Baseline nausea, prior triptan use may influence oral diclofenac potassium solution efficacy in migraine
Nausea at the time of dosing does not reduce the efficacy of diclofenac potassium for oral solution (DPOS) in acute migraine treatment, while prior triptan use predicted poor headache response compared with triptan-naïve patients, according to a study.
The pooled population from two double-blind trials included 1,272 patients aged 18–65 years (85 percent female) with at least a 1-year history of migraine attacks with or without aura who were randomized to receive 50 mg DPOS (n=628) or placebo (n=644). Participants were evaluated at 1, 2, and 8 hours postdosing to determine the intensity of migraine outcomes such as headache, photophobia, or phonophobia.
Sixty-two percent (n=783) of participants reported migraine-associated nausea at baseline, while 45 percent (n=570) had prior triptan use.
At 2 hours post-treatment, patients with baseline nausea who received DPOS had better responses compared with those receiving placebo in terms of headache relief (25 percent vs 9 percent; p<0.001) and absence of photophobia (45 percent vs 33 percent; p=0.002) or phonophobia (51 percent vs 36 percent; p<0.001). [Headache 2017;57:756-765]
Results were similar in participants without baseline nausea who demonstrated better relief on DPOS vs placebo in terms of headache relief (26 percent vs 13 percent; p<0.001) and absence of photophobia (54 percent vs 43 percent; p=0.009) or phonophobia (57 percent vs 44 percent; p=0.002).
The similar findings suggest that DPOS was effective regardless of presence of nausea at baseline, noted the researchers. “The rapid absorption profile [of DPOS] may enhance the effectiveness in patients with nausea,” they said.
Among patients with prior triptan use, DPOS-treated participants had better headache relief at 2 hours postdose compared with placebo-treated patients (20 percent vs 7 percent; p<0.001), though the efficacy appeared lower than that among triptan-naïve patients (30 percent vs 14 percent; p<0.001).
Prior triptan use did not predict relief of other measured parameters (ie, photophobia, phonophobia, or nausea) at 2 hours.
“These results suggest there may be a subset of patients who are more likely to be refractory to both triptans and diclofenac,” said the researchers, noting that this would require further investigation.
With previous evidence showing baseline nausea as a predictor of poor response to migraine treatment with triptans, it would be important to identify other migraine medications such as DPOS for effectively treating patients with poor triptan response, they added.