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EVIDENCE UPDATE Guidelines Approached Mylan for an Educational Grant to Support the Production of a Supplement The importance of the progestogenic component of hormone replacement therapy in women with a uterus Dr John C Stevenson, Consultant Physician and Endocrinologist, Royal Brompton Hospital; Reader in Metabolic Medicine, Imperial College London Dr Sophia Tsiligiannis, Specialty Trainee in Obstetrics and Gynaecology, Chelsea and Westminster Hospital; Clinical Research Fellow, Imperial College London EVIDENCE UPDATE Guidelines approached Mylan for an educational grant to support the production of a supplement. The cPD credits grant included honoraria for the authors. Mylan has had no influence over the selection of the authors or the content of the supplement and has reviewed it for technical accuracy and to ensure compliance with regulations. The views and opinions of the authors are not necessarily those of Mylan, or of Guidelines, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher. © MGP 2019 Date of preparation: July 2019 www.Guidelines.co.uk THE PROGESTOGENIC COMPONENT OF HRT The importance of the progestogenic component of hormone replacement therapy in women with a uterus Dr John C Stevenson, Consultant Physician and Endocrinologist, Royal Brompton Hospital; Reader in Metabolic Medicine, Imperial College London Dr Sophia Tsiligiannis, Specialty Trainee in Obstetrics and Gynaecology, Chelsea and Westminster Hospital; Clinical Research Fellow, Imperial College London Introduction in the UK currently use HRT to manage their symptoms.6 The menopause transition is a critical stage in women’s health. The oestrogen deficiency that accompanies the menopause is associated Rationale behind progestogen with irregular periods, eventual amenorrhoea, prescribing and multiple other symptoms—the most common being hot flushes and night sweats, Oestrogen alone can be offered to women vaginal dryness, mood changes, sexual without a uterus, whereas the addition of a dysfunction (including loss of libido), memory and progestogen is required for women with a concentration changes, headaches, and joint uterus.6 A regimen containing bazedoxifene and muscle complaints. Around 80% of women (BZA; a selective oestrogen receptor modulator) will experience vasomotor symptoms,1 with most combined with conjugated equine oestrogens rating these as moderate to severe.2 An American (CEE) is available as a progestogen‑free observational study indicated that the median alternative for use in women with a uterus.9 vasomotor symptom duration is 7.4 years.3 Tibolone is a synthetic compound with weak Furthermore, vasomotor symptoms are oestrogenic, progestogenic, and androgenic independently associated with multiple indicators activity, and is also licensed for HRT use in the of elevated cardiovascular risk,4 and reduction in UK.10 It may be given to women with low libido, bone mineral density (BMD).5 but adverse metabolic effects limit its use. NICE guidance advises offering hormone The association between unopposed oestrogen replacement therapy (HRT) for vasomotor therapy and endometrial hyperplasia/ symptoms after discussing with women the neoplasia is established.11 A 20% incidence short‑term (up to 5 years) and longer‑term of endometrial hyperplasia was shown benefits and risks.6 However, the management with 1 year of unopposed oestrogen use.12 of menopausal symptoms often presents a Cyclical progestogen given in combination clinical challenge to prescribers. Concerns about with low‑dose oestrogen for 10 days monthly breast cancer risk have contributed to reduced reduced endometrial hyperplasia to placebo prescribing of HRT in the UK. Initial data from the rate,13 and the WHI trial, which used continuous 2002 Women’s Health Initiative (WHI) trial showed combined HRT, demonstrated a 19% reduction an increased risk of breast cancer, albeit not (non‑significant) in endometrial hyperplasia statistically significant, and possible early harm compared with placebo.14 from coronary heart disease (CHD) in women receiving combined oestrogen and progesterone.7 In some cases, progestogens (in a combined Subsequently, follow‑up data from the same HRT regimen) are prescribed to women study published in 2013 showed no detrimental without a uterus but with a history of severe effect on CHD.8 With careful consideration of endometriosis to prevent symptom reactivation the risks and benefits, around 1 million women (e.g. pelvic pain), recurrence, and malignant 2 THE PROGESTOGENIC COMPONENT OF HRT transformation of endometriotic foci.15 discomfort.17 General contraindications include Despite a lack of high‑quality studies, case breast, ovarian, or uterine cancer, a history of reports consistently show a predominance of blood clots, and liver disease,17 with specific