The adverse event profile of pregabalin: A systematic review and meta‐analysis of randomized controlled trials

Purpose:  Despite the widespread use of antiepileptic drugs (AEDs) across different neurologic and psychiatric disorders, no study has systematically reviewed all available randomized controlled trials (RCTs) of a given AED to fully uncover its tolerability profile.

[1]  P. Whorwell,et al.  Effect of a second-generation alpha2delta ligand (pregabalin) on visceral sensation in hypersensitive patients with irritable bowel syndrome. , 2007, Gut.

[2]  J. Davidson,et al.  Pregabalin in generalized anxiety disorder: a placebo-controlled trial. , 2003, The American journal of psychiatry.

[3]  A G Marson,et al.  Clobazam as an add-on in the management of refractory epilepsy. , 2008, The Cochrane database of systematic reviews.

[4]  C. Elger,et al.  Pregabalin Add‐on Treatment in Patients with Partial Seizures: A Novel Evaluation of Flexible‐dose and Fixed‐dose Treatment in a Double‐blind, Placebo‐controlled Study , 2005, Epilepsia.

[5]  Philip J Mease,et al.  A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. , 2008, The Journal of rheumatology.

[6]  James P. Young,et al.  Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): A 6-month, double-blind, placebo-controlled trial with pregabalin , 2008, PAIN.

[7]  R. Fieve,et al.  Efficacy of Pregabalin in the Treatment of Generalized Anxiety Disorder: Double-blind, Placebo-Controlled Comparison of BID versus TID Dosing , 2005, Journal of clinical psychopharmacology.

[8]  A. Marson,et al.  New antiepileptic drugs: a systematic review of their efficacy and tolerability , 1996, BMJ.

[9]  M. Versavel,et al.  Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial , 2004, Pain.

[10]  C. Salzman,et al.  Update: New Uses for Lithium and Anticonvulsants , 2007, CNS Spectrums.

[11]  M. Versavel,et al.  Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: A randomized, double‐blind study , 2008, European journal of pain.

[12]  S. Kasper,et al.  Efficacy and safety of pregabalin in the treatment of generalized anxiety disorder: a 6-week, multicenter, randomized, double-blind, placebo-controlled comparison of pregabalin and venlafaxine. , 2006, The Journal of clinical psychiatry.

[13]  A. Marson,et al.  Zonisamide add-on for drug-resistant partial epilepsy. , 2005, The Cochrane database of systematic reviews.

[14]  S. Arroyo,et al.  Pregabalin Add‐on Treatment: A Randomized, Double‐blind, Placebo‐controlled, Dose–Response Study in Adults with Partial Seizures , 2004, Epilepsia.

[15]  Jason L Salemi,et al.  A pilot, double‐blind, placebo‐controlled trial of pregabalin (Lyrica) in the treatment of essential tremor , 2007, Movement disorders : official journal of the Movement Disorder Society.

[16]  R. Shrivastava,et al.  A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study of Pregabalin in Patients With Generalized Anxiety Disorder , 2003, Journal of clinical psychopharmacology.

[17]  M. Brodie.  Adverse antiepileptic drug effects: toward a clinically and neurobiologically relevant taxonomy , 2010 .

[18]  R. Poole,et al.  Pregabalin relieves symptoms of painful diabetic neuropathy , 2004, Neurology.

[19]  L. Arnold,et al.  The effect of anxiety and depression on improvements in pain in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. , 2007, Pain medicine.

[20]  J. Jankovic,et al.  Efficacy and tolerability of pregabalin in essential tremor: A randomized, double-blind, placebo-controlled, crossover trial , 2009, Journal of the Neurological Sciences.

[21]  J. Rosenstock,et al.  Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: A double-blind placebo-controlled trial , 2008, BMC neurology.

[22]  A. Satoa,et al.  ehavioral and neurochemical characterization of mice deficient in the N-type a 2 + channel 1 B subunit , 2010 .

[23]  P. Ryvlin,et al.  Pregabalin for the management of partial epilepsy , 2008, Neuropsychiatric disease and treatment.

[24]  William B. Dobyns,et al.  Autosomal dominant cerebellar ataxia (SCA6) associated with small polyglutamine expansions in the α1A-voltage-dependent calcium channel , 1997, Nature Genetics.

[25]  J. Rosenstock,et al.  Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial , 2004, Pain.

[26]  M. Rowbotham,et al.  Pregabalin for postherpetic neuralgia: placebo-controlled trial of fixed and flexible dosing regimens on allodynia and time to onset of pain relief. , 2008, The journal of pain : official journal of the American Pain Society.

[27]  M. Rowbotham,et al.  Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. , 2005, Arthritis and rheumatism.

