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PREGNANCY AND SMOKING CESSATION

PREGNANCY AND SMOKING CESSATION. Funda Öztuna, MD Karadeniz Technical University, School of Medicine, Dept. of Chest Diseases The 12th Annual Congress of the Turkish Thoracic Society , 08-12 April, 2009 in Antalya . PLAN OF PRESENTATION. General information

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PREGNANCY AND SMOKING CESSATION

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  1. PREGNANCY AND SMOKING CESSATION Funda Öztuna, MD Karadeniz Technical University, School of Medicine, Dept. of Chest Diseases The 12th Annual Congress of the Turkish Thoracic Society, 08-12 April, 2009 in Antalya

  2. PLAN OF PRESENTATION • General information • Assessment of tobacco use in pregnancy • Treatment of smoking cessation • Summary

  3. FETAL-EFFECTS • Ectopic pregnancy • Placentaprevia • Placental abruption • Premature rupture of membranes • Stillbirth • Low birth weight Dominguez-Rojas V, et al.Eur J Epidemiology. 1994;10:665. Armstrong BG,et al.Am J Public Health. 1992;82:85. Hadley CB,et al.AmJPerinatology. 1990;7:374. Harger JH, et al.Am J Obstet Gynecol1990;163:130–137. Raymond EG, et al. Obstet Gynecol Scand.1993;72:633.

  4. FETAL-EFFECTS • Neonatal respiratory distress syndrome • Patent ductus arteriosus • Intraventricular hemorrhage • Necrotizing enterocolitis • Retinopathy • Increased chromosomal instability in amniocytes Kolas T, et al.Acta Obstet Gynecol Scand.2000;79:644–648. Wang X, et al.JAMA. 2002;287:195. de la Chica RA, et al.JAMA. 2005;293:1212.

  5. INFANTS AND CHILDREN -EFFECTS • Sudden infant death syndrome • Respiratory infections • Reactive airway diseases • Otitis media • Bronchiolitis • Hyperactivity • Decreased school performance • Atopi • Asthma US Department of Health and HumanServices. Exposure to Tobacco Smoke: 2006.

  6. WHY? • Psychosocial problems (depression) • Anxiety • High job strain • Lesser education,low economic status • Partner smoking • Heavier smokers Goedhart G. Et al. Addictive Behaviors 34 (2009) 403–406 DiClemente et al., 2000; Phares TM et al., 2004 Department of Health and Human Services.Women and Smoking: A report of the Surgeon General-2001

  7. PREGNANCY IS METHOHD OF SMOKING CESSATION??? Pregnant women; • Clearance of nicotine and cotinine increased 60 and 140% But • 20-30% spontaneously quit smoking after learning of pregnancy • Another 12% quit later on; however, the majority of pregnantsmokers cut down, but do not quit Dempsey D, et al. J Pharmacol Exp Ther 2002;301(2):594–598 Lumley J, et al.CochraneDatabase Syst Rev. 2005. Floydet al., 1993; LeClere & Wilson, 1997; Severson et al., 1995 Fingerhut et al., 1991

  8. 746 pregnant women • 151- current smoker 102- %67 quit smoke while pregnancy 49- %32.5 continuoussmoking • 595- no smoking Karadeniz Technical University, Dept. of Publc Health, Study of violence in pregnancy, unprinted data, 2006

  9. Assessing tobacco dependence

  10. 5A • ASK • ADVİSE • ASSESS • ASSİST • ARRANGE

  11. Mullen PD, Am J Obstet Gynecol.1991;165:409–413.

  12. CLINIC ASSESMENT • Questionnaire forms -FagerstromTest for Nicotine Dependence -DSM-IV • Biochemical parameters -Nicotine -Cotinine -CO World Health Organization. International Classification of Diseases, 10th Edn. Geneva, World Health Organization, 1992. Etter JF, LeHouezec J, Perneger TV. Neuropsychopharmacology 2003; 28: 359–370.

