Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial

Fertility and Sterility

Volumn 89, Issue 5, 2008, Pages 1221-1228

  Lindholm, Åsa ^a   Bixo, Marie ^b   Björn, Inger ^b,c   Wölner Hanssen, Pål ^d   Eliasson, Mats ^a   Larsson, Anders ^e   Johnson, Owe ^b   Poromaa, Inger Sundström ^f  

^a SUNDERBY HOSPITAL   (Sweden)

^b UMEÅ UNIVERSITY HOSPITAL   (Sweden)

^c Läkarhuset Björnen   (Sweden)

^d LUND UNIVERSITY HOSPITAL   (Sweden)

^e UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^f UPPSALA UNIVERSITY   (Sweden)

Author keywords

obesity; Polycystic ovary syndrome; randomized clinical trial; sibutramine

Indexed keywords

APOLIPOPROTEIN A; APOLIPOPROTEIN B; CYSTATIN C; PLACEBO; SIBUTRAMINE; TRIACYLGLYCEROL;

ADULT; ARTICLE; BODY MASS; CARDIOVASCULAR RISK; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; HUMAN; LIFESTYLE MODIFICATION; MENSTRUAL CYCLE; MULTICENTER STUDY; OBESITY; OVARY POLYCYSTIC DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; WAIST CIRCUMFERENCE; WEIGHT REDUCTION;

ADOLESCENT; ADULT; APPETITE DEPRESSANTS; BODY WEIGHT; CARDIOVASCULAR DISEASES; CYCLOBUTANES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LIFE STYLE; MENSTRUATION DISTURBANCES; OBESITY; POLYCYSTIC OVARY SYNDROME; PROSPECTIVE STUDIES; RISK FACTORS; SEX HORMONE-BINDING GLOBULIN; WEIGHT LOSS;

EID: 43449104710     PISSN: 00150282     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fertnstert.2007.05.002     Document Type: Article

References (55)

