Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD). SOLVD Investigators.
In the Studies of Left Ventricular Dysfunction (LVD), enalapril or placebo was administered in a double-blind fashion to 6797 participants with ejection fraction < or = 0.35. During 40 months' average follow-up, 28.1% of participants randomized to enalapril reported side effects compared with 16.0% in the placebo group (p < 0.0001). Enalapril use was associated with a higher rate of symptoms related to hypotension (14.8% vs 7.1%, p < 0.0001), azotemia (3.8% vs 1.6%, p < 0.0001), cough (5.0% vs 2.0%, p < 0.0001), fatigue (5.8% vs 3.5%, p < 0.0001), hyperkalemia (1.2% vs 0.4%, p = 0.0002), and angioedema (0.4% vs 0.1%, p < 0.05). Side effects resulted in discontinuation of blinded therapy in 15.2% of the enalapril group compared with 8.6% in the placebo group (p < 0.0001). Thus enalapril is well tolerated by patients with LVD; however, hypotension, azotemia, cough, fatigue, and other side effects result in discontinuation of therapy in a significant minority of patients.
Kostis
J B
JB
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA.
Shelton
B
B
Gosselin
G
G
Goulet
C
C
Hood
W B
WB
Kohn
R M
RM
Kubo
S H
SH
Schron
E
E
Weiss
M B
MB
Willis
P W
PW
Young
J B
JB
Probstfield
J
J
D000368:Aged; D000799:Angioedema / Q000139:chemically induced; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D003371:Cough / Q000139:chemically induced; D004311:Double-Blind Method; D004656:Enalapril / Q000009:adverse effects* / Q000627:therapeutic use; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy; D006801:Humans; D006947:Hyperkalemia / Q000139:chemically induced; D007022:Hypotension / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D013997:Time Factors; D014511:Uremia / Q000139:chemically induced; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology
D000806:Angiotensin-Converting Enzyme Inhibitors; D004656:Enalapril