  13. TREATMENT • Cognitive-behavioral interventions • Pharmacotherapies

  14. BEHAVIORAL INTERVENTION • Brief – intensive counseling -Videotape (information on risks, barriers,) -Problem Solving Skills and Coping Strategies -Tips for quitting • Pregnancy-specific self-help materials • Telephone followup calls Treating Tobacco Use and Dependence:Clinical Practice Guideline2008 Update

  15. Treating Tobacco Use and Dependence:Clinical Practice Guideline2008 Update

  16. PHARMACOTHERAPIES • Nicotine Replacement Treatment • Non –Nicotine Treatment • Bupropion • Varenicline • Cytisine • Rimonabant • Clonidine • Nortriptyline • Nicotine vaccine • Maclobemide • Serotonin reuptake inhibitors • Opioids

  17. FDA Pregnancy Category Definitions A;Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote. B;Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters). C;Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus. D;There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). X; Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant

  18. Nicotine Treatment Nicotine gum and patch; • Maternal Blood pressure↑ ↑ • Maternal heart rate↑ ↑ • Fetus herat rate↑ • Smoking? Dempsey D, et al. J Pharmacol Exp Ther 2002;301(2):594–598

  19. Gennser G, et al. Am J Obstet Gynecol 1975;123:861-7. *Manning FA, et al. Br J Obstet Gynecol 1976;83:262-70 &Russel Mah,et al. Drug metab.Rev.1978;8:894-902

  20. NRT

  21. Effects of short-term use of nicotine gum in pregnant smokers Pregnant women who smoked chronically were randomly assigned 1. group that smoked cigarettes (n = 10) 2. group that chewed at nicotine gum (2 mg nicotine per piece) (n = 19). • Plasma nicotine and cotinine concentrations • Maternal and fetal hemodynamics • Maternal heart rate and blood pressure • Uterine resistance index • Fetal heart rate • Umbilical artery resistance index Oncken CA, et al. Effects of short term nicotine gum use in pregnant smokers Clin Pharmacol ther 1996;59:654-1

  22. Peak Nicotine Concentrations (ng/mL) 25 Smokers Gum chewers 20 15 Trough Nicotine Concentrations (ng/mL) 10 14 5 Smokers 12 Gum chewers NS p<.0001 10 0 Follow-up Baseline 8 6 4 2 NS p<.0025 0 Follow-up Baseline

  23. Nicotine patches for pregnant smokers: a randomized controlled study Pregnant women who smoked 10 or more cigarettes after the first trimester (n: 250) Nicotine patches (n = 124) 15-mg patches (16 hours/day) for 8 weeks 10-mg patches (16 hours/day) for 3 weeks Placebo patches (n = 126) Mean birth weight difference was 186 g (95% CI 35, 336 g) higher in the nicotine than placebo group There was no difference in the rate of preterm delivery between the two groups Wisborg K, et al. ObstetGynecol. 2000 ;96(6):967-71

  24. Quit rates Wisborg K, et al. ObstetGynecol. 2000 ;96(6):967-71

  25. Multimodal intervention raises smoking cessation rate during pregnancy 647 pregnant smokers • Intervention group (n = 327) • Usual care group (n = 320) Outcome was; • self-reported • cotinine saliva concentration NRT cessation rates (14%) Usual care cessation rates (5.0%) (p < 0.0001) (Fisher's exact test) Hegaard HK, et al.Acta Obstet Gynecol Scand. 2003 ;82(9):813-9

  26. Nicotine replacement and behavioral therapy for smoking cessation in pregnancy 2:1 randomization Arm 1:Cognitive Behavioral Treatment (n=59) Arm 2:Cognitive Behavioral Treatment + NRT (n=122) patch, gum, or lozenge, 6 CBT Outcomes were; 7weekspostrandomization 38 weeksgestation 3monthspostpartum Pollak KI, Oncken CA, Lipkus et al., AJPM 2007;33:297-305

  27. Cessation Rates * p<.05 Pollak KI, Oncken CA, Lipkus et al., AJPM 2007;33:297-305

  28. Smoking cessation in pregnancy BACKGROUND: Pregnant women who continue to smoke expose their developing fetus to a wide range of risks. Assisting these patients to stop smoking can be an important intervention for the health of the baby and the mother. The management of pregnant smokers can be challenging, due to the potential risks of pharmacotherapy. There are a number of options available to the clinician to aid smoking cessation in non pregnant women. These include nicotine replacement therapy (NRT), bupropion, varenicline, and a range of non-drug therapies. OBJECTIVE: To provide guidance to prescribers on the best way to manage smoking cessation in the pregnant patient, reviewing the risks and efficacy of the different approaches. METHODS: An extensive literature search was carried out to find original studies which examined issues surrounding the safety and efficacy of methods of smoking cessation in pregnancy. RESULTS/CONCLUSION:NRT is the agent of choice for smoking cessation in pregnancy as the safety of other therapies in pregnancy have not yet been proved. Rore C, et al. Expert Opin Drug Saf. 2008 Nov;7(6):727-37

