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University of Groningen the Pill and Thrombosis Van Vlijmen, Elizabeth University of Groningen The pill and thrombosis van Vlijmen, Elizabeth Femma Willemien IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2016 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): van Vlijmen, E. F. W. (2016). The pill and thrombosis. Rijksuniversiteit Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 23-09-2021 Chapter1 General introduction and outline of thesis Introduction Chapter 1 Introduction Combined oral contraceptives and venous thromboembolism The combined oral contraceptive, i.e. the ‘Pill’, was the first medicinal product developed that had to be taken every day on a regular basis by persons not suffe- ring from any disease. Today, world-wide more than 100 million women start the day with taking the ‘Pill’.1 Although the Pill is a safe and highly effective contracep- tive method in the vast majority of women, in a small group of women its use is associated with a rare but potentially serious adverse event, i.e. venous throm- boembolism (VTE). Up to now, this association has been the topic of many studies, including the studies presented in this thesis, and probably there are many more to follow, as even after the recent 50th anniversary of the Pill this risk still has not been solved. Combined oral contraceptives Composition Combined oral contraceptives (COCs) contain a combination of a synthetic estro- gen and a synthetic progestogen. The estrogen component is ethinylestradiol and recently also estradiol, but there are many different types of synthetic proges- togens, e.g. levonorgestrel, norethisterone, desogestrel, gestodene, dienogest, drospirenone, norgestimate, etonogestrel, norelgestromin, nomegestrol, chlor- madinone, and cyproterone. Initially, the dose of ethinylestradiol was up to 150 micrograms, but since the early seventies the dose is steadily lowered to 35-15 micrograms (so-called sub-50 Pills) that are used today. Also the progestogen doses have decreased substantially. Further, currently several COCs have standard and low-dose versions. Additionally, there are not only oral combined contraceptives, but also non-oral preparations such as a vaginal ring to be applied once a month and a patch to be applied once weekly. 11 Introduction The reason why there are so many synthetic progestogens is that the initially deve- loped progestagens, besides the desired progestogenic effects, also had androge- nic effects. Androgenic properties could result in androgenic side effects like acne, hirsutism, and negative effects on the lipid metabolism. Development therefore focused on progestagens having less androgenic properties. The consecutive development of new COCs, i.e. with a new synthetic proges- togen, is divided into ‘generations‘, and is related to the time point of their market launch. ‘First generation’ is related to the very first COCs, which were approved around 1960. An overview of several generations of COCs with different synthetic progestogens and their first date of introduction is given in Table 1. Table 1. Combined hormonal contraceptives divided into generations Type of progestogen Generation Market introduction Ethinylestradiol/norethisterone-containing COC (Modicon©) 1st generation 1960 Ethinylestradiol/levonorgestrel-containing COC (Microgynon 30©) 2nd generation 1974 Ethinylestradiol/norgestimate-containing COC (Cilest©) 2nd generation 1990 Ethinylestradiol/desogestrel-containing COC (Marvelon©) 3rd generation 1984 Ethinylestradiol/gestodene-containing COC (Femodeen©) 3rd generation 1984 Ethinylestradiol/cyproterone-containing COC (Diane 35©) 4th generation 1987 Ethinylestradiol/chlormadinone-containing COC (Madinelle©)a 4th generation 1995 Ethinylestradiol/drospirenone-containing COC (Yasmin©) 4th generation 2000 Ethinylestradiol/etonogestrel-containing vaginal ring (NuvaRing©) 4th generation 2001 Ethinylestradiol/norelgestromin-containing patch (Evra©) 4th generation 2002 Estradiol/dienogest-containing COC (Qlaira©) ‘5th’ generation 2008 Estradiol/nomegestrol-containing COC (Zoely©) ‘5th’ generation 2011 a: ethinylestradiol/chlormadinone-containing COCs are not available in NL However, as there are now many different preparations, it is suggested not to use these terms any longer, as they lead to confusion. In practice this has already resulted in studies on COCs and thromboembolism with