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Francis De Zegher - One of the best experts on this subject based on the ideXlab platform.
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flutamide metformin plus ethinylestradiol Drospirenone for lipolysis and antiatherogenesis in young women with ovarian hyperandrogenism the key role of metformin at the start and after more than one year of therapy
2005Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Flutamide (Flu)-metformin (Met) with ethinylestradiol-Drospirenone is a combination therapy that reduces the total and abdominal fat excess, diminishes the lean mass deficit, and attenuates the dysadipocytokinemia of young and nonobese women with ovarian hyperandrogenism, a variant of polycystic ovary syndrome. We have now questioned the need: 1) to add Met at the start of Flu plus ethinylestradiol-Drospirenone; and 2) to maintain Met after more than 1 yr on full combination therapy. The additive effects of Met (850 mg/d) were assessed in studies A and B, over 3 months, in young patients with hyperinsulinemic hyperandrogenism. In study A, all participants [n = 31; age ∼16 yr; body mass index ∼ 22 kg/m2] started on Flu (62.5 mg/d) and an oral contraceptive (ethinyl-estradiol + Drospirenone), and they were randomized to receive Met in addition or not. In study B, all participants (n = 42; age ∼19 yr; body mass index ∼ 22 kg/m2) had been treated with Flu-Met plus the same contraceptive for a mean duration of...
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flutamide metformin plus ethinylestradiol Drospirenone for lipolysis and antiatherogenesis in young women with ovarian hyperandrogenism the key role of metformin at the start and after more than one year of therapy
2005Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Flutamide (Flu)-metformin (Met) with ethinylestradiol-Drospirenone is a combination therapy that reduces the total and abdominal fat excess, diminishes the lean mass deficit, and attenuates the dysadipocytokinemia of young and nonobese women with ovarian hyperandrogenism, a variant of polycystic ovary syndrome. We have now questioned the need: 1) to add Met at the start of Flu plus ethinylestradiol-Drospirenone; and 2) to maintain Met after more than 1 yr on full combination therapy. The additive effects of Met (850 mg/d) were assessed in studies A and B, over 3 months, in young patients with hyperinsulinemic hyperandrogenism. In study A, all participants [n = 31; age approximately 16 yr; body mass index approximately 22 kg/m(2)] started on Flu (62.5 mg/d) and an oral contraceptive (ethinyl-estradiol + Drospirenone), and they were randomized to receive Met in addition or not. In study B, all participants (n = 42; age approximately 19 yr; body mass index approximately 22 kg/m(2)) had been treated with Flu-Met plus the same contraceptive for a mean duration of 17 months, and they were randomized for discontinuation of Met or not. Fasting blood glucose, serum insulin, testosterone, lipid profile, adiponectin, and IL-6 were determined at the start and after 3 months, together with body composition, by dual energy x-ray absorptiometry. The results of studies A and B complemented each other; the addition of Met was found to have consistently (more) normalizing effects on IL-6 and adiponectin, on lean mass (mean Met benefit of +1.2 kg in study A and +0.6 kg in study B), and in particular on abdominal fat excess [Met benefit of -0.7 kg (A) and -0.3 kg (B)]. In conclusion, Met proved to be a pivotal component of a prime combination therapy that attenuates the dysadipocytokinemia, the lean mass deficit, and the central adiposity of young patients with polycystic ovary syndrome.
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flutamide metformin plus ethinylestradiol Drospirenone for lipolysis and antiatherogenesis in young women with ovarian hyperandrogenism the key role of early low dose flutamide
2004Co-Authors: Lourdes Ibanez, Carme Valls, Sergi Cabre, Francis De ZegherAbstract:A low-dose combination of flutamide-metformin and ethinylestradiol-Drospirenone was recently found to reduce the excess of total and abdominal fat, to diminish the deficit in lean mass, and to attenuate the dysadipocytokinemia of young women with ovarian hyperandrogenism, a variant of polycystic ovary syndrome. We questioned the need to give flutamide, an androgen receptor blocker, together with an oral contraceptive that contains Drospirenone, a progestin claimed to have antiandrogen properties. The additive effects of low-dose flutamide (62.5 mg/d) were assessed over 3 months in young patients with hyperinsulinemic ovarian hyperandrogenism (n = 40; age, ∼17 yr; body mass index, ∼22 kg/m2); all participants started on metformin (850 mg/d) and a fourth-generation contraceptive (ethinylestradiol 30 μg plus Drospirenone 3 mg, 21 d/month), and they were randomized to receive flutamide in addition (n = 20) or not (n = 20). Fasting blood glucose, serum insulin, lipid profile, testosterone, adiponectin, and IL-...
