M Vardi1,2, B L Cryer3, M Cohen4, A Lanas5, T J Schnitzer6, P Lapuerta7, M A Goldsmith8, L Laine9,10, G Doros1,2, Y Liu1, A I McIntosh2, C P Cannon1,11,12, D L Bhatt11,12. 1. Harvard Clinical Research Institute, Boston, MA, USA. 2. Boston University School of Public Health, Boston, MA, USA. 3. University of Texas Southwestern and VA North Texas Health Care System, Dallas, TX, USA. 4. Newark Beth Israel Medical Center, Newark, NJ, USA. 5. Instituto Jnvestigación Sanitaria Aragón (IIS Aragon), CIBERehd (Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas), University of Zaragoza, Zaragoza, Spain. 6. Departments of Physical Medicine and Rehabilitation and Internal Medicine/Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 7. Lexicon Pharmaceuticals, Princeton, NJ, USA. 8. Third Rock Ventures, San Francisco, CA, USA. 9. Yale School of Medicine, New Haven, CT, USA. 10. VA Connecticut Healthcare System, West Haven, CT, USA. 11. Brigham and Women's Hospital Heart & Vascular Center, Boston, MA, USA. 12. Harvard Medical School, Boston, MA, USA.
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. AIM: 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.
RCT Entities:
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. AIM: 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: Linda Rabeneck; Kimberly Wristers; Jay L Goldstein; Glenn Eisen; Seema D Dedhiya; Thomas A Burke Journal: Am J Gastroenterol Date: 2002-01 Impact factor: 10.864
Authors: N L de Groot; H G M van Haalen; B M R Spiegel; L Laine; A Lanas; J Jaspers Focks; P D Siersema; M G H van Oijen Journal: Cardiovasc Drugs Ther Date: 2013-08 Impact factor: 3.727