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Published on: May 26, 2022
One year experience of elderly hypertensive patients with isradipine therapy
G H Stein1, B P Hamilton, J H Hamilton
1Veterans Affairs Medical Center, Gainesville, FL.
Insights
Long-term use of isradipine effectively controls blood pressure in elderly patients with essential hypertension. This dihydropyridine calcium channel blocker demonstrated good tolerability and safety over one year of treatment.
Area of Science:
- Cardiology
- Geriatrics
- Pharmacology
Background:
- Essential hypertension is a prevalent condition in the elderly population.
- Long-term treatment options for hypertension in older adults require evaluation for safety and efficacy.
- Dihydropyridine calcium channel blockers are a common class of antihypertensive medications.
Purpose of the Study:
- To evaluate the long-term (one year) safety and efficacy of isradipine in elderly patients with essential hypertension.
- To assess the tolerability and blood pressure control achieved with isradipine monotherapy or in combination with hydrochlorothiazide.
- To determine the optimal dosing regimen for isradipine in this patient population.
Main Methods:
- Open-label, continuation study of patients who completed a 3-month double-blind trial comparing isradipine to hydrochlorothiazide.
- Inclusion criteria: age >= 60 years, sitting diastolic blood pressure (DBP) 95-120 mmHg.
- Isradipine titration (5-15 mg once daily or 2.5-10 mg twice daily) to achieve DBP <= 90 mmHg; hydrochlorothiazide (12.5-50 mg once daily) could be added.
Main Results:
- 136 patients completed the one-year study.
- Isradipine monotherapy was used in 114 patients (84%), with a mean dose of 9.7 mg/day.
- Significant reduction in DBP (mean change -19 mmHg) and SBP observed, similar across age groups and races.
- 94% of patients on isradipine monotherapy achieved blood pressure control.
- 16% of patients withdrew; 7% due to adverse reactions (headache, pedal edema).
Conclusions:
- Isradipine is a well-tolerated, safe, and effective agent for long-term blood pressure control in elderly patients with essential hypertension.
- The drug demonstrated sustained efficacy in reducing both systolic and diastolic blood pressure.
- Adverse events were generally mild and infrequent, supporting its use in this demographic.
Abstract:
This is the first report of long-term use (one year) of isradipine, a new dihydropyridine calcium channel blocker, in the treatment of elderly patients with essential hypertension. Patients completing a three month, double-blind, multicentre study comparing isradipine to hydrochlorothiazide (HCTZ) were eligible to enroll in this open-label, continuation study. At initial baseline, patients were at least 60 years of age and had DBP from 95 mmHg to 120 mmHg. Patients were titrated when necessary every two weeks with isradipine, 5 mg to 15 mg once daily or 2.5 mg to 10 mg twice daily, to maintain sitting DBP < or = 90 mmHg. HCTZ, 12.5 mg to 50 mg once daily, could be added for better BP control. A total of 136 patients completed the one year, open-label phase. One hundred and fourteen patients (84%) received isradipine as monotherapy (mean dose, 9.7 mg/day); 22 received concomitant HCTZ therapy at one year. Reduction in DBP was significant and similar among all age groups and races (mean change of -19 mmHg). Reduction in SBP was similar among all age groups. Ninety-four per cent of those receiving isradipine monotherapy achieved BP control during the last four months of treatment. Twenty-six patients (16%) withdrew from the study: 11 (7%) had adverse reactions (one with headache, two with pedal oedema, eight with other problems); 11 (7%) had nondrug-related problems; and in four (2%), the drugs were ineffective. Based on these observations, isradipine is a well-tolerated, safe and effective agent for long-term BP control in elderly patients with essential hypertension.
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