Immediate and controlled-release pregabalin for the treatment of epilepsy

References

• World Health Organization. https://www.who.int/en/news-room/fact-sheets/detail/epilepsy
   Google Scholar
• Remy S, Beck H. Molecular and cellular mechanisms of pharmacoresistance in epilepsy. Brain. 2006;129(Pt 1):18–35.
   PubMed Web of Science ®Google Scholar
• Faught E, Duh MS, Weiner JR, et al. Nonadherence to antiepileptic drugs and increased mortality: findings from the RANSOM study. Neurology. 2008;71(20):1572–1578.
   PubMed Web of Science ®Google Scholar
• Brodtkorb E, Samsonsen C, Sund JK, et al. Treatment non-adherence in pseudo-refractory epilepsy. Epilepsy Res. 2016;122:1–6.
   PubMed Web of Science ®Google Scholar
• Hill AC, Thomson KE, Newell TG, et al. Correction of medication nonadherence results in better seizure outcomes than dose escalation in a novel preclinical epilepsy model of adherence. Epilepsia. 2019;60(3):475–484.
   PubMed Web of Science ®Google Scholar
• O’ Rourke G, O’ Brien JJ. Identifying the barriers to antiepileptic drug adherence among adults with epilepsy. Seizure. 2017;45:160–168.
   PubMed Web of Science ®Google Scholar
• Pellock JM, Smith MC, Cloyd JC, et al. Extended-release formulations: simplifying strategies in the management of antiepileptic drug therapy. Epilepsy Behav. 2004;5(3):301–307.
   PubMed Web of Science ®Google Scholar
• Perucca E. Extended-release formulations of antiepileptic drugs: rationale and comparative value. Epilepsy Curr. 2009;9(6):153–157.
   PubMed Web of Science ®Google Scholar
• Ummadi S, Shravani B, Raghavendra Rao NG, et al. Overview on controlled release dosage form. Int J Pharm Sci. 2013;3(4):258–269.
   Google Scholar
• Calandre EP, Rico-Villademoros F, Slim M. Alpha2delta ligands, gabapentin, pregabalin and mirogabalin: a review of their clinical pharmacology and therapeutic use. Expert Rev Neurother. 2016;16(11):1263–1277.
   PubMed Web of Science ®Google Scholar
• Grosshans M, Lemenager T, Vollmert C, et al. Pregabalin abuse among opiate addicted patients. Eur J Clin Pharmacol. 2013;69(12):2021–2025.
   PubMed Web of Science ®Google Scholar
• Schulze-Bonhage A. Pharmacokinetic and pharmacodynamic profile of pregabalin and its role in the treatment of epilepsy. Expert Opin Drug Metab Toxicol. 2013;9:105–115.
   PubMed Web of Science ®Google Scholar
• Babu E, Kanai Y, Chairoungdua A, et al. Identification of a novel system L amino acid transporter structurally distinct from heterodimeric amino acid transporters. J Biol Chem. 2003;278(44):43838–43845.
   PubMed Web of Science ®Google Scholar
• Feng MR, Turluck D, Burleigh J, et al. Brain microdialysis and PK/PD correlation of pregabalin in rats. Eur J Drug Metab Pharmacokinet. 2001;26(1–2):123–128.
   PubMed Web of Science ®Google Scholar
• Takahashi Y, Nishimura T, Higuchi K, et al. Transport of pregabalin via L-type amino acid transporter 1 (SLC7A5) in human brain capillary endothelial cell line. Pharm Res. 2018 Oct 29;35(12):246.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency Lyrica, INN-pregabalin. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000546/WC500046602.pdf
   Google Scholar
• Alciati A, Atzeni F, Masala IF, et al. Controlled-release pregabalin in the treatment of fibromyalgia. Expert Rev Neurother. 2018;18:617–623.
   PubMed Web of Science ®Google Scholar
• Chew ML, Plotka A, Alvey CW, et al. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014;34:617–626.
   PubMed Web of Science ®Google Scholar
• Asconapé JJ. Use of antiepileptic drugs in hepatic and renal disease. Handb Clin Neurol. 2014;119:417–432.
   PubMedGoogle Scholar
• Chew ML, Alvey CW, Plotka A, et al. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014;34:627–637.
