Adjunctive Duloxetine and the Relief of Osteoarthritic Pain
Adjunctive Duloxetine and the Relief of Osteoarthritic Pain
The authors of the study acknowledged that the short duration of this study (10 weeks) limits conclusions about the long-term use of adjunctive duloxetine and also the potential for bleeding-related complications. Whether or not the results of this study can be generalisable to other antidepressants, particularly to those with similar mechanisms of action on serotonin and norepinephrine transporters, will need to be confirmed by the conduct of appropriately designed clinical trials. Appraisal of sexual dysfunction will also need to be carefully performed as the emergence of this adverse event can be unacceptable for many patients; clinical trials have underestimated the frequency of this, as they usually measure this outcome by spontaneous adverse event reporting rather than by specific inquiry.
Although the duloxetine monotherapy trials included path analyses to demonstrate duloxetine's direct analgesic effect rather than it being dependent on improvement in depression or anxiety symptoms, there is no mention of this being done for the data collected in the adjunctive duloxetine study.
NNT and NNH are clinically intuitive measures of effect size differences, but there are limitations to their use. When comparing results from different studies when no head-to-head data are available, rates of events (and their respective NNTs and NNHs) are dependent on the particular study population from which they are derived. When comparing outcomes from different studies, it is important assess whether the study populations are 'similar enough' or whether significant differences (aside from the drug) may be accounting for the observed outcomes. This also applies when determining whether or not the study (or studies) in question is (are) generalisable to patients treated in the clinic.
Limitations
The authors of the study acknowledged that the short duration of this study (10 weeks) limits conclusions about the long-term use of adjunctive duloxetine and also the potential for bleeding-related complications. Whether or not the results of this study can be generalisable to other antidepressants, particularly to those with similar mechanisms of action on serotonin and norepinephrine transporters, will need to be confirmed by the conduct of appropriately designed clinical trials. Appraisal of sexual dysfunction will also need to be carefully performed as the emergence of this adverse event can be unacceptable for many patients; clinical trials have underestimated the frequency of this, as they usually measure this outcome by spontaneous adverse event reporting rather than by specific inquiry.
Although the duloxetine monotherapy trials included path analyses to demonstrate duloxetine's direct analgesic effect rather than it being dependent on improvement in depression or anxiety symptoms, there is no mention of this being done for the data collected in the adjunctive duloxetine study.
NNT and NNH are clinically intuitive measures of effect size differences, but there are limitations to their use. When comparing results from different studies when no head-to-head data are available, rates of events (and their respective NNTs and NNHs) are dependent on the particular study population from which they are derived. When comparing outcomes from different studies, it is important assess whether the study populations are 'similar enough' or whether significant differences (aside from the drug) may be accounting for the observed outcomes. This also applies when determining whether or not the study (or studies) in question is (are) generalisable to patients treated in the clinic.
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