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ethinylestradiol Drospirenone flutamide metformin or both for adolescents and women with hyperinsulinemic hyperandrogenism opposite effects on adipocytokines and body adiposity
2004Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Hyperinsulinemic hyperandrogenism with anovulation, the so-called polycystic ovary syndrome (PCOS), is the most frequent endocrine disorder of young women. One of the stigmata of PCOS is a deficit of lean mass and an excess of fat, in particular, abdominal fat, even in the absence of obesity. Adiponectin and IL-6 are among the adipocytokines that have recently been related to abdominal fat excess, insulin resistance states, and cardiovascular disease risk. We studied the effects of two new treatment options, ethinylestradiol-Drospirenone and flutamide-metformin, and of their combination on adipocytokinemia and body adiposity in adolescents and women with PCOS. Adolescents with PCOS (n = 32; age, ∼15 yr; body mass index, ∼22 kg/m2) were randomly assigned to receive the oral contraceptive (OC) ethinylestradiol-Drospirenone, or the low-dose generic duo of flutamide (62.5 mg/d) plus metformin (850 mg/d). Young women with PCOS (n = 22; age, ∼19 yr; body mass index, ∼22 kg/m2) were randomized to receive the sam...
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ethinylestradiol Drospirenone flutamide metformin or both for adolescents and women with hyperinsulinemic hyperandrogenism opposite effects on adipocytokines and body adiposity
2004Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Hyperinsulinemic hyperandrogenism with anovulation, the so-called polycystic ovary syndrome (PCOS), is the most frequent endocrine disorder of young women. One of the stigmata of PCOS is a deficit of lean mass and an excess of fat, in particular, abdominal fat, even in the absence of obesity. Adiponectin and IL-6 are among the adipocytokines that have recently been related to abdominal fat excess, insulin resistance states, and cardiovascular disease risk. We studied the effects of two new treatment options, ethinylestradiol-Drospirenone and flutamide-metformin, and of their combination on adipocytokinemia and body adiposity in adolescents and women with PCOS. Adolescents with PCOS (n = 32; age, approximately 15 yr; body mass index, approximately 22 kg/m(2)) were randomly assigned to receive the oral contraceptive (OC) ethinylestradiol-Drospirenone, or the low-dose generic duo of flutamide (62.5 mg/d) plus metformin (850 mg/d). Young women with PCOS (n = 22; age, approximately 19 yr; body mass index, approximately 22 kg/m(2)) were randomized to receive the same OC, either alone or with flutamide-metformin. Fasting blood glucose, serum insulin, lipids, androgens, IL-6, adiponectin, and body composition (by absorptiometry) were assessed at the start, and after 3 and/or 9 months. At the start, serum concentrations of the proinflammatory IL-6 were high, and those of the antiinflammatory adiponectin were low; body composition was adipose in each subpopulation. Abnormal adipocytokine levels, hypertriglyceridemia, and body adiposity diverged further from the norm in adolescents on OC; in contrast, girls on flutamide-metformin reverted all study indices toward normal, lost part of their fat excess, and reduced their lean mass deficit. In comparison to the girls on OC, those on flutamide-metformin lost a mean of approximately 4 kg of fat and gained approximately 4 kg of lean mass. Similarly, abnormal adipocytokine levels and adiposity were aggravated in women on OC alone and improved in women on OC plus flutamide-metformin; within 9 months, the latter subgroup lost a mean of approximately 3 kg of fat and gained approximately 3 kg of lean mass, in comparison to women on OC alone. In conclusion, young and nonobese PCOS patients were found to be in a low-grade, chronic inflammation state, and to have a body adiposity that evolves according to the balance of circulating adipocytokines and lipids, rather than to androgen excess or fasting hyperinsulinemia. Monotherapy with ethinylestradiol-Drospirenone may not be a prime choice for PCOS, given its inefficacy to attenuate abnormal adipocytokine levels and body adiposity; ethinylestradiol-Drospirenone plus flutamide-metformin, however, is a first OC combination that was found capable of reverting both the adipocytokine balance and the body composition toward normal, and that may therefore improve the long-term cardiovascular perspectives of women with PCOS.
