HRT, UPDATE 2009 Progestinici e nuove associazioni

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1 HRT, UPDATE 2009 Progestinici e nuove associazioni Marco Gambacciani Executive Board International Menopause School Executive Board European Menopause and Andropause Society Menopause and Osteoporosis Unit Pisa University Hospital, Italy Research Support, Grants and Occasional Honoraria: Bracco, Eli Lilly&Company, Igea, Lunar Corporation, MS&D, Novartis, Novo Nordisk, Organon, Pfizer, P&G, Schering, Solvay, Wyeth.

2 The International Menopause Society The IMS Updated Recommendations on postmenopausal hormone therapy February 27, 2007 Climacteric 2007;10:181 94

3 ULTIMATE HRT EFFECTS PATIENT SELECTION TIMING OF INTERVENTION TYPE AND DOSES OF HORMONES

4 Classification of synthetic progestogens Progestogens C-21 progestogens C-19 nortestosterone Spirolactone Pregnanes Estranes Gonanes Drospirenone Medroxyprogesterone acetate Megestrol acetate Cyproterone acetate Dehydrogesterone Norethindrone Noreth. acetate Ethynodiol diacetate Lynestrenol Norethynodrel Norgestrel Levonorgestrel Norgestimate Desogestrel Gestodene Dienogest

5 Comparison of drospirenone with other progestins Progestogenic activity Androgenic activity Antiandrogenic activity Antialdosterone activity Glucocorticoid activity P4 + (+) + DRSP CPA + + (+) DSG + (+) GD + (+) (+) LNG + (+) NGM + (+) MPA + (+) (+) NETA + (+) + relevant activity; (+) activity not clinically relevant; no activity CPA: cyproterone acetate; DSG: desogestrel; GD: Gestoden; LNG: levonorgestrel; NGM: norgestimate; MPA: medroxy progesterone acetate; NETA: noretisterone acetate Schindler AE et al. Maturitas. 2003;46(suppl 1):S7-S16; Rübig A. Climacteric. 2003;6(suppl 3):49-54.

6 Invasive Breast Cancer 0,03 Cumulati ive Hazard 0,02 0,01 Placebo CEE + MPA HR % CI Time, y WHI, JAMA 2002

7 Effects of CEE on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy Stefanick et al., JAMA. 2006;295:

8 Combined hormone replacement therapy and risk of breast cancer a French cohort study including 3175 PMW followed for a mean of 8.9 years ( woman-years) (55%) of these women were users of one type of estrogen replacement with systemic effect during at least 12 months, any time after the menopause, and were classified as HRT users. Among them, 83% were receiving exclusively or mostly a combination of a transdermal estradiol gel and a progestin other than MPA. 105 cases of breast cancer occurred during the follow-up period, corresponding to a mean of 37 new cases per women/year. 2 1,5 control HRT RR 0.98, 95% confidence interval (CI): RR 1 0,5 0 B. de Lignières et al., Climacteric, 2002; 5:

9 E3N-EPIC EPIC French cohort study postmenopausal women (teachers) HRT users versus non users Mean age at inclusion 52.8 yrs Mean follow up: 5.8 yrs HRT use (mean duration 2.8 yrs) Breast cancer RR 95%C.I. Ever E alone E+P syntetic P micronized P Fournier, Int J Cancer 2005

10 progestins and breast cancer Effects of P4 and progestins alkaline phosphatase enzymatic activity in T47Dco cells. Bray et al, Journal of Steroid Biochemistry & Molecular Biology, 2005

11 progestins and breast cancer Number of genes regulated by progestin treatment in T47D breast cancer cells The bars represent the results of three independent and time-separated experiments. The number of up-regulated (white bars) and down-regulated (black bars) genes are indicated. Bray et al, Journal of Steroid Biochemistry & Molecular Biology, 2005

12 Comparative effects of different progestin on the activation of the actin-regulatory protein, moesin BMC Cancer. 2008; 8: 166.

13 Progestins alone or in combination with E2 promote T47-D breast cancer cell invasion. * = P < 0.01 vs. control; # = P < 0.05 vs. E2. BMC Cancer. 2008; 8: 166.

