Evidence Review A: Interventions for Chronic Hypertension
Total Page：16
File Type：pdf, Size：1020Kb
National Institute for Health and Care Excellence FINAL Hypertension in pregnancy [A] Evidence review for interventions for chronic hypertension NICE guideline NG133 Evidence reviews June 2019 FINAL These evidence reviews were developed by The National Guideline Alliance hosted by the Royal College of Obstetricians and Gynaecologists FINAL Interventions for chronic hypertension Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn. Copyright © NICE 2019. All rights reserved. Subject to Notice of Rights ISBN: 978-1-4731-3434-8 FINAL Interventions for chronic hypertension FINAL Contents Contents Review question: What interventions for chronic hypertension are effective at improving outcomes for women and infants? ......................................................... 7 Introduction ........................................................................................................... 7 Summary of the protocol ....................................................................................... 7 Methods and process ............................................................................................ 8 Clinical evidence ................................................................................................... 9 Summary of clinical studies included in the evidence review ................................. 9 Economic evidence ............................................................................................. 14 Evidence statements ........................................................................................... 14 Comparison 1. Induction of labour versus expectant management ...................... 14 Comparison 2. Exercise versus no intervention ................................................... 15 Comparison 3. Less-tight versus tight control of blood pressure .......................... 16 Comparison 4. Atenolol versus placebo .............................................................. 17 Comparison 5. Labetalol versus no intervention .................................................. 18 Comparison 6. Labetalol versus nifedipine .......................................................... 19 Comparison 7. Labetalol versus methyldopa ....................................................... 20 Comparison 8. Methyldopa versus placebo ......................................................... 22 Comparison 9. Methyldopa versus no intervention .............................................. 22 Comparison 10. Amlodipine versus aspirin .......................................................... 24 Comparison 11. Aspirin versus no intervention .................................................... 25 The committee’s discussion of the evidence ........................................................ 26 References .......................................................................................................... 30 Appendices ........................................................................................................................ 32 Appendix A – Review protocol ...................................................................................... 32 Appendix B – Literature search strategies .................................................................... 44 Health economics search strategies .................................................................... 49 Appendix C – Clinical evidence study selection ............................................................ 56 Appendex D – Clinical evidence tables ......................................................................... 57 Appendix E – Forest plots........................................................................................... 101 Appendix F – GRADE tables ...................................................................................... 104 Appendix G – Economic evidence study selection ...................................................... 125 Appendix H – Economic evidence tables .................................................................... 126 Appendix I – Health economic evidence profiles ......................................................... 127 Appendix J – Health economic analysis ...................................................................... 128 Appendix K – Excluded studies .................................................................................. 129 Clinical studies .................................................................................................. 129 Economic studies .............................................................................................. 142 Appendix L – Research recommendations ................................................................. 145 5 FINAL Contents 1. In women who require treatment for chronic hypertension in pregnancy, what is the effectiveness and safety of antihypertensive agents (compared in head-to-head trials) in improving maternal and perinatal outcomes? ............................................................................... 145 2. In women who require treatment for hypertension in pregnancy, what are the adverse neonatal outcomes associated with maternal use of beta-blockers (or mixed alpha-beta blockers)? ....................................... 146 6 FINAL Interventions for chronic hypertension Review question: What interventions for chronic hypertension are effective at improving outcomes for women and infants? Introduction Chronic hypertension in pregnancy is hypertension present at the booking visit or before 20 weeks, or if the woman is already taking antihypertensive medication when presenting to maternity services. It can be primary or secondary in aetiology. Its pathophysiology is likely to be different from gestational hypertension, and intervention in chronic hypertension which are successful in reducing complications in the mother and baby may be different from those interventions which improve outcomes in gestational hypertension. This review will look at the evidence for interventions in chronic hypertension in pregnancy to determine which improve outcomes in the woman and her baby. Summary of the protocol See Table 1 for a summary of the population, intervention, comparison and outcome (PICO) characteristics of this review. Table 1: Summary of the protocol (PICO table) Population Pregnant women with chronic hypertension. This population includes women with: Essential (primary) hypertension Secondary hypertension e.g. secondary to chronic kidney disease, diabetes. Intervention Centrally acting alpha2-adrenoceptor agonists Beta-blockers/mixed alpha/beta-blockers Calcium channel blockers Diuretics Angiotensin converting enzyme (ACE) inhibitors Acetylsalicylic acid/aspirin Elective (planned) delivery versus expectant management Tight management (for example, diastolic target = 85mmHg) Less-tight management (for example, diastolic target = 100 mmHg) Automated monitoring of blood pressure Ambulatory/self-monitoring of blood pressure Exercise Dietary interventions Dietary salt reduction Comparison No intervention Placebo Each other of the interventions outlined above Combinations of the interventions outlined above Outcome Outcomes for babies Critical outcomes: 7 Hypertension in pregnancy: evidence review for interventions for chronic hypertension FINAL (June 2019) FINAL Interventions for chronic hypertension Perinatal mortality o Stillbirth (include if reported as part of perinatal mortality) o Neonatal death up to 7 days (include if reported as part of perinatal mortality) Small-for-gestational age (birthweight <10th centile) Important outcomes: Birth weight Gestational age at birth Preterm birth (<28 weeks, <34 weeks, <37 weeks) Admission to neonatal unit Neurodevelopmental outcomes: o Cerebral palsy (CP) (dichotomous outcome, reported as present/absent, not severity of condition) o Neurodevelopmental delay (dichotomous outcome, not continuous outcomes such as mean change in score): - Severe (score of >2SD below normal on validated assessment scales, or Bayley assessment scale of mental development index [MDI] or psychomotor developmental index [PDI] <70,