Drospirenone as estrogen-free pill and hemostasis: coagulatory study results comparing a novel 4 mg formulation in a 24 + 4 cycle with desogestrel 75 μg per day

Regidor, Pedro‐Antonio; Colli, Enrico; Schindler, A. E.

doi:10.3109/09513590.2016.1161743

Cited by 36 publications

(39 citation statements)

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“…These data agree with the neutral effects of 4 mg drospirenone on haemostatic variables reported in a long-term study [21]. Thus, 4 mg drospirenone may be considered a safe contraceptive option that may be used in women with a thromboembolic risk factor, without increasing the risk of a venous or arterial thromboembolic event.…”

Section: Safetysupporting

confidence: 88%

“…The study comprised 39 women who took the 4 mg drospirenone POP (24/4) and 29 women who took desogestrel 75 lg daily for nine continuous cycles. The haemostatic variables evaluated were activated protein C resistance, antithrombin III, D-dimer, C-reactive protein and coagulation factors VII and VIII [21]. The study results showed that 4 mg drospirenone did not influence the haemostatic variables and did not affect the balance between procoagulant and anticoagulant factors.…”

Section: Safetymentioning

confidence: 88%

“…Haemostatic variables. A long-term study assessed the impact of 4 mg drospirenone on coagulation factors and possible thrombotic risks from a haemostatic point of view [21]. The study comprised 39 women who took the 4 mg drospirenone POP (24/4) and 29 women who took desogestrel 75 lg daily for nine continuous cycles.…”

Section: Safetymentioning

confidence: 99%

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Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Palacios

Regidor²,

Colli

et al. 2020

The European Journal of Contraception & Reproductive Health

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Purpose: The contraceptive pill is an effective and safe method of preventing pregnancy. The progestins used for contraception either are components of a combined hormonal contraceptive (tablets, patches or vaginal rings) or are used alone in progestin-only formulations. Progestin-only contraceptives are available as daily oral preparations, subcutaneous or intramuscular injectables (every 1-3 months), subdermal implants (every 3-5 years) and intrauterine systems (every 3-5 years). Long-acting progestins are highly effective in typical use and have a very low risk profile and few contraindications. Material and Methods: A new progestin-only, oestrogen-free contraceptive, drospirenone, in a dosage of 4 mg/day in a 24/4 regimen, has received regulatory approval in the USA and the EU. The molecule has antigonadotropic, antimineralocorticoid, antiestrogenic and antiandrogenic properties. Results: The regimen was chosen to improve the bleeding profile; maintain plasma oestradiol levels at those of the early follicular phase, to avoid hypoestrogenism; and preserve efficacy even with a missed pill, as drospirenone has a half-life of 30-34 h. Conclusions: Clinical studies have shown good efficacy, very low cardiovascular side effects and a favourable bleeding pattern, as well as maintenance of ovulation inhibition after scheduled 24 h delays in pill intake. ARTICLE HISTORY

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Section: Safetysupporting

confidence: 88%

Section: Safetymentioning

confidence: 88%

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Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Palacios

Regidor²,

Colli

et al. 2020

The European Journal of Contraception & Reproductive Health

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“…This is induced by the action of ethinylestradiol on hepatic and vascular function and is documented by the rise of sex hormone‐binding globule (SHBG) . Progestogens with pronounced androgenic properties, eg levonorgestrel, may counteract estrogen‐induced changes in the hepatic synthesis of hematological factors; other progestogens with antiandrogenic properties or with neutral androgenetic properties may not …”

