Drug products: Brieka, LYRICA®, Pregabalin 1A Farma, Pregabalin Accord, Pregabalin Accord Healthcare, Pregabalin EQL Pharma, Pregabalin Krka, Pregabalin Orion, Pregabalin Ranbaxy, Pregabalin Sandoz, Pregabalin Sandoz GmbH, Pregabalin STADA, Pregabalin Teva
ATC code: N03AX16
Pregabalin has the indication neuropathic pain, generalized anxiety syndrome and as additive treatment for partial epilepsy. The anticonvulsant effect is similar in men and women.
Adverse effects have been shown to be similar in men and women. Weight gain is not associated with sex.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Pregabalin is indicated for management of neuropathic pain in adults, as adjunctive therapy for partial seizures in adults and as treatment of generalized anxiety disorder.
Population pharmacokinetic analyses of the clinical studies showed that the relationship between daily dose and pregabalin drug exposure is similar between women and men . Clinical trials have shown that patient's sex don’t have any clinically significant impact on the plasma concentration of pregabalin . A randomized controlled trial showed that women had a slightly smaller volume of distribution than men. This is not likely to be of clinical significance. Pregabalin oral clearance was independent of sex. The population estimate of Vd/F was dependent on body weight, which was accounted for by sex differences, with women having an approximately 20% lower value than men . Despite the pharmacokinetic differences of pregabalin, the clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested .
The anti-seizure efficacy of pregabalin has no clinically important sex differences, according to the manufacturer .
The overall adverse event profile of pregabalin in clinical trials was similar between women and men, despite indication. Pregabalin associated weight gain has shown to be related to dose and duration of exposure, but did not appear to be associated with baseline BMI, sex or age .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Pregabalin abuse and dependence has recently been studied in Germany. The analysis was based on cases reported to the database of German medical regulatory body (BfArM) since 2008. The majority of patients identified were men (63.6%). However, there was a small number of cases (n = 55) and data was insufficient .
Date of litterature search: 2013-03-12
Reviewed by: Expertrådet för neurologiska sjukdomar, Ellen Vinge, Lars Lööf
Approved by: Mia von Euler