  29. Nicotine Treatment Pregnant women can use nicotine replacement “afterdiscussion with a doctor’’ Treating Tobacco Use and Dependence:Clinical Practice Guideline2008 Update

  30. NRT • Metabolism of nicotine increase in pregnancy • Nicotine replacement generally is not very successful • Effects on fetus unclear • First trimester- high risk Kapur B, et al. Curr Ther Res 2001 62(4):274–278 Hotham ED, et al.Drug Alcohol Rev 2002 21:163–168 Schroeder DR, et al.J Matern Fetal Neonatal Med 2002 11(2):100–107. Wisborg K, et Obstet Gynecol 2000 96(6):967–971 Morales-Suarez MM,et al. Obstet Gyneocol. 2006;107:51–57.

  31. BUPROPiON • FDA-Class B • Dose: 1x150mg three day,2x150mg 7-12 wk • Bupropion and its metabolites are secreted in human milk • Insomnia, dry mouth, increased risk of seizures • More effective and safe than NRT Chun-Fai-Chan B, et al. AJOG 2005;192:953–936. Hale T. Pharmasoft Publishing;2000. bgy65

  32. BUPROPiON • 136 pregnant women Live births-105 The mean birth weight was- 3450g The mean gestational age-40wk Spontaneous abortions-20 *(p=0.009) Therapeutic abortions- 10 Stillbirth -1 Neonatal death-1 There was no fetal anomaly Chun-Fai-Chan B, et al. Am J Obstet Gynecol 2005 192(3):932–936

  33. Smoking Cessation Medication Use Among Pregnant and Postpartum Smokers OBJECTIVE: To assess how often pregnant and postpar-tum smokers use medications and how often obstetricproviders recommend them. METHODS: We analyzed end-of-pregnancy and 3-monthpostpartum surveysof296 pregnant smokers enrolled ina randomized controlled trial of Telephonecounseling forsmoking cessation that did not include medication. Patients wereasked whether any obstetric provider discussed cessation medication andwhether they had usedmedication. Nancy A. Rigotti,et al. Obstetrıcs & Gynecologyvol. 111, No. 2, Part 1, February 2008

  34. P<.001) P=.001 Nancy A. Rigotti,et al. Obstetrıcs & Gynecologyvol. 111, No. 2, Part 1, February 2008

  35. Nancy A. Rigotti,et al. Obstetrıcs & Gynecologyvol. 111, No. 2, Part 1, February 2008

  36. VARENICLINE • FDA-Class C • Congenital malformation risk is not high in animal studies • Low weight of rabbit fetus (+) • Excreted in human milk • No available study on pregnant women Stack NM. Pharmacotherapy 2007; 27 (11):1550–1557

  37. BROMOCRIPTINE • It is usedin the treatment of hyperprolactinemia • Dopaminergic properties are similar to those ofbupropion 2,587 pregnancies in 2,437 women treatedwith bromocriptine No congenital malformation, spontaneous abortion or multiple pregnancy Krupp P, et al. J Molec Med 1987; 65(17):823–827.

  38. CYTISINE • A natural plant alkaloid • Molecularstructure somewhat similar to that of nicotine and varenicline • No information on safety of the drug in pregnancy Tutka P, et al. Pharmacol Rep 2006; 58(6):777–798

  39. OTHER DRUGS CLONIDINE - FDA Class C NORTRIPTYLINE- FDA-Class D MACLOBEMIDE- FDA Klas C Briggs GG,et al. 2002.

  40. POSTPARTUM PERIOD About half of thewomen who quit duringpregnancy resume smoking within 6 months afterdelivery and up to 80%within 12 months Folow up must be done after birth. Because; • Nicotine is secreted in humanbreast milk • It may lead to a decrease in milk production Lelong N, et al.Eur J Public Health 2001; 11: 334–9. Colman G-J, Joyce T.. Am J Prev Med 2003; 24:29–35. Lawrence T, et al. Addiction 2005;100(1):107–116 Matheson I, Rivrud GN. JAMA 1989; 261(1):42–43 Hopkinson JM,et al.Pediatrics 1992;90(6):934–938

  41. REASONS • Pregnancy related Stress of caring for a newborn, breast-feeding • Social reasons Smoking partner, drinking alcohol or coffee • Other Exhaustion, weight gain, heavy smoker,age Fang WL, et al. J Am Board Fam Pract 2004; 17: 264–75.

  42. Private and social support are important Don’t forget power of maternity There is no safe drug The risks and benefits must bediscussed Close following

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