   PubMed Web of Science ®Google Scholar
• Kim TE, Jeon JY, Gu N, et al. Comparative pharmacokinetics of a controlled-release pregabalin tablet (GLA5PR GLARS-NF1) and an immediate-release pregabalin capsule in healthy male volunteers. Clin Ther. 2018;40(12):2112–2124.
   PubMed Web of Science ®Google Scholar
• French JA, Kugler AR, Robbins JL, et al. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology. 2003;60(10):1631–1637.
   PubMed Web of Science ®Google Scholar
• Arroyo S, Anhut H, Kugler AR, et al. Pregabalin add-on treatment: a randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures. Epilepsia. 2004;45(1):20–27.
   PubMed Web of Science ®Google Scholar
• Beydoun A, Uthman BM, Kugler AR, et al. Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy. Neurology. 2005;64(3):475–480.
   PubMed Web of Science ®Google Scholar
• Elger CE, Brodie MJ, Anhut H, 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. Epilepsia. 2005;46(12):1926–1936.
   PubMed Web of Science ®Google Scholar
• Lee BI, Yi S, Hong SB, et al. Pregabalin add-on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: a double-blind, randomized, placebo-controlled, multicenter trial. Epilepsia. 2009;50(3):464–474.
   PubMed Web of Science ®Google Scholar
• Uthman BM, Bazil CW, Beydoun A, et al. Long-term add-on pregabalin treatment in patients with partial-onset epilepsy: pooled analysis of open-label clinical trials. Epilepsia. 2010;51(6):968–978.
   PubMed Web of Science ®Google Scholar
• Carreño M, Maestro I, Molins A, et al. Pregabalin as add-on therapy for refractory partial seizures in every day clinical practice. Seizure. 2007;16(8):709–712.
   PubMed Web of Science ®Google Scholar
• Valentin A, Moran N, Hadden R, et al. Pregabalin as adjunctive therapy for partial epilepsy: an audit study in 96 patients from the South East of England. Seizure. 2009;18(6):450–452.
   PubMed Web of Science ®Google Scholar
• Huber B, Bocchicchio M, Feuerbaum E, et al. Efficacy and tolerability of pregabalin in patients with difficult-to-treat epilepsy and intellectual disability. Epilepsy Behav. 2008;13(2):397–401.
   PubMed Web of Science ®Google Scholar
• Modur PN, Milteer WE. Adjunctive pregabalin therapy in mentally retarded, developmentally delayed patients with epilepsy. Epilepsy Behav. 2008;13(3):554–556.
   PubMed Web of Science ®Google Scholar
• Stephen LJ, Parker P, Kelly K, et al. Adjunctive pregabalin for uncontrolled partial-onset seizures: findings from a prospective audit. Acta Neurol Scand. 2011;124(2):142–145.
   PubMed Web of Science ®Google Scholar
• Brodie MJ, Kelly K, Stephen LJ. Prospective audits with newer antiepileptic drugs in focal epilepsy: insights into population responses? Epilepsy Behav. 2014;31:73–76.
   PubMed Web of Science ®Google Scholar
• Viteva E, Zahariev Z. Comparative effectiveness of add-on therapy with newer-generation antiepileptic drugs in Bulgarian patients with refractory epilepsy. Epilepsy Behav. 2018;87:137–145.
   PubMed Web of Science ®Google Scholar
• Baulac M, Leon T, O’Brien TJ, et al. A comparison of pregabalin, lamotrigine, and placebo as adjunctive therapy in patients with refractory partial-onset seizures. Epilepsy Res. 2010;1(1):10–19.
   Google Scholar
• Kwan P, Brodie MJ, Kälviäinen R, et al. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011;10(10):881–890.
   PubMed Web of Science ®Google Scholar
• Zhou Q, Zheng J, Yu L, et al. Pregabalin monotherapy for epilepsy. Cochrane Database Syst Rev. 2012;10:CD009429.
   PubMedGoogle Scholar
• Pulman J, Hemming K, Marson AG. Pregabalin add-on for drug-resistant partial epilepsy. Cochrane Database Syst Rev. 2014;12(3):CD005612.
   Google Scholar
• Zaccara G, Almas M, Pitman V, et al. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014;55(7):1048–1057.
   PubMed Web of Science ®Google Scholar
• Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707–724.
