Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Pediatric Drugs
Published in: Pediatric Drugs 5/2015

01-10-2015 | Original Research Article

Comparison of Drug Utilization Patterns in Observational Data: Antiepileptic Drugs in Pediatric Patients

Authors: Florence T. Bourgeois, Karen L. Olson, Annapurna Poduri, Kenneth D. Mandl

Published in: Pediatric Drugs | Issue 5/2015

Login to get access

Abstract

Purpose

Physicians require information on the comparative benefits and harms of medications for optimal treatment decisions. However, this type of data is limited, especially for pediatric patients.

Objective

Our aim was to use observational data to measure and compare medication utilization patterns in a pediatric patient population.

Methods

Using pharmacy claims data from a large, national-scale insurance program in the USA, we identified all patients with a diagnosis of epilepsy treated with a first-generation antiepileptic drug (carbamazepine, ethosuximide, phenobarbital, phenytoin, or valproate) or a second-generation antiepileptic drug [carbamazepine extended release (XR), gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproate XR, or zonisamide]. Treatment periods were defined on the basis of prescription fill dates and medication days supplied. Medication use was measured for individual antiepileptic drugs and for first-generation and second-generation drugs as groups.

Results

There were 2527 patients (54 %) who initiated therapy with first-generation antiepileptics and 2139 patients (46 %) who initiated therapy with second-generation antiepileptics. First- and second-generation drugs had the same 1-year retention rates [26 % (95 % confidence interval (CI) 24–28) and 26 % (95 % CI 25–28), respectively], and 26 % of patients (95 % CI 25–28) and 29 % of patients (95 % CI 27–31) who started on a first- or second-generation antiepileptic medication, respectively, resumed treatment with the initial drug after discontinuation. Overall, 73 % of patients (95 % CI 71–74) were treated with only one antiepileptic drug, with similar rates for patients started on first- and second-generation drugs [71 % (95 % CI 69–73) versus 74 % (95 % CI 72–76)].

