Abstract
BackgroundPrevious studies indicate that sumatriptan is not effective when second messenger levels are high as after cilostazol provocation. Therefore, we have conducted the present study, where sumatriptan is administrated as pretreatment before cAMP increases due to cilostazol intake. Our hypothesis was that pretreatment with sumatriptan would have a significant effect against cilostazol induced headache in healthy volunteers.MethodsIn a double-blind, randomized, crossover design, 30 healthy volunteers of both sexes received cilostazol 200 mg on two separate days, each day preceded by oral sumatriptan (2 × 50 mg) or placebo. Headache response and accompanying symptoms were registered in a questionnaire by the participants themselves.ResultsCilostazol induced a mild to moderate headache in all but 3 participants (Range 0–7 on Numerical Rating Scale). There was no significant difference in headache score 2 h (p = 0.67) or 4 h (p = 0.1) after treatment between the 2 days. Median peak headache score was 1.5 (range 0–5) on the sumatriptan day and 2 (range 0–7) on the placebo day (p = 0.26).ConclusionPre-treatment with sumatriptan prevents cilostazol induced headache from developing. However, the placebo group did not develop enough headache to get statistical significant results. The cilostazol pre-treatment model is valuable for experimental headache research and perhaps for testing drugs with another mechanism of action.Trial registrationClinicalTrials.gov Identifier: NCT03156920.
Highlights
Previous studies indicate that sumatriptan is not effective when second messenger levels are high as after cilostazol provocation
When treating cilostazol induced headache in healthy volunteers with sumatriptan, we saw a trend towards an effect [4] and the trend was stronger when the same study was conducted in migraine without aura (MO) patients [5]
Modifying the model from previous studies In previous studies, we showed a trend towards an effect of sumatriptan on cilostazol induced headache in both healthy volunteers and in MO patients [2, 3]
Summary
Previous studies indicate that sumatriptan is not effective when second messenger levels are high as after cilostazol provocation. We have conducted the present study, where sumatriptan is administrated as pretreatment before cAMP increases due to cilostazol intake. Our hypothesis was that pretreatment with sumatriptan would have a significant effect against cilostazol induced headache in healthy volunteers. We have tried to develop the model in both healthy volunteers and in patients with migraine without aura (MO) using two different headache inducing. When treating cilostazol induced headache in healthy volunteers with sumatriptan, we saw a trend towards an effect [4] and the trend was stronger when the same study was conducted in MO patients [5]. All three studies indicate that sumatriptan is not effective when second messenger levels (cGMP and cAMP), are increased in the system. We have conducted the present study, where sumatriptan is administrated as pretreatment before cAMP increases
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