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Buprenorphine versus methadone treatment for opiate addiction in pregnancy, an evaluation of neonatal outcomes

Buprenorphine versus methadone treatment for opiate addiction in pregnancy, an evaluation of neonatal outcomes. Michael Czerkes, MD (PGY-3) Jaquelyn Blackstone, DO John Pulvino, MD Maine Medical Center Portland, ME District I. Hypothesis.

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Buprenorphine versus methadone treatment for opiate addiction in pregnancy, an evaluation of neonatal outcomes

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  1. Buprenorphine versus methadone treatment for opiate addiction in pregnancy, an evaluation of neonatal outcomes Michael Czerkes, MD (PGY-3) Jaquelyn Blackstone, DO John Pulvino, MD Maine Medical Center Portland, ME District I

  2. Hypothesis • Women treated with buprenorphine for opiate addiction while pregnant will have fewer babies born with neonatal abstinence requiring treatment, shorter hospital stays, and lower overall NAS scores compared to women treated with methadone.

  3. Significance • Prevalence of opiate addiction 1-2% of pregnant women, up to 21% in some communities • Opiate abusers: • More likely to neglect prenatal care • More likely to neglect nutrition • If using needles, clear increase in infections (Hepatitis, HIV) • Methadone maintenance • More stable with mental and physical health • More likely to attend prenatal visits.

  4. Nonmedical Use of Pain Relievers in Past Year among Persons Aged 18 to 25, by State: Percentages, Annual Averages 2004 and 2005 Source: SAMHSA, Office of Applied Studies, National Survey on Drug Use and Health, 2004 and 2005

  5. Background • Methadone is considered the “gold standard” of treatment • However, significant neonatal effects • Neonatal abstinence syndrome (NAS) • Prolonged monitoring, prolonged hospital stays • Thought that buprenorphine may be safer (less readily crosses the placenta) • Does this result in less neonatal effects? • Has not been extensively studied in the literature

  6. Pharmacology • Methadone • Full mu-opioid agonist • Blocks effects of other opioids if taken/used • Half-life 15-60 hours • Most patients are required to visit clinic daily • Once proven sober for months, may begin to receive take home doses.

  7. Pharmacology • Buprenorphine • Partial mu-opioid receptor agonist/antagonist • Less euphoric effect • Less likely to be diverted on black market • Very high affinity for receptor • Half life approximately 36 hours • Can be given as month’s supply, no need to attend clinic daily

  8. Significance • Maine has one of the highest rates of opiate addiction • Approximately 13% of persons aged 18-25 are narcotic abusers • 2% over the age of 26 • Large problem in pregnant population

  9. Background (cont) • Johnson 2001, 2003 • Buprenorphine is a safe alternative and has limited perinatal effects. • Cochrane review 2008 • 3 randomized trials • No difference noted between methadone and buprenorphine • 3 trials with total of 93 patients were used • Not powered enough to draw conclusions • Jones et al. 2005 • No statistically significant difference • N=20 (11 methadone, 9 buprenorphine)

  10. Background (cont) • Lejeune et al. France 2006 • 100 methadone, 159 “high dose buprenorphine” • No differences in NAS scores • However, no standardized scoring system across hospitals or observers. • Kakko 2008 • 66 patients • 39 buprenorphine • 26 methadone • Shorter hospital stays • Decreased NAS scores • Decreased need for treatment

  11. Methods • IRB approval at Maine Medical Center • Retrospective chart review • 2004-2008 • Searched for all deliveries at Maine Medical Center with dependency coded in Logician and Sunrise Clinical Manager • Inclusion criteria • Delivery at Maine Medical Center • Delivery beyond 37 weeks • Treatment with methadone or buprenorphine

  12. Methods (cont) • Number of patients • Methadone n=101 • Average dose 102 mg • Buprenorphine n=68 • Average dose 15mg

  13. Methods (cont) • Data Collected • Patient age • Gestational age • Form of delivery • Other medications • Dosage of medications • Apgar Scores • Cord pH • Birth Weight • Length of stay mom and baby • NAS score • Treatment needed with DTO or phenobarbital • BPP’s • Other antenatal complications

  14. Results p<0.0001 p=0.0012

  15. Results (cont) P<0.001

  16. Results (cont) p=0.3

  17. Results (cont) p=0.11

  18. Results (cont) p=0.29

  19. Results (cont) p=0.86 p=0.08 p=0.82

  20. Conclusions • Improved outcomes with buprenorphine : • Length of Stay (15.7 vs 8.4 days) • Peak NAS score (12.5 vs 10.7) • Number needing treatment (75% vs 50%) • No difference in other pregnancy outcomes • Buprenorphine appears safe when compared with methadone

  21. Conclusions • Clinical implications • Decreased hospital stay = significant decrease in medical cost • 7 days in NICU at Maine Med = $28,553 • 7 days in Children’s Hospital = $8,071 • Fewer needing treatment = decreased need for IV starts, fewer exposure to IV medication • Day of withdrawal consistent for subutex (peak on day 3) vs methadone (day 2-6) • Possible impact on screening procedures • SSRI use trend toward greater use among buprenorphine patients

  22. Limitations • Retrospective chart review • No long term outcome information • Not powered enough to detect differences in IUGR, PTL/PTD, abruption • Based on power calculation would need approximately 400 in each group • Also did not compare to controls

  23. Future research • Large prospective randomized control trials needed • Powered enough to detect differences in antenatal outcomes as well as neonatal outcomes • Long term outcome comparisons • Cost analysis reports

  24. References • Fischer G, Eder H, Jagsch R, Lennkh C, Habeler A, Schauer HN, Kasper S. 1998. Maintenance therapy with synthetic opioids within a multidisciplinary program – a stabilizing necessity for pregnant opioid dependent women. Archives of Women’s Mental Health 1998; 1: 109-16 • Fischer G. Treatment of opioid dependence in pregnant women. Addiction 2000; 95: 1141-4. • Johnson RE, Hendree EJ, Jasinski DR,Svikis DS, Haug NA, Janson LM et al. Buprenorphine treatment of pregnant opioid-dependent women: maternal and neonatal outcomes. Drug and Alcohol Dependence 2001; 63: 97-103. • Jones H, Johnson R, Jasinki D, O’Grady K, Chisolm C, Choo R, et al. Buprenorphine versus methadone in the treatment of pregnant opioid dependent patients: effects on the neonatal abstinence system. Drug and Alcohol dependence 2005; 79: 1-10 • Kakko J, Heilig M, Ihsan S. Buprenorphine and methadone treatment of opiate dependence during pregnancy: Comparison of fetal growth and neonatal outcomes in two consecutive case series. Drug and Alcohol Dependence 2008; 96: 69-78

  25. References • Legeune C, Simmat-Durand L, Gourarier L, Aubisson, S. Prospective multicenter observational study of 260 infants born to 259 opiate-dependent mothers on methadone or high-dose buprenorphine subsitution. Drug and Alcohol Dependence 2006; 82: 250-7. • Mattick RP, Kimber J, Breen C, Davoli M 2004. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database System 2004. Rev., CD002207 • Minozzi S, Amato L, Vecchi S, Davoli M. Maintenance agonist treatmentfor opiate dependent pregnant women. Cochrane Database of Systematic Reviews 2008; Issue 2 Art No: CD006318. DOI: 10.1002/14651858.CD006318.pub2

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