Safety and efficacy of therapeutically equivalent doses of sustained-release formulations of isradipine and felodipine.
This open-label, drug substitution study was conducted to determine if subjects receiving sustained-release isradipine (SR-I) can be safely switched to sustained-release felodipine (SR-F) and to assess whether SR-I provides better 24-hour blood pressure (BP) control than SR-F. Forty-one men receiving either SR-F 5 mg or SR-F 10 mg once daily for at least 6 months were switched to an equivalent dose of SR-I; BP was measured 2, 4, and 6 weeks after substitution. Significant reductions in systolic BP were seen in the SR-I 10 mg group after 4 weeks and they remained significantly lower through 6 weeks (p< or =0.05). Diastolic BP was reduced, but not significantly. After 6 weeks, SR-F therapy was reinstated, and BP returned toward baseline values. No serious adverse events were reported. SR-I can be safely substituted for SR-F and may provide better 24-hour control of BP than SR-F.
Ganz
Michael B
MB
Cleveland Clinic Foundation, Meridia Health System, Department of Medicine, Cleveland, OH 44112, USA.
Saska
Brett A
BA
D000368:Aged; D000842:Ankle; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects; D003971:Diastole / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004487:Edema / Q000139:chemically induced; D015736:Felodipine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D017275:Isradipine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009820:Ohio; D013599:Systole / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D015736:Felodipine; D017275:Isradipine