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Published on: January 31, 2019
Isradipine: overall clinical experience in hypertension in the United States
1Sandoz Research Institute, East Hanover, New Jersey 07936.
Insights
Isradipine effectively treats hypertension in diverse patients, showing superior blood pressure reduction compared to placebo and active controls. This dihydropyridine calcium antagonist is well-tolerated with minimal adverse effects over time.
Area of Science:
- Cardiovascular Pharmacology
- Clinical Hypertension Management
Background:
- Hypertension remains a leading global health concern requiring effective therapeutic agents.
- Dihydropyridine calcium antagonists are a cornerstone in antihypertensive therapy.
Purpose of the Study:
- To evaluate the efficacy and safety of isradipine in treating patients with hypertension.
- To compare isradipine's effectiveness against placebo and active comparators.
Main Methods:
- A large-scale, double-blind clinical trial involving 934 hypertensive patients.
- Comparison of isradipine versus placebo, hydrochlorothiazide, and enalapril.
- Assessment of blood pressure changes and patient response rates.
Main Results:
- Isradipine demonstrated superior reductions in both systolic and diastolic blood pressure compared to placebo and active controls.
- Optimal blood pressure response was observed with daily doses up to 10-15 mg.
- Adverse reaction incidence was comparable to active controls, with fewer discontinuations and decreasing adverse events over 24 months.
Conclusions:
- Isradipine is an efficacious, safe, and well-tolerated antihypertensive medication for a broad patient population.
- The drug exhibits a favorable safety profile with no negative inotropic effects or significant laboratory parameter changes.
- Long-term treatment with isradipine leads to sustained blood pressure control and a reduced incidence of adverse reactions.
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 to 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, a decrease in the incidence of new adverse reactions with increasing duration of treatment, down to 1% at 24 months.
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