Analgesic Safety - Myths, Mysteries and Misconceptions
Analgesic Safety - Myths, Mysteries and Misconceptions
The GI risks associated with the use of prescription-strength NSAIDs are well-documented and range from mild symptoms such as nausea, vomiting and stomach pain to serious events such as GI bleeding. Evidence for such potential complications is consistent across meta-analyses, randomised controlled studies and large observational/real-world studies.
Of the various NSAIDs, ibuprofen carries the lowest relative risk, usually because it is only used in practice at doses up to 1200 mg a day. In a meta-analysis published by the safety of non-steroidal anti-inflammatory drugs (SOS) collaborative project, the relative risk of upper GI complications was 1.8 with ibuprofen, compared with 3.3 for diclofenac and 4.1 for naproxen.
The SOS project investigators looked at analgesic and anti-inflammatory doses combined. This is an important point to consider because the risk of GI complications is dose-dependent and is considerably lower if ibuprofen is used in an OTC setting. In fact, the risk might not be increased at all if ibuprofen is used at single OTC doses, as indicated by two Cochrane reviews. Derry et al. examined all evidence for single doses of ibuprofen in the range of 50–400 mg. The analysis included 72 high-quality clinical studies comparing ibuprofen with placebo in over 9000 individuals. The risk of GI adverse events with ibuprofen was found to be the same as placebo. Rabbie et al. looked at the treatment of migraine headache episodes with a single ibuprofen dose and came to the same conclusion.
Studies comparing the incidence of GI side effects with paracetamol and ibuprofen in the OTC setting also found no difference between these two agents. In the PAIN study, a large RCT involving 8677 people who used ibuprofen, paracetamol or aspirin at maximum or near-maximum OTC doses for the treatment of common painful conditions, the risk of GI events was lower with ibuprofen than with paracetamol (Figure 1).
(Enlarge Image)
Figure 1.
Rate of GI side effects with ibuprofen vs. paracetamol in the PAIN study. Adapted from Moore et al. (11)
GI Safety
The GI risks associated with the use of prescription-strength NSAIDs are well-documented and range from mild symptoms such as nausea, vomiting and stomach pain to serious events such as GI bleeding. Evidence for such potential complications is consistent across meta-analyses, randomised controlled studies and large observational/real-world studies.
Of the various NSAIDs, ibuprofen carries the lowest relative risk, usually because it is only used in practice at doses up to 1200 mg a day. In a meta-analysis published by the safety of non-steroidal anti-inflammatory drugs (SOS) collaborative project, the relative risk of upper GI complications was 1.8 with ibuprofen, compared with 3.3 for diclofenac and 4.1 for naproxen.
The SOS project investigators looked at analgesic and anti-inflammatory doses combined. This is an important point to consider because the risk of GI complications is dose-dependent and is considerably lower if ibuprofen is used in an OTC setting. In fact, the risk might not be increased at all if ibuprofen is used at single OTC doses, as indicated by two Cochrane reviews. Derry et al. examined all evidence for single doses of ibuprofen in the range of 50–400 mg. The analysis included 72 high-quality clinical studies comparing ibuprofen with placebo in over 9000 individuals. The risk of GI adverse events with ibuprofen was found to be the same as placebo. Rabbie et al. looked at the treatment of migraine headache episodes with a single ibuprofen dose and came to the same conclusion.
Studies comparing the incidence of GI side effects with paracetamol and ibuprofen in the OTC setting also found no difference between these two agents. In the PAIN study, a large RCT involving 8677 people who used ibuprofen, paracetamol or aspirin at maximum or near-maximum OTC doses for the treatment of common painful conditions, the risk of GI events was lower with ibuprofen than with paracetamol (Figure 1).
(Enlarge Image)
Figure 1.
Rate of GI side effects with ibuprofen vs. paracetamol in the PAIN study. Adapted from Moore et al. (11)
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