e.g. COCs being catego- 12 Introduction rized as a ‘3rd generation’, ‘4th generation’ or as a ‘2nd generation’, which makes- the interpretation of clinical results for the individual progestogens such as risk of VTE, challenging.2 History of combined hormonal contraceptives Around 1920, several Austrian scientists demonstrated the occurrence of tempo- rary contraception by transplantation of ovaries of a pregnant animal into a non- pregnant animal. These experiments were followed by studies in mice showing that extracts of ovaries could inhibit ovulation. These first studies were performed by Ludwig Haberlandt, an Austrian professor of physiology. He is seen as the Grandfather of the ‘Pill’, as he was the first to perform experiments with the goal to obtain contraception by using female sex hormones. His aim was to develop hormonal contraception by mimicking a pregnant state, which would create a ‘temporary hormonal sterilization’. In 1931, he started the production of a hormo- nal extract ‘Infecundin’ in co-operation with the Hungarian pharmaceutical com- pany Gedeon-Richter. However, he was severely criticized by his colleagues and in the lay public press, who accused him of hindering the unborn life. Despite all opposition, he started the first clinical trials. Unfortunately, he died at an early age and his co-worker Otto Fellner lost his life during World War II, which brought an end to this first initiative.3,4 Although Gabriel Fallopinus already in 1561 mentioned the existence of a ‘corpus luteum’, of which the structure is described by the Dutch anatomist Volcher Coiter in 1573,5 its function in regulating the menstrual cycle remained unknown for long. Only at the end of the nineteenth century scientists in Europe and USA discovered the endocrine function of this temporary existing ‘gland’ after ovulation has taken place. Between 1930-1937, scientists unraveled the action of the corpus luteum hormone as well as its chemical structure, and named the hormone ‘progesterone’.6,7 But at the time, it was still difficult and very expensive to produce sex hormones, as the only way was to process thousands of animal ovaries to retrieve a small amount of sex hormones. In early 1941, the American chemist Russell Marker solved this problem by the discovery of the Mexican wild Yam plant, which contained the plant steroid diosgenin. This plant was said used by Mexican 13 Introduction women for treatment of menstrual cramps. This phytoestrogen could be used as a source to produce large amounts of progesterone. Carl Djerassi in Mexico and other chemists in the US improved the potency of the ‘Yam’ progesterone by removing the carbon at the 19-position, which led to the first synthetic proges- togen ‘norethindrone’. Meantime in Europe, chemists at Schering AG in Germany developed the potent synthetic estrogen ‘ethinylestradiol’. The latter became the estrogen compound in future developed combined oral contraceptives.8 In 1944, disappointed by the negative attitude of politics of academic institutions at the time, the physiologists Gregory Pincus, Hudson Hoagland, Min-Chueh Chang, and John Rock, gynecologist, started the ‘Worchester foundation’, a private research center for experimental biology. With financial support and encouragement of biologist Katharine McCormick and Margaret Sanger of the Planned Parenthood association, they focused on development of oral hormonal contraception.9.10 This collaboration led to a first study in women who received oral natural progesterone. In this first study, a 20-day dose regimen starting at day 5 of the menstrual cycle was chosen as it covers the period in the cycle during which ovulation occurs. Discontinuation after these 20 days would result in a withdrawal bleeding thereby mimicking the normal menstrual bleeding, which could reassure women that they are not pregnant. In 1956, a first study was performed in women who received a synthetic proges- togen and results were published in Science.11 The results indicated that ovulation inhibition could be achieved and that after discontinuation a rapid return to fertility was observed. However, the synthetic progestogen norethindrone used appeared to be contaminated with the estrogen ‘mestranol’. When repeating this study using non-contaminated progestogen, the women reported unwanted irregular (breakthrough) bleeding. Based on these results, it
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