Cited by 216Ovarian function and disordersDiabetes, Cardiovascular Risks, and LipoproteinsGenetic and Kidney Cyst Diseases

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Effect of flutamide and metformin administered alone or in combination in dieting obese women with polycystic ovary syndrome

Gambineri, Alessandra, Pelusi, Carla, Genghini, Silvia, Morselli‐Labate, Antonio Maria, Cacciari, Mauro, Pagotto, Uberto, Pasquali, Renato·2004·Clinical Endocrinology

DOI 10.1111/j.1365-2265.2004.01973.x

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Abstract

Summary: background Hyperandrogenism, hyperinsulinaemia and obesity play a key and coordinating roles in the pathogenesis of polycystic ovary syndrome (PCOS), contributing in different ways to the clinical expression of the syndrome. Weight loss is beneficial, but the additional administration of insulin‐lowering drugs, such as metformin, and antiandrogens may produce further benefits, due to their different spectrum of action. The effects of long‐term metformin and flutamide, an antiandrogen drug, added alone or in combination with a low‐calorie diet, on body weight and fat distribution, androgens, metabolic parameters and clinical status in obese women with PCOS were investigated. methods Forty obese women with PCOS were enrolled in the study. After a 1‐month diet, according to single‐blind design, the patients were allocated to treatment with placebo, metformin (850 mg/orally, twice daily), flutamide (250 mg/orally, twice daily) or metformin (850 mg/orally, twice daily) + flutamide (250 mg/orally, twice daily) for the following 6 months, while continuing hypocaloric dieting. At baseline and at the end of the study, sex hormone, SHBG, lipid, insulin and insulin sensitivity determinations were evaluated. At the same time, clinical parameters such as anthropometry, total (TAT), visceral (VAT) and subcutaneous (SAT) adipose tissue, hirsutism and menses were also measured. results We found that, in obese PCOS women, following a hypocaloric diet the addition of metformin, flutamide or the combined metformin + flutamide treatment had some specific additional favourable effects with respect to the low‐calorie diet alone. In particular, flutamide treatment seemed to add a significant effect in decreasing visceral fat, androstenedione, DHEA‐S, total and low density lipoprotein (LDL) cholesterol and in improving hirsutism. Conversely, metformin had significant benefits on the menstrual status. The two drugs showed an additive effect in reducing testosterone concentrations and a synergistic effect in increasing high density lipoprotein (HDL) cholesterol and SHBG levels. Improvement of insulin sensitivity and hyperinsulinaemia appeared to depend on hypocaloric diet, without any further significant effect of the pharmacological treatments, either alone or in combination. conclusions We conclude that, in obese PCOS women, following a hypocaloric diet the addition of metformin, flutamide or the combined metformin + flutamide treatment appears to have a more favourable outcome on body fat distribution, androgens, lipids, hirsutism and menses. However, our data emphasize the dominant role of hypocaloric dieting in improving insulin resistance and hyperinsulinaemia. Therefore, this study provides a rationale for specifically targeting different therapeutical options for PCOS according to the required outcomes.