14 PROGESTOGEN MAKES THE DIFFERENCE DROSPIRENONE The Unique Progestogen Progesterone effects Endometrial safety Cycle control Antimineralocorticoid activity Progesterone-like effects on sodium and water retention breast tension edema body weight Some premenstrual symptoms CVD risk (?) Antiandrogenic activity Blockage of androgen receptor acne seborrhea Progestogen with Aldosterone Receptor Antagonism (PARA)

15 Renin-angiotensin-aldosterone system (RAAS) Angiotensin I + Renin substrate (angiotensinogen) Estrogen Renin - Increased plasma volume - Increased blood pressure in susceptibles - Water retention-related symptoms (edema, bloating, weight gain, breast tension) Angiotensin II Na + /water retention K + elimination Drospirenone Progesterone Aldosterone

16 Different estrogens have different dose-related effects on angiotensinogen % of ba aseline β-E 1 mg 17β-E 2 mg EV 2 mg 17β-E TD 50 µg EV = estradiol valerate; TD = transdermal Adapted from Lippert TH et al. Sex Steroids and the Cardiovascular System. Carnforth, UK, Parthenon, 1998:201 10

17 RAAS Plays a Central Role in Organ Damage A II Aldosterone Atherosclerosis* Vasoconstriction Vascular hypertrophy Endothelial dysfunction LV hypertrophy Fibrosis Remodeling Apoptosis Stroke Hypertension Heart failure MI DEATH GFR Proteinuria Aldosterone release Glomerular sclerosis *preclinical data LV = left ventricular; MI = myocardial infarction; GFR = glomerular filtration rate Renal failure Adapted from Willenheimer R et al Eur Heart J 1999; 20(14): ; Dahlöf B J Hum Hypertens 1995; 9(suppl 5): S37 S44; Daugherty A et al J Clin Invest 2000; 105(11): ; Fyhrquist F et al J Hum Hypertens 1995; 9(suppl 5): S19 S24; Booz GW, Baker KM Heart Fail Rev 1998; 3: ; Beers MH, Berkow R, eds. The Merck Manual of Diagnosis and Therapy. 17th ed. Whitehouse Station, NJ: Merck Research Laboratories 1999: ; Anderson S Exp Nephrol 1996; 4(suppl 1): 34 40; Fogo AB Am J Kidney Dis 2000; 35(2):

18 Pharmacological and clinical effects of aldosterone and anti-aldosterone action of DRSP

19 Antimineralocorticoid activity 1000 Relative ef fficiency in rats Spironolactone Progesterone Gestodene DRSP Losert W et al. Drug Res. 1985;35:

20 ALDOSTERONE AND ANTIALDOSTERONE DRUGS Role on Bone Metabolism and Density

21 Loss of bone minerals and strength in rats with aldosteronism isolated rat femurs Chhokar, V. S. et al. Am J Physiol Heart Circ Physiol 287: H2023-H ; doi: /ajpheart

22 Spironolactone Prevents Bone Loss in Women Treated with GnRH Agonist gray bar GnRHa alone white bar GnRHa + FLU;. black bar, GnRHa + SPL; *, P < 0.05 vs. baseline, P < 0,05 vs. GnRHa + SPL. Moghetti, P. et al. J Clin Endocrinol Metab 1999;84:

23 Relationship of Use of Spironolactone to Fractures Fracture Site Cases Controls Crude OR (95% CI) p Value Adjusted OR (95% CI) * p Value Total ( ) ( ) Hip ( ) ( ) Wrist ( ) Vertebral ( ) ( ) Other ( ) ( ) * Adjusted for smoking, body mass index, prevalent fracture, and medication exposures. CI = confidence interval Laura D. Carbone, et al, Am Coll Cardiol, 2008; 52:

24 Relationship of Duration of Use of Spironolactone to Total Fractures (vs. Nonuse) Duration of Spironolactone Use Crude Odds Ratio (95% CI) p Value Adjusted Odds Ratio (95% CI) * p Value <6 months (n = 71) ( ) ( ) >6 months (n = 156) ( ) ( ) * Adjusted for smoking, body mass index, prevalent fracture, and medication exposures. Laura D. Carbone, et al, Am Coll Cardiol, 2008; 52:

25 Spironolactone and bone metabolism important skeletal implications aldosteronism in rats is associated with bone loss and a reduction in bone strength decrease calcium and magnesium excretion increase potassium levels Macdonald HM, New SA, Fraser WD, Campbell MK, Reid DM. Low dietary potassium intakes and high dietary estimates of net endogenous acid production are associated with low bone mineral density in premenopausal women and increased markers of bone resorption in postmenopausal women. Am J Clin Nutr 2005;81: Kitchin B, Morgan SL. Not just calcium and vitamin D: other nutritional considerations in osteoporosis. Curr Rheumatol Rep 2007; 9:85 92.

