Generic versus branded pharmacotherapy in Parkinson's disease: Does it matter? A review

Parkinsonism and Related Disorders

Volumn 17, Issue 5, 2011, Pages 308-312

  Go, Criscely L ^a   Rosales, Raymond L ^b   Schmidt, Peter ^c   Lyons, Kelly E ^d   Pahwa, Rajesh ^d   Okun, Michael S ^a  

^a UNIVERSITY OF FLORIDA   (United States)

^b UNIVERSITY OF SANTO TOMAS HOSPITAL   (Philippines)

^c National Parkinson Foundation   (United States)

^d UNIVERSITY OF KANSAS SCHOOL OF MEDICINE   (United States)

Author keywords

Dopamine agonist; Generics; Levodopa; Movement disorders; Parkinson disease; Pharmacotherapy

Indexed keywords

CARBIDOPA PLUS LEVODOPA; GENERIC DRUG; LEVODOPA;

BIOEQUIVALENCE; COST OF ILLNESS; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG RESPONSE; DRUG USE; DYSKINESIA; HEALTH INSURANCE; HUMAN; PARKINSON DISEASE; PATIENT ATTITUDE; PATIENT COMPLIANCE; PRIORITY JOURNAL; REVIEW;

ANTIPARKINSON AGENTS; DRUG INTERACTIONS; DRUGS, GENERIC; HUMANS; PARKINSON DISEASE; PATIENT COMPLIANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79957934569     PISSN: 13538020     EISSN: 18735126     Source Type: Journal    
DOI: 10.1016/j.parkreldis.2011.02.005     Document Type: Review

References (50)

