Randomised controlled trialindependent cross-checkabstract only checked★ key study I-PPI-08 in-depth review
Omeprazole prevents bleeding with dual antiplatelet therapy
Clopidogrel with or without omeprazole in coronary artery disease.
Overview
Bhatt DL et al.. N Engl J Med 2010 · PMID 20925534 · DOI 10.1056/NEJMoa1007964
GI events fell from 2.9% to 1.1% with omeprazole.
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Prevent GI bleeding.
- How was the study done?
RCT.
- How many people, animals or samples were studied?
3,761.
- What was actually found?
Fewer GI events.
- How large was the observed effect?
HR 0.34.
- What do the results mean in everyday life?
PPIs protect high-risk patients.
- What are the study's limitations?
Early stop; industry.
- What does it say about Elawady's specific claim?
Contradicts universal ban.
- Do the results apply to Germany and Europe?
Applicable.
Scientific in-depth review
1. Full reference
- Authors
- Bhatt DL et al.
- Journal
- N Engl J Med
- Year
- 2010
- Identifier
- PMID 20925534 DOI 10.1056/NEJMoa1007964
- Verification
- verified – PubMed efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract | Funding (abstract): Cogentus Pharmaceuticals
2. Research question
Does a PPI reduce GI complications in patients on dual antiplatelet therapy?
3. Study design and population
- Study design
- Randomised controlled trial – Randomised double-blind placebo-controlled trial (COGENT)
- Population
Patients with indication for aspirin + clopidogrel
- Country
Multinational
- Period
terminated early
- Sample size
3,873 randomised; 3,761 analysed
- Inclusion and exclusion criteria
DAPT indication
4. Methods and endpoints
- Exposure / intervention
Omeprazole + clopidogrel + aspirin
- Comparator
Placebo + clopidogrel + aspirin
- Endpoints
GI composite (bleeding, ulcer, obstruction, perforation); CV composite
- Statistical methods
Cox
5. Actual results
- Results
GI events 1.1% vs 2.9% at 180 days, HR 0.34 (0.18–0.63); overt upper GI bleeding HR 0.13 (0.03–0.56); CV events HR 0.99 (0.68–1.44); more diarrhoea with omeprazole.
- Absolute risks
Absolute reduction about 1.8 percentage points in GI events at 180 days
- Authors' conclusion
Prophylactic PPI reduced upper GI bleeding with DAPT; no apparent CV interaction.
6. Strengths
- RCT
- Clinically important outcome
7. Weaknesses
- Stopped early (loss of funding)
- Industry-funded (Cogentus)
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Early termination.
9. Assessment of the statistical interpretation
Large relative reduction.
10. Relevance to the specific claim
C-PPI-10 (indication).
11. Independent contrary findings
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
Strong evidence of benefit for bleeding prophylaxis.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
15. Linked fact checks
- All acid-suppressing medicines (PPIs and H2 blockers) are permanently forbidden; heartburn should stop through the diet, not through drugs. – Studies contradicting or limiting the claim