Section: Discussionmentioning

confidence: 99%

Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone‐only pill

Palacios

Colli

Regidor³

2019

Acta Obstet Gynecol Scand

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Introduction Approximately 100 million women currently use combined oral contraceptives. Combined oral contraceptives use is associated with increased risk of venous thromboembolic events and cardiovascular disease. Progestin‐only pills do not increase the risk of venous thromboembolic events, stroke and myocardial infarction but are associated with a poor cycle control. A novel estrogen‐free pill containing only drospirenone (DRSP) was developed to improve bleeding pattern, tolerability and acceptance without increasing venous thromboembolic events risks in contraception. Material and methods Two prospective, multicenter Phase III studies in healthy women aged 18‐45 years were performed to demonstrate the efficacy and safety of a drospirenone‐only pill in a regimen of 24 days of 4 mg of drospirenone tablets followed by 4 days of placebo. A total of 1571 women (14 329 exposure cycles) were analyzed: 713 patients in the 13‐cycle study 1 with 7638 exposure cycles and 858 patients in the 9‐cycle study 2 with 6691 exposure cycles. The primary endpoint was the overall Pearl index, calculated for each study separately, and for both pooled. As main secondary efficacy endpoint, the “method failure Pearl index” including all pregnancies during “perfect medication cycles” was evaluated. EudraCT registration numbers: 2010‐021787‐15 & 2011‐002396‐42. Results Calculations on pooled studies 1 and 2 with 1571 patients gave an overall Pearl index (based on 14 329 cycles) of 0.7258 (95% CI 0.3133 to 1.4301). No single case of deep vein thrombosis or pulmonary embolism and only one case of hyperkalemia were reported. Additional information such as laboratory parameters, body mass index, bodyweight, heart rate and blood pressure showed no statistically significant changes due to the treatment. Conclusions This is the first report of a new drospirenone‐only oral contraceptive providing clinical efficacy similar to combined oral contraceptives, with a good safety profile, and favorable cycle control.

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“…Следовательно, он может противодействовать стимуляции коагуляции, вызванной активацией РААС. Дроспиренон в отсутствие эстрогена уменьшает активность коагуляцииснижает уровни фактора VII и D-димера [36]. Однако в комбинации с эстрогеном он повышает риск ВТЭ [37].…”

Section: влияние гестагенов на параметры коагуляцииunclassified

Thrombosis and Gestagens

Kareva¹

2019

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Цель обзора: представить роль гестагенов в механизмах развития венозных и артериальных побочных эффектов комбинированной гормональной терапии. Основные положения. Гестагенный компонент комбинированного гормонального препарата (ГП) модулирует действие эстрогенного компонента на сердечно-сосудистую систему. Гестаген с андрогенной активностью нивелирует отрицательное влияние эстрогена на гемостаз, в результате снижается риск тромбофилии. Гестагены с антиандрогенной активностью не препятствуют пролонгированному положительному метаболическому эффекту эстрогена, однако риск венозной тромбоэмболии у женщин выше при назначении ГП с антиандрогенными гестагенами, а также в первые месяцы терапии. Минимальный риск индукции тромбофилии характерен для ГП на основе гестагена с андрогенным или нулевым андрогенным потенциалом (прогестерона, дидрогестерона). Заключение. Безопасность комбинированных ГП можно повысить использованием комбинаций эстрогенов с прогестинами, более близкими к прогестерону (дидрогестерон), с минимальными дополнительными эффектами. Теоретически этот вариант может обеспечить более благоприятный метаболический профиль с меньшей стимуляцией синтеза прокоагулянтов в печени. Кроме того, сверхнизкодозовая гормональная терапия положительно влияет на гемостаз за счет усиления фибринолиза. Ключевые слова: комбинированная гормональная терапия, тромбофилия, сердечно-сосудистые осложнения, гестагены, механизм действия, дидрогестерон.

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Drospirenone as estrogen-free pill and hemostasis: coagulatory study results comparing a novel 4 mg formulation in a 24 + 4 cycle with desogestrel 75 μg per day

Abstract: DRSP 4 mg was not associated with any meaningful changes on hemostatic parameters, indicating a lack of effect on hemostasis.

Cited by 36 publications

References 13 publications

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone‐only pill

Thrombosis and Gestagens

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