pregabalin and Intellectual-Disability

Pregabalin is an antiepileptic drug frequently prescribed to pregnant women. Risks of adverse birth and postnatal neurodevelopmental outcomes following prenatal exposure to pregabalin are uncertain.. To investigate the association between prenatal exposure to pregabalin and the risks of adverse birth and postnatal neurodevelopmental outcomes.. This study was conducted using population-based registries in Denmark, Finland, Norway, and Sweden (2005-2016). We compared pregabalin exposure against no exposure to antiepileptics and against active comparators lamotrigine and duloxetine. We obtained pooled propensity score-adjusted estimates of association using fixed-effect and Mantel-Haenszel (MH) meta-analyses.. The total number of pregabalin-exposed births was 325/666,139 (0.05%) in Denmark, 965/643,088 (0.15%) in Finland, 307/657,451 (0.05%) in Norway, and 1275/1,152,002 (0.11%) in Sweden. The adjusted prevalence ratios (aPRs) with 95% confidence interval (CI) following pregabalin exposure versus no exposure were 1.14 (0.98-1.34) for major congenital malformations and 1.72 (1.02-2.91) for stillbirth, which attenuated to 1.25 (0.74-2.11) in MH meta-analysis. For the remaining birth outcomes, the aPRs were close to or attenuated toward unity in analyses using active comparators. Adjusted hazard ratios (95% CI) contrasting prenatal pregabalin exposure versus no exposure were 1.29 (1.03-1.63) for ADHD and attenuated when using active comparators, 0.98 (0.67-1.42) for autism spectrum disorders, and 1.00 (0.78-1.29) for intellectual disability.. Prenatal exposure to pregabalin was not associated with low birth weight, preterm birth, small for gestational age, low Apgar score, microcephaly, autism spectrum disorders, or intellectual disability. On the basis of the upper value of the 95% confidence interval, increased risks greater than 1.8 were unlikely for any major congenital malformation and ADHD. For stillbirth and most groups of specific major congenital malformations, the estimates attenuated in MH meta-analysis.

Topics: Anticonvulsants; Cohort Studies; Female; Humans; Infant, Newborn; Intellectual Disability; Pregabalin; Pregnancy; Premature Birth; Prenatal Exposure Delayed Effects; Scandinavian and Nordic Countries; Stillbirth

This retrospective study evaluated the efficacy and tolerability of adjunctive pregabalin (PGB) therapy in mentally retarded, developmentally delayed patients. The primary efficacy measure was the change in the median frequency of seizure days per week between the baseline (8 weeks prior to initiating PGB) and treatment (12 weeks of titration and maintenance) periods. Inclusion criteria were: documented epilepsy treated with antiepileptic drug, at least one seizure during the baseline period, and lack of prior exposure to PGB. Seven patients (four female, three male, mean age=43) with multiple seizure types (generalized tonic-clonic, tonic, partial, and atypical absence) met the inclusion criteria. The mean dose of PGB was 293 mg/day (range=150-350 mg/day). PGB was efficacious, resulting in a significant reduction in the median frequency of seizure days/week between baseline and treatment (1.38 vs 0.50, P=0.018). The 50% responder rate was 71%. The adverse effects at last follow-up (mean 13 months) included weight gain, myoclonus, and sedation.

Topics: Adult; Anticonvulsants; Epilepsy; Female; Follow-Up Studies; gamma-Aminobutyric Acid; Humans; Intellectual Disability; Male; Middle Aged; Pregabalin; Retrospective Studies

In a retrospective evaluation of 32 inpatients with therapy-resistant epilepsy and intellectual disability, the efficacy of pregabalin (PGB) treatment was assessed after 6 and 12 months. The combined efficacy measure included the percentage reduction in seizure frequency, as well as the Clinical Global Impression (CGI) scale. Tolerability was assessed using a list of the 10 adverse effects most frequently observed in the regulatory studies and also by the CGI scale. After 6 months, the retention rate was 75%. Six patients (18.75%) were responders (50% seizure reduction and/or "good" or "very good" effect on CGI). No patient was seizure free. Seven patients had adverse effects that were not impairing. Eight patients had side effects that were essentially impairing. Weight gain, somnolence, asthenia, and ataxia were the most frequent adverse effects. Rare adverse events were severe mental slowing and loss of daily life capacities on a low dose of PGB in one patient and increase in auto-aggression in another patient. After 12 months, the retention rate was 40.6%, the responder rate was 25%, and one patient was seizure free. Statistical analysis did not identify any predictor of outcome (seizure type, epilepsy syndrome, co-medication, degree of intellectual disability). In this highly selected population, the efficacy of PGB was only moderate.

Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Anticonvulsants; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance; Drug Therapy, Combination; Epilepsies, Partial; Epilepsy; Female; Follow-Up Studies; gamma-Aminobutyric Acid; Humans; Intellectual Disability; Male; Pregabalin; Retrospective Studies; Treatment Outcome