Actos and Metformin in women with Polycystic Ovary Syndrome not optimally responsive to Metformin Glueck CJ, Goldenberg NM...
ACTOS <ul><li>Used for the treatment of type 2 DM </li></ul><ul><li>Insulin sensitizing agent (PPAR-  γ receptor) </li></u...
OBJECTIVE : <ul><li>Assess efficacy-safety of Actos (45 mg/d, median 10 months) when added to antecedent metformin (2.55 g...
DESIGN : <ul><li>Prospective open label study of treatment of PCOS with metformin-diet, Actos-metformin-diet </li></ul><ul...
PATIENTS: <ul><li>15 oligo-amenorrheic women with PCOS not optimally responsive to metformin+diet (did not resume normal m...
INTERVENTIONS: <ul><li>Diet  (1500 calorie, 26% protein, 44% carbohydrate [42% complex], 40% fat, polyunsaturated/saturate...
Main Outcome Measures: <ul><li>Menstrual status </li></ul><ul><li>Changes in sex hormones </li></ul><ul><li>Insulin </li><...
Actos-Metformin Results: <ul><li>In the 13 non-responsive women who took metformin + Actos for a median of 10 months, comp...
13 non-Responders on Met for 12 months vs on Met+ Actos for 10 months P=.15 P=.34 P=.24 P=.0005 P=.47 P=.0046 P=.15 P=.003...
Results: Menstrual Status <ul><li>Non-responders:  Versus 14% at pre-treatment baseline, at 3, 6, 9, and 12 months on metf...
Menstrual Status on Actos-metformin   By paired comparison with metformin alone, 67% vs 46% of expected menses occurred at...
Percent of menses occurring in women with PCOS P=.094 .0039 . 016 Responders better over 12 months p=0.0002 Non-responders...
SAFETY (Actos-Metformin): No change in liver function tests. No edema. No  hypoglycemia
CONCLUSION: <ul><li>In women with PCOS who failed to respond optimally to metformin, when Actos was added, insulin, insuli...
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Actos And Metformin In Women With Polycystic Ovary

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  • Actos And Metformin In Women With Polycystic Ovary

    1. 1. Actos and Metformin in women with Polycystic Ovary Syndrome not optimally responsive to Metformin Glueck CJ, Goldenberg NM, Wang P, Sieve L
    2. 2. ACTOS <ul><li>Used for the treatment of type 2 DM </li></ul><ul><li>Insulin sensitizing agent (PPAR- γ receptor) </li></ul><ul><li>Class C agent during pregnancy </li></ul>
    3. 3. OBJECTIVE : <ul><li>Assess efficacy-safety of Actos (45 mg/d, median 10 months) when added to antecedent metformin (2.55 g/d, median 12 months) and diet, in 15 women with polycystic ovary syndrome (PCOS) not optimally responsive to metformin and diet </li></ul>
    4. 4. DESIGN : <ul><li>Prospective open label study of treatment of PCOS with metformin-diet, Actos-metformin-diet </li></ul><ul><li>Metformin-diet: 15 non-responsive vs 30 responsive women with PCOS for 12 months </li></ul><ul><li>Actos-metformin-diet: 13 of the non-responsive women for 10 months compared to their antecedent 12 months on metformin+diet </li></ul><ul><li>Setting : Outpatient clinical research center </li></ul>
    5. 5. PATIENTS: <ul><li>15 oligo-amenorrheic women with PCOS not optimally responsive to metformin+diet (did not resume normal menses, did not lose weight, did not reduce hyperandrogenemia) </li></ul><ul><li>30 oligo-amenorrheic women with PCOS, matched by age and previous menstrual history, responsive to metformin+diet </li></ul>
    6. 6. INTERVENTIONS: <ul><li>Diet (1500 calorie, 26% protein, 44% carbohydrate [42% complex], 40% fat, polyunsaturated/saturate ratio 2/1) throughout </li></ul><ul><li>Metformin (2.55 g/day) given to two cohorts of women (n =15 non-responsive, n = 30 responsive) for medians of 12, 13 months </li></ul><ul><li>Actos (45 mg/d) added for median 10 months in 13 of the non-responsive women </li></ul>
    7. 7. Main Outcome Measures: <ul><li>Menstrual status </li></ul><ul><li>Changes in sex hormones </li></ul><ul><li>Insulin </li></ul><ul><li>Insulin resistance (IR), insulin secretion by HOMA model </li></ul><ul><li>Cholesterol </li></ul>
    8. 8. Actos-Metformin Results: <ul><li>In the 13 non-responsive women who took metformin + Actos for a median of 10 months, compared to metformin-diet alone: </li></ul><ul><li>On Actos + metformin: </li></ul><ul><li>DHEAS fell (200 to 160 ug/dl, p =. 0046), </li></ul><ul><li>Insulin fell (16 to 11 uU/ml, p =. 0007), IR fell (3.73 to 2.11, p =. 003), insulin secretion fell (221 to 125, p=.0005), </li></ul><ul><li>HDL cholesterol rose (38 to 41 mg/dl, p=.033) </li></ul>
    9. 9. 13 non-Responders on Met for 12 months vs on Met+ Actos for 10 months P=.15 P=.34 P=.24 P=.0005 P=.47 P=.0046 P=.15 P=.0034 P=.033 P=.0007
    10. 10. Results: Menstrual Status <ul><li>Non-responders: Versus 14% at pre-treatment baseline, at 3, 6, 9, and 12 months on metformin, 46% (p=.042), 38% (p=.03), 27%, and 24% of expected menses occurred </li></ul><ul><li>Responders: Versus 12% at pre-treatment baseline, at 3, 6, 9, and 12 months on metformin, 75%, 81%, 88%, and 94% of expected menses occurred, p =. 036, =. 0009, .0007, <. 0001 compared to 15 non-responsive women </li></ul>
    11. 11. Menstrual Status on Actos-metformin By paired comparison with metformin alone, 67% vs 46% of expected menses occurred at 3 months (p = .09), 77% vs 38% at 6 months (p = .004), 73% vs 27% at 9 months (p= .016)
    12. 12. Percent of menses occurring in women with PCOS P=.094 .0039 . 016 Responders better over 12 months p=0.0002 Non-responders improved over 9 months P=.016
    13. 13. SAFETY (Actos-Metformin): No change in liver function tests. No edema. No hypoglycemia
    14. 14. CONCLUSION: <ul><li>In women with PCOS who failed to respond optimally to metformin, when Actos was added, insulin, insulin resistance, insulin secretion, and DHEAS fell, HDL cholesterol rose, and menstrual regularity improved, without adverse side effects </li></ul>

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