Primærstudier, tabell 2: Studier hvor flesteparten (mer enn halvparten) av kvinnene fikk behandling gjennom hele svangerskapet

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1 Primærstudier, tabell 2: Studier hvor flesteparten (mer enn halvparten) av kvinnene fikk behandling gjennom hele svangerskapet Utfallsmål for gravide kvinner, nyfødte og barn Studiene er presentert med resultater slik de fremstår i publikasjonene. Studie (land) Utfallsmål Design (utvalg/n) Tekst/forklaring Referanse Bakstad 2009 (Norge) (inngår noen av datene i Welle- Strand 2012 og dermed Zedler 2016?) Gravide: bruk av rusmidler siste trimester prematuritet fødselsvekt hodeomkrets behandlet for lengde på Prospektiv studie (N=38) Met=26 Bup=12 SIGN FORSKJELL (?) Two women in the methadone group and none in the buprenorphine group had consumed an illegal opiate during the last trimester. Six women on methadone, but only 1 in the buprenorphine group reported some use of benzodiazepines during the last trimester of pregnancy. In the last month of pregnancy, only 2 women used benzodiazepines (1 prescription from the patient s physician). One patient also had 2 positive urine tests on opioid in the same period. In the methadone group, 1 premature birth occurred at less than 34 weeks. The mean birth weight was close to the expected mean in the general population for smoking mothers: 3,150 g (range 2,280 4,684 g) for the methadone group and 3,130 g (range 2,280 3,830 g) for the buprenorphine group. (SE OVER) The head circumference for the 2 groups was 33.9 and 34.3 cm, respectively. The numbers of infants treated for were 15 (58%) in the methadone group and 8 (67%) in the buprenorphine group. There were no statistically significant differences between the 2 groups for the occurrence (p = 0.73). Bakstad B, Sarfi M, Welle-Strand GK, Ravndal E. Opioid maintenance treatment during pregnancy: Occurrence and severity of neonatal abstinence syndrome. European Addiction Research 2009;15(3):

2 behandling av There were no statistically significant differences between the 2 groups for the duration of (p = 0.64). The mean number of treatment days was 43 days (range days) for the methadone-exposed infants and 37 days (range 4 73 days) for the buprenorphine-exposed infants. Bier 2015 (Sverige) Prematuritet fødselsvekt Retrospektiv studie (N=220) Lavdose metadon (<100 mg) =84 Høydose metadon ( 100 mg)=81 Buprenorfin=55 Lavdose met= 18 (21%) Høydose met= 13 (16%) Bup=5 (9%) There were no differences in mean birth weight, gestational age at birth, gender, maternal age, prenatal care, neonatal complications or infants receiving treatment with phenobarbital. Lavdose met= 2755 g (± 565) Høydose met= 2748 g (±639) Bup=2895 g (±569) Bier JB, Finger AS, Bier BA, Johnson TA, Coyle MG. Growth and developmental outcome of infants with inutero exposure to methadone vs buprenorphine. Journal of Perinatology 2015;35(8): Behandlet for There were no differences in mean birth weight, gestational age at birth, gender, maternal age, prenatal care, neonatal complications or infants receiving treatment with phenobarbital. Lavdose met= 72 (85%) Høydose met=73 (90%) Bup=45 (82%) There were no differences in mean birth weight, gestational age at birth, gender, maternal age, prenatal care, neonatal complications or infants receiving treatment with phenobarbital.

3 Liggetid på sykehus SIGN FORSKJELL Lavdose met=36 dager (±22 dg) Høydose met=44 dager (±26 dg) Bup=21 dager (±13 dg) (p=<0.001) Kognitiv utvikling ved 4 mnd (Bayley Mental Developmental Index) Motorisk utvikling ved 4 mnd (Alberta Infant Motor Scale, AIMS, prosent) All three groups differed in their mean length of hospitalization, with the high-dose methadone group hospitalized the longest (44 ± 26 days), followed by the low-dose methadone group (36 ± 22 days), with the buprenorphine exposed infants discharged at a mean of 21 ± 13 days (P<0.001) chronological age. Lavdose met=96.6±7 Høydose met= 94.3±9 Bup= 95.7±7 There was no significant difference in Bayley Mental Developmental Index scores between the groups. SIGN FORSKJELL Lavdose met=44.8±24 Høydose met= 38.1±24 Bup= 53.5±23 (p<0,025 ) A significant difference among the three groups was found in AIMS scores, with the buprenorphine group having a higher score. Results of t-tests revealed a significant difference between the high-dose methadone group and the buprenorphine group. Gordon 2012 (Australia) Gravide: rusmiddelbruk Prospektiv kohortstudie og matchet kontrollgruppe [?] Gordon AL, Lopatko OV, Stacey H, Pearson V, Woods A, Fisk A, et al. Patterns of symptom reporting during pregnancy comparing opioid maintained and control women. Journal of Addiction Medicine 2012;6(4):