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“always, includes rapid, major weight gain from menarche to young adulthood [7,8], clinical hyperandrogenism (severe acne, hirsutism), oligo-amenorrhea, polycystic ovaries, and insulin resistance [9-20].”
Background
Interventions for hirsutism (excluding laser and photoepilation therapy alone)
van Zuuren, E. J., Fedorowicz, Z., Carter, B., & Pandis, N. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010334.pub2 · Cited by 65
Combined Lifestyle Modification and Metformin in Obese Patients with Polycystic Ovary Syndrome: A Randomized, Placebo-controlled, Double-blind Multicentre Study
Tang, T. H., Glanville, J., Hayden, C. J., White, D. M., Barth, J. H., & Balen, A. H. (2006) · Obstetrical & Gynecological Survey · doi:10.1097/01.ogx.0000197800.07214.dc · Cited by 65
“, 2003) or androgen-lowering medication (Gambineri et al., 2004).”
Background
Polycystic Ovary Syndrome
King, J. (2006) · Journal of Midwifery & Women s Health · doi:10.1016/j.jmwh.2006.01.008 · Cited by 64
Review of cardiovascular risk factors in women
Evangelista, O., & McLaughlin, M. A. (2009) · Gender Medicine · doi:10.1016/j.genm.2009.02.004 · Cited by 62
Evidence-based approach to cutaneous hyperandrogenism in women
Schmidt, T. H., & Shinkai, K. (2015) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2015.05.026 · Cited by 60
Insulin-sensitizing agents: use in pregnancy and as therapy in polycystic ovary syndrome
Checa, M. Á., Requena, A., Salvador, C., Tur, R., Callejo, J., Espinós, J. J., Fábregues, F., Herrero, J. C., & (Reproductive Endocrinology Interest Group of the Spanish Society of Fertility) (2005) · Human Reproduction Update · doi:10.1093/humupd/dmi015 · Cited by 60
“…particularly those with a high BMI, should be reviewed regularly with respect to impaired glucose tolerance, as the rate of conversion from impaired glucose tolerance to non-insulin dependent diabetes mellitus is substantial (Ehrmann et al., 1999; Norman et al., 2001; Gambineri et al., 2004b).”
Background
Treatment of hirsutism and acne in hyperandrogenism
Moghetti, P., & Toscano, V. (2006) · Best Practice & Research Clinical Endocrinology & Metabolism · doi:10.1016/j.beem.2006.03.003 · Cited by 57
PCOS: an ovarian disorder that leads to dysregulation in the hypothalamic–pituitary–adrenal axis?
Doi, S. A. R., Towers, P. A., Scott, C., & Al-Shoumer, K. A. S. (2004) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2004.06.024 · Cited by 57
“Regardless of the pathogenesis of this effect, the dominant role of hypocaloric dieting in improving features of this syndrome has been demonstrated in recent studies and emphasizes the dominant role of obesity in the perpetuation of insulin resistance and its consequences in PCOS [86,132].”
BackgroundInfluential
Developmental Programming: Prenatal and Postnatal Androgen Antagonist and Insulin Sensitizer Interventions Prevent Advancement of Puberty and Improve LH Surge Dynamics in Prenatal Testosterone-Treated Sheep
Padmanabhan, V., Veiga‐Lopez, A., Herkimer, C., Salloum, B. A., Moeller, J., Beckett, E. M., & Sreedharan, R. (2015) · Endocrinology · doi:10.1210/en.2015-1235 · Cited by 54
“Combination of androgen receptor blockade and insulin sensitization were reported to provide significant endocrine-metabolic benefits in both nonobese (69, 70) and obese women with PCOS (71).”
Background
Insulin-Like Factor 3: A New Circulating Hormone Related to Luteinizing Hormone-Dependent Ovarian Hyperandrogenism in the Polycystic Ovary Syndrome
Gambineri, A., Patton, L., IASIO, R. D., Palladoro, F., Pagotto, U., & Pasquali, R. (2007) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2006-1678 · Cited by 50
“75 ng/ml], obtained in normal-weight ovulatory women, (19), according to the National Institutes of Health 1990 criteria (20).”
BackgroundSelf-citation
Androgens in Polycystic Ovary Syndrome: The Role of Exercise and Diet
Giallauria, F., Palomba, S., Vigorito, C., Tafuri, M. G., Colao, A., Lombardi, G., & Orio, F. (2009) · Seminars in Reproductive Medicine · doi:10.1055/s-0029-1225258 · Cited by 52
“The duration of treatment seems to be critical: overweight or obese PCOS women treated for 12 months with flutamide showed that the improvement in insulin sensitivity increased with time, there being an additional benefit at 12 months compared with 6 months of treatment,(82) suggesting that short duration of therapy m…”
Background
Metformin in polycystic ovary syndrome
Lord, J. M., & Wilkin, T. J. (2004) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/00001703-200412000-00008 · Cited by 50
Regulation of Androgen Receptor Expression Alters AMPK Phosphorylation in the Endometrium: In Vivo and In Vitro Studies in Women with Polycystic Ovary Syndrome
Li, X., Pishdari, B., Cui, P., Hu, M., Yang, H.-P., Guo, Y.-R., Jiang, H., Feng, Y., Billig, H., & Shao, R. (2015) · International Journal of Biological Sciences · doi:10.7150/ijbs.13109 · Cited by 48
“Because hyperandrogenism is one of the main clinical complications of PCOS [1, 3], accumulating evidence suggests that flutamide (an AR antagonist) therapy exerts beneficial ovarian, endocrine, and metabolic effects in PCOS patients [22-27].”
Background
Polycystic Ovary Syndrome and the Metabolic Syndrome
Sharpless, J. L. (2003) · Clinical Diabetes · doi:10.2337/diaclin.21.4.154 · Cited by 49
A combination of polymorphisms in HSD11B1 associates with in vivo 11β-HSD1 activity and metabolic syndrome in women with and without polycystic ovary syndrome
