Is tocolytic therapy of value ??? Tractocile vs Nifedipine


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tocolytic therapy has been adopted for prevention of preterm labor. is this true: which tocolytic should we use?

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  • Fig 7 Rankings for efficacy of tocolytics and adverse events. Graph displays distribution of probabilities for each outcome. Ranking indicates probability that drug class is first “best,” second “best,” etc. Dot-dashed line represents 48 hour delay in delivery. Solid line indicates neonatal mortality. Dashed line indicates respiratory distress syndrome. Dotted line represents all cause maternal side effects
  • Is tocolytic therapy of value ??? Tractocile vs Nifedipine

    1. 1. Tocolytic Therapy for preterm labor Atosiban vs Nifedipine: meta- analysis
    2. 2. The perfect tocolytic  is uniformly effective with complete fetomaternal safety does not exist
    3. 3. Types  beta-agonists,  Ca(2+) channel blockers  oxytocin receptor antagonists.  differ in cost, utero-specificity, safety, efficacy
    4. 4. Tocolytic agents  ß-agonist  ß2-receptor: uterus, blood vessels, bronchioles  Stimulate receptoren -> adenyl cyclase -> ↑ cAMP -> ↓ calcium  Most important: ritodrine
    5. 5. Side Effects : Maternal
    6. 6. Side Effects: Fetal
    7. 7. RCOG, 2002  If tocolysis is indicated, B2-agonist should not be used  Choice should be either CCB or Atosiban
    8. 8. CCB: Nifdipine (Adalat )  Effective  SE: Hypotension & tachycardia especially multiple pregnancy
    9. 9. Tractocile® : uterospecific  Introduced in Europe in 2000  Atosiban = structure similar to oxytocine -> inhibit uterus contractions
    10. 10. Tractocile®
    11. 11. Tractocile vs Nifedipine  Both drugs are effective but maternal adverse events are more with Nifedipine (Al-Omari et al, 2006)
    12. 12. In another RCT  Atosiban was effective in 75% of the cases, and nifedipin in 65% of the cases, for delaying delivery for more than 7 days.  The maternal side effects in the atosiban group were 17.5%, and in the nifedipin group they were 40%, which had a statistically significant difference (p=0.027). (Kanashian et al, 2005)
    13. 13. How to use
    14. 14.  Injection  Not longer than 48 hour infusion  Total dose: < 330 mg atosiban
    15. 15. Interesting  Both B2 agonists and Atosiban are registered in Europe for management of preterm labor  Nifedipine: no
    16. 16. Objective of Meta-analysis  to determine the comparative clinical value of atosiban versus nifedipine in women in preterm labor by evaluating both, their comparative effectiveness and safety profiles
    17. 17. Methodology: Meta-analysis  Randomised controlled trials  according to the guidelines of the Cochrane handbook for systematic reviews of interventions (version 5.0.1)
    18. 18. Outcomes  Prolongation of pregnancy  prevention of preterm labor  maternal and fetal side effects and infant morbidity and mortality
    19. 19. safety in favor of atosiban:  there were lower incidence of adverse drug reactions, flushing, GIT upset, hypotension, palpitation, and tachycardia in women prescribed atosiban, with the exception of nausea, which was more frequent in such women
    20. 20. So  The balance of evidence indicates that atosiban is as effective as nifedipine and is significantly safer than it
    21. 21. However We have two major problems:  Cost  Real value
    22. 22. Cost  Atosiban is extremely expensive compared to Nifidipine  This is a major limiting issue in the use of Atosiban
    23. 23. Sustained Tocolysis? Nifidipine could be better choice  406 women with threatened preterm birth randomised to an additional 12 days of nifedipine or placebo after completion of a 48-hour initial course of tocolysis.  The probability of adverse perinatal outcomes was similar between groups, as were mean gestational age and birth weight and likelihood of neonatal intensive care unit admission .
    24. 24. Moreover  Among participants still using Nifedipine at the time of delivery, mean blood loss was higher in those women assigned to nifedipine (432 mL vs. 307 mL; P=0.045). Journal Watch Women's Health January 17, 2013
    25. 25. Why tocolysis?  To allow for a course of corticosteroids  To allow for in utero transfer (women go to tertiary center)
    26. 26. Questioning Tocolysis!!!!  Patient oriented outcome: neonatal mortality ????
    27. 27. What a surprise!!!  No clear evidence was found for the relative effectiveness of any tocolytic versus placebo being beneficial for neonatal mortality
    28. 28. Fig Compared to Placebo Haas D M et al. BMJ 2012;345:bmj.e6226 ©2012 by British Medical Journal Publishing Group
    29. 29. No evidence !!  No evidence of beneficial effect does not mean Evidence of no value  No evidence could be due to small number of patients (type II error), or heteregeneity of studies, or different entry point at time of study
    30. 30. What to do now??  we have become accustomed to the fact that tocolytics buy us time.  The question is : Does it Worth?
    31. 31. To get an answer  is a large scale multi-centred randomised non-blinded trial, analysed by intention to treat.
    32. 32. Till then  Tocolysis will continue  So use the most cost effective modality : CCB
    33. 33. Thank You