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Update on hormone therapy

• 1. Manage a newly menopausal woman’s • 3. Understand the data in the most recent paper from WHI on breast cancer and combined HT The WHO Terminology for Adverse Event Rates
1 to 10/10,000
Council for International Organizations of Medical Sciences (CIOMS).
Guidelines for preparing core clinical-safety information on drugs. 2nd edition. Geneva:CIOMS: 1998 • 52 year old healthy female complains of severe flushes, feels that she is waking 12 times thru the night and is frequently drenched at work • Has tried a supplement of clover and black cohosh, silken tofu, progesterone cream and meditation • She exercises regularly and has read about layering her clothes, stopped hot drinks, spicy foods and wine • Venlafaxine(Effexor) XR 37.5-75 mg OD • Gabapentin 300 mg HS to start then tid if tolerated (alternate Lyrica 50mg am 25 HS) • Progestin only: MPA( Provera) 20-30 mg 5 extra CHD
• How does this affect the counselling? • Estradiol 1 mg oral/ 50 patch/2 squirts • (no longer have E1 Ogen)• If there is a uterus need Prometrium 200 mg HS/Provera 2.5mg/or norethindrone acetate 0.35mg(Micronor) daily or Mirena • If there are fibroids or a very big woman or high risk for hyperplasia might start cyclically to minimize biopsy repeats for persistent bleeding • Specific timelines gone- no longer less than 5 years- with adequate risk benefit counselling and if symptomatic can continue to treat.
• Patient and caregiver often try to reduce dose • Sometimes get spotting with dose reduction and still need to see them for it-ET or Bx if able • Absolutely no need to stop early menopause • Tried to stop HT after a new article in the • What are the risks of starting at 62 ? • 1 extra CHD
• 9 extra CVA
• 16 extra VTE
• 8 extra Br Ca
• 5 extra Deaths
• 19 extra CVA
8 extra VTE
• 1 extra CHD 4 less
• 9 extra CVA 19 extra
• 16 extra VTE 8 extra
• 8 extra Br Ca 10 less
• 5 extra Deaths same
Step Down the Dose if able since risks are assumed to be less with lower dose- not a lot of good evidence though • Good time to try low dose- might have • Estradiol 0.5mg/ patch 25 or 35/ gel 1 • Breast cancer mortality reported in E&P • Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women JAMA v305 no 15 p1684-92 Differences Between the Observational Nurses Mean age or age range at enrollment
Smokers (past and current)
BMI (mean)
25.1 kg/m2
28.5 kg/m2*
Aspirin users
HRT regimen
Menopausal symptoms (flushing)
*34.1% had BMI 30 kg/m2
Grodstein et al. Ann Intern Med 200;133:933-41. Writing Group for the WHI Investigators. JAMA 2002;288:321-33.
hysterectomy randomly assigned to E&P followed after trial completed in 83% had new consent • Mean intervention time of 5.6(SD 1.4) • E&P was associated with more invasive • Br Ca in E&P were similar in histology and grade to placebo Br ca cases but were more likely to be node positive • 25 deaths (0.03% per year) vs 12 deaths • HR 1.96 ( 95% CI 1-4.04) as well as more deaths from all causes after a diagnosis of Br ca (51 vs 31) • From observational trials most but not all breast cancers associated with combined hormone therapy have favourable characteristics less advanced stage and less mortality risk • For women entering the study with no prior hormone use the HR for Br Ca was 1.16 (95% CI .98-1.37) • compared to 1.85 (1.25-2.80) for women • Increased risk of Br Ca on combined E&P hormone therapy is the same risk women assume if they consume alcohol, fail to exercise regularly or become overweight after menopause.
• Need to promote high quality women’s health with up to date risk benefit information • The level of increased risk is defined as • A rare risk according to WHO classification of adverse events with 8 additional breast cancer cases detected among 10,000 women on combined therapy • 1.3 additional deaths per 10,000 women for combination hormone therapy users in WHI • In Million Women observational study combined HT was associated with higher Br Ca mortality HR 1.22 ( 95% CI 1.00-1.48) p=0.05 • From 50-59 years 5/1000 women currently die of Br Ca while 55 die of other causes • From 60-69 7/1000 women currently die • From 70-79 9/1000 deaths of Br Ca while • From 80-89 11/1000 deaths of Br Ca while


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