Gambineri, A., Tomassoni, F., Munarini, A., Stimson, R. H., Mioni, R., Pagotto, U., Chapman, K. E., Andrew, R., Mantovani, V., Pasquali, R., et al. (2011) · European Journal of Endocrinology · doi:10.1530/eje-11-0091 · Cited by 49
Self-citation
Efficacy of Octreotide-LAR in Dieting Women with Abdominal Obesity and Polycystic Ovary Syndrome
Gambineri, A., Patton, L., IASIO, R. D., Cantelli, B., Cognini, G. E., Filicori, M., Barreca, A., Diamanti‐Kandarakis, E., Pagotto, U., & Pasquali, R. (2005) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2004-2490 · Cited by 47
“A computerized tomography (CT) scan measurement of body fat distribution was also performed at the level of L4–L5 to estimate total (TAT), visceral (VAT), and sc (SAT) adipose tissue areas (25).”
MethodResultSelf-citation
Prominent role of low HDL-cholesterol in explaining the high prevalence of the metabolic syndrome in polycystic ovary syndrome
Gambineri, A., Repaci, A., Patton, L., Grassi, I., Pocognoli, P., Cognigni, G. E., Pasqui, F., Pagotto, U., & Pasquali, R. (2009) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2009.01.007 · Cited by 46
Self-citation
Polycystic ovary syndrome: A review for dermatologists
Buzney, E. A., Sheu, J., Buzney, C. D., & Reynolds, R. V. (2014) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2014.05.009 · Cited by 47
“Metformin has been shown to be less effective than both flutamide and spironolactone in the treatment of hirsutism; however, the addition of flutamide was more effective than metformin alone.(107,148,157,158) A year-long comparison found a 25% FG score reduction with metformin compared with a 5% reduction with CPA(134…”
Result
Statins in the Treatment of Polycystic Ovary Syndrome
Kodaman, P. H., & Dulęba, A. J. (2008) · Seminars in Reproductive Medicine · doi:10.1055/s-2007-992933 · Cited by 43
“This dyslipidemia correlates with the hyperinsulinemia and hyperandrogenemia of PCOS,(52) and treatment of these conditions can lead to improvements in the lipid profile.(53,54) Homocysteine levels are also higher in women with PCOS compared with healthy subjects, and hyperhomocysteinemia represents another independen…”
Polycystic ovary syndrome: chemical pharmacotherapy
Rocca, M. L., Venturella, R., Mocciaro, R., Cello, A. D., Sacchinelli, A., Russo, V. M., Trapasso, S., Zullo, F., & Morelli, M. (2015) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2015.1047344 · Cited by 41
“The combination metformin plus flutamide provides beneficial effect [98,107,125-127], however, the embryotoxicity limits their use.”
Background
The (endo)cannabinoid signaling in female reproduction: What are the latest advances?
Cecconi, S., Rapino, C., Nisio, V. D., Rossi, G., & Maccarrone, M. (2019) · Progress in Lipid Research · doi:10.1016/j.plipres.2019.101019 · Cited by 45
Apolipoprotein B/apolipoprotein A1 ratio is a good predictive marker of metabolic syndrome and pre‐metabolic syndrome in Chinese adolescent women with polycystic ovary syndrome
Yin, Q., Chen, X., Li, L., Zhou, R. R., Huang, J., & Yang, D. (2012) · Journal of obstetrics and gynaecology research · doi:10.1111/j.1447-0756.2012.01907.x · Cited by 38
“The aim of this study was to investigate whether the ApoB/ApoA1 ratio can be used as a predictive marker of MS and pre-MS in Chinese adolescent women with PCOS.”
BackgroundInfluential
Cardiometabolic abnormalities in the polycystic ovary syndrome: Pharmacotherapeutic insights
Westerveld, H. E., Hoogendoorn, M., de Jong, A. W. F., Goverde, A. J., Fauser, B. C. J. M., & Dallinga‐Thie, G. M. (2008) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2008.04.009 · Cited by 38
Role of changes in dietary habits in polycystic ovary syndrome
Pasquali, R., & Gambineri, A. (2004) · Reproductive BioMedicine Online · doi:10.1016/s1472-6483(10)60927-3 · Cited by 39
“These same conclusions were achieved in another more recent study 437 investigating the effect of metformin and flutamide, a pure antiandrogen, given alone or in combination, added to a hypocaloric diet in obese women with PCOS (Gambineri et al., 2004).”
BackgroundResultSelf-citation
Pharmacological Approaches to Controlling Cardiometabolic Risk in Women with PCOS
Cignarella, A., Mioni, R., Sabbadin, C., Dassie, F., Parolin, M., Vettor, R., Barbot, M., & Scaroni, C. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21249554 · Cited by 36
“On the other hand, several authors showed that FLU was not very effective in improving IR, when administered alone, while if associated with metformin, a well-known insulin-sensitizing drug, FLU significantly improves both IR indices and visceral adipose distribution, mobilizing visceral fat at abdominal level, and fi…”
Background
Adiponectin levels in women with polycystic ovary syndrome: impact of metformin treatment in a randomized controlled study
Trolle, B., Lauszus, F. F., Frystyk, J., & Flyvbjerg, A. (2010) · Fertility and Sterility · doi:10.1016/j.fertnstert.2010.01.057 · Cited by 36
Targeting insulin sensitivity in the treatment of polycystic ovary syndrome
Pasquali, R., & Gambineri, A. (2009) · Expert Opinion on Therapeutic Targets · doi:10.1517/14728220903190699 · Cited by 35
“Targets (2009) 13(10) 1219 groups of age- and BMI-matched groups of obese women with PCOS, to investigate the effects of long-term treatment with a hypocaloric diet alone, metformin (850 mg/orally, twice daily), and flutamide (250 mg/orally, twice daily) administered alone or in combination and added to a low-calorie…”
Self-citation