1. Yahr M.D., Duvoisin R.C., Schear M.J., Barrett R.E., Hoehn M.M. Treatment of parkinsonism with levodopa. Arch Neurol 1969 Oct, 21(4):343-354.
2. Van Den Eeden S.K., Tanner C.M., Bernstein A.L., Fross R.D., Leimpeter A., Bloch D.A., et al. Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol 2003 Jun 1, 157(11):1015-1022.
3. Dowding C.H., Shenton C.L., Salek S.S. A review of the health-related quality of life and economic impact of Parkinson's disease. Drugs Aging 2006, 23(9):693-721.
4. Rubenstein L.M., DeLeo A., Chrischilles E.A. Economic and health-related quality of life considerations of new therapies in Parkinson's disease. Pharmacoeconomics 2001, 19(7):729-752.
5. Duh M.S., Cahill K.E., Paradis P.E., Cremieux P.Y., Greenberg P.E. The economic implications of generic substitution of antiepileptic drugs: a review of recent evidence. Expert Opin Pharmacother 2009 Oct, 10(14):2317-2328.
6. Berg M.J., Gross R.A., Haskins L.S., Zingaro W.M., Tomaszewski K.J. Generic substitution in the treatment of epilepsy: patient and physician perceptions. Epilepsy Behav 2008 Nov, 13(4):693-699.
7. Kesselheim A.S., Stedman M.R., Bubrick E.J., Gagne J.J., Misono A.S., Lee J.L., et al. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis. Drugs 2010 Mar 26, 70(5):605-621.
8. Borgheini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 2003 Jun, 25(6):1578-1592.
9. Bobo W.V., Stovall J.A., Knostman M., Koestner J., Shelton R.C. Converting from brand-name to generic clozapine: a review of effectiveness and tolerability data. Am J Health Syst Pharm 2010 Jan 1, 67(1):27-37.
10. Oluboka O., Stewart S., Landry S., Adams S. Does therapeutic equivalence follow bioequivalence? A randomized trial to assess clinical effects after switching from clozaril to generic clozapine (gen-clozapine). J Clin Pharmacol 2010 May, 50(5):531-535.
11. Masri M.A., Andrysek T., Rizk S., Matha V. The role of generics in transplantation: TM-MMF versus cellcept in healthy volunteers. Transplant Proc 2004 Jan-Feb, 36(1):84-85.
12. Kesselheim A.S., Misono A.S., Lee J.L., Stedman M.R., Brookhart M.A., Choudhry N.K., et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. J Am Med Assoc 2008 Dec 3, 300(21):2514-2526.
13. Noyes K., Liu H., Li Y., Holloway R., Dick A.W. Economic burden associated with Parkinson's disease on elderly medicare beneficiaries. Mov Disord 2006 Mar, 21(3):362-372.
14. Centers for Medicare and Medicaid Services Medicare benefit policy 2010, [cited 2010 August 15, 2010]; Available from:. http://www.cms.hhs.gov/manuals/102_policy/bp102index.asp.
15. Aitken M., Berndt E.R., Cutler D.M. Prescription drug spending trends in the United States: looking beyond the turning point. Health Aff (Millwood) 2009 Jan-Feb, 28(1):w151-w160.
16. Dorsey E.R., Constantinescu R., Thompson J.P., Biglan K.M., Holloway R.G., Kieburtz K., et al. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology 2007 Jan 30, 68(5):384-386.
17. O'Brien J.A., Ward A., Michels S.L., Tzivelekis S., Brandt N.J. Economic burden associated with Parkinson disease. Drug Benefit Trends 2009, 21(6):179-190.
18. Winter Y., von Campenhausen S., Popov G., Reese J.P., Klotsche J., Botzel K., et al. Costs of illness in a Russian cohort of patients with Parkinson's disease. Pharmacoeconomics 2009, 27(7):571-584.
19. Winter Y., von Campenhausen S., Reese J.P., Balzer-Geldsetzer M., Longo K., Spiga G., et al. Costs of Parkinson's disease and antiparkinsonian pharmacotherapy: an Italian cohort study. Neurodegener Dis 2010 Jun 4, 4:4.
20. Spottke A.E., Reuter M., Machat O., Bornschein B., von Campenhausen S., Berger K., et al. Cost of illness and its predictors for Parkinson's disease in Germany. Pharmacoeconomics 2005, 23(8):817-836.
21. US Food and Drug Administration Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general consideration 2010, [July 18, 2010]; Available from:. http://www.fda.gov/cder/guidance/4964dft.pdf.
22. US Food and Drug Administration Approved drug products with therapeutic equivalence evaluations. Center for drug evaluation and research 2010, Available from:. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm, 30th ed.
23. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003 Nov, 25(11):2875-2890.
24. Fernandez N., Garcia J.J., Diez M.J., Sahagun A.M., Gonzalez A., Diez R., et al. Effects of slowed gastrointestinal motility on levodopa pharmacokinetics. Auton Neurosci 2010 Aug 25, 156(1-2):67-72.
