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Isradipine: overall clinical experience in hypertension in the United States
1Sandoz Research Institute, East Hanover, New Jersey.
Insights
Isradipine effectively treats hypertension in diverse patients. This dihydropyridine calcium antagonist demonstrates superior blood pressure reduction compared to placebo and active controls, with a favorable safety profile.
Area of Science:
- Cardiology
- Pharmacology
- Internal Medicine
Background:
- Hypertension is a prevalent global health concern.
- Dihydropyridine calcium antagonists are a cornerstone in antihypertensive therapy.
Purpose of the Study:
- To evaluate the efficacy and safety of isradipine in hypertension management.
- To compare isradipine's effectiveness against placebo and active controls.
Main Methods:
- Double-blind hypertension trials involving 934 patients.
- Comparison of isradipine with placebo, hydrochlorothiazide, and enalapril.
- Dose-response assessment up to 15 mg daily.
Main Results:
- Isradipine showed greater blood pressure reduction than placebo and active controls.
- Efficacy increased with dose up to 10-15 mg daily.
- Adverse reaction incidence was similar to active controls, with decreasing incidence over time.
Conclusions:
- Isradipine is an efficacious, safe, and well-tolerated antihypertensive agent.
- No negative inotropism or significant laboratory changes observed.
- Treatment duration correlates with reduced adverse event incidence.
Abstract:
Isradipine is a new dihydropyridine calcium antagonist shown to be efficacious, safe, and well tolerated in the treatment of hypertension, regardless of patient age or race. There has been no evidence of negative inotropism, atrioventricular conduction delay, nor clinically significant changes in laboratory parameters associated with isradipine treatment. A total of 934 patients have been treated with isradipine in double-blind hypertension trials (involving 297 patients treated with placebo and 414 treated with active controls, such as hydrochlorothiazide and enalapril). Both the mean changes from baseline in diastolic and systolic blood pressures and the percentage of patients responding to treatment (blood pressure decrease of at least 10 mm Hg) were greater with isradipine than with placebo or active controls. Blood pressure response increases with increases in isradipine dose up to 10-15 mg daily; higher doses do not, on average, result in greater blood pressure reduction. The incidence of adverse reactions with isradipine is similar to that for active controls and slightly more than for placebo. There were fewer discontinuations with isradipine and, in addition, the incidence of new adverse reactions decreased with increasing duration of treatment, down to 1% at 24 months.
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