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Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity.

Abstract

OBJECTIVE

To determine whether insulin-sensitizing drugs would improve ovulation and T levels in women with polycystic ovary syndrome (PCOS), without clinical or biochemical criteria indicating insulin resistance and whether the combination of two distinct insulin-sensitizing drugs would be of any benefit over either drug alone.

DESIGN

Randomized controlled double-blind trial.

SETTING

A referral center in Caracas, Venezuela.

PATIENT(S)

One hundred twenty-eight nonobese PCOS women with normal indices of insulin sensitivity-that is, normal glucose tolerance, fasting insulin, peak insulin during an oral glucose tolerance test (OGTT), and fasting glucose-to-insulin ratio. Twenty-eight women were lost to follow-up initially and did not receive any intervention.

INTERVENTION(S)

One hundred women received twice daily one of the following for 6 months: metformin (850 mg), rosiglitazone (4 mg), combination of both drugs, or at least one placebo.

MAIN OUTCOME MEASURE(S)

Frequencies of ovulation and serum free T after 6 months.

RESULT(S)

Frequencies of ovulation were higher after treatment with an insulin-sensitizing drug (ovulations per subject in 6 months: metformin, 3.3; rosiglitazone, 2.4; and combination, 3.4) than with placebo (0.4). Ovulatory frequencies increased significantly more with metformin than rosiglitazone, and the combination was not more potent. After treatment, serum free-T levels were comparable among all active treatment groups (metformin: 2.34 pg/mL, rosiglitazone: 3.06 pg/mL, and combination: 2.39 pg/mL) and were significantly lower than in the placebo group (7.26 pg/mL). Compared with placebo, fasting insulin levels, area under the insulin curve during OGTT, the homeostatic model assessment of insulin sensitivity, and OGTT-derived insulin sensitivity index improved significantly after metformin or combination therapies but not after rosiglitazone.

CONCLUSION(S)

These findings suggest that insulin-sensitizing drugs increase ovulatory frequency and ameliorate hyperandrogenemia, even in nonobese women with PCOS who appear to have normal insulin sensitivity.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.

    , , ,

    Source

    Fertility and sterility 82:4 2004 Oct pg 893-902

    MeSH

    Adolescent
    Adult
    Blood Glucose
    Dehydroepiandrosterone Sulfate
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Humans
    Hypoglycemic Agents
    Insulin Resistance
    Metformin
    Ovulation
    Polycystic Ovary Syndrome
    Rosiglitazone
    Sex Hormone-Binding Globulin
    Testosterone
    Thiazolidinediones
    Venezuela

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    15482765

    Citation

    Baillargeon, Jean-Patrice, et al. "Effects of Metformin and Rosiglitazone, Alone and in Combination, in Nonobese Women With Polycystic Ovary Syndrome and Normal Indices of Insulin Sensitivity." Fertility and Sterility, vol. 82, no. 4, 2004, pp. 893-902.
    Baillargeon JP, Jakubowicz DJ, Iuorno MJ, et al. Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity. Fertil Steril. 2004;82(4):893-902.
    Baillargeon, J. P., Jakubowicz, D. J., Iuorno, M. J., Jakubowicz, S., & Nestler, J. E. (2004). Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity. Fertility and Sterility, 82(4), pp. 893-902.
    Baillargeon JP, et al. Effects of Metformin and Rosiglitazone, Alone and in Combination, in Nonobese Women With Polycystic Ovary Syndrome and Normal Indices of Insulin Sensitivity. Fertil Steril. 2004;82(4):893-902. PubMed PMID: 15482765.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity. AU - Baillargeon,Jean-Patrice, AU - Jakubowicz,Daniela J, AU - Iuorno,Maria J, AU - Jakubowicz,Salomon, AU - Nestler,John E, PY - 2003/10/15/received PY - 2004/02/13/revised PY - 2004/02/13/accepted PY - 2004/10/16/pubmed PY - 2004/12/16/medline PY - 2004/10/16/entrez SP - 893 EP - 902 JF - Fertility and sterility JO - Fertil. Steril. VL - 82 IS - 4 N2 - OBJECTIVE: To determine whether insulin-sensitizing drugs would improve ovulation and T levels in women with polycystic ovary syndrome (PCOS), without clinical or biochemical criteria indicating insulin resistance and whether the combination of two distinct insulin-sensitizing drugs would be of any benefit over either drug alone. DESIGN: Randomized controlled double-blind trial. SETTING: A referral center in Caracas, Venezuela. PATIENT(S): One hundred twenty-eight nonobese PCOS women with normal indices of insulin sensitivity-that is, normal glucose tolerance, fasting insulin, peak insulin during an oral glucose tolerance test (OGTT), and fasting glucose-to-insulin ratio. Twenty-eight women were lost to follow-up initially and did not receive any intervention. INTERVENTION(S): One hundred women received twice daily one of the following for 6 months: metformin (850 mg), rosiglitazone (4 mg), combination of both drugs, or at least one placebo. MAIN OUTCOME MEASURE(S): Frequencies of ovulation and serum free T after 6 months. RESULT(S): Frequencies of ovulation were higher after treatment with an insulin-sensitizing drug (ovulations per subject in 6 months: metformin, 3.3; rosiglitazone, 2.4; and combination, 3.4) than with placebo (0.4). Ovulatory frequencies increased significantly more with metformin than rosiglitazone, and the combination was not more potent. After treatment, serum free-T levels were comparable among all active treatment groups (metformin: 2.34 pg/mL, rosiglitazone: 3.06 pg/mL, and combination: 2.39 pg/mL) and were significantly lower than in the placebo group (7.26 pg/mL). Compared with placebo, fasting insulin levels, area under the insulin curve during OGTT, the homeostatic model assessment of insulin sensitivity, and OGTT-derived insulin sensitivity index improved significantly after metformin or combination therapies but not after rosiglitazone. CONCLUSION(S): These findings suggest that insulin-sensitizing drugs increase ovulatory frequency and ameliorate hyperandrogenemia, even in nonobese women with PCOS who appear to have normal insulin sensitivity. SN - 0015-0282 UR - https://www.unboundmedicine.com/medline/citation/15482765/Effects_of_metformin_and_rosiglitazone_alone_and_in_combination_in_nonobese_women_with_polycystic_ovary_syndrome_and_normal_indices_of_insulin_sensitivity_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015-0282(04)01094-5 DB - PRIME DP - Unbound Medicine ER -