title: The effects of proton pump inhibition on patient-reported severity of dyspepsia when receiving dual anti-platelet therapy with clopidogrel and low-dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial.
abstract: BACKGROUND
  Dual anti-platelet therapy with clopidogrel and low-dose aspirin increases the risk for gastrointestinal clinical events. Omeprazole has been shown to significantly reduce these events without compromising cardiovascular safety in patients treated with dual anti-platelet therapy. Whether or not omeprazole improves patient-reported outcomes is undetermined.
  
  
  OBJECTIVE
  To assess the impact of prophylactic omeprazole with background dual anti-platelet therapy on patient-reported symptoms of dyspepsia compared to placebo.
  
  
  METHODS
  We analysed results of the Severity of Dyspepsia Assessment questionnaires collected in the Clopidogrel and the Optimization of Gastrointestinal Events Trial.
  
  
  RESULTS
  Patient-reported outcome data from 3759 subjects were available for analysis. At 4 weeks, the mean scores of pain intensity and nonpain symptoms were lower in the omeprazole group (5.61 ± 0.17 vs. 6.40 ± 0.17, P = 0.001, and 10.61 ± 0.07 vs. 11.00 ± 0.07, P < 0.001 respectively). These differences were maintained at 24 weeks (5.91 ± 0.35 vs. 7.10 ± 0.37, P = 0.020 for pain intensity; 10.36 ± 0.12 vs. 10.93 ± 0.13, P = 0.001 for nonpain symptoms). After adjusting for covariates there were no statistically significant differences between the groups in the percent of patients with dyspepsia during follow-up.
  
  
  CONCLUSIONS
  In addition to reducing the risk of gastrointestinal bleeding, statistically significant benefits with prophylactic omeprazole use on both pain and nonpain symptoms were evident at 4 weeks and sustained through 24 weeks. The clinical significance of these overall results is unclear, but greater in patients with pain at baseline.
authors.affiliation: Harvard Clinical Research Institute, Boston, MA, USA.|Boston University School of Public Health, Boston, MA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Vardi
authors.affiliation: University of Texas Southwestern and VA North Texas Health Care System, Dallas, TX, USA.
authors.forename: B L
authors.initials: BL
authors.lastname: Cryer
authors.affiliation: Newark Beth Israel Medical Center, Newark, NJ, USA.
authors.forename: M
authors.initials: M
authors.lastname: Cohen
authors.affiliation: Instituto Jnvestigación Sanitaria Aragón (IIS Aragon), CIBERehd (Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas), University of Zaragoza, Zaragoza, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Lanas
authors.affiliation: Departments of Physical Medicine and Rehabilitation and Internal Medicine/Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: T J
authors.initials: TJ
authors.lastname: Schnitzer
authors.affiliation: Lexicon Pharmaceuticals, Princeton, NJ, USA.
authors.forename: P
authors.initials: P
authors.lastname: Lapuerta
authors.affiliation: Third Rock Ventures, San Francisco, CA, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Goldsmith
authors.affiliation: Yale School of Medicine, New Haven, CT, USA.|VA Connecticut Healthcare System, West Haven, CT, USA.
authors.forename: L
authors.initials: L
authors.lastname: Laine
authors.affiliation: Harvard Clinical Research Institute, Boston, MA, USA.|Boston University School of Public Health, Boston, MA, USA.
authors.forename: G
authors.initials: G
authors.lastname: Doros
authors.affiliation: Harvard Clinical Research Institute, Boston, MA, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Boston University School of Public Health, Boston, MA, USA.
authors.forename: A I
authors.initials: AI
authors.lastname: McIntosh
authors.affiliation: Harvard Clinical Research Institute, Boston, MA, USA.|Brigham and Women's Hospital Heart & Vascular Center, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: C P
authors.initials: CP
authors.lastname: Cannon
authors.affiliation: Brigham and Women's Hospital Heart & Vascular Center, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: D L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000009:adverse effects* / Q000627:therapeutic use; D001792:Blood Platelets; D000077144:Clopidogrel; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D054328:Proton Pump Inhibitors; D000077144:Clopidogrel; D009853:Omeprazole; D013988:Ticlopidine; D001241:Aspirin