Abstract


Polycystic ovary syndrome (PCOS) is a common endocrine disorder in young women. Metformin is used off label in pregnancy. Our aim was to investigate the long-term metabolic health of a well-characterized group of women with PCOS who participated in an RCT on metformin or placebo during pregnancy.

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Polycystic ovary syndrome (PCOS) is a common endocrine disorder in young women. Metformin is used off label in pregnancy. Our aim was to investigate the long-term metabolic health of a well-characterized group of women with PCOS who participated in an RCT on metformin or placebo during pregnancy.

The present study is a follow-up of The PregMet study1 in which 258 women with PCOS were randomly assigned to metformin (1000mg x 2 daily) or placebo from first trimester to delivery. Study medication was stopped at delivery. Baseline is considered as inclusion to the PregMet study at 1st trimester of pregnancy. In all, 130 (50%) women from the original RCT participated in the follow-up. Follow-up time was median (range) 7.6 years (4.9-11.1). Healthy mothers (N=48) were included as controls from a previous study on Doppler measurements in pregnancy, median follow-up time was 5.5 years (4.1-7.1).

At baseline; in 1st trimester, no difference was found between participating women with PCOS and those who declined to enter the follow-up study. Women with PCOS had higher BMI (28.6±6.6 vs. 23.0±3.6; P=<0.001), and higher systolic (118±12mmHg vs.114±10mmHg; P=0.045) and diastolic blood pressures (73mmHg±10 vs. 69±9mmHg; P=0.03) compared to controls.

At follow-up; 5-11 years after pregnancy, no difference was observed between women with PCOS randomized to metformin or placebo regarding BMI, blood pressure or muscle mass and visceral fat area (VFA) by InBody scan. Weight development from baseline to follow-up was also similar (1.8kg±10.4 vs. 1.8kg±11.2). There was no difference in serum lipids, fasting glucose, insulin C-peptide and HbA1C either between women on metformin or placebo. Development of metabolic syndrome, defined by the AHA-criteria2, was similar in the two groups (n=14 vs. n=12, p=0.15).

At follow-up, all PCOS vs. healthy women: Women in the healthy control group were younger (38.2±4.6 vs. 34.4±3.7, P=˂0.001), the follow-up time was shorter (7.9±1.7 vs. 5.5±0.8, P=˂0.001. Women with PCOS had higher BMI (29.6±6.9 vs. 23.9±3.9, P=˂0.001). When adjusted for age, follow-up time and BMI-at-baseline, women with PCOS had higher BPs (119±14mmHg vs. 111±9mmHg, P=0.32) and BPd (78±10mmHg vs 70±6mmHg, P=˂0.001) compared to controls. BMI change from baseline to follow-up was similar in the PCOS vs. control group. Adjusted for age and follow-up time, women with PCOS had increased muscle mass, (28.6±3.8kg vs.26.5±2.9kg, P=0.04) and visceral fat area (134.4±68.0 vs. 85.4±43.8, P=˂0.04) compared to healthy controls at follow-up.

Twenty-six (20%) of the PCOS women and 4 (8.3%) of the healthy controls were diagnosed with metabolic syndrome (P=0.07).
In conclusion, metformin treatment in pregnancy did not affect long-term metabolic health of PCOS women. Significant metabolic disturbances were present at 5-11 years follow-up in women with PCOS compared to control women.

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