Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers
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Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers. / Falkenberg, Katrine; Olesen, Jes.
I: The Journal of Headache and Pain, Bind 19, 71, 2018.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 -
ID: 218472018