1. Diamanti-Kandarakis E., Kouli C.R., Bergiele A.T., Filandra F.A., Tsianateli T.C., Spina G.G., et al. A survey of the polycystic ovary syndrome in the Greek island of Lesbos: hormonal and metabolic profile. J Clin Endocrinol Metab 84 (1999) 4006-4011
2. Azziz R., Woods K.S., Reyna R., Key T.J., Knochenhauer E.S., and Yildiz B.O. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab 89 (2004) 2745-2749
3. Asuncion M., Calvo R.M., San Millan J.L., Sancho J., Avila S., and Escobar-Morreale H.F. A prospective study of the prevalence of the polycystic ovary syndrome in unselected Caucasian women from Spain. J Clin Endocrinol Metab 85 (2000) 2434-2438
4. Dahlgren E., Janson P.O., Johansson S., Lapidus L., and Oden A. Polycystic ovary syndrome and risk for myocardial infarction. Evaluated from a risk factor model based on a prospective population study of women. Acta Obstet Gynecol Scand 71 (1992) 599-604
5. Dahlgren E., Johansson S., Lindstedt G., Knutson F., Oden A., and Janson P.O. Women with polycystic ovary syndrome wedge resected in 1956 to 1965: a long-term follow-up focusing on natural history and circulating hormones. Fertil Steril 57 (1992) 505-513
6. Solomon C.G., Hu F.B., Dunaif A., Rich-Edwards J.E., Stampfer M.J., Willet W.C., et al. Menstrual cycle irregularity and risk for future cardiovascular disease. J Clin Endocrinol Metab 87 (2002) 2013-2017
7. Ehrmann D.A., Barnes R.B., Rosenfield R.L., Cavaghan M.K., and Imperial J. Prevalence of impaired glucose tolerance and diabetes in women with polycystic ovary syndrome. Diabetes Care 22 (1999) 141-146
8. Legro R.S., Kunselman A.R., Dodson W.C., and Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab 84 (1999) 165-169
9. Lakhani K., Constantinovici N., Purcell W.M., Fernando R., and Hardiman P. Internal carotid artery haemodynamics in women with polycystic ovaries. Clin Sci (Lond) 98 (2000) 661-665
10. Lakhani K., Constantinovici N., Purcell W.M., Fernando R., and Hardiman P. Internal carotid-artery response to 5% carbon dioxide in women with polycystic ovaries. Lancet 356 (2000) 1166-1167
11. Lakhani K., Seifalian A.M., and Hardiman P. Impaired carotid viscoelastic properties in women with polycystic ovaries. Circulation 106 (2002) 81-85
12. Macut D., Micic D., Cvijovic G., Sumarac M., Kendereski A., Zoric S., et al. Cardiovascular risk in adolescent and young adult obese females with polycystic ovary syndrome (PCOS). J Pediatr Endocrinol Metab 14 Suppl 5 (2001) 1353-1359
13. Pasquali R., and Casimirri F. The impact of obesity on hyperandrogenism and polycystic ovary syndrome in premenopausal women. Clin Endocrinol (Oxf) 39 (1993) 1-16
14. Holte J., Bergh T., Berne C., and Lithell H. Serum lipoprotein lipid profile in women with the polycystic ovary syndrome: relation to anthropometric, endocrine and metabolic variables. Clin Endocrinol (Oxf) 41 (1994) 463-471
15. Robinson S., Henderson A.D., Gelding S.V., Kiddy G., Niththyananthan R., Bush A., et al. Dyslipidaemia is associated with insulin resistance in women with polycystic ovaries. Clin Endocrinol (Oxf) 44 (1996) 277-284
16. Wild R.A., Painter P.C., Coulson P.B., Carruth K.B., and Ranney G.B. Lipoprotein lipid concentrations and cardiovascular risk in women with polycystic ovary syndrome. J Clin Endocrinol Metab 61 (1985) 946-951
17. Atiomo W.U., Bates S.A., Condon J.E., Shaw S., West J.H., and Prentice A.G. The plasminogen activator system in women with polycystic ovary syndrome. Fertil Steril 69 (1998) 236-241
18. Sampson M., Kong C., Patel A., Unwin R., and Jacobs H.S. Ambulatory blood pressure profiles and plasminogen activator inhibitor (PAI-1) activity in lean women with and without the polycystic ovary syndrome. Clin Endocrinol (Oxf) 45 (1996) 623-629
19. Holte J., Gennarelli G., Berne C., Bergh T., and Lithell H. Elevated ambulatory day-time blood pressure in women with polycystic ovary syndrome: a sign of a pre-hypertensive state?. Hum Reprod 11 (1996) 23-28
20. Holte J., Bergh T., Berne C., Wide L., and Lithell H. Restored insulin sensitivity but persistently increased early insulin secretion after weight loss in obese women with polycystic ovary syndrome. J Clin Endocrinol Metab 80 (1995) 2586-2593
21. Huber-Buchholz M.M., Carey D.G., and Norman R.J. Restoration of reproductive potential by lifestyle modification in obese polycystic ovary syndrome: role of insulin sensitivity and luteinizing hormone. J Clin Endocrinol Metab 84 (1999) 1470-1474
22. Lord J.M., Flight I.H., and Norman R.J. Insulin-sensitising drugs (metformin, troglitazone, rosiglitazone, pioglitazone, D-chiro-inositol) for polycystic ovary syndrome. Cochrane Database Syst Rev (2003) CD003053
23. Tang T., Glanville J., Hayden C.J., White D., Barth J.H., and Balen A.H. Combined lifestyle modification and metformin in obese patients with polycystic ovary syndrome. A randomized, placebo-controlled, double-blind multicentre study. Hum Reprod 21 (2006) 80-89
24. Lord J., Thomas R., Fox B., Acharya U., and Wilkin T. The effect of metformin on fat distribution and the metabolic syndrome in women with polycystic ovary syndrome-a randomised, double-blind, placebo-controlled trial. BJOG 113 (2006) 817-824
25. Luque C.A., and Rey J.A. Sibutramine: a serotonin-norepinephrine reuptake-inhibitor for the treatment of obesity. Ann Pharmacother 33 (1999) 968-978
26. Wadden T.A., Berkowitz R.I., Womble L.G., Sarwer D.B., Phelan S., Cato R.K., et al. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med 353 (2005) 2111-2120
