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Phannacologv Once-daily diltiazem equals the conventional regimen A once-dail\' controlled-release formulation of diltiazem was "found to be bioequivalent to a conventional diltiazem regimen, with comparable antihypertensive effects. In the pharmacokinetic study, 20 healthy male volunteers randomly received conventional diltiazem 60mg qid, 2 X 120mg controlled-release capsules once-daily, and I x 240mg controlled- release capsule once-daily, in a crossover fashion for 5 days each, with 7 days between treatment periods. The AUe, and maximum and average plasma concentrations were similar with the 3 treatments; however, the apparent diltiazem elimination rate was significantly slower after the once-daily formulation compared with after conventional therapy. In the clinical study, 144 evaluable patients with essential hypertension randomly received titrated doses of controlled-release diltiazem 120-360mg once-daily (n = 102) or placebo for 12 weeks in a double-blind fashion, following a 4-week placebo washout period. Supine diastolic BP and standing systolic and diastolic BP were reduced from baseline to a significantly greater extent in diltiazem recipients compared with placebo recipients. The antihypertensive effects of diltiazem remained apparent immediately prior to the following dose. Nine diltiazem recipients experienced oedema and 9 reported tiredness. Kelly JG, Devane JG, Geoghegan B. Pharmacokinetic properties and antihypertensive efficacy of once-daily diltiazem. Journal of Cardiovascular Pharmacology 17: 957·963, Jun 1991 7)41 ISS.''' 0156·]703/91/0814·0017/0$01.00/0 © Adi! [,.ul7laliollai Ltd 17 I ..... PHARMA@U Aug 1991 _

Once-daily diltiazem equals the conventional regimen

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Phannacologv

Once-daily diltiazem equals the conventional regimen

A once-dail\' controlled-release formulation of diltiazem was "found to be bioequivalent to a conventional diltiazem regimen, with comparable antihypertensive effects.

In the pharmacokinetic study, 20 healthy male volunteers randomly received conventional diltiazem 60mg qid, 2 X 120mg controlled-release capsules once-daily, and I x 240mg controlled­release capsule once-daily, in a crossover fashion for 5 days each, with 7 days between treatment periods. The AUe, and maximum and average plasma concentrations were similar with the 3 treatments; however, the apparent diltiazem elimination rate was significantly slower after the once-daily formulation compared with after conventional therapy.

In the clinical study, 144 evaluable patients with essential hypertension randomly received titrated doses of controlled-release diltiazem 120-360mg once-daily (n = 102) or placebo for 12 weeks in a double-blind fashion, following a 4-week placebo washout period. Supine diastolic BP and standing systolic and diastolic BP were reduced from baseline to a significantly greater extent in diltiazem recipients compared with placebo recipients. The antihypertensive effects of diltiazem remained apparent immediately prior to the following dose. Nine diltiazem recipients experienced oedema and 9 reported tiredness. Kelly JG, Devane JG, Geoghegan B. Pharmacokinetic properties and antihypertensive efficacy of once-daily diltiazem. Journal of Cardiovascular Pharmacology 17: 957·963, Jun 1991 7)41

ISS.''' 0156·]703/91/0814·0017/0$01.00/0 © Adi! [,.ul7laliollai Ltd 17

I ..... PHARMA@U Aug 1991 _