   PubMed Web of Science ®Google Scholar
• French J, Glue P, Friedman D, et al. Adjunctive pregabalin vs gabapentin for focal seizures: interpretation of comparative outcomes. Neurology. 2016;87(12):1242–1249.
   PubMed Web of Science ®Google Scholar
• French J, Brandt C, Friedman D, et al. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014;55(8):1220–1228.
   PubMed Web of Science ®Google Scholar
• Huffman CL, Goldenberg JN, Weintraub J, et al. Efficacy and safety of once-daily controlled-release pregabalin for the treatment of patients with postherpetic neuralgia: a double-blind, enriched enrollment randomized withdrawal, placebo-controlled trial. Clin J Pain. 2017;33(7):569–578.
   PubMed Web of Science ®Google Scholar
• Arnold LM, Arsenault P, Huffman C, et al. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin. 2014;30(10):2069–2083.
   PubMed Web of Science ®Google Scholar
• Brandt C, May TW, Pohlmann-Eden B, et al. Retention rate of pregabalin in drug-resistant epilepsy: 1-year follow-up, single-centre observation in 105 consecutive, adult patients. Seizure. 2009;18(9):634–638.
   PubMed Web of Science ®Google Scholar
• Yuen AW, Singh R, Bell GS, et al. The long-term retention of pregabalin in a large cohort of patients with epilepsy at a tertiary referral centre. Epilepsy Res. 2009;87(2–3):120–123.
   PubMed Web of Science ®Google Scholar
• Zaccara G, Gangemi P, Perucca P, et al. The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials. Epilepsia. 2011;52(4):826–836.
   PubMed Web of Science ®Google Scholar
• Zaccara G, Perucca P, Gangemi PF. The adverse event profile of pregabalin across different disorders: a meta-analysis. Eur J Clin Pharmacol. 2012;68(6):903–912.
   PubMed Web of Science ®Google Scholar
• Stahl SM, Porreca F, Taylor CP, et al. The diverse therapeutic actions of pregabalin: is a single mechanism responsible for several pharmacological activities? Trends Pharmacol Sci. 2013;34(6):332–339.
   PubMed Web of Science ®Google Scholar
• Roth T, Arnold LM, Garcia-Borreguero D, et al. A review of the effects of pregabalin on sleep disturbance across multiple clinical conditions. Sleep Med Rev. 2014;18(3):261–271.
   PubMed Web of Science ®Google Scholar
• Salinsky M, Storzbach D, Munoz S. Cognitive effects of pregabalin in healthy volunteers: a double-blind, placebo-controlled trial. Neurology. 2010;74(9):755–761.
   PubMed Web of Science ®Google Scholar
• Desai A, Kherallah Y, Szabo C, et al. Gabapentin or pregabalin induced myoclonus: a case series and literature review. J Clin Neurosci. 2019;61:225–234.
   PubMed Web of Science ®Google Scholar
• Huppertz HJ, Feuerstein TJ, Schulze-Bonhage A. Myoclonus in epilepsy patients with anticonvulsive add-on therapy with pregabalin. Epilepsia. 2001;42(6):790–792.
   PubMed Web of Science ®Google Scholar
• Knake S, Klein KM, Hattemer K, et al. Pregabalin-induced generalized myoclonic status epilepticus in patients with chronic pain. Epilepsy Behav. 2007;11(3):471–473.
   PubMed Web of Science ®Google Scholar
• Kirac LB, Aydogdu I, Acarer A, et al. Myoclonic status epilepticus in six patients without epilepsy. Epilepsy Behav Case Rep. 2013;1:10–13.
   PubMedGoogle Scholar
• Kim JB, Jung JM, Park MH, et al. Negative myoclonus induced by gabapentin and pregabalin: a case series and systematic literature review. J Neurol Sci. 2017;382:36–39.
   PubMed Web of Science ®Google Scholar
• Hellwig S, Amtage F. Pregabalin-induced cortical negative myoclonus in a patient with neuropathic pain. E&B. 2008;13(2):418–420.
   PubMed Web of Science ®Google Scholar
• Lee S. Pregabalin intoxication-induced encephalopathy with triphasic waves. Epilepsy Behav. 2012;25(2):170–173.