27. Berkowitz R.I., Fujioka K., Daniels S.R., Hoppin A.G., Owen S., Perry A.C., et al. Effects of sibutramine treatment in obese adolescents: a randomized trial. Ann Intern Med 145 (2006) 81-90
28. Avenell A., Brown T.J., McGee M.A., Campbell M.K., Grant A.M., Broom J., et al. What interventions should we add to weight reducing diets in adults with obesity? A systematic review of randomized controlled trials of adding drug therapy, exercise, behaviour therapy or combinations of these interventions. J Hum Nutr Diet 17 (2004) 293-316
29. Mathus-Vliegen E.M. Long-term maintenance of weight loss with sibutramine in a GP setting following a specialist guided very-low-calorie diet: a double-blind, placebo-controlled, parallel group study. Eur J Clin Nutr 59 Suppl 1 (2005) S31-S38
30. Redmon J.B., Reck K.P., Raatz S.K., Swanson J.E., Kwong C.A., Ji H., et al. Two-year outcome of a combination of weight loss therapies for type 2 diabetes. Diabetes Care 28 (2005) 1311-1315
31. Lazurova I., Dravecka I., Kraus V., and Petrovicova J. Metformin versus sibutramine in the treatment of hyperinsulinemia in chronically anovulating women. Bratisl Lek Listy 105 (2004) 207-210
32. Sabuncu T., Harma M., Nazligul Y., and Kilic F. Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome. Fertil Steril 80 (2003) 1199-1204
33. Welt C.K., Gudmundsson J.A., Arason G., Adams J., Palsdottir H., Gudlaugsdottir G., et al. Characterizing discrete subsets of polycystic ovary syndrome as defined by the Rotterdam criteria: the impact of weight on phenotype and metabolic features. J Clin Endocrinol Metab 91 (2006) 4842-4848
34. Gennarelli G., Holte J., Berglund L., Berne C., Massobrio M., and Lithell H. Prediction models for insulin resistance in the polycystic ovary syndrome. Hum Reprod 15 (2000) 2098-2102
35. Albareda M., Rodriguez-Espinosa J., Murugo M., de Leiva A., and Corcoy R. Assessment of insulin sensitivity and beta-cell function from measurements in the fasting state and during an oral glucose tolerance test. Diabetologia 43 (2000) 1507-1511
36. Filippatos T.D., Kiortsis D.N., Liberopoulos E.N., Mikhailidis D.P., and Elisaf M.S. A review of the metabolic effects of sibutramine. Curr Med Res Opin 21 (2005) 457-468
37. Appolinario J.C., Bacaltchuk J., Sichieri R., Claudino A.M., Godoy-Matos A., Morgan C., et al. A randomized, double-blind, placebo-controlled study of sibutramine in the treatment of binge-eating disorder. Arch Gen Psychiatry 60 (2003) 1109-1116
38. Pasquali R., Casimirri F., and Vicennati V. Weight control and its beneficial effect on fertility in women with obesity and polycystic ovary syndrome. Hum Reprod 12 Suppl 1 (1997) 82-87
39. Walldius G., and Jungner I. The apoB/apoA-I ratio: a strong, new risk factor for cardiovascular disease and a target for lipid-lowering therapy-a review of the evidence. J Intern Med 259 (2006) 493-519
40. Walldius G., Jungner I., Aastveit A.H., Holme I., Furberg C.D., and Sniderman A.D. The apoB/apoA-I ratio is better than the cholesterol ratios to estimate the balance between plasma proatherogenic and antiatherogenic lipoproteins and to predict coronary risk. Clin Chem Lab Med 42 (2004) 1355-1363
41. Rosner W. Plasma steroid-binding proteins. Endocrinol Metab Clin North Am 20 (1991) 697-720
42. Bataille V., Perret B., Evans A., Amouyel P., Arveiler D., Ducimetiere P., et al. Sex hormone-binding globulin is a major determinant of the lipid profile: the PRIME study. Atherosclerosis 179 (2005) 369-373
43. Preziosi P., Barrett-Connor E., Papoz L., Roger M., Saint-Paul M., Nahoul K., et al. Interrelation between plasma sex hormone-binding globulin and plasma insulin in healthy adult women: the telecom study. J Clin Endocrinol Metab 76 (1993) 283-287
44. Larsson A. Cystatin C: an emerging glomerular filtration rate marker. Scand J Clin Lab Invest 65 (2005) 89-91
45. Shlipak M.G., Katz R., Sarnak M.J., Fried L.F., Newman A.B., Stehman-Breen C., et al. Cystatin C and prognosis for cardiovascular and kidney outcomes in elderly persons without chronic kidney disease. Ann Intern Med 145 (2006) 237-246
46. Shlipak M.G., Sarnak M.J., Katz R., Fried L.F., Seliger S.L., Newman A.B., et al. Cystatin C and the risk of death and cardiovascular events among elderly persons. N Engl J Med 352 (2005) 2049-2060
47. Larsson A., Helmersson J., Hansson L.O., and Basu S. Increased serum cystatin C is associated with increased mortality in elderly men. Scand J Clin Lab Invest 65 (2005) 301-305
48. Padwal R., Li S.K., and Lau D.C. Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev (2004) CD004094
49. De Santis M., Straface G., Cavaliere A.F., Carducci B., and Caruso A. Early first-trimester sibutramine exposure: pregnancy outcome and neonatal follow-up. Drug Saf 29 (2006) 255-259
50. Einarson A., Bonari L., Sarkar M., McKenna K., and Koren G. Exposure to sibutramine during pregnancy: a case series. Eur J Obstet Gynecol Reprod Biol 116 (2004) 112
51. Kadioglu M., Ulku C., Yaris F., Kesim M., Kalyoncu N.I., and Yaris E. Sibutramine use in pregnancy: report of two cases. Birth Defects Res A Clin Mol Teratol 70 (2004) 545-546
52. Ramzi F., Elias D., Mona S., and Zreik T.G. Sibutramine in pregnancy. Eur J Obstet Gynecol Reprod Biol 122 (2005) 243-244
53. Morrison J.L., Riggs K.W., and Rurak D.W. Fluoxetine during pregnancy: impact on fetal development. Reprod Fertil Dev 17 (2005) 641-650
54. Gentile S. SSRIs in pregnancy and lactation: emphasis on neurodevelopmental outcome. CNS Drugs 19 (2005) 623-633
55. Nordeng H., and Spigset O. Treatment with selective serotonin reuptake inhibitors in the third trimester of pregnancy: effects on the infant. Drug Saf 28 (2005) 565-581