Estrogen (conjugated estrogens & ethinyl estradiol) Addition to the List

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1 Estrogen (conjugated estrogens & ethinyl estradiol) Addition to the List Note: Commonly prescribed medication. Literature question Is estrogen effective and safe? Are conjugated estrogens effective and safe? Literature search Medline: Conjugated estrogens AND efficacy AND limit to (meta-analysis or review); Ethinyl estrogen AND efficacy AND limit to (meta-analysis or review) Cochrane: Conjugated estrogens AND efficacy And limit to (meta-analysis or review); Ethinyl estrogen AND efficacy And limit to (meta-analysis or review) Boardman HMP, Hartley L, Eisinga A, Main C, Roque I Figuls M, Bonfill Cosp X, Gabriel Sanchez R, Knight B. Hormone therapy for preventing cardiovascular disease in post-menopausal women (Review). The Cochrane Library (2015). We found high quality evidence that hormone therapy in both primary and secondary prevention conferred no protective effects for all-cause mortality, cardiovascular death, non-fatal myocardial infarction, angina, or revascularisation. However, there was an increased risk of stroke in those in the hormone therapy arm for combined primary and secondary prevention (RR 1.24, 95% CI 1.10 to 1.41). Venous thromboembolic events were increased (RR 1.92, 95% CI 1.36 to 2.69), as were pulmonary emboli (RR 1.81, 95% CI 1.32 to 2.48) on hormone therapy relative to placebo.

2 Heidi D Nelson. Commonly Used Types of Postmenopausal Estrogen for Treatment of Hot Flashes. JAMA 2004 (291): All 8 trials of oral CEE reported statistically significant improvements in hot flash frequency, severity, or both compared with placebo (Table 1, Table 7, Table 8).20,42-48 Three trials included treatment groups with concomitant progestin or progesterone use (cyclic and continuous medroxyprogesterone acetate, cyclic micronized progesterone).42,47,48 One trial compared 3 doses of CEE alone (0.3, 0.45, and mg/d) and reported bigger treatment effects with 0.625mg than 0.45 mg or 0.3 mg (P_.05).48 Differences between estrogen doses were not found in patients provided with CEE (0.3, 0.45, and mg/d) and continuous medroxyprogesterone acetate (1.5 or 2.5 mg/d) in this trial.48 Lethaby A, Hogervorst E, Richards M, Yesufu A, and Yaffe K. Hormone replacement therapy for cognitive function in postmenopausal women (Review). The Cochrane Library (2015). Meta-analyses showed no effects of either ERT or HRT on prevention of cognitive impairment after five and four years of treatment, respectively (odds ratio 1.34, 95% CI 0.95 to 1.9; odds ratio 1.05, 95% CI 0.72 to 1.54 respectively) (trend favouring control in both instances). Analyses assessing the effects of treatment over time found that both ERT and HRT did not maintain or improve cognitive function and may even adversely affect this outcome (WMD = -0.45, 95% CI to 0.09;WMD = -0.16, 95% CI to 0.26, respectively at maximum follow up). Negative effects were found for ERT after one year and HRT after three and four years of therapy. Results from smaller trials assessing effects onindividual cognitive domains mostly reported no evidence of benefit. Suckling JA, Kennedy R, Lethaby A, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women (Review). The Cochrane Library (2010). The vaginal oestrogen ring was significantly more effective than placebo in reducing the following symptoms of vaginal atrophy: dyspareunia, pallor, friability, pruritis and dryness. The oestrogen vaginal tablets, when compared to the ring and placebo, were significantly more effective for reducing the symptoms of dyspareunia, frequency, dryness and burning and itching. Vaginal oestrogen cream was significantly effective for reducing vaginal dryness, vaginal moisture, vaginal fluid volume and elasticity when compared to moisturizing gel. When the ring was compared to the cream there were no noted significant differences. The cream (conjugated equine oestrogen), when

3 compared with the tablets (17B-oestradiol), was the only treatment with any reported significant adverse effects (uterine bleeding, breast pain and perineal pain). These results should be viewed with caution as they are based on the results of two trials. Although not statistically significant, there were cases of hyperplasia and endometrial overstimulation with the ring, cream and tablets (17B-oestradiol). This raises the question of whether women need progestogenic protection from possible vaginal absorption of oestrogen from the ring, cream or tablets when used beyond six months. Menopause; Amie J. Cullimore, Bed, MD, MSc, FRCSC. e-cps. Date of Revision: July Class Drug Dosage Adverse Effects Comments Cost Estrogens, oral Conjugated estrogens mg daily $ Premarin Bloating, headache, nausea, chloasma, breast tenderness, breakthrough bleeding/spotting. Increased risk of VTE, CVD, breast cancer Administer with a progestogen in patients with intact uterus to prevent endometrial hyperplasia or cancer. Consider vaginal estrogen for patients with vaginal symptoms only.

