Sildenafil provokes headache but not migraine in men with migraine without aura: a randomized, placebo-controlled crossover trial
Abstract
BACKGROUND: Cyclic guanosine monophosphate (cGMP)-mediated mechanisms plays a role in migraine pathophysiology. Sildenafil, a phosphodiesterase type 5 inhibitor, increases intracellular cGMP and can reliably induce migraine attacks in women. However, its migraine-inducing potential in men remains largely unknown. METHODS: In this randomized, double-blind, placebo-controlled crossover trial, 12 men with migraine without aura received sildenafil (100 mg) and placebo in separate sessions ≥ 7 days apart. An open-label parallel cohort of 15 women with migraine received sildenafil (100 mg) under similar experimental conditions. The primary endpoints were (i) the incidence of migraine-like attacks after sildenafil compared with placebo in men, and (ii) the incidence of migraine-like attacks after sildenafil in men and women. RESULTS: In men, sildenafil induced headache more frequently than placebo (83% vs. 25%, p = 0.033), whereas the incidence of migraine-like attacks did not differ between sildenafil and placebo (25% vs. 17%, p = 0.500). In women, sildenafil induced headache in all participants and migraine-like attacks in 67%, a significantly higher proportion than in men (67% vs. 25%, p = 0.038). Adverse events were more frequent after sildenafil than placebo, most commonly flushing and nasal congestion. CONCLUSIONS: Sildenafil provoked headache but not migraine in men with migraine without aura, whereas women showed a markedly greater susceptibility to migraine induction.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
Read the paper
Related studies
- Drug repositioning: a brief overview
- Cyclic nucleotide phosphodiesterases in Drosophila melanogaster
- Time-resolved in silico modeling of fine-tuned cAMP signaling in platelets: feedback loops, titrated phosphorylations and pharmacological modulation
- Current View on Green Tea Catechins Formulations, Their Interactions with Selected Drugs, and Prospective Applications for Various Health Conditions
- In silico Structure-based Identification of Novel Acetylcholinesterase Inhibitors Against Alzheimer’s Disease
- Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.