High- vs. low-dose diclofenac and cardiovascular risks: a target trial emulation
Authors' conclusion
Initiators of high- and low-dose diclofenac had comparably increased cardiovascular risks.
Study context
- Population
- Danish adults without recent NSAID prescriptions, contraindications (GI disease, thrombocytopenia, HF) or conditions with low adherence (dementia, psychiatric disease), 1996–20201,894,834 diclofenac initiators
- Exposure
- High-dose (≥150 mg/day) vs low-dose (<150 mg/day) diclofenac, and diclofenac initiators vs healthcare-seeking non-initiators
- Non-initiatorsn = 3,789,617reference
- Outcome
- MACE
- Follow-up
- Within 30 days following initiation
Methodological detailsseries of nationwide cohort studies, 300 nationwide cohort studies, Danish health registries, adjusted Cox regression, Adjusted for age, sex, calendar period, comorbidity, comedication and socioeconomic position
- Series of nationwide cohort studies
- 300 nationwide cohort studies
- Danish health registries
- Adjusted Cox regression
- Adjusted for age, sex, calendar period, comorbidity, comedication and socioeconomic position
Main finding
As reported in the abstract
MACE by diclofenac dose · 30 days
Incidence rate ratio (95% CI)
High-dose diclofenacvs Non-initiators
1.55(1.40–1.71)
Low-dose diclofenacvs Non-initiators
1.52(1.41–1.63)
High-dose diclofenacvs Low-dose diclofenachead-to-head analysis
1.01(0.90–1.12)
Observational data: associations, not effects.
Further findings
| Outcome | IRR (95% CI) | |
|---|---|---|
| MACE, all diclofenac initiatorsvs non-initiators · 30 days | 1.53 (1.43–1.63) | |
| MACE components, diclofenac initiators vs non-initiators · 30 daysDiclofenac initiatorsvs Non-initiatorsMI | 1.54 (1.40–1.69) | |
| MACE components, diclofenac initiators vs non-initiators · 30 daysDiclofenac initiatorsvs Non-initiatorsIschaemic stroke | 1.29 (1.14–1.45) | |
| MACE components, diclofenac initiators vs non-initiators · 30 daysDiclofenac initiatorsvs Non-initiatorsCardiac death | 1.92 (1.71–2.16) | |
| MACE in headache (subgroup) · 30 daysDiclofenac initiatorsvs Non-initiators | 5.10 (1.46–17.85) | |
| 0.050.21520Incidence rate ratio (log scale) |
Major adverse cardiovascular events (MACE) in headache (subgroup) · 30 days
- Risk increase observed for most conditions with chronic pain
Original publication
High- vs. low-dose diclofenac and cardiovascular risks: a target trial emulation. Eur Heart J Cardiovasc Pharmacother. Published 15 March 2023. doi:10.
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