[Dose-dependent side effects of acetylsalicylic acid therapy. Results of a prospective randomized clinical study in patients with peripheral arterial occlusive disease].
METHODS
In 359 patients with peripheral arterial occlusive disease who had undergone percutaneous transluminal angioplasty (PTA), a randomized double-blind, controlled clinical study was done to investigate the tolerability of acetyl salicylic acid (ASA) given for reocclusion prophylaxis. A comparison was made between a conventional daily dose of 900 mg ASA and a dose of 50 mg ASA.


RESULTS
Within an observation period of one year following PTA, 35 patients (20%) in the 900 mg group, and 32 patients (17%) in the 50 mg group left the trial because of side effects (p = NS). Under the higher dose, however, severe gastrointestinal side effects (ulcer, haemorrhagic gastritis requiring transfusion) were significantly more common (nine patients delta 5.1% vs two patients delta 1.1%, respectively; p = 0.03). Overall, 107 patients (30%) reported subjective side effects such as upper abdominal pain, a sensation of fullness or nausea during the course of the trial. 62 of these patients were from the 900 mg group (35%) as compared with 45 patients (24%) in the 50 mg group (p = 0.02). Self-scoring of epigastric pain on the basis of a visual analogue scale revealed a score of 1.3 (95% confidence interval 0.9 to 1.6) in the 900 mg group and 0.8 (95% confidence interval 0.6 to 1.0) in the 50 mg group. The subjective pain intensity showed a uniform time course for all three types of symptom, with a maximum after three months.


CONCLUSIONS
Our results confirm the superior tolerability of the lower dose, in particular in elderly patients. For long-term treatment, the smallest possible effective dose should be chosen.
Ranke
C
C
Abteilung Angiologie, Medizinische Hochschule, Hannover.
Creutzig
A
A
Luska
G
G
Wagner
H H
HH
Galanski
M
M
Bode-Böger
S
S
Frölich
J
J
Avenarius
H J
HJ
Hecker
H
H
Alexander
K
K
D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005756:Gastritis / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000139:chemically induced; D011446:Prospective Studies
D001241:Aspirin
Dosisabhängige Nebenwirkungen der Acetylsalicylsäuretherapie. Ergebnisse einer prospektiven, randomisierten klinischen Studie bei Patienten mit peripherer arterieller Verschlusskrankheit.