A new trial of the efficacy, tolerability, and safety of angiotensin-converting enzyme inhibition in mild systemic hypertension with concomitant diseases and therapies. Perindopril Therapeutic Safety Study Group (PUTS).
A multicenter, double-blind, randomized, and placebo-controlled trial, the Perindopril Therapeutic Safety Study (PUTS), was designed to assess the interaction between angiotensin-converting enzyme (ACE) inhibition and the diseases and therapies commonly found associated with mild hypertension. A total of 480 male and female patients aged 30-70 years with a diastolic pressure of 90-104 mm Hg were included after a 3-week placebo run-in if they satisfied standard criteria for any of the following: hyperlipidemia, type II diabetes, ischemic heart disease, cardiac arrhythmia, peripheral arterial occlusive disease, nephropathy with proteinuria, chronic obstructive lung disease or treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). At the end of the placebo run-in period, patients were randomly assigned to either placebo or perindopril 4 mg once daily. A total of 460 patients completed the 6-week double-blind phase, comprising 3 assessments at 1, 3, and 6 weeks. In this report, the principal results obtained in 5 disease groups (hyperlipidemia, type II diabetes, ischemic heart disease, nephropathy with proteinuria, and NSAID treatment) will be reported. A total of 269 patients belonging to one of the aforementioned 5 disease groups completed the double-blind phase of the study and were included for statistical evaluation. In the perindopril group, systolic and diastolic blood pressures decreased significantly more than in the placebo group, and a sitting diastolic blood pressure of 90 mm Hg was achieved in 65% of patients in the perindopril group and 30% of patients in the placebo group. The incidence of symptoms spontaneously reported by the patients was low: 2 patients of the perindopril group complained of cough.(ABSTRACT TRUNCATED AT 250 WORDS)
Stumpe
K O
KO
Medizinische Universitäts-Poliklinik, Bonn, Germany.
Overlack
A
A
D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000150:complications; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007211:Indoles / Q000627:therapeutic use*; D007674:Kidney Diseases / Q000150:complications; D008297:Male; D008875:Middle Aged; D020913:Perindopril; D011507:Proteinuria / Q000150:complications; D016896:Treatment Outcome
D000806:Angiotensin-Converting Enzyme Inhibitors; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007211:Indoles; D020913:Perindopril