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HRT.

HRT. Dr Lisa Pickles. GP Brig Royd, Ripponden. June 2010. Plan for this afternoon. ‘I’d like to go on HRT.’ The initial and FU consultations. Key messages. Other snippets. References/things to look up. The initial HRT consultation. How to structure this. Where to start?

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HRT.

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  1. HRT. Dr Lisa Pickles. GP Brig Royd, Ripponden. June 2010.

  2. Plan for this afternoon. • ‘I’d like to go on HRT.’ The initial and FU consultations. • Key messages. • Other snippets. • References/things to look up.

  3. The initial HRT consultation. How to structure this. Where to start? What areas need to be covered and in what order?

  4. Consultation contd: Take history in order to work out: • Indication vasomotor symptoms esp. flushes. (not cycle control, osteoporosis, or depression). • Patient expectations.

  5. Consultation contd: Contraindications. • Pregnancy and BF. • Abnormal vaginal bleeding. • DVT. • Active or recent angina/MI. • Ca breast – suspected, current or past. • Ca endometrium or other oestrogen dependent cancer. • Active liver disease with abnormal LFTs.

  6. Consultation contd: Side effects. What would you mention?

  7. Consultation contd: I mention: • Sore breasts. • Leg cramps. • Bloating. (NOT weight gain, but CARE – most women put weight on because of the menopause itself. Not due to HRT). Ask patient to read the PIL that you will supply for more information.

  8. Consultation contd: Risks. Mention: • Ca breast (OE2 only, less risk than combined). • DVT . • Stroke. • Ca ovary. • Endometrial ca , only if unopposed with uterus.

  9. Consultation contd: Risks. Show: • NPCi patient decision aid.

  10. Consultation contd: Benefits. • Improved vasomotor and urogenital symptoms. • Better sleep and mood consequent upon night sweats reduction. • Prevention of osteoporosis whilst taking it. • Reduced colorectal cancer. (see NPCi pda)

  11. Consultation contd: Examine. • BP. • PV – only if indicated by eg abnormal bleeding. • Encourage ‘breast aware’ /mammograms and up to date smears. (I don’t weigh patients. Guidance often suggests that we should).

  12. Consultation contd: Prescribe. Consider: • lowest strength possible for the shortest length of time. • Oral v patches (or gel) . oral cheaper, usually 1st line. • Systemic or local (cream, pessary or ring). • Choice of oestrogen. conjugated OE2 (premarin) v oestradiol. (tibolone, see end.)

  13. Consultation contd: Prescribe. • Strength of oestrogen. 1mg oestradiol< or = 0.625mcg conjgd OE2 < 2mg oestradiol < 1.25mcg conjgd OE2. (tibolone probably the ‘weakest’ in effect). note patches: 0.5mg oestradiol patch ~/= 2mg oral oestradiol. 0.25mg oestradiol patch ~/= 1mg oral oestradiol.

  14. Consultation contd: Prescribe. • Unopposed (oestrogen only). If patient has had hysterectomy. • Combined (OE2 and progesterone). Has uterus. Cyclical v continuous. (can use latter if amenorrhoeic for > 1 year or if > 54 years old on existing cylical HRT)

  15. Consultation contd: Prescribe. • Tibolone. Is a Selective Estrogen Receptor Modulator (SERM). Has oestrogenic, progestogenic and androgenic properties. Is a fairly ‘weak’ oestrogen. Less ca breast risk than combined (slightly more than OE2 only), BUT increased ca endometrium risk and stroke risk. Not to use in > 60 years old due to CVA risk.

  16. Consultation contd: Prescribe. • Possible indications for tibolone. - ‘hormone’ SE on other HRT. - if libido a problem? - if risk factors or concern re ca breast? • Testosterone patches (Intrinsa). - licensed for reduced libido ONLY in women who have had a surgically induced menopause (who are also receiving oestrogen therapy). • Choose preparation as per Formulary. www. formulary.cht.nhs.uk

  17. Consultation contd: Prescribe. • Supply. 3 months supply. Then annually if all well. • Duration . 2 years or so is often enough for vasomotor sypmtoms (remember plan HRT for ‘shortest possible time’). If premature menopause, usually till 50. • Prescription charge. Double if combined.

  18. Consultation continued: Follow up. • Inform re arrangements. At Brig Royd, see GP for 1st consultation and rx. If all well, can see nurse at 3months and annually. Back to GP every 2 years. Adv to see GP if any problems.

  19. Consultation contd: Issue Leaflet. • NPCi patient decision aid re risks and benefits. • PIL of own choice eg CKS, patient.co.uk, webmentor.

