and peripheral oedema over time (3.6 versus 5.8%; n.s.).Conclusion:N/C combination was effective in participants with hypertension and showed an improved side effect profile compared with N monotherapy.

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Section: Discussionsupporting

confidence: 56%

Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile

Kjeldsen

Sica

Haller

et al. 2014

Journal of Hypertension

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“…For subsequent doses, repeated every 24 h, relatively constant concentrations at this level are maintained with minimal fluctuations within the dosing interval. Similar pharmakokinetic studies have recently been reported concerning other extended-release nifedipine tablets [15] and comparing them to the standard formulation [16]. According to the manufacturer's recommendations the usual initial dose of this nifedipine formulation is 30 mg o.d.…”

Section: Introductionmentioning

confidence: 52%

Prospective Controlled Trial of Two Nifedipine Extended Release Formulations in the Treatment of Essential Hypertension

Pivac

Naranča

Vujić-Podlipec³

et al. 2011

Arzneimittelforschung

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The aim of this study was to assess the pharmacodynamic equivalence of two different slow-release formulations of nifedipine (CAS-21829-25-4). In a prospective, controlled, double-blind clinical trial, 42 patients with essential hypertension (sitting diastolic blood pressure (DBP) 95-114 mmHg) underwent an initial washout, drug free period of 2 weeks, after which they were randomized to receive either 30 mg of nifedipine in the test preparation "XL" (Nifecard) or 30 mg of nifedipine in a reference formulation, "LA", during six weeks. The response to treatment was assessed by measuring the blood pressure (BP) every two weeks (standard office mercury sphygmomanometry) and by 24-h ambulatory blood pressure monitoring (ABPM). Of the 42 included patients 36 (85.5%) completed the trial: 19 on "XL" and 17 on "LA". After 2 weeks of therapy the DBP decreased by about 11% (-13.4 mmHg) and 10% (-9.5%), respectively, after 4 weeks the mean decrease versus the end of the placebo period reached about 14% (-15.5 mmHg) and 11% (-13 mmHg), and at the end of the trial the DBPs were lower by about 13% (-14.5 mmHg) in both groups. In all these measurements the within group differences were significant (p < 0.001), while the between groups differences were not (p > 0.05). Quite comparable results were obtained with ABPM, e.g. in the "XL" group the systolic blood pressure at the end of the study was lower by 12.3% (-4.6 mm Hg) and in the "LA" group, by 10.6% (-9.0 mm Hg); p = 0.358. The adverse effects were similar in both groups and they required neither particular interventions nor withdrawal from the study. The drugs under study were comparably effective and well tolerated antihypertensives.

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“…Although no placebo comparison was included, previous studies have shown that nifedipine GITS 20 mg is superior to placebo 1 and suggest it is likely to be less effective than nifedipine GITS 30 mg. 4 However, the incidence of adverse effects was also lower than may be expected with higher doses. 5 Thus the data from this study demonstrates that nifedipine GITS 20 mg once daily is an effective treatment of mild-to-moderate hypertension, being at least equivalent to bendrofluazide 2.5 mg once daily in reducing trough diastolic blood pressure.…”

Section: Discussionmentioning

confidence: 89%

A randomised double-blind study comparing nifedipine GITS 20 mg and bendrofluazide 2.5 mg administered once daily in mild-to-moderate hypertension

Isles

Kitchin

1999

J Hum Hypertens

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A multicentre, randomised, double-blind, parallel group comparison of nifedipine GITS 20 mg (Adalat ® LA) once daily and bendrofluazide 2.5 mg once daily in patients with mild-to-moderate hypertension was conducted. Two hundred patients with a diastolic blood pressure (BP) in the range 95 to 109 mm Hg were randomised to active treatment for 6 weeks. For the per-protocol efficacy population, both treatments resulted in clinically significant mean reductions of trough diastolic BP (nifedipine GITS −8.9 mm Hg, bendrofluazide −7.9 mm Hg) and systolic BP (nifedipine GITS −10.4 mm Hg, bendrofluazide −10.5 mm Hg). The study demonstrated that nifedipine GITS was 'at least equivalent' to bendrofluazide in the reduction of trough diastolic BP (onesided upper 95% confidence limit, 0.5 mm Hg), where inequivalence had been pre-defined as a difference in

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Nifedipine gastrointestinal therapeutic system (GITS) for hypertensive patients in a primary care setting: results of the Extended Release Adalat Canadian Trial (EXACT)

Cited by 16 publications

References 6 publications

Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile

Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile

Prospective Controlled Trial of Two Nifedipine Extended Release Formulations in the Treatment of Essential Hypertension

A randomised double-blind study comparing nifedipine GITS 20 mg and bendrofluazide 2.5 mg administered once daily in mild-to-moderate hypertension

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