Conclusion

Comparing drug utilization patterns in a pediatric population using observational data, we found similar rates of retention and therapeutic changes. These findings are consistent with the available comparative data and demonstrate an approach that could be extended to other drug classes and conditions in pediatric populations to examine drug effectiveness.
Appendix
Available only for authorised users
Literature
1.
2.
Mittler JN, Landon BE, Fisher ES, Cleary PD, Zaslavsky AM. Market variations in intensity of Medicare service use and beneficiary experiences with care. Health Serv Res. 2010;45(3):647–69.CrossRefPubMedCentralPubMed
3.
Bourgeois FT, Murthy S, Pinto C, Olson KL, Ioannidis JP, Mandl KD. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics. 2012;130(2):285–92.CrossRefPubMedCentralPubMed
4.
Cohen E, Goldman RD, Ragone A, et al. Child vs adult randomized controlled trials in specialist journals: a citation analysis of trends, 1985–2005. Arch Pediatr Adolesc Med. 2010;164(3):283–8.CrossRefPubMed
5.
Cohen E, Uleryk E, Jasuja M, Parkin PC. An absence of pediatric randomized controlled trials in general medical journals, 1985–2004. J Clin Epidemiol. 2007;60(2):118–23.CrossRefPubMed
6.
Hamm MP, Hartling L, Milne A, et al. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007. BMC Pediatr. 2010;10:96.CrossRefPubMedCentralPubMed
7.
Martinez-Castaldi C, Silverstein M, Bauchner H. Child versus adult research: the gap in high-quality study design. Pediatrics. 2008;122(1):52–7.CrossRefPubMed
8.
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981–97.CrossRef
9.
Cipriani A, Furukawa TA, Salanti G, et al. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009;373(9665):746–58.CrossRefPubMed
10.
Tsai AC, Rosenlicht NZ, Jureidini JN, Parry PI, Spielmans GI, Healy D. Aripiprazole in the maintenance treatment of bipolar disorder: a critical review of the evidence and its dissemination into the scientific literature. PLoS Med. 2011;8(5):e1000434.CrossRefPubMedCentralPubMed
11.
Chokshi DA, Avorn J, Kesselheim AS. Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature. Health Aff (Millwood). 2010;29(10):1842–8.CrossRefPubMed
12.
Stafford RS, Wagner TH, Lavori PW. New, but not improved? Incorporating comparative-effectiveness information into FDA labeling. N Engl J Med. 2009;361(13):1230–3.CrossRefPubMed
13.
O’Connor AB. Building comparative efficacy and tolerability into the FDA approval process. JAMA. 2010;303(10):979–80.CrossRefPubMed
14.
Hollingworth SA, Eadie MJ. Antiepileptic drugs in Australia: 2002–2007. Pharmacoepidemiol Drug Saf. 2010;19(1):82–9.CrossRefPubMed
15.
Weijenberg A, Offringa M, Brouwer OF, Callenbach PM. RCTs with new antiepileptic drugs in children: a systematic review of monotherapy studies and their methodology. Epilepsy Res. 2010;91(1):1–9.CrossRefPubMed
16.
Hansen RA, Dusetzina SB, Dominik RC, Gaynes BN. Prescription refill records as a screening tool to identify antidepressant non-adherence. Pharmacoepidemiol Drug Saf. 2010;19(1):33–7.CrossRefPubMedCentralPubMed
17.
Norris SL, Atkins D, Bruening W, et al. Observational studies in systemic reviews of comparative effectiveness: AHRQ and the Effective Health Care Program. J Clin Epidemiol. 2011;64(11):1178–86.CrossRefPubMed
18.
Shcherbakova N, Rascati K, Brown C, et al. Factors associated with seizure recurrence in epilepsy patients treated with antiepileptic monotherapy: a retrospective observational cohort study using US administrative insurance claims. CNS Drugs. 2014;28(11):1047–58.CrossRefPubMed
19.
20.
Pellock JM, Bourgeois BFD, Dodson WE, editors. Pediatric epilepsy: diagnosis and therapy. 3rd ed. New York: Demos Medical Publishing; 2008.
21.
Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. 2006;15(8):565–74 (discussion 575–567).
22.
Vink NM, Klungel OH, Stolk RP, Denig P. Comparison of various measures for assessing medication refill adherence using prescription data. Pharmacoepidemiol Drug Saf. 2009;18(2):159–65.CrossRefPubMed
23.
Hudson M, Rahme E, Richard H, Pilote L. Comparison of measures of medication persistency using a prescription drug database. Am Heart J. 2007;153(1):59–65.CrossRefPubMed
24.
25.
Guerreiro MM, Vigonius U, Pohlmann H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in children and adolescents with epilepsy. Epilepsy Res. 1997;27(3):205–13.CrossRefPubMed
26.
Nieto-Barrera M, Brozmanova M, Capovilla G, et al. A comparison of monotherapy with lamotrigine or carbamazepine in patients with newly diagnosed partial epilepsy. Epilepsy Res. 2001;46(2):145–55.CrossRefPubMed
27.
Resendiz-Aparicio JC, Rodriguez-Rodriguez E, Contreras-Bernal J, et al. A randomised open trial comparing monotherapy with topiramate versus carbamazepine in the treatment of paediatric patients with recently diagnosed epilepsy. Rev Neurol. 2004;39(3):201–4.
28.
Wheless JW, Neto W, Wang S. Topiramate, carbamazepine, and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. J Child Neurol. 2004;19(2):135–41.PubMed
29.
Thomson D, Hartling L, Cohen E, Vandermeer B, Tjosvold L, Klassen TP. Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948–2006. PLoS One. 2010;5(9):e13106.CrossRefPubMedCentralPubMed
