O. Petricoul, E. Fuseau.
Glaxo Wellcome Research and Development
This study is a population PK/PD meta-analysis of five clinical studies where Sumatriptan nasal spray was administered to patients during a migraine attack. A total of 1052 patients were included in the analysis. The model describing sumatriptan absorption used a combination of zero-order and first order absorption processes. The probability of having a particular headache score was modelled with a logit function having contributions of time (placebo) and sumatriptan effect-site concentrations. Covariates (demography, migraine history) effects on the PK and on the PK/PD relationship were investigated. Preliminary results showed that height moderately affects clearance and volume of distribution; that the probability of success with nasal spray is greater in patients with moderate as opposed to severe baseline headache; that inter-subject variability on placebo response is very large. Simulations were used to investigate the influence of drug exposure on the rate of response to sumatriptan nasal spray in the treatment of migraine attack.
Reference: PAGE 8 () Abstr 164 [www.page-meeting.org/?abstract=164]
Poster: poster