Double-blind, placebo-controlled study of ramipril in diabetics with mild to moderate hypertension.
Although hypertension and diabetes mellitus frequently appear as comorbidities, the pharmacotherapy of hypertension in patients with diabetes mellitus can aggravate underlying carbohydrate and lipid abnormalities. To evaluate the efficacy and safety of the long-acting angiotensin converting enzyme inhibitor ramipril in patients with insulin-dependent or non-insulin-dependent diabetes mellitus, the authors conducted a double-blind, placebo-controlled study. After a single-blind washout period, 58 patients were randomly assigned to receive 2.5 mg of ramipril or a 2.5-mg placebo, each once daily. Each patient underwent titration and maintenance phases for a total treatment period of 12 weeks. By the end of maintenance, 54% of patients maintained the target blood pressure 24 hours after receiving ramipril compared with 19% in the placebo group (P = 0.008). Between baseline and the end of maintenance, ramipril decreased mean supine systolic/diastolic blood pressure (SBP/DBP) measured 24 hours after the last dose by 9/8 mmHg (P < or = 0.001/P < or = 0.001); placebo decreased SBP/DBP by 2/4 mmHg (NS/P < or = 0.05). Between-group differences were significant (P < 0.05). During this time, blood glucose, hemoglobin Alc, lipoproteins, and biochemistry were unchanged in the ramipril group. There were no between-group differences in the number or types of adverse events. In our study of patients with diabetes mellitus, once-daily ramipril controlled blood pressure, was well tolerated, and had no effects on carbohydrate or lipid metabolism.
Schwartz
S L
SL
Diabetes and Glandular Disease Clinic, San Antonio, Texas.
Hanson
C
C
Lucas
C
C
Rosenblatt
S
S
Rosenstock
J
J
Whittier
F
F
Wistran
D
D
Riche
C
C
Mulcahy
W S
WS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D017257:Ramipril / Q000009:adverse effects / Q000627:therapeutic use*
D001786:Blood Glucose; D008055:Lipids; D017257:Ramipril