Lourdes Ibanez - One of the best experts on this subject based on the ideXlab platform.
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flutamide metformin plus ethinylestradiol Drospirenone for lipolysis and antiatherogenesis in young women with ovarian hyperandrogenism the key role of metformin at the start and after more than one year of therapy
2005Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Flutamide (Flu)-metformin (Met) with ethinylestradiol-Drospirenone is a combination therapy that reduces the total and abdominal fat excess, diminishes the lean mass deficit, and attenuates the dysadipocytokinemia of young and nonobese women with ovarian hyperandrogenism, a variant of polycystic ovary syndrome. We have now questioned the need: 1) to add Met at the start of Flu plus ethinylestradiol-Drospirenone; and 2) to maintain Met after more than 1 yr on full combination therapy. The additive effects of Met (850 mg/d) were assessed in studies A and B, over 3 months, in young patients with hyperinsulinemic hyperandrogenism. In study A, all participants [n = 31; age ∼16 yr; body mass index ∼ 22 kg/m2] started on Flu (62.5 mg/d) and an oral contraceptive (ethinyl-estradiol + Drospirenone), and they were randomized to receive Met in addition or not. In study B, all participants (n = 42; age ∼19 yr; body mass index ∼ 22 kg/m2) had been treated with Flu-Met plus the same contraceptive for a mean duration of...
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flutamide metformin plus ethinylestradiol Drospirenone for lipolysis and antiatherogenesis in young women with ovarian hyperandrogenism the key role of metformin at the start and after more than one year of therapy
2005Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Flutamide (Flu)-metformin (Met) with ethinylestradiol-Drospirenone is a combination therapy that reduces the total and abdominal fat excess, diminishes the lean mass deficit, and attenuates the dysadipocytokinemia of young and nonobese women with ovarian hyperandrogenism, a variant of polycystic ovary syndrome. We have now questioned the need: 1) to add Met at the start of Flu plus ethinylestradiol-Drospirenone; and 2) to maintain Met after more than 1 yr on full combination therapy. The additive effects of Met (850 mg/d) were assessed in studies A and B, over 3 months, in young patients with hyperinsulinemic hyperandrogenism. In study A, all participants [n = 31; age approximately 16 yr; body mass index approximately 22 kg/m(2)] started on Flu (62.5 mg/d) and an oral contraceptive (ethinyl-estradiol + Drospirenone), and they were randomized to receive Met in addition or not. In study B, all participants (n = 42; age approximately 19 yr; body mass index approximately 22 kg/m(2)) had been treated with Flu-Met plus the same contraceptive for a mean duration of 17 months, and they were randomized for discontinuation of Met or not. Fasting blood glucose, serum insulin, testosterone, lipid profile, adiponectin, and IL-6 were determined at the start and after 3 months, together with body composition, by dual energy x-ray absorptiometry. The results of studies A and B complemented each other; the addition of Met was found to have consistently (more) normalizing effects on IL-6 and adiponectin, on lean mass (mean Met benefit of +1.2 kg in study A and +0.6 kg in study B), and in particular on abdominal fat excess [Met benefit of -0.7 kg (A) and -0.3 kg (B)]. In conclusion, Met proved to be a pivotal component of a prime combination therapy that attenuates the dysadipocytokinemia, the lean mass deficit, and the central adiposity of young patients with polycystic ovary syndrome.