25. Lauterbach E.C., Freeman A., Vogel R.L. Correlates of generalized anxiety and panic attacks in dystonia and Parkinson disease. Cogn Behav Neurol 2003 Dec, 16(4):225-233.
26. Dissanayaka N.N., Sellbach A., Matheson S., O'Sullivan J.D., Silburn P.A., Byrne G.J., et al. Anxiety disorders in Parkinson's disease: prevalence and risk factors. Mov Disord 2010 May 15, 25(7):838-845.
27. Pahwa R., Marjama J., McGuire D., Lyons K., Zwiebel F., Silverstein P., et al. Pharmacokinetic comparison of Sinemet and Atamet (generic carbidopa/levodopa): a single-dose study. Mov Disord 1996 Jul, 11(4):427-430.
28. Pahwa R.P.R., Lyons K.E., Majama J., McGuire D., Koller W., Silverstein P., et al. Clinical experience with generic carbidopa levodopa (G-L) in patients with Parkinson's disease (PD). Neurology 1994, 44:A244.
29. Gregoire L., Samadi P., Graham J., Bedard P.J., Bartoszyk G.D., Di Paolo T. Low doses of sarizotan reduce dyskinesias and maintain antiparkinsonian efficacy of l-Dopa in parkinsonian monkeys. Parkinsonism Relat Disord 2009 Jul, 15(6):445-452.
30. Cummings J.L. Depression and Parkinson's disease: a review. Am J Psychiatry 1992 Apr, 149(4):443-454.
31. Schrag A. Quality of life and depression in Parkinson's disease. J Neurol Sci 2006 Oct 25, 248(1-2):151-157.
32. Walsh K., Bennett G. Parkinson's disease and anxiety. Postgrad Med J 2001 Feb, 77(904):89-93.
33. Goetz C.G. Hallucinations in Parkinson's disease: the clinical syndrome. Adv Neurol 1999, 80:419-423.
34. Spina E., de Leon J. Metabolic drug interactions with newer antipsychotics: a comparative review. Basic Clin Pharmacol Toxicol 2007 Jan, 100(1):4-22.
35. Spina E., Santoro V., D'Arrigo C. Clinically relevant pharmacokinetic drug interactions with second-generation antidepressants: an update. Clin Ther 2008 Jul, 30(7):1206-1227.
36. Urichuk L., Prior T.I., Dursun S., Baker G. Metabolism of atypical antipsychotics: involvement of cytochrome p450 enzymes and relevance for drug-drug interactions. Curr Drug Metab 2008 Jun, 9(5):410-418.
37. Delafuente J.C. Understanding and preventing drug interactions in elderly patients. Crit Rev Oncol Hematol 2003 Nov, 48(2):133-143.
38. Andermann F., Duh M.S., Gosselin A., Paradis P.E. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia 2007 Mar, 48(3):464-469.
39. Olling M., Mensinga T.T., Barends D.M., Groen C., Lake O.A., Meulenbelt J. Bioavailability of carbamazepine from four different products and the occurrence of side effects. Biopharm Drug Dispos 1999 Jan, 20(1):19-28.
40. Ferner R.E., Lenney W., Marriott J.F. Controversy over generic substitution. BMJ 2010, 340(340):c2548.
41. Sims-McCallum R.P. Adverse reaction caused by excipients in mercaptopurine tablets. Ann Pharmacother 2007 Sep, 41(9):1548.
42. Hebron B.S., Hebron H.J. Aspirin sensitivity: acetylsalicylate or excipients. Intern Med J 2009 Aug, 39(8):546-549.
43. Swen J.J., Huizinga T.W., Gelderblom H., de Vries E.G., Assendelft W.J., Kirchheiner J., et al. Translating pharmacogenomics: challenges on the road to the clinic. PLoS Med 2007 Aug, 4(8):e209.
44. Skipper L., Liu J.J., Tan E.K. Polymorphisms in candidate genes: implications for the current treatment of Parkinson's disease. Expert Opin Pharmacother 2006 May, 7(7):849-855.
45. Arbouw M.E., van Vugt J.P., Egberts T.C., Guchelaar H.J. Pharmacogenetics of antiparkinsonian drug treatment: a systematic review. Pharmacogenomics 2007 Feb, 8(2):159-176.
46. Westerlund M., Belin A.C., Anvret A., Hakansson A., Nissbrandt H., Lind C., et al. Association of a polymorphism in the ABCB1 gene with Parkinson's disease. Parkinsonism Relat Disord 2009 Jul, 15(6):422-424.
47. Vautier S., Fernandez C. ABCB1: the role in Parkinson's disease and pharmacokinetics of antiparkinsonian drugs. Expert Opin Drug Metab Toxicol 2009 Nov, 5(11):1349-1358.
48. Thuerauf N., Fromm M.F. The role of the transporter P-glycoprotein for disposition and effects of centrally acting drugs and for the pathogenesis of CNS diseases. Eur Arch Psychiatry Clin Neurosci 2006 Aug, 256(5):281-286.
49. Duh M.S., Paradis P.E., Latremouille-Viau D., Greenberg P.E., Lee S.P., Durkin M.B., et al. The risks and costs of multiple-generic substitution of topiramate. Neurology 2009 Jun 16, 72(24):2122-2129.
50. Reiffel J.A., Kowey P.R. Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias. Am J Cardiol 2000 May 1, 85(9):1151-1153. A10.