Saturday, 26 September 2020

Abbott presents Dydrogesterone's clinical study data

27 January 2020 | News

For 60 years, Abbott’s dydrogesterone medicine has supported more than 20 million pregnancies.

A quarter of the women who suffer from infertility in the world, i.e., 15-20 million, reside in India. Moreover, there seems to be a higher prevalence of miscarriage among Indian women, as compared to western data. Scientific solutions such as oral dydrogesterone, which helps improve pregnancy outcomes, are essential. Evidence from over 300 published studies, including the recent LOTUS II study, shows oral dydrogesterone is a potent treatment for many different gynecological disorders, including prevention of miscarriage during the first trimester and for luteal phase support for in-vitro fertilization. Over 60 years, Abbott’s dydrogesterone has had a lasting impact on the lives of millions of women worldwide by helping them with healthy pregnancy outcomes.

Commenting on the importance of addressing infertility and pregnancy health in India, Dr. Nandita Palshetkar, President Federation of Obstetric & Gynecological Societies of India (FOGSI), observed, “Though infertility has multiple causes, studies suggest that advancing age of motherhood is one of the key risk factors. Given rapid urbanization and the shift in cultural dynamics, maternal age in India is advancing. Moreover, an increase in the number of miscarriages can lead to an increase in the likelihood of subsequent miscarriages, to 13-17% after the first miscarriage, and 55% after the third miscarriage. This underscores the need for medicines and treatments that ensure healthy pregnancies.”

Studies indicate higher prevalence of miscarriage in Indian women with history of miscarriage at 32% , as well as recurrent spontaneous miscarriage at a prevalence as high as 7.5% compared to the global average of 0.8–1.4%. Dr. Ameet Patki, Medical Director, Fertility Associates and the investigator from India for the international LOTUS II study explained, “To have a healthy pregnancy, a woman needs to have sufficient levels of progesterone, which is an important female hormone. A deficiency of progesterone can cause implantation failure and early miscarriages. Dydrogesterone, a progesterone, can increase the chances of a successful pregnancy in women with a history of recurrent abortions. In fact, one study shows that the use of dydrogesterone can reduce the
incidence of miscarriage in women by 47%. And the LOTUS I and LOTUS II studies have shown that dydrogesterone can be used effectively and safely for luteal phase support as part of in-vitro fertilization (IVF) treatments. Approximately 40,000 women in India undergoing in vitro fertilization (IVF) treatment each year can benefit from oral dydrogesterone. ”

Abbott is the world’s leading manufacturer of dydrogesterone, which has supported over 20 million pregnancies across 100 countries over 60 years. Sieneke Bult-Muntinga, Site Director, Abbott Netherlands commented on the significance of the new indication to support women undergoing IVF treatment, “Both micronized progesterone and dydrogesterone can increase progesterone levels in a woman’s body. Compared to micronized progesterone, dydrogesterone is easily absorbed by the body and is more effective orally. This means dydrogesterone can be effective at a dose that is 10-20 times lower. It is taken orally as a tablet, which is more convenient than a vaginal cream or
intramuscular injection. Of course, like any other prescription medicine, it should always be taken as per the advice of one’s doctor.”

The repercussions of infertility and pregnancy health go beyond birth outcomes. For many couples, the inability to conceive a child can be devastating. Sieneke Bult-Muntinga said, “Pregnancy is an emotional journey even when everything goes right. Any medicine which can improve the conditions for birth is invaluable. But such medicines need to be of the highest manufacturing quality and need to be accurate in their ingredients. Dydrogesterone with its unique manufacturing process is one of many examples of Abbott's life changing technologies that are helping people live better and healthier lives. And we are proud to aid healthier pregnancies in India by making quality dydrogesterone
available in this country.”

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