Treatment of essential hypertension with PN 200-110 (isradipine).
The safety and antihypertensive efficacy of PN 200-110 (isradipine), a novel calcium antagonist, are discussed in a preliminary report of double-blind, multicenter, controlled, phase III clinical trials for essential hypertension. Patients who qualified for entry after a 3 week placebo-washout period were enrolled in 1 of 5 studies; 2 studies were placebo controlled; 3 studies evaluated PN 200-110 against 1 of 3 active controls: hydrochlorothiazide (HCTZ) propranolol or prazosin. A separate study assessing the effects of PN 200-110 in combination with HCTZ versus propranolol plus HCTZ is also discussed. Compared with placebo, PN 200-110 decreased mean supine systolic and diastolic blood pressures by 20/16 mm Hg versus 4/6 mm Hg. Compared with placebo and active control drugs, PN 200-110 normalized supine diastolic blood pressure to less than or equal to 90 mm Hg in 72% of patients, versus 13% in the placebo group, 74% in the HCTZ group, 45% in the propranolol group and 69% in the prazosin group. In the ability to decrease diastolic blood pressure by greater than or equal to 10 mm Hg, PN 200-110 compared favorably to prazosin (81% vs 81%), and was superior to HCTZ (81% vs 61%) and propranolol (81% vs 36%). In combination with HCTZ, PN 200-110 exerted as great an antihypertensive effect as propranolol plus HCTZ. Long-term therapy with PN 200-110 was also effective. Supine systolic and diastolic blood pressures decreased a mean of 15/13 mm Hg at 3 months, and 18/20 mm Hg at 12 months. PN 200-110 is well tolerated with relatively few adverse effects reported.
D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy*; D017275:Isradipine; D008297:Male; D008875:Middle Aged; D010069:Oxadiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D011224:Prazosin / Q000627:therapeutic use; D011433:Propranolol / Q000627:therapeutic use; D011897:Random Allocation; D013997:Time Factors
D002121:Calcium Channel Blockers; D010069:Oxadiazoles; D006852:Hydrochlorothiazide; D011433:Propranolol; D011224:Prazosin; D017275:Isradipine