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flutamide metformin plus ethinylestradiol Drospirenone for lipolysis and antiatherogenesis in young women with ovarian hyperandrogenism the key role of early low dose flutamide
2004Co-Authors: Lourdes Ibanez, Carme Valls, Sergi Cabre, Francis De ZegherAbstract:A low-dose combination of flutamide-metformin and ethinylestradiol-Drospirenone was recently found to reduce the excess of total and abdominal fat, to diminish the deficit in lean mass, and to attenuate the dysadipocytokinemia of young women with ovarian hyperandrogenism, a variant of polycystic ovary syndrome. We questioned the need to give flutamide, an androgen receptor blocker, together with an oral contraceptive that contains Drospirenone, a progestin claimed to have antiandrogen properties. The additive effects of low-dose flutamide (62.5 mg/d) were assessed over 3 months in young patients with hyperinsulinemic ovarian hyperandrogenism (n = 40; age, ∼17 yr; body mass index, ∼22 kg/m2); all participants started on metformin (850 mg/d) and a fourth-generation contraceptive (ethinylestradiol 30 μg plus Drospirenone 3 mg, 21 d/month), and they were randomized to receive flutamide in addition (n = 20) or not (n = 20). Fasting blood glucose, serum insulin, lipid profile, testosterone, adiponectin, and IL-...
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ethinylestradiol Drospirenone flutamide metformin or both for adolescents and women with hyperinsulinemic hyperandrogenism opposite effects on adipocytokines and body adiposity
2004Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Hyperinsulinemic hyperandrogenism with anovulation, the so-called polycystic ovary syndrome (PCOS), is the most frequent endocrine disorder of young women. One of the stigmata of PCOS is a deficit of lean mass and an excess of fat, in particular, abdominal fat, even in the absence of obesity. Adiponectin and IL-6 are among the adipocytokines that have recently been related to abdominal fat excess, insulin resistance states, and cardiovascular disease risk. We studied the effects of two new treatment options, ethinylestradiol-Drospirenone and flutamide-metformin, and of their combination on adipocytokinemia and body adiposity in adolescents and women with PCOS. Adolescents with PCOS (n = 32; age, ∼15 yr; body mass index, ∼22 kg/m2) were randomly assigned to receive the oral contraceptive (OC) ethinylestradiol-Drospirenone, or the low-dose generic duo of flutamide (62.5 mg/d) plus metformin (850 mg/d). Young women with PCOS (n = 22; age, ∼19 yr; body mass index, ∼22 kg/m2) were randomized to receive the sam...
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ethinylestradiol Drospirenone flutamide metformin or both for adolescents and women with hyperinsulinemic hyperandrogenism opposite effects on adipocytokines and body adiposity
2004Co-Authors: Lourdes Ibanez, Francis De ZegherAbstract:Hyperinsulinemic hyperandrogenism with anovulation, the so-called polycystic ovary syndrome (PCOS), is the most frequent endocrine disorder of young women. One of the stigmata of PCOS is a deficit of lean mass and an excess of fat, in particular, abdominal fat, even in the absence of obesity. Adiponectin and IL-6 are among the adipocytokines that have recently been related to abdominal fat excess, insulin resistance states, and cardiovascular disease risk. We studied the effects of two new treatment options, ethinylestradiol-Drospirenone and flutamide-metformin, and of their combination on adipocytokinemia and body adiposity in adolescents and women with PCOS. Adolescents with PCOS (n = 32; age, approximately 15 yr; body mass index, approximately 22 kg/m(2)) were randomly assigned to receive the oral contraceptive (OC) ethinylestradiol-Drospirenone, or the low-dose generic duo of flutamide (62.5 mg/d) plus metformin (850 mg/d). Young women with PCOS (n = 22; age, approximately 19 yr; body mass index, approximately 22 kg/m(2)) were randomized to receive the same OC, either alone or with flutamide-metformin. Fasting blood glucose, serum insulin, lipids, androgens, IL-6, adiponectin, and body composition (by absorptiometry) were assessed at the start, and after 3 and/or 