4 Topical estrogen Addition to the list Explanation for addition we did not list any hormone molecules (i.e. Premarin Vaginal Cream, Vagifem tablets) for intravaginal application. - Norm (Research pharmacist in CLEAN Meds Research Team) Relevant medications on CLEAN Meds Essential Medication List Ethinyl estradiol (added on March, 2016) Literature review question Is the transdermal or intravaginal estradiol effective and safe for vasomotor or genitourinary symptoms in postmenopausal women? Is the topical/intravaginal estradiol superior to oral medications with respect to safety profile (uterine cancer, heart diseases, stroke, DVT, dementia, etc.)? Brief literature search strategies Utilized electronic databases PubMed and Cochrane Search strategies [(systematic review filter) AND (Topical estrogen OR estradiol) AND (post menopause OR menopause)] OR [(systematic review filter) AND (hormone replacement therapy)] Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database of Systematic Reviews. 2016; (8). Aim: The objective of this review was to compare the efficacy and safety of intra-vaginal oestrogenic preparations in relieving the symptoms of vaginal atrophy in postmenopausal women. Studies Included: 30 RCTs (6235 women) comparing different intra-vaginal oestrogenic preparations with each other and with placebo. Outcome Measures: Primary Outcomes 1. improvement in symptoms (participant-assessed) 2. adverse event endometrial thickness. Secondary outcomes 1. improvement in symptoms (clinician-assessed), 2. other adverse events (breast disorders e.g. breast pain, enlargement or engorgement, total adverse events, excluding breast disorders) 3. adherence to treatment

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8 Journal of Obstetrics and Gynaecology Canada/ The Society of Obstetricians and Gynaecologists of Canada: Managing Menopause Vasomotor Symptoms: Recommendations: 2. Health care providers should offer hormone therapy, estrogen alone or combined with a progestin, as the most effective agents for the medical management of menopausal symptoms. (I-A) Urogential Health: Recommendations 1. Conjugated estrogen cream, an intravaginal sustained-release estradiol ring, and low-dose estradiol vaginal tablets are recommended as effective treatment for vaginal atrophy. (I-A) 2. Routine progestin co-therapy is not required for endometrial protection in women receiving vaginal estrogen therapy in an appropriate dose. (III-C) 3. Vaginal lubricants may be recommended for subjective symptom improvement of dyspareunia. (II-2B) 4. Because systemic absorption of vaginal estrogen is minimal, its use is not contraindicated in women with contraindications to systemic estrogen therapy, including recent stroke and thromboembolic disease. (III-C) However, there are currently insufficient data to recommend its use in women with breast cancer who are receiving aromatase inhibitors (where the goal of adjuvant therapy is a complete absence of estrogen at the tissue level). Its use in this circumstance needs to be dictated by quality-of-life concerns after discussion of possible risks. (III-C) 8. Vaginal estrogen therapy can be recommended for the prevention of recurrent urinary tract infections in postmenopausal women. (I-B)

9 NICE (National Institute for Health and Care Excellence) Menopause Clinical Guideline Recommendations 14. Offer women HRT for vasomotor symptoms after discussing with them the short-term (up to 5 years) and longer-term benefits and risks. Offer a choice of preparations as follows: oestrogen and progestogen to women with a uterus oestrogen alone to women without a uterus 26. Offer vaginal oestrogen to women with urogenital atrophy (including those on systemic HRT) and continue treatment for as long as needed to relieve symptoms 27. Consider vaginal oestrogen for women with urogenital atrophy in whom systemic HRT is contraindicated, after seeking advice from a healthcare professional with expertise in menopause. 28. If vaginal oestrogen does not relieve symptoms of urogenital atrophy, consider increasing the dose after seeking advice from a healthcare professional with expertise in menopause. 29. Explain to women with urogenital atrophy that: symptoms often come back when treatment is stopped adverse effects from vaginal oestrogen are very rare they should report unscheduled vaginal bleeding to their GP 39. Explain to women that the risk of VTE associated with HRT is greater for oral than transdermal preparations 40. Consider transdermal rather than oral HRT for menopausal women who are at increased risk of VTE, including those with a BMI over 30 kg/m2 46. Explain to women that taking HRT (either orally or transdermally) is not associated with an increased risk of developing type 2 diabetes. American Association of clinical endocrinologists (AACE) Medical Guidelines for Clinical Practice for Diagnosis and Treatment of Menopause 2011 R1. Menopausal hormone therapy (MHT) may be appropriate for the relief of severe menopausal symptoms in selected postmenopausal women, on the basis of an individually determined benefit-versusrisk profile (Grade A; BEL 1). R2. MHT may be prescribed during the perimenopause and early menopause for relief of menopausal symptoms and treatment of vulvovaginal atrophy (Grade A; BEL 1). R3. The use of the transdermal route of estrogen administration should be considered in order to avoid the hepatic first-pass effect, which may theoretically reduce the risk of thromboembolic disease (Grade B; BEL 3). R4. The use of transvaginal estrogen may be considered to provide topical effects with less systemic absorption (Grade B; BEL 3) R10. MHT should be used in the lowest dose and for the shortest period necessary to control menopausal symptoms (Grade A; BEL 1).

