title: Acetylsalicylic acid/esomeprazole fixed-dose combination.
abstract: The fixed-dose acetylsalicylic acid (ASA)/esomeprazole capsule combines the cardiovascular (CV) protective effects of low-dose ASA with the gastroprotective effects of the proton pump inhibitor esomeprazole. It is approved for use as a convenient once-daily regimen in the prevention of CV and cerebrovascular events in patients requiring continuous low-dose ASA who are at risk of developing gastric and/or duodenal (peptic) ulcers. In two large, 26-week, randomized, double-blind, multinational, phase III trials (ASTERIX and OBERON) in patients who were receiving low-dose ASA for the prevention of CV events and who had an increased risk of ulcer development, the incidence of endoscopy-proven peptic ulcers (primary endpoint) was significantly lower with the addition of esomeprazole 20 mg/day versus placebo. Moreover, patient-reported dyspeptic symptoms (epigastric pain and epigastric burning) were reported in significantly fewer patients in the low-dose ASA plus esomeprazole group than in the low-dose ASA plus placebo group. Low-dose ASA plus esomeprazole treatment was generally well tolerated, with a similar adverse event profile to that seen with low-dose ASA plus placebo.
authors.affiliation: Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz.
authors.forename: Celeste B
authors.initials: CB
authors.lastname: Burness
authors.affiliation: Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand.
authors.forename: Lesley J
authors.initials: LJ
authors.lastname: Scott
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D002214:Capsules; D002318:Cardiovascular Diseases / Q000517:prevention & control; D004338:Drug Combinations; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D010437:Peptic Ulcer / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D011355:Prodrugs / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D002214:Capsules; D004338:Drug Combinations; D010975:Platelet Aggregation Inhibitors; D011355:Prodrugs; D054328:Proton Pump Inhibitors; D064098:Esomeprazole; D001241:Aspirin