title: [Dose-dependent side effects of acetylsalicylic acid therapy. Results of a prospective randomized clinical study in patients with peripheral arterial occlusive disease].
abstract: 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.
authors.affiliation: Abteilung Angiologie, Medizinische Hochschule, Hannover.
authors.forename: C
authors.initials: C
authors.lastname: Ranke
authors.forename: A
authors.initials: A
authors.lastname: Creutzig
authors.forename: G
authors.initials: G
authors.lastname: Luska
authors.forename: H H
authors.initials: HH
authors.lastname: Wagner
authors.forename: M
authors.initials: M
authors.lastname: Galanski
authors.forename: S
authors.initials: S
authors.lastname: Bode-Böger
authors.forename: J
authors.initials: J
authors.lastname: Frölich
authors.forename: H J
authors.initials: HJ
authors.lastname: Avenarius
authors.forename: H
authors.initials: H
authors.lastname: Hecker
authors.forename: K
authors.initials: K
authors.lastname: Alexander
mesh_terms: 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
chemical_list: D001241:Aspirin
vernacular_title: Dosisabhängige Nebenwirkungen der Acetylsalicylsäuretherapie. Ergebnisse einer prospektiven, randomisierten klinischen Studie bei Patienten mit peripherer arterieller Verschlusskrankheit.