   PubMed Web of Science ®Google Scholar
• Parekh M, Dash GK, Ahamed I. Pregabalin toxicity manifesting as reversible encephalopathy with continuous triphasic waves in electroencephalogram. Clin Neuropharmacol. 2017;40(5):226–228.
   PubMed Web of Science ®Google Scholar
• Anand P, Kaplan PW. Triphasic waves and encephalopathy in the setting of pregabalin toxicity. J Clin Neurophysiol. 2018;35(6):515–517.
   PubMed Web of Science ®Google Scholar
• Hoppe C, Rademacher M, Hoffmann JM, et al. Bodyweight gain under pregabalin therapy in epilepsy: mitigation by counseling patients? Seizure. 2008;17(4):327–332.
   PubMed Web of Science ®Google Scholar
• Cabrera J, Emir B, Dills D, et al. Characterizing and understanding body weight patterns in patients treated with pregabalin. Curr Med Res Opin. 2012;28(6):1027–1037.
   PubMed Web of Science ®Google Scholar
• Page RL 2nd, Cantu M, Lindenfeld J, et al. Possible heart failure exacerbation associated with pregabalin: case discussion and literature review. J Cardiovasc Med (Hagerstown). 2008;9(9):922–925.
   PubMed Web of Science ®Google Scholar
• Jung YJ, Lee DY, Kim HW, et al. a case report of syndrome of inappropriate antidiuretic hormone induced by pregabalin. Electrolyte Blood Press. 2016;14:31–34.
   PubMedGoogle Scholar
• Schifano F. Misuse and abuse of pregabalin and gabapentin: cause for concern? CNS Drugs. 2014 Jun;28(6):491–496.
   PubMed Web of Science ®Google Scholar
• Winterfeld U, Merlob P, Baud D, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology. 2016;86(24):2251–2257.
   PubMed Web of Science ®Google Scholar
• Patorno E, Bateman BT, Huybrechts KF, et al. Pregabalin use early in pregnancy and the risk of major congenital malformations. Neurology. 2017;88(21):2020–2025.
   PubMed Web of Science ®Google Scholar
• Vidaurre J, Gedela S, Yarosz S. antiepileptic drugs and liver disease. Pediatr Neurol. 2017;77:23–36.
   PubMed Web of Science ®Google Scholar
• Shepard PW, St Louis EK. Seizure treatment in transplant patients. Curr Treat Options Neurol. 2012;14(4):332–347.
   PubMed Web of Science ®Google Scholar
• Becker HC. Alcohol dependence, withdrawal, and relapse. Alcohol Res Health. 2008;31(4):348–361.
   PubMedGoogle Scholar
• Hughes JR. Alcohol withdrawal seizures. Epilepsy Behav. 2009;15(2):92–97.
   PubMed Web of Science ®Google Scholar
• Becker HC, Myrick H, Veatch LM. Pregabalin is effective against behavioral and electrographic seizures during alcohol withdrawal. Alcohol Alcohol. 2006;41(4):399–406.
   PubMed Web of Science ®Google Scholar
• Rustembegovic A, Sofic E, Tahirović I, et al. A study of gabapentin in the treatment of tonic-clonic seizures of alcohol withdrawal syndrome. Med Arh. 2004;58(1):5–6.
   PubMedGoogle Scholar
• Oulis P, Konstantakopoulos G. Efficacy and safety of pregabalin in the treatment of alcohol and benzodiazepine dependence. Expert Opin Investig Drugs. 2012;21(7):1019–1029.
   PubMed Web of Science ®Google Scholar
• Hasin DS, Stinson FS, Ogburn E, et al. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry. 2007;64(7):830–842.
   PubMed Web of Science ®Google Scholar
• Mula M. Pharmacological treatment of anxiety disorders in adults with epilepsy. Expert Opin Pharmacother. 2018;19(17):1867–1874.
   PubMed Web of Science ®Google Scholar
• Brandt C, Mula M. Anxiety disorders in people with epilepsy. Epilepsy Behav. 2016;59:87–91.
   PubMed Web of Science ®Google Scholar
• Brandt C, Schoendienst M, Trentowska M, et al. Efficacy and safety of pregabalin in refractory focal epilepsy with and without comorbid anxiety disorders - results of an open-label, parallel group, investigator-initiated, proof-of-concept study. Epilepsy Behav. 2013;29(2):298–304.
   PubMed Web of Science ®Google Scholar