title: Safety and tolerability of extended-release acetylsalicylic acid capsules: a summary of double-blind comparative studies.
abstract: To evaluate tolerability of a new extended-release acetylsalicylic acid (ER-ASA).
  
  
  
  Daily ER-ASA (162.5-1300 mg) for up to 6 weeks was evaluated (four studies; n = 565). Safety of ER-ASA, immediate-release (IR; 150-1200 mg) ASA and enteric-coated ASA (75 mg) was assessed.
  
  
  
  Forty-three out of 184 (23.4%) patients with atherosclerosis (ER-ASA 162.5 mg group) experienced adverse events versus 51/195 (26.2%) patients receiving IR-ASA 150 mg. Overall, 48.7 and 51.3% of patients in the ER-ASA group experienced no gastrointestinal discomfort or any gastrointestinal symptoms, respectively, versus 42.1 and 57.9% of patients in the IR-ASA group, respectively. In healthy volunteers, adverse event incidence was comparable between ER-ASA and IR-ASA and between ER-ASA and enteric-coated ASA.
  
  
  
  Safety of the new ER-ASA formulation was consistent with other ASA formulations.
authors.affiliation: New Haven Pharmaceuticals, Inc., North Haven, CT 06473, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Patrick
authors.affiliation: New Haven Pharmaceuticals, Inc., North Haven, CT 06473, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Johnson
authors.affiliation: New Haven Pharmaceuticals, Inc., North Haven, CT 06473, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Dillaha
authors.affiliation: New Haven Pharmaceuticals, Inc., North Haven, CT 06473, USA.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Pennell
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D050197:Atherosclerosis / Q000188:drug therapy*; D002214:Capsules; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D003692:Delayed-Action Preparations; D001241:Aspirin
keywords: antiplatelet; aspirin; secondary prevention