Diltiazem as monotherapy for systemic hypertension: A multicenter, randomized, placebo-controlled trial

Pool, Peter E.; Massie, Barry M.; Venkataraman, Kalyanasundaram; Hirsch, Alan T.; Samant, Dinesh R.; Seagren, Shirley C.; Gaw, Johnny; Salel, Antone F.; Tubau, Julio F.; Vollmer, Carol; Walker, Steve; Skalland, M. Lorie

doi:10.1016/0002-9149(86)90893-3

Cited by 72 publications

(14 citation statements)

References 15 publications

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“…The efficacy and the adequate duration of action of the sustained-release formulation of diltiazem, which was designed for the treatment of hypertension, has been documented in a number of studies [1][2][3][4][5][6]. However, it is the prompt-release formulation of diltiazem, which is used for the treatment of angina pectoris, which has become the most commonly prescribed cardiovascular drug in the United States.…”

Section: Discussionmentioning

confidence: 99%

“…concentrations, calcium antagonist Diltiazem, in a sustained-release (SR) capsule formulation designed for twice daily use [1][2][3][4][5][6], has recently been approved by the FDA for the treatment of hypertension. The prompt-release tablet formulation (three to four times/day), which has been available for the treatment of angina pectoris, has not been evaluated for efficacy in hypertension, except in one comparative study with hydrochlorothiazide [7].…”

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confidence: 99%

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Antihypertensive monotherapy with tablet (Prompt-release) diltiazem: Multicenter controlled trials

Pool¹,

Nappi²,

Weber³

1990

Cardiovasc Drug Ther

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The tablet formulation of diltiazem has been available for the treatment of angina pectoris but has not been comprehensively evaluated in hypertension. This study's aim was to evaluate the efficacy, dose-response characteristics, and duration of action of tablet (prompt-release) diltiazem in mild to moderate hypertension. Three placebo-controlled trials were designed. The first (trial #1) evaluated the dose response of 120, 240, and 360 mg/day (q12h regimen) of diltiazem in parallel fixed-dose fashion using hourly blood pressures. The second (trial #2) evaluated a q12h titration from 240 to 360 mg/day, which could be switched to q8h. The third (trial #3) evaluated a q8h titration from 180 to 270 to 360 mg/day, followed by conversion to a q12h regimen. The goal was a supine diastolic blood pressure of less than 90 mmHg and 10 mmHg less than baseline. With doses of diltiazem increasing from 120 to 240 to 360 mg/day, there was a progressive decrease in the average mean arterial pressure, describing a dose response with 120 mg/day as the ineffective dose. The peak effect for each dose regimen was found at 6 hours, with significant reductions lasting over 10 hours in the 240 mg/day and 360 mg/day groups. Peak plasma concentrations occurred at 3 hours. The residual effect at the trough of the 240 mg/day and 360 mg/day doses was 48% and 53% of the peak effect, respectively. When titration was carried out on a q8h regimen, both systolic and diastolic blood pressures were significantly decreased. When the regimen was switched from q8h to q12h, the effect was not maintained.(ABSTRACT TRUNCATED AT 250 WORDS)

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Antihypertensive monotherapy with tablet (Prompt-release) diltiazem: Multicenter controlled trials

Pool¹,

Nappi²,

Weber³

1990

Cardiovasc Drug Ther

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“…In addition to the questioning for general well-being at the pre-study examination and at the time of hospitalization, questioning for general well-being was also performed in the morning prior to the study drug administration as well as 1,4,8,12,24,36, and 48 hours post administration and at the post study examination. Blood pressure and pulse rate were measured in the morning prior to the study drug administration as well as 1, 2, 4, 8, 12, 24, 36, and 48 hours post administration.…”

Section: Clinical Studymentioning

confidence: 99%

A Comparative Single Dose Bioequivalence Study of Extended Release Antihypertensive Drug Formulation among Healthy Human Volunteers

Deshpande

Paithankar

2013

ELECTRON J GEN MED

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“…In placebo-controlled studies, the frequency of edema in the diltiazem group varied from 2% to 9%, compared with 0 to 3.3% in the placebo group. [57][58][59] Non-placebo-controlled studies have found the frequency of edema with diltiazem to be 2% to 9%. 60 -62 Two non-placebo-controlled studies did not report edema as an adverse event of diltiazem.…”

Section: Calcium Channel Blockersmentioning

confidence: 99%

Fluid Matters in Choosing Antihypertensive Therapy: A Hypothesis That the Data Speak Volumes

Blankfield

2005

The Journal of the American Board of Family Medicine

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Assuming that blood pressure is lowered equivalently, diuretics are more effective than angiotensinconverting enzyme inhibitors (ACEIs), calcium channel blockers (CCBs), and ␣-adrenergic receptor blockers (␣-blockers) at preventing heart failure, and they are more effective than ACEIs and ␣-blockers at preventing strokes. Compared with ␤-adrenergic receptor blockers (␤-blockers) and ACEIs, CCBs are less effective at reducing myocardial infarcts and heart failure. There is currently no conceptual framework by which to organize data indicating that some antihypertensive medications are better than others at preventing cardiovascular diseases. The thesis of this article is that the fluid reduction or fluid retention attributable to antihypertensive medications, either alone or in combination, provides a basis for ranking these medications. Diuretics have a theoretical advantage compared with other antihypertensive medications because they reduce total body fluid more than other agents. Therefore, they are the preferred drugs for treating hypertension. Provided that blood pressure is lowered comparably, diuretics have been demonstrated to be more effective than angiotensin-converting enzyme inhibitors (ACEIs), calcium channel blockers (CCBs), and ␣-adrenergic receptor blockers (␣-blockers) at preventing heart failure, and diuretics have been found to be more effective than ACEIs and ␣-blockers at preventing stokes.

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Diltiazem as monotherapy for systemic hypertension: A multicenter, randomized, placebo-controlled trial

Cited by 72 publications

References 15 publications

Antihypertensive monotherapy with tablet (Prompt-release) diltiazem: Multicenter controlled trials

Antihypertensive monotherapy with tablet (Prompt-release) diltiazem: Multicenter controlled trials

A Comparative Single Dose Bioequivalence Study of Extended Release Antihypertensive Drug Formulation among Healthy Human Volunteers

Fluid Matters in Choosing Antihypertensive Therapy: A Hypothesis That the Data Speak Volumes

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