26 ULTIMATE HRT EFFECTS PATIENT SELECTION TIMING OF INTERVENTION TYPE AND DOSES OF HORMONES

27 Reasons for taking HRT 1023 women consulting the Menopause Centre, University Hospital Santa Chiara, Pisa, Italy, in 2002 Osteoporosis prevention Psychological symptoms Genitourinary symptoms Vasomotor symptoms % of patients Gambacciani M. Endocrine 2004

28 Women s Health Questionnaire The Limouzin-Lamotte formula was used to transfer scores into % 0% = worst QoL; 100% = optimal QoL Change from baseline e in WHQ score (Improveme ent) 10 Estradiol 1 mg * Somatic symptoms Depressed mood Anxiety/ fears Sexual functioning Sleep problems Cognitive difficulties Menstrual problems Angeliq Attractiveness ** Global score *P = versus unopposed estradiol; ** p=0.034 versus unopposed estradiol Modified from Archer D et al. Menopause 2005;12:

29 The International Menopause Society Controversial issues in climacteric medicine III HRT IN CLIMACTERIC AND AGING BRAIN, Pisa March, 2003 Estrogen deprivation and symptomatic postmenopausal women 75% of women report hot flushes (HF) around menopause 25% remain symptomatic for >5 years Not all women will experience HF when they become menopausal HF are not just a symptom In postmenopausal women suffering from HF, the brain sensitivity to estrogen depletion is higher

30 Hot flash correlates with high blood pressure Menopause 2007; 14:

31 Menopausal complaints worsen cardiovascular risk 5523 women aged years, of whom 38 percent reported night sweats and 39 percent hot flashes OR in PMW with HF HTN 1.20 ( ) HyperCh 1.52 ( ) Gast et al., Hypertension ,5 1 1,5 2

32 Impact of High-Normal Blood Pressure on the Risk of CVD Definitions and Classification of Blood Pressure Levels European Society of Hypertension European Society of Cardiology (2003) Category Systolic (mmhg) Diastolic (mmhg) Optimal <120 <80 Normal High normal Grade 1 hypertension (mild) Grade 2 hypertension (moderate) Grade 3 hypertension (severe) Isolated systolic hypertension >180 >110 > Journal of Hypertension 2003, Vol 21 No 6

33 Effect of DRSP in human epicardial primary preadipocytes differentiation Courtesy of M Caprio, GM Rosano UNTREATED DROSPIRENONE 10-6M 40x ALDOSTERONE 10-8 M ALDOSTERONE + DROSPIRENONE

34 Effect of Ovarian Hormone Deficiency on Body Fat Distribution T B % FAT MASS * * * LEGS % FAT MASS * TRUNK % FAT MASS * ARMS % FAT MASS * MONTHS OF OBSERVATION MONTHS OF OBSERVATION Gambacciani et al.: Maturitas 2001 *, p<0.01 vs corresponding basal value

35 American Association of Clinical Endocrinologists meta-analysis of 23 trials HRT does not appear to convey cardiovascular risk to younger women in early menopause younger than 60 years or had gone through the menopause less than 10 years with those in older women HRT may even be beneficial. Physicians may safely counsel women to use estrogen for the relief of menopausal symptoms. Each patient should be evaluated for the severity of her symptoms, her age, and specific risk factors that might impact on her use of HRT American Association of Clinical Endocrinologists

36 New progestogens can minimize progestogenic sideeffects through anti-androgenic and antimineralocorticoid effects, e.g. drospirenone

37 EFFETTI DELLA HRT 1. Inizio della terapia 2. selezione delle pazienti 3. Tipo e dose

38 The use of hormones in early menopause and up to age 60 years has a very minor potential for harm, but may carry substantial benefits. Pines A, et al, for the International Menopause Society. Press statement: Recommendations on postmenopausal hormone therapy, 27 February 2007.

39 A volte l'uomo inciampa nella verità, ma nella maggior parte dei casi, si rialza e continua per la sua strada Sir W. Churchill

40

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