Efficacy and safety of innovator versus generic drugs in patients with epilepsy: A systematic review

Pharmacotherapy

Volumn 32, Issue 4, 2012, Pages 314-322

  Talati, Ripple ^a   Scholle, Jennifer M ^a   Phung, Olivia P ^a   Baker, Erika L ^a   Baker, William L ^a   Ashaye, Ajibade ^a   Kluger, Jeffrey ^a   Coleman, Craig I ^a   White, C Michael ^a  

^a UNIVERSITY OF CONNECTICUT   (United States)

Author keywords

AEDs; Antiepileptic; Generic; Innovator

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; GENERIC DRUG; LAMOTRIGINE; PHENYTOIN; TOPIRAMATE; VALPROIC ACID;

AREA UNDER THE CURVE; ASTHENIA; ATAXIA; BONE DENSITY; COGNITION; COMPARATIVE EFFECTIVENESS; DIPLOPIA; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPILEPSY; FATIGUE; HEADACHE; HEALTH CARE UTILIZATION; HUMAN; HYPOTENSION; LENGTH OF STAY; MOOD; NAUSEA; NEUROLOGIC DISEASE; NYSTAGMUS; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; QUALITATIVE RESEARCH; REVIEW; SIDE EFFECT; SOMNOLENCE; SUICIDAL IDEATION; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREMOR; VOMITING; BIOASSAY; COMPARATIVE STUDY; DOSE RESPONSE; HOSPITALIZATION; META ANALYSIS; META ANALYSIS (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL ANALYSIS;

ANTICONVULSANTS; CARBAMAZEPINE; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, GENERIC; ENDPOINT DETERMINATION; EPILEPSY; HOSPITALIZATION; HUMANS; LENGTH OF STAY; META-ANALYSIS AS TOPIC; PHENYTOIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; VALPROIC ACID;

EID: 84864104064     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1875-9114.2012.01099.x     Document Type: Review

References (32)

1. Assessment: generic substitution for antiepileptic medication. Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology. Neurology 1990;40:1641-3.
2. Liow K, Barkley GL, Pollard JR, et al. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology 2007;68:1249-50.
3. Percucca E, Albani F, Capovilla G, et al. Recommendations of the Italian League against epilepsy working group on generic products of antiepileptic drugs. Epilepsia 2006;47(suppl 5):16-20.
4. LeLorier J, Duh MS, Paradis PE, et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology 2008;70:2179-86.
5. American Society of Health-System Pharmacists. Comments from the FDA on narrow therapeutic index drugs and generic substitution. Available from http://www.ashp.org/import/news/NewsCapsules/article.aspx?id=2. Accessed October 22, 2010.
6. Williams RL. Therapeutic equivalence of generic drugs response to National Association of Board of Pharmacy. Available from http://www.fda.gov/ Drugs/DevelopmentApproval Process/HowDrugsareDevelopedandApproved/ ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm0732 24.htm. Accessed October 22, 2010.
7. Nightingale SL. Therapeutic equivalence of generic drugs letter to health practitioners. Available from http://www.fda. gov/Drugs/ DevelopmentApprovalProcess/HowDrugsareDeveloped andApproved/ ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm. Accessed October 22, 2010.
8. National Conference of State Legislatures. 2006 prescription drug state legislation. Available from www.ncsl.org/programs/health/drugbill06.htm. Accessed March 19, 2009.
9. National Conference of State Legislatures. 2007 prescription drug state legislation. Available from www.ncsl.org/programs/health/drugbill07.htm. Accessed March 19, 2009.
10. National Conference of State Legislatures. 2008 prescription drug state legislation. Available from www.ncsl.org/programs/health/drugbill08.htm. Accessed March 19, 2009.
11. National Conference of State Legislatures. Condition-specific drug substitution legislation: epilepsy. Available from www. ncsl.org/programs/ health/Rx-substitution08.htm. Accessed March 19, 2009.
12. Agency for Healthcare Research and Quality (AHRQ). Effective Health Care Program. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Available from http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides- reviewsand-reports/?pageaction=displayproduct&productid=318. Accessed December 23, 2010.
13. DerSimonian R, Laird N. Meta-Analysis in clinical trials. Control Clin Trials 1986;3:177-88.
14. Follman D, Elliot P, Suh I, et al. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol 1992;45:769-73.
15. Higgins JPT, Green S, Editors. Cochrane handbook for systematic reviews of intervention. Posted February 2008. Version 5.0.0. Available from www.cochrane-handbook.org. Accessed February 18, 2008.
16. Aldenkamp AP, Rentmeester T, Hulsman J, et al. Pharmacokinetics and cognitive effects of carbamazepine formulations with different dissolution rates. Eur J Clin Pharmacol 1998;54:185-92.
17. Silpakit O, Amornpichetkoon M, Kaojarern S. Comparative study of bioavailability and clinical efficacy of carbamazepine in epileptic patients. Ann Pharmacother 1997;31:548-52.
18. Oles KS, Penry JK, Smith LD, et al. Therapeutic bioequivalency study of brand name versus generic carbamazepine. Neurology 1992;42:1147-53.
19. Hartley R, Aleksandrowicz J, Ng PC, et al. Breakthrough seizures with generic carbamazepine: a consequence of poorer bioavailability?. Br J Clin Pract 1990;44:270-3.
20. Jumao-As A, Bella I, Craig B, et al. Comparison of steady-state blood levels of two carbamazepine formulations. Epilepsia 1989;30:67-70.
21. Kishore K, Jailakhani BL, Sharma JN, et al. Serum phenytoin levels with different brands. Indian J Physiol Pharmacol 1986;30:171-6.
22. Vadney VJ, Kraushaar KW. Effects of switching from Depakene to generic valproic acid on individuals with mental retardation. Ment Retard 1997;35:468-72.
23. Garnett WR, Gilbert TD, O'Connor P. Patterns of care, outcomes, and direct health plan costs of antiepileptic therapy: a pharmacoeconomic analysis of the available carbamazepine formulations. Clin Ther 2005;27:1092-103.
24. Labiner D, Paradis PE, Manjunath R, et al. Generic antiepileptic drugs and associated medical resource utilization in the United States. Neurology 2010;74:1566-74.
25. Duh MS, Paradis PE, Latremouille-Viau D, et al. The risks and costs of multiple-generic substitution of topiramate. Neurology 2009;72:2122-9.
26. Paradis PE, Latremouille-Viau D, Moore Y, et al. Projected economic impact of clinical findings of generic entry of topiramate on G4 European countries. Curr Med Res Opin 2009;25:1793-805.
27. Zachry WM, 3rd, Doan QD, Clewell JD, et al. Case-control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia 2009;50:493-500.
28. Rascati KL, Richards KM, Johnsrud MT, et al. Effects of antiepileptic drug substitutions on epileptic events requiring acute care. Pharmacotherapy 2009;29:769-74.
29. Devine ST, Barron J, Behm A. Acute epilepsy exacerbations in patients switched between A-rated anti-epileptic drugs. Curr Med Res Opin 2010;26:455-63.
30. Kesselheim AS, Stedman MR, Bubrick EJ, et al. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs. Drugs 2010;70:605-21.
31. Wolf P, May T, Tiska G, et al. Steady state concentrations and diurnal fluctuations of carbamazepine in patients after different slow release formulations. Arzeimittelforschung 1992;42 (3):284-8.
32. Hartley R, Aleksandrowicz J, Bowmer CJ, et al. Dissolution and relative bioavailability of two carbamazepine preparations for children with epilepsy. J Pharm Pharmacol 1991;43:117-19.