Combined androgen excess and Western-style diet accelerates adipose tissue dysfunction in young adult, female nonhuman primates
Varlamov, O., Bishop, C. V., Handu, M., Takahashi, D., Srinivasan, S., White, A., & Roberts, C. T. (2017) · Human Reproduction · doi:10.1093/humrep/dex244 · Cited by 34
“, 2013), resulting in improved insulin sensitivity and reduced hyperandrogenemia (Pasquali et al., 1989; Holte et al., 1995; Gambineri et al., 2004; Mehrabani et al., 2012; Thomson et al., 2008), suggesting that obesity may exaggerates hyperandrogenemiarelated symptoms in PCOS patients.”
Background
Effect of metformin and flutamide on insulin, lipogenic and androgen-estrogen signaling, and cardiometabolic risk in a PCOS-prone metabolic syndrome rodent model
Kupreeva, M., Diané, A., Lehner, R. S., Watts, R., Ghosh, M., Proctor, S. D., & Vine, D. F. (2018) · American Journal of Physiology-Endocrinology and Metabolism · doi:10.1152/ajpendo.00018.2018 · Cited by 34
Sonochemical synthesis and fabrication of perovskite type calcium titanate interfacial nanostructure supported on graphene oxide sheets as a highly efficient electrocatalyst for electrochemical detection of chemotherapeutic drug
Tseng, T., Rajaji, U., Chen, T., Chen, S., Huang, Y., Mani, V., & Jothi, A. I. (2020) · Ultrasonics Sonochemistry · doi:10.1016/j.ultsonch.2020.105242 · Cited by 34
The effects of metformin on endogenous androgens and SHBG in women: a systematic review and meta‐analysis
Barba, M., Schünemann, H. J., Sperati, F., Akl, E. A., Musicco, F., Guyatt, G. H., & Muti, P. C. (2009) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2008.03459.x · Cited by 34
Hepatotoxicity with low- and ultralow-dose flutamide: a surveillance study on 203 hyperandrogenic young females
Bruni, V., Peruzzi, E., Dei, M., Nannini, S., Seravalli, V., Sisti, G., & Fambrini, M. (2012) · Fertility and Sterility · doi:10.1016/j.fertnstert.2012.06.018 · Cited by 34
Modulation of Ovarian Structure and Abdominal Obesity in Curcumin- and Flutamide-treated Aging FSH-R Haploinsufficient Mice
Tiwari-Pandey, R., & Sairam, M. R. (2009) · Reproductive Sciences · doi:10.1177/1933719109332822 · Cited by 32
“Recent studies on spice-derived components such as CR reporting suppression of obesity-induced inflammatory response indicate reduction in adipose tissue macrophage accumulation or activation, with a potential to improve chronic inflammatory conditions associated with obesity.(42) In PCOS patients, FL treatment alone…”
Biochemical hyperandrogenism is associated with metabolic syndrome independently of adiposity and insulin resistance in Romanian polycystic ovary syndrome patients
Albu, A. I., Radian, S., Fica, S. V., & Barbu, C. G. (2014) · Endocrine · doi:10.1007/s12020-014-0340-9 · Cited by 31
“The increased androgens may amplify both IR and visceral adiposity, as suggested by clinical and in vitro studies [15–18].”
Background
HMG-CoA Reductase Inhibitors
Kodaman, P. H., & Dulęba, A. J. (2008) · Drugs · doi:10.2165/00003495-200868130-00001 · Cited by 31
“For instance, the dyslipidaemia of PCOS correlates with hyperandrogenaemia[11] and treatment of the latter leads to improvements in lipid profile.[12,13] Hyperandrogenaemia also represents an independent risk factor for the development of hypertension among women with PCOS.”
Impact of metformin on the clinical and metabolic parameters of women with polycystic ovary syndrome: a systematic review and meta-analysis of randomised controlled trials
Abdalla, M. A., Shah, N., Deshmukh, H., Sahebkar, A., Östlundh, L., Al-Rifai, R. H., Atkin, S. L., & Sathyapalan, T. (2022) · Therapeutic Advances in Endocrinology and Metabolism · doi:10.1177/20420188221127142 · Cited by 33
Tissue-specific dysregulation of 11β-hydroxysteroid dehydrogenase type 1 in overweight/obese women with polycystic ovary syndrome compared with weight-matched controls
Gambineri, A., Fanelli, F., Tomassoni, F., Munarini, A., Pagotto, U., Andrew, R., Walker, B. R., & Pasquali, R. (2014) · European Journal of Endocrinology · doi:10.1530/eje-13-1030 · Cited by 30
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Retrospective observational study on the effects and tolerability of flutamide in a large population of patients with various kinds of hirsutism over a 15-year period
Paradisi, R., & Venturoli, S. (2010) · European Journal of Endocrinology · doi:10.1530/eje-10-0100 · Cited by 30
Anti-androgen Treatments
Bachelot, A., Chabbert‐Buffet, N., Salenave, S., Kerlan, V., & Galand-Portier, M.-B. (2010) · Annales d Endocrinologie · doi:10.1016/j.ando.2009.12.001 · Cited by 30
Effects of metformin on blood lipid profiles in nondiabetic adults: a meta-analysis of randomized controlled trials
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Prevalence, pathogenesis and management of prediabetes and type 2 diabetes mellitus in patients with polycystic ovary syndrome
Lazaridou, S., Dinas, K., & Tziomalos, K. (2017) · HORMONES · doi:10.14310/horm.2002.1757 · Cited by 27
Polycystic ovary syndrome: An overview
Bako, A. U., Morad, S., & Atiomo, W. (2005) · Reviews in Gynaecological Practice · doi:10.1016/j.rigp.2005.04.001 · Cited by 29
Increased clearance of cortisol by 5β-reductase in a subgroup of women with adrenal hyperandrogenism in polycystic ovary syndrome
Gambineri, A., Forlani, G., Munarini, A., Tomassoni, F., Cognigni, G. E., Ciampaglia, W., Pagotto, U., Walker, B. R., & Pasquali, R. (2009) · Journal of Endocrinological Investigation · doi:10.1007/bf03346454 · Cited by 28
Self-citation