10 The American College of Obstetricians and Gynecologists. Practice Bulletin No. 141: Management of Menopausal Symptoms Clinical Considerations and Recommendations What hormonal medications are effective in treating vasomotor symptoms? Systemic hormone therapy (HT), with estrogen alone or in combination with progestin, is the most effective therapy for vasomotor symptoms related to menopause. Data do not support the use of progestin-only medications, testosterone, or compounded bioidentical hormones for the treatment of vasomotor symptoms Routes of Administration There are a variety of preparations available for systemic estrogen therapy. Estrogen with or without progestin can be administered orally or transdermally in the forms of patches, gels, or sprays. All of these delivery methods have been shown to relieve vasomotor symptoms, and also include other delivery methods, such as intranasal and buccal systems that are not available in the United States Estrogen therapy effectively alleviates atrophic vaginal symptoms related to menopause. Local therapy is advised for the treatment of women with only vaginal symptoms. Local vaginal estradiol and local conjugated equine estrogen, which can be administered in cream, ring, and tablet formulations, are effective in treating atrophic vaginitis in menopausal women.

11 Complete search strategy PubMed (n=344) #2 Search (((systematic review [ti] OR meta-analysis [pt] OR meta-analysis [ti] OR systematic literature review [ti] OR this systematic review [tw] OR pooling project [tw] OR (systematic review [tiab] AND review [pt]) OR meta synthesis [ti] OR meta synthesis [ti] OR integrative review [tw] OR integrative research review [tw] OR rapid review [tw] OR consensus development conference [pt] OR practice guideline [pt] OR drug class reviews [ti] OR cochrane database syst rev [ta] OR acp journal club [ta] OR health technol assess [ta] OR evid rep technol assess summ [ta] OR jbi database system rev implement rep [ta]) OR (clinical guideline [tw] AND management [tw]) OR ((evidence based[ti] OR evidence-based medicine [mh] OR best practice* [ti] OR evidence synthesis [tiab]) AND (review [pt] OR diseases category[mh] OR behavior and behavior mechanisms [mh] OR therapeutics [mh] OR evaluation studies[pt] OR validation studies[pt] OR guideline [pt] OR pmcbook)) OR ((systematic [tw] OR systematically [tw] OR critical [tiab] OR (study selection [tw]) OR (predetermined [tw] OR inclusion [tw] AND criteri* [tw]) OR exclusion criteri* [tw] OR main outcome measures [tw] OR standard of care [tw] OR standards of care [tw]) AND (survey [tiab] OR surveys [tiab] OR overview* [tw] OR review [tiab] OR reviews [tiab] OR search* [tw] OR handsearch [tw] OR analysis [ti] OR critique [tiab] OR appraisal [tw] OR (reduction [tw]and (risk [mh] OR risk [tw]) AND (death OR recurrence))) AND (literature [tiab] OR articles [tiab] OR publications [tiab] OR publication [tiab] OR bibliography [tiab] OR bibliographies [tiab] OR published [tiab] OR pooled data [tw] OR unpublished [tw] OR citation [tw] OR citations [tw] OR database [tiab] OR internet [tiab] OR textbooks [tiab] OR references [tw] OR scales [tw] OR papers [tw] OR datasets [tw] OR trials [tiab] OR meta-analy* [tw] OR (clinical [tiab] AND studies [tiab]) OR treatment outcome [mh] OR treatment outcome [tw] OR pmcbook)) NOT (letter [pt] OR newspaper article [pt]))) #3 Search ((((topical estrogen*) OR topical estradiol*) OR agents, estrogenic[mesh Terms]) OR estradiol[mesh Terms]) OR conjugated estrogens[mesh Terms] #4 Search (((post menopause[mesh Terms]) OR menopause[mesh Terms]) OR premenopause[mesh Terms]) OR hot flashes[mesh Terms] #5 Search hormone replacement therapy, post menopausal[mesh Terms] #6 Search ((#2 AND #5) OR (#2 AND #3 AND #4)) 810 #8 Search ((#2 AND #5) OR (#2 AND #3 AND #4)) Filters: published in the last 10 years 344 Cochrane (n= 23) #1 topical estrogen:ti,ab,kw (Word variations have been searched) 134 #2 MeSH descriptor: [Estradiol] explode all trees 3583 #3 MeSH descriptor: [Estrogens] explode all trees 1448 #4 MeSH descriptor: [Postmenopause] explode all trees 4275 #5 (#4) and (#1 or #2 or #3) 1340 #6 Limited to Cochrane review and other review articles 23

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