oestrogen‑only HRT in women with recurrence contraindications for each preparation. of endometriosis and malignancy.15 As a result, combined preparations are often favoured.15 Risks associated with progestogen prescribing Progestogens currently available for prescription Breast cancer Broadly speaking, progestogens have one effect NICE guidance advises explaining to women in common: the induction of a characteristic around the natural age of menopause that the effect on the oestrogen‑primed endometrium.16 baseline risk of breast cancer varies according There are, however, large variations in the myriad to the presence of underlying risk factors.6 HRT other biological effects elicited by different with oestrogen alone is associated with little or progestogens.16 The progestogenic activity of no change in the risk of breast cancer relative to any substance also depends on its timing and baseline risk, whereas HRT with oestrogen and route of administration. A list of progestogens progestogen can be associated with a slightly currently licenced for use in the UK as part of increased risk of breast cancer.6 combined HRT and their receptor activities is provided in Table 1. NICE guidance reports a baseline population risk of breast cancer of 22.48 per 1000 women Progestogens also exhibit antigonadotropic over 7.5 years.6 Follow‑up data from the WHI effects, which inhibit ovulation when prescribed trial demonstrated that, for current HRT users, for contraceptive use.16 there were four fewer cases of breast cancer per 1000 women among women using oestrogen alone relative to baseline, although this was not Contraindications and side‑effects statistically significant.8 There were five additional cases of breast cancer per 1000 women among Specific side‑effects depend on the type of women using oestrogen and progestogen receptor activity exhibited by each progestogen, relative to baseline.8 In simple terms, use of as demonstrated in Table 1. Common combined HRT is associated with approximately side‑effects for most progestogens include one extra case of breast cancer for every 1000 headache, menstrual cycle irregularities, breast users per year compared with use of oestrogen pain, skin reactions, and gastrointestinal alone.8 Table 1: Progestogens currently licenced for use in the UK as part of combined HRT Anti‑ Anti‑ Progestogen Oestrogenic Androgenic Glucocorticoid Antimineralocorticoid oestrogenic androgenic Norethisterone ✓ ✓ ✓ ✗ ✗ ✗ Levonorgestrel/ Norgestrel (including ✗ ✓ ✓ ✗ ✗ ✗ intrauterine devices) Progesterone ✗ ✓ ✗ ✓ ✓ ✓ Medroxyprogesterone ✗ ✓ ✓ ✗ ✓ ✗ acetate Dydrogesterone ✗ ✓ ✗ ✓ ✗ ✓ 3 THE PROGESTOGENIC COMPONENT OF HRT In the WHI trial, combined HRT consisted of CEE Cardiovascular disease with medroxyprogesterone acetate (MPA),7,8 and the same risk may not apply to different types of HRT has the potential to improve cardiovascular progestogen. Two cohort studies showed that risk because of beneficial effects on lipids, oestrogen combined with either progesterone vascular function, and glucose metabolism.27 An or dydrogesterone is not associated with updated analysis of the WHI trial showed that a statistically significantly increased risk of initiating oestrogen alone closer to the onset of breast cancer.18,19 This may be because some menopause was associated with lower CHD risk progestogens reduce proliferation; however, their and a reduction in total mortality.8,28 Randomised effects on breast tissue are complex and poorly controlled trials, observational studies, and meta‑ understood.18 A case‑control analysis by the analyses consistently support primary prevention UK‑based General Practice Research Database of CHD and reduction in overall mortality in also demonstrated that use of oestrogen with women initiating HRT nearer to the onset of dydrogesterone is not associated with an menopause. The data suggest that the ‘window increased risk of breast cancer.20 of opportunity’ for reducing CHD and overall mortality is initiation of HRT prior to 60 years of Venous thromboembolism age and/or within 10 years of the menopause.29 The risk of venous thromboembolism (VTE) Lipid profiles is increased by oral HRT relative to baseline population risk.8 Conversely, epidemiological All CEE and CEE/MPA regimens have favourable studies have not identified a risk of VTE effects on lipid profiles, including reductions above baseline population risk with the use in low‑density lipoprotein cholesterol (LDL) of transdermal HRT.21–23 This is likely because and increases in high‑density lipoprotein transdermal delivery avoids first‑pass liver cholesterol (HDL), although triglyceride increases metabolism of oestrone (the main metabolite have also been observed with oral therapy.30 of oral oestradiol) in the liver, which increases Similarly,
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