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24-hour efficacy of once-daily diltiazem in essential hypertension
B M Massie1, E Der, T S Herman
1University of California, San Francisco.
Insights
This study shows that a new once-daily diltiazem hydrochloride extended-release formulation (diltiazem CD) effectively lowers blood pressure in patients with essential hypertension over a 24-hour period.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
Background:
- Essential hypertension is a widespread condition requiring effective long-term management.
- Diltiazem hydrochloride is a calcium channel blocker used to treat hypertension.
- Evaluating new formulations for improved patient compliance and sustained efficacy is crucial.
Purpose of the Study:
- To assess the safety and effectiveness of a novel once-daily diltiazem hydrochloride extended-release formulation (diltiazem CD).
- To determine if diltiazem CD provides 24-hour blood pressure control in patients with essential hypertension.
Main Methods:
- A randomized, placebo-controlled trial involving 127 patients with essential hypertension.
- Patients received either diltiazem CD (n=61) or placebo (n=66), with dose titration up to 360 mg/day.
- Ambulatory blood pressure monitoring was used in a subset of patients to evaluate 24-hour efficacy.
Main Results:
- Diltiazem CD significantly reduced supine systolic blood pressure (SBP) by -8.4 mmHg and diastolic blood pressure (DBP) by -8.6 mmHg (p<0.0075).
- Heart rate remained largely unchanged, indicating a favorable safety profile.
- Sixty-nine percent of patients achieved a clinical response, and 24-hour blood pressure control was demonstrated.
Conclusions:
- Once-daily diltiazem CD is a safe and effective treatment for essential hypertension.
- The formulation provides sustained 24-hour blood pressure reduction, supporting its use for improved patient adherence.
Abstract:
The safety and effectiveness of a once daily formulation of diltiazem hydrochloride (diltiazem CD) in the treatment of essential hypertension was assessed in a total of 127 patients with supine diastolic blood pressures (DBP) of 95 to 110 mmHg randomized to diltiazem CD (n = 61) or placebo (n = 66). Patients were titrated to doses of 120, 240, or 360 mg to achieve DBP reduction to less than 90 mmHg. At end study diltiazem CD changed trough supine SBP and DBP by -8.4 +/- 1.7 (p = 0.0009) and -8.6 +/- 1.1 mmHg (p = 0.0075), respectively. Heart rate was not significantly changed (-1.3 +/- 1.1 beats/min, p = 0.4362). The average dose of diltiazem CD was 268 mg with 69% achieving a clinical response. A subset of 47 patients underwent ambulatory blood pressure monitoring to assess the consistency of the effect over the full 24-h dosing interval. Diltiazem CD lowered DBP and SBP throughout the dosing interval. The overall side effect profile was similar to placebo. This study provides evidence of 24-h efficacy of this new, once daily formulation of diltiazem.
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