An open multicenter study to assess the long-term efficacy, tolerance, and safety of the oral angiotensin converting enzyme inhibitor ramipril in patients with mild to moderate essential hypertension.
Three hundred thirty-one patients with mild to moderate essential hypertension, 182 males and 149 females with a mean age of 54 (range, 17-87 years), were studied for 1 year in a clinical trial with ramipril, an angiotensin converting enzyme (ACE) inhibitor. The patients included had completed double-blind trials with ramipril vs. captopril, HCT, atenolol and ramipril plus piretanide. All cases were treated first with 5 mg ramipril and, where appropriate, also with 25 mg HCT. Adjustment of the dose in the range 1.25-20 mg ramipril was left to the investigator. Overall, a consistent reduction in blood pressure was achieved. Only small changes in mean blood pressure were noted during the 12 months (mean diastolic blood pressure 84.3-86.9 mm Hg, mean systolic blood pressure 145.6-148.2 mm Hg). Two hundred sixty-two (82%) of the 331 patients had diastolic values consistently equal to or lower than 95 mm Hg. There was a downward shift in the dosages upon which the investigators finally settled during the 12-month period in the patients receiving ramipril monotherapy. In patients also receiving HCT the initial dose was increased in most cases. Adverse events were observed in 6.7% of patients taking ramipril alone. The most frequent symptoms were dizziness, asthenia, pain in the upper abdomen and headache. Adverse effects occurred more frequently under continuous additional treatment with HCT, the same symptoms being reported. The clinical trial was prematurely terminated in six patients, in only two cases for medical reasons. The analysis of the laboratory findings revealed no general deterioration.(ABSTRACT TRUNCATED AT 250 WORDS)
Bauer
B
B
Hoechst AG, Clinical Research, Frankfurt/Main, F.R.G.
Lorenz
H
H
Zahlten
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001643:Bridged Bicyclo Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D017257:Ramipril; D011897:Random Allocation
D000806:Angiotensin-Converting Enzyme Inhibitors; D001643:Bridged Bicyclo Compounds; D001952:Bridged-Ring Compounds; D006852:Hydrochlorothiazide; D017257:Ramipril