Authors: Gambineri, A., Pelusi, C., Genghini, S., Morselli‐Labate, A. M., Cacciari, M., Pagotto, U., & Pasquali, R.
Affiliations: IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
Corresponding author: Pasquali, Renato
ORCID: Gambineri, Alessandra
Pelusi, Carla
Morselli‐Labate, Antonio Maria
Pagotto, Uberto
Venue: Clinical Endocrinology
Publisher: Wiley
Published: 2004-01-16
Volume: 60
Issue: 2
Pages: 241-249
ISSN: 0300-0664 (ISSN-L)
1365-2265
DOI: 10.1111/j.1365-2265.2004.01973.x
OpenAlex: W2102239047
Cited by: 216
References: 49
Citations by year: 2026: 3 · 2025: 2 · 2024: 3 · 2023: 4 · 2022: 8 · 2021: 10 · 2020: 6 · 2019: 2 · 2018: 6 · 2017: 12 · 2016: 5 · 2015: 11 · 2014: 10 · 2013: 7 · 2012: 11
FWCI: 19.48
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Clinical Endocrinology (publishedVersion)
PubMed (publishedVersion)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Topics: Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetic and Kidney Cyst Diseases
Keywords: polycystic ovary syndrome, obesity, flutamide, metformin, hypocaloric diet, weight loss, androgen receptor antagonists, insulin sensitivity, hyperinsulinemia, hyperandrogenism, visceral fat, hirsutism, menstrual status, sex hormone-binding globulin, lipid profile, testosterone, combination therapy, adipose tissue
MeSH terms: Adult, Analysis of Variance, Androgen Antagonists, Combined Modality Therapy, Diet, Reducing, Drug Therapy, Combination, Female, Flutamide, Humans, Hypoglycemic Agents, Metformin, Obesity, Pilot Projects, Polycystic Ovary Syndrome, Single-Blind Method

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Effect of flutamide and metformin administered alone or in combination in dieting obese women with polycystic ovary syndrome

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