  20. Consultation contd: Summary of 1st consultation. a. Discuss. • Indication • Expectations • CI • SE • Risks/benefits. b. Examine. • BP c.Prescribe. • Combined/unopposed. Tablets/patches. • Formulary. • 3 months supply. • Lowest dose possible for shortest time. d.Follow up. • Arrange. e.Issue leaflet. Due to time limits, ? carry out a. + b. + e., then return for prescription and further explanation at a 2nd appointment.

  21. Follow up consultations. At review: • Ask re SE, bleeding. • Check re planned duration of use. Consider whether to stop (usually reducing plan. CKS can be helpful here). Or can dose be reduced? • Can cyclical combined be changed to continuous? ( yes if has reached age 54) • Revisit risk/benefit ratio and provide with up to date information. • Check BP and up to date w smear and mammogram. • Provide 12 month supply and arrange FU.

  22. Follow up consultations: Dealing with problems. Consider – change of preparation, if ‘hormone’ SE. - if poor symptom control. Increase oestrogen, change route, add vaginal OE2, ?expectation, check patches stick. - bleeding. Is hysteroscopy necessary? (Yes, if bleeding restarts after amenorrhoea or if bleeding persists > 6m after starting continuous combined preparation or tibolone in previously amenorrhoeic patient).

  23. Key messages. • Lowest dose possible for shortest time. • Risk/benefit ratio – use NPCi patient decision aid and other PIL. • Weight is not a SE (but menopause causes weight gain). • Check BP. • Opposed oestrogen if has uterus (carries greater ca breast risk than unopposed). • Prescribe as per formulary. Tablets first line.

  24. Other snippets: • Endometrial cancer risk is greatly reduced with cyclical combined HRT and abolished with continuous combined HRT. • Mirena (IUS) can be used as progesterone component of HRT, licensed for 4 years for this use (5 years for contraception). • HRT is not contraceptive. It can be used with the POP. COC can be used till age 50 and may have HRT like effects till then. • Remember that tibolone is unsuitable for women> 60 years in view of stroke risk.

  25. Other snippets: • Women with premature menopause (<45)should be offered HRT to alleviate symptoms of oestrogen deficiency and prevent osteoporosis. Little is known re risks. But lower baseline rate of risk when younger hence fewer absolute numbers. Consider treating till average age of menopause (50-51). • Younger women with surgical menopause tend to need higher doses of HRT. Abrupt cessation of ovarian function rather than gradual failing at natural menopause. Start low and work up. • Not indicated in the management of osteoporosis unless other medicines licensed for this use are unsuitable.

  26. Other snippets: • Some evidence of lower DVT risk with transdermal delivery rather than systemic. Not yet proven. • BMJ study 2010 suggests no increased stroke risk with low dose transdermal OE2; however, high doses DO increase risk of stroke (RR1.88). Oral formulations – RR 1.25-1.3, regardless of dose. • Million Women Study (looked at almost 1,000,000 women who were attending for mammograms and who also took HRT. Questionnaire study. On varied regimes) and Womens Health Initiative Study (USA. Criticised as average age studied was 63. Much older than most of our patients) were landmark studies responsible for the ‘HRT scare’. Looked at risks. 2002/2003.

  27. Other snippets: • Liberate trial. More recent. Looked at whether tibolone increased risk of recurrence if used in women after ca breast. It did, so trial stopped. Also, increased endometrial thickness and spotting. • Lift study. More recent. Found increased risk of CVA with tibolone compared other HRT especially if > 60y RR 2.2. (combined HRT RR 1.3). • MWS found ca breast risk: OE2 only RR 1.3 Tibolone RR 1.5 Combined RR 2.0

  28. Other snippets: • Remember that irregular bleeding can occur and is acceptable for up to 6 months on CCHRT (investigate if prolonged after this). • HRT can be given if raised BP is found so long as BP is treated and controlled 1st. • MHRA Sept 07, risks and benefits of OE2 only and combined HRT is key document. • ‘Natural remedies’/little or no evidence/expensive/?don’t seem to work/ foodstuffs/may have oestrogenic activity. • Give lifestyle advice. Healthy diet, exercise, reduce alcohol.

  29. References and things to look up. • Womens Health Initiative Trial. JAMA 2002. • Million Women Study. Lancet 2003. • www.mhra.gov.uk. Drug safety update vol 1 issue 2 september 2007. • CKS (Clinical Knowledge Summaries) -menopause. • www.npci.org.uk - <60 minute workshop. - patient decision aid HRT (combined and oestrogen only). • MeRec bulletin March 2005. • BNF. • MIMs table of HRT preparations. • www.menopausematters.co.uk. Useful website for patients. • www.formulary.cht.nhs.uk. Google South West Yorkshire area prescribing committee if problems finding this website. • www.pennine-gp-training.co.uk . Abnormal vaginal bleeding guidelines (in clinical section under women’s health) and this presentation. • www.ffprhc.org.uk .Contraception for women aged over 40 years.

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