4 Met=25 Bup= Ikkeeksponerte=25 Selvrapportert bruk og testing ved urinprøver av opioider, benzodiazepiner og cannabis viste få forskjeller mellom gravide som hadde brukt henholdsvis metadon og buprenorfin. There was little difference between MM and BM women, with the majority of women reporting use of opioids, benzodiazepines, and cannabis. Kakko 2008 Inkludert i systematisk oversikt av Zedler 2016 Kakko J, Heilig M, Sarman I. Buprenorphine and methadone treatment of opiate dependence during pregnancy: comparison of fetal growth and neonatal outcomes in two consecutive case series. Drug Alcohol Depend 2008;96(1-2):69-78 Kelty 2017 (Australia) Fosterdød, dødfødsel, spebarnsdødelighet prematuritet misdannelser Retrospektiv kohortstudie (N=391) Met=199 barn Bup=124 barn Natrekson= 68 barn SIGN FORSKJELL [?] Signifikant flere dødfødsler og spebarnsdød i metadongruppen sammenlignet med kontrollgruppen; ikke signifikant flere i buprenorfingruppen enn i kontrollgruppen. (While rates of stillbirth and neonatal mortality in NEN and buprenorphine-exposed neonates (BEN) were also not significantly different than the CN, rates of neonatal mortality in the methadone-exposed neonates (MEN) were significantly higher than for the CN [odds ratio (OR) 11.65, 95% confidence interval (CI) ].) SIGN FORSKJELL (p=0.03) Met=39 av 199 (19,6%) Bup=13 av 124 (10,5%) SIGN FORSKJELL [?] Signifikant flere misdannelser i metadongruppen sammenlignet med kontrollgruppen; ikke signifikant flere i buprenorfingruppen enn i kontrollgruppen med unntak av én type. Kelty E, Hulse G. A Retrospective Cohort Study of Birth Outcomes in Neonates Exposed to Naltrexone in Utero: A Comparison with Methadone-, Buprenorphine- and Non-opioid-Exposed Neonates. Drugs 2017;77(11): (MEN were associated with an overall higher incidence of total (OR 2.57, 95% CI ) and major (OR 2.32, 95% CI ) birth anomalies compared with the control group, with

5 fødselsvekt hodeomkrets behandlet for elevated rates of musculoskeletal (OR 5.15, 95% CI ) and other anomalies (OR 5.15, 95% CI ). Additionally, two incidences of chromosomal defects were also observed in the MEN, but not in the other three groups.) SIGN FORSKJELL (p=0.03) Met=2884,1 g (SD 658,8 g) Bup= 3035,8 g (SD 594,5 g) (p=0.12) Met=33,1 cm (SD 2,7 cm) Bup=33,6 cm (SD 3,0 cm) (p=0,09) Met= 103 av 199 (51.5%) Bup= 52 av 124 (41.8%) liggedøgn på sykehus Uvisst om det er sign forskjell Met=11,3 dager (0 68 dg) Bup=8,0 dager (0 49 dg) Kelty 2017 (Australia) Spontan/ andre aborter Retrospektiv kohortstudie/ registerstudie (N=5034) Met=1204 Bup=1178 Naltrexon=676 Kontroll=1976 SIGN FORSKJELL Risiko for abort, Met= RR 0,80 (95% KI 0,56 1,14) Risiko for abort, Bup=RR 0,63, (95% KI 0,43 0,92) Overall rates of abortive outcomes (requiring hospital admission or ED attendance) in naltrexone-treated women were not significantly different to women treated with methadone (RR 0.80, 95% CI ) but were higher than those treated with buprenorphine (RR 0.63, 95% CI ) and the control group (RR 0.37, 95% CI ). Kelty E, Hulse G. A Retrospective Cohort Study of Obstetric Outcomes in Opioid-Dependent Women Treated with Implant Naltrexone, Oral Methadone or Sublingual Buprenorphine, and Non-Dependent Controls. Drugs 2017;77(11): Lacroix 2011 Inkludert i systematisk oversikt av Zedler 2016 Lacroix I, Berrebi A, Garipuy D, Schmitt L, Hammou Y, Chaumerliac C, et al. Buprenorphine versus methadone in pregnant opioid-dependent women: a prospective

6 multicenter study. Eur J Clin Pharmacol 2011;67(10): Lejeune 2006 Inkludert i systematisk oversikt av Zedler 2016 Lejeune C, Simmat-Durand L, Gourarier L, Aubisson S, Groupe d'etudes Grossesse et A. Prospective multicenter observational study of 260 infants born to 259 opiatedependent mothers on methadone or high-dose buprenophine substitution. Drug Alcohol Depend 2006;82(3):250-7.