[28]  M. Pollack,et al.  Pregabalin for treatment of generalized anxiety disorder: a 4-week, multicenter, double-blind, placebo-controlled trial of pregabalin and alprazolam. , 2005, Archives of general psychiatry.

[29]  J. Davidson,et al.  Efficacy of the Novel Anxiolytic Pregabalin in Social Anxiety Disorder: A Placebo-Controlled, Multicenter Study , 2004, Journal of clinical psychopharmacology.

[30]  B. Uthman,et al.  Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy , 2005, Neurology.

[31]  A. Marson,et al.  Zonisamide add-on for drug-resistant partial epilepsy. , 2013, The Cochrane database of systematic reviews.

[32]  A. Petralia,et al.  P0080 - Efficacy of Pregabalin and Venlafaxine-XR in generalized anxiety disorder: Results of a double-blind, placebo-controlled 8-week trial , 2008, European Psychiatry.

[33]  E. Ben-Menachem.  Pregabalin Pharmacology and Its Relevance to Clinical Practice , 2004, Epilepsia.

[34]  H. Wittchen,et al.  Long-term efficacy of pregabalin in generalized anxiety disorder , 2008, International clinical psychopharmacology.

[35]  L. Lamoreaux,et al.  Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. , 2005, The journal of pain : official journal of the American Pain Society.

[36]  K. Tan-No,et al.  Behavioral and neurochemical characterization of mice deficient in the N-type Ca2+ channel α1B subunit , 2010, Behavioural Brain Research.

[37]  E. Whalen,et al.  Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens , 2005, Pain.

[38]  P. Ryvlin,et al.  Pregabalin in partial seizures: a pragmatic 21‐week, open‐label study (PREPS) , 2010, European journal of neurology.

[39]  C. Johannessen Landmark,et al.  Antiepileptic drugs in non-epilepsy disorders: relations between mechanisms of action and clinical efficacy. , 2008, CNS drugs.

[40]  A. Marson,et al.  Levetiracetam, oxcarbazepine, remacemide and zonisamide for drug resistant localization-related epilepsy: a systematic review , 2001, Epilepsy Research.

[41]  S. Montgomery,et al.  Efficacy and safety of pregabalin in elderly people with generalised anxiety disorder , 2008, British Journal of Psychiatry.

[42]  P. Whorwell,et al.  Oesophagogastric fistula: a post-operative complication , 2007, Gut.

[43]  R. Poole,et al.  Pregabalin for the treatment of postherpetic neuralgia , 2003, Neurology.

[44]  J. Shane,et al.  PREGABALIN IN CENTRAL NEUROPATHIC PAIN ASSOCIATED WITH SPINAL CORD INJURY: A PLACEBO-CONTROLLED TRIAL , 2007, Neurology.

[45]  S. I. Lee,et al.  Pregabalin add‐on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: A double‐blind, randomized, placebo‐controlled, multicenter trial , 2009, Epilepsia.

[46]  M. H. Vegt,et al.  Pregabalin in patients with central neuropathic pain: A randomized, double-blind, placebo-controlled trial of a flexible-dose regimen , 2008, PAIN.

[47]  A. Marson,et al.  Levetiracetam add-on for drug-resistant localization related (partial) epilepsy. , 2001, The Cochrane database of systematic reviews.

[48]  A. Marson,et al.  Vigabatrin for refractory partial epilepsy. , 2008, The Cochrane database of systematic reviews.

[49]  C. J. Landmark,et al.  Antiepileptic Drugs in Non-Epilepsy Disorders , 2012 .

[50]  E. Boyden,et al.  Anti-Ca2+ channel antibody attenuates Ca2+ currents and mimics cerebellar ataxia in vivo , 2008, Proceedings of the National Academy of Sciences.

[51]  A. G. Marson,et al.  Remacemide for drug-resistant localization related epilepsy. , 2002, The Cochrane database of systematic reviews.

[52]  J. V. van Gerven,et al.  Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy. , 2007, Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine.

[53]  J. French,et al.  Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures , 2003, Neurology.

[54]  M. Versavel,et al.  Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13‐week, randomized trial , 2006, Current medical research and opinion.

[55]  A. Marson,et al.  Lamotrigine add-on for drug-resistant partial epilepsy. , 2016, The Cochrane database of systematic reviews.

[56]  L. Arnold,et al.  Randomized , Double-Blinded , Placebo-Controlled onotherapy Trial of Pregabalin in Patients With Fibromyalg esley , 2008 .

[57]  P. Siddall,et al.  Pregabalin in central neuropathic pain associated with spinal cord injury , 2006, Neurology.

[58]  A. Marson,et al.  Tiagabine add-on for drug-resistant partial epilepsy. , 2002, The Cochrane database of systematic reviews.

[59]  A. Marson,et al.  Topiramate add-on for drug-resistant partial epilepsy. , 2008, The Cochrane database of systematic reviews.