TY - JOUR

T1 - Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers

AU - Falkenberg, Katrine

AU - Olesen, Jes

PY - 2018

Y1 - 2018

N2 - BACKGROUND: Previous 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.METHODS: In 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.RESULTS: Cilostazol 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).CONCLUSION: Pre-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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03156920 .

AB - BACKGROUND: Previous 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.METHODS: In 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.RESULTS: Cilostazol 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).CONCLUSION: Pre-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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03156920 .

KW - Adult

KW - Cilostazol

KW - Cross-Over Studies

KW - Double-Blind Method

KW - Female

KW - Headache/chemically induced

KW - Healthy Volunteers

KW - Humans

KW - Male

KW - Middle Aged

KW - Migraine Disorders/drug therapy

KW - Sumatriptan/administration & dosage

KW - Surveys and Questionnaires

KW - Tetrazoles/adverse effects

KW - Vasoconstrictor Agents/administration & dosage

KW - Vasodilator Agents/adverse effects

KW - Young Adult

U2 - 10.1186/s10194-018-0890-y

DO - 10.1186/s10194-018-0890-y

M3 - Journal article

C2 - 30120600

VL - 19

JO - Journal of Headache and Pain

JF - Journal of Headache and Pain

SN - 1129-2369

M1 - 71

ER -