Gaetano Zaccara1, Fabio Giovannelli1,2, Filippo Sean Giorgi3, Valentina Franco4, Sara Gasparini5, Francesco Mandò Tacconi6. 1. Unit of Neurology, Department of Medicine, Florence Health Authority, Florence, Italy. 2. Department of Neuroscience, Psychology, Pharmacology and Child Health (NEUROFARBA), University of Florence, Florence, Italy. 3. Department of Clinical and Experimental Medicine, Section of Neurology, University of Pisa and Pisa University Hospital, Pisa, Italy. 4. Department of Internal Medicine and Therapeutics, Division of Clinical and Experimental Pharmacology, University of Pavia, Pavia, Italy. 5. Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy. 6. Pharmacovigilance Centre, Florence Health Authority, Florence, Italy.
Abstract
AIMS: Experimental studies show that some antiepileptic drugs (AEDs) may modify natural immune defences, thus influencing the risk of developing infectious diseases. The aim of this meta-analysis was to explore whether AEDs as a class of drugs or singularly may increase risk of infectious diseases. METHODS: A meta-analysis of all randomized, double-blind, placebo-controlled trials (RCTs) investigating any AED in any condition was performed. All terms that could be coded in the System Organ Classes (SOCs) of infections and infestations using the Medical Dictionary for Regulatory Activities were recorded. Additional subanalyses were performed also pooling together AEDs sharing similar mechanisms of action. RESULTS: Two hundreds and sixty-nine double-blind, placebo-controlled studies were identified and, among them, 127 RCTs with 16 AEDs (brivaracetam, gabapentin, lacosamide, levetiracetam, lamotrigine, oxcarbazepine, perampanel, pregabalin, phenytoin, remacemide, retigabine, rufinamide, tiagabine, topiramate, valproate, zonisamide) reported at least one of 19 symptoms or diseases that could be included in the Medical Dictionary for Regulatory Activities SOC term infections and infestations. These terms were singularly recorded and then pooled together in the SOC term infection and infestation. Topiramate was significantly associated with an increased risk of infection (risk difference = 0.04; 95% confidence interval = 0.01/0.06), while oxcarbazepine was significantly associated with a lower risk (-0.005; -0.09/-0.01). Risk difference of all studies with all AEDs showed a slight, but significantly increased risk of infection (0.01; 0.00/0.002). Levetiracetam and brivaracetam RCTs, when pooled together, were associated with a significantly increased risk of infection (0.03; 0.01/0.05). CONCLUSIONS: Some AEDs are associated with a mild increased risk of infection.
AIMS: Experimental studies show that some antiepileptic drugs (AEDs) may modify natural immune defences, thus influencing the risk of developing infectious diseases. The aim of this meta-analysis was to explore whether AEDs as a class of drugs or singularly may increase risk of infectious diseases. METHODS: A meta-analysis of all randomized, double-blind, placebo-controlled trials (RCTs) investigating any AED in any condition was performed. All terms that could be coded in the System Organ Classes (SOCs) of infections and infestations using the Medical Dictionary for Regulatory Activities were recorded. Additional subanalyses were performed also pooling together AEDs sharing similar mechanisms of action. RESULTS: Two hundreds and sixty-nine double-blind, placebo-controlled studies were identified and, among them, 127 RCTs with 16 AEDs (brivaracetam, gabapentin, lacosamide, levetiracetam, lamotrigine, oxcarbazepine, perampanel, pregabalin, phenytoin, remacemide, retigabine, rufinamide, tiagabine, topiramate, valproate, zonisamide) reported at least one of 19 symptoms or diseases that could be included in the Medical Dictionary for Regulatory Activities SOC term infections and infestations. These terms were singularly recorded and then pooled together in the SOC term infection and infestation. Topiramate was significantly associated with an increased risk of infection (risk difference = 0.04; 95% confidence interval = 0.01/0.06), while oxcarbazepine was significantly associated with a lower risk (-0.005; -0.09/-0.01). Risk difference of all studies with all AEDs showed a slight, but significantly increased risk of infection (0.01; 0.00/0.002). Levetiracetam and brivaracetam RCTs, when pooled together, were associated with a significantly increased risk of infection (0.03; 0.01/0.05). CONCLUSIONS: Some AEDs are associated with a mild increased risk of infection.
Authors: M Kubera; B Budziszewska; L Jaworska-Feil; A Basta-Kaim; M Leśkiewicz; M Tetich; M Maes; G Kenis; A Marciniak; S J Czuczwar; G Jagła; W Nowak; W Lasoń Journal: Pol J Pharmacol Date: 2004 Sep-Oct
Authors: Gang Li; Mareike Nowak; Sebastian Bauer; Kerstin Schlegel; Susanne Stei; Lena Allenhöfer; Anne Waschbisch; Björn Tackenberg; Matthias Höllerhage; Günter U Höglinger; Sven Wegner; Xin Wang; Wolfgang H Oertel; Felix Rosenow; Hajo M Hamer Journal: Seizure Date: 2013-04-29 Impact factor: 3.184
Authors: Parthena Martin; Maciej Czerwiński; Pallavi B Limaye; Seema Muranjan; Brian W Ogilvie; Steven Smith; Brooks Boyd Journal: Pharmacol Res Perspect Date: 2022-06