30.
Demauro SB, Giaccone A, Kirpalani H, Schmidt B. Quality of reporting of neonatal and infant trials in high-impact journals. Pediatrics. 2011;128(3):e639–44.PubMed
31.
Lindkvist J, Airaksinen M, Kaukonen AM, Klaukka T, Hoppu K. Evolution of paediatric off-label use after new significant medicines become available for adults: a study on triptans in Finnish children 1994–2007. Br J Clin Pharmacol. 2011;71(6):929–35.CrossRefPubMedCentralPubMed
32.
33.
Viner RM, Hsia Y, Tomsic T, Wong IC. Efficacy and safety of anti-obesity drugs in children and adolescents: systematic review and meta-analysis. Obes Rev. 2010;11(8):593–602.CrossRefPubMed
34.
Murray ML, de Vries CS, Wong IC. A drug utilisation study of antidepressants in children and adolescents using the General Practice Research Database. Arch Dis Child. 2004;89(12):1098–102.CrossRefPubMedCentralPubMed
35.
Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. A simple and valid tool distinguished efficacy from effectiveness studies. J Clin Epidemiol. 2006;59(10):1040–8.CrossRefPubMed
36.
Sorenson C, Naci H, Cylus J, Mossialos E. Evidence of comparative efficacy should have a formal role in European drug approvals. BMJ. 2011;343:d4849.CrossRefPubMed
37.
Travers J, Marsh S, Williams M, et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax. 2007;62(3):219–23.CrossRefPubMedCentralPubMed
38.
Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290(12):1624–32.CrossRefPubMed
39.
Smith B. Comparative-effectiveness research as it affects clinical pharmacology. Clin Pharmacol Ther. 2011;90(6):751–4.CrossRefPubMed
40.
Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff (Millwood). 2010;29(10):1818–25.CrossRefPubMed
41.
Concato J, Lawler EV, Lew RA, Gaziano JM, Aslan M, Huang GD. Observational methods in comparative effectiveness research. Am J Med. 2010;123(12 Suppl 1):e16–23.CrossRefPubMed
42.
Schneeweiss S, Gagne JJ, Glynn RJ, Ruhl M, Rassen JA. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development. Clin Pharmacol Ther. 2011;90(6):777–90.CrossRefPubMed
43.
Chung S, Wang N, Hank N. Comparative retention rates and long-term tolerability of new antiepileptic drugs. Seizure. 2007;16(4):296–304.CrossRefPubMed
44.
Wong IC, Mawer GE, Sander JW, Lhatoo SD. A pharmacoepidemiologic study of factors influencing the outcome of treatment with lamotrigine in chronic epilepsy. Epilepsia. 2001;42(10):1354–8.CrossRefPubMed
45.
Bootsma HP, Ricker L, Diepman L, et al. Long-term effects of levetiracetam and topiramate in clinical practice: a head-to-head comparison. Seizure. 2008;17(1):19–26.CrossRefPubMed
46.
Ben-Menachem E, Sander JW, Privitera M, Gilliam F. Measuring outcomes of treatment with antiepileptic drugs in clinical trials. Epilepsy Behav. 2010;18(1–2):24–30.CrossRefPubMed
47.
Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000;41(12):1592–6.CrossRefPubMed
48.
Sander JW. New antiepileptic drugs in practice—how do they perform in the real world? Acta Neurol Scand Suppl. 2005;181:26–9.CrossRefPubMed
49.
Simister RJ, Sander JW, Koepp MJ. Long-term retention rates of new antiepileptic drugs in adults with chronic epilepsy and learning disability. Epilepsy Behav. 2007;10(2):336–9.CrossRefPubMed
50.
Bootsma HP, Ricker L, Hekster YA, et al. The impact of side effects on long-term retention in three new antiepileptic drugs. Seizure. 2009;18(5):327–31.CrossRefPubMed
51.
Bourgeois FT, Murthy S, Mandl KD. Comparative effectiveness research: an empirical study of trials registered in ClinicalTrials.gov. PLoS One. 2012;7(1):e28820.CrossRefPubMedCentralPubMed
52.
Dunn AG, Bourgeois FT, Murthy S, Mandl KD, Day RO, Coiera E. The role and impact of research agendas on the comparative-effectiveness research among antihyperlipidemics. Clin Pharmacol Ther. 2012;91(4):685–91.CrossRefPubMed
53.
van Luijn JC, Stolk P, Gribnau FW, Leufkens HG. Gap in publication of comparative information on new medicines. Br J Clin Pharmacol. 2008;65(5):716–22.CrossRefPubMedCentralPubMed
Metadata
Title
Comparison of Drug Utilization Patterns in Observational Data: Antiepileptic Drugs in Pediatric Patients
Authors
Florence T. Bourgeois
Karen L. Olson
Annapurna Poduri
Kenneth D. Mandl
Publication date
01-10-2015
Publisher
Springer International Publishing
Published in
Pediatric Drugs / Issue 5/2015
Print ISSN: 1174-5878
Electronic ISSN: 1179-2019
DOI
https://doi.org/10.1007/s40272-015-0139-z

Other articles of this Issue 5/2015

Pediatric Drugs 5/2015 Go to the issue

Therapy in Practice

Management of Functional Constipation in Children: Therapy in Practice

Current Opinion

Pain in Intellectually Disabled Children: Towards Evidence-Based Pharmacotherapy?

Review Article

Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities

Therapy in Practice

Pharmacological Management of Pediatric Patients with Comorbid Attention-Deficit Hyperactivity Disorder Oppositional Defiant Disorder

Adis Drug Evaluation

Darunavir: A Review in Pediatric HIV-1 Infection

Review Article

Options and Considerations for Procedural Sedation in Pediatric Imaging