9 months. At the start, serum concentrations of the proinflammatory IL-6 were high, and those of the antiinflammatory adiponectin were low; body composition was adipose in each subpopulation. Abnormal adipocytokine levels, hypertriglyceridemia, and body adiposity diverged further from the norm in adolescents on OC; in contrast, girls on flutamide-metformin reverted all study indices toward normal, lost part of their fat excess, and reduced their lean mass deficit. In comparison to the girls on OC, those on flutamide-metformin lost a mean of approximately 4 kg of fat and gained approximately 4 kg of lean mass. Similarly, abnormal adipocytokine levels and adiposity were aggravated in women on OC alone and improved in women on OC plus flutamide-metformin; within 9 months, the latter subgroup lost a mean of approximately 3 kg of fat and gained approximately 3 kg of lean mass, in comparison to women on OC alone. In conclusion, young and nonobese PCOS patients were found to be in a low-grade, chronic inflammation state, and to have a body adiposity that evolves according to the balance of circulating adipocytokines and lipids, rather than to androgen excess or fasting hyperinsulinemia. Monotherapy with ethinylestradiol-Drospirenone may not be a prime choice for PCOS, given its inefficacy to attenuate abnormal adipocytokine levels and body adiposity; ethinylestradiol-Drospirenone plus flutamide-metformin, however, is a first OC combination that was found capable of reverting both the adipocytokine balance and the body composition toward normal, and that may therefore improve the long-term cardiovascular perspectives of women with PCOS.
Jeanmichel Foidart - One of the best experts on this subject based on the ideXlab platform.
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reduced hemostatic effects with Drospirenone based oral contraceptives containing estetrol vs ethinyl estradiol
2017Co-Authors: Cornelis Kluft, Jeanmichel Foidart, Ingrid Duijkers, Yvette Zimmerman, Marie Mawet, Christine Klipping, Jacoline Neuteboom, Herjan Coelingh J T BenninkAbstract:Summary Objective The effects of estetrol (E4), a natural fetal estrogen, combined with Drospirenone (DRSP) were evaluated on plasma levels of sex hormone-binding globulin (SHBG), angiotensinogen and 12 hemostasis markers. Study design Combinations of 3 mg DRSP with 5 or 10 mg E4 were compared with YAZ® (20 mcg ethinyl estradiol and 3 mg DRSP; EE/DRSP) in parallel groups of 15–18 healthy young women. Main outcome was the relative change from pretreatment to the end (day 24±1) of the third treatment cycle. Results All E4 combinations showed low estrogen impact compared to EE/DRSP. Effects on SHBG and angiotensinogen of 10 mg E4 combined with DRSP were 15%–20% that of EE/DRSP. Both E4/DRSP combinations reduced D-dimer level and the 5 mg E4/DRSP combination also decreased fragment 1+2. Conclusions The reduction in coagulation markers suggests an anticoagulant effect from DRSP. The indications of a low thrombosis risk for E4 preparations should be validated in larger studies. Implication statement • The oral estrogens, 17-β-estradiol and ethinyl estradiol, are known for significant effects on estrogenic and hemostatic variables. • Effects of oral estetrol (E4) combined with Drospirenone (DRSP) are significantly less for these variables. • This suggests a low procoagulant effect of E4/DRSP that should be clinically verified for low antithrombotic consequences.
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effects of oral contraception with ethinylestradiol and Drospirenone on oxidative stress in women 18 35 years old
2009Co-Authors: Donat De Groote, Sophie Perrier Dhauterive, Axelle Pintiaux, Benedicte Balteau, Colette Gerday, Jurgen Claesen, Jeanmichel FoidartAbstract:Abstract Background Oral contraceptives (OCs) with estrogens and progestins may affect oxidative stress (OS) status. Study design A group of 32 women using oral contraceptives (OCU) containing 0.03 mg ethinylestradiol and 3 mg Drospirenone have been compared to a matched control group of 30 noncontraception users (NCU). Blood levels of antioxidants, trace elements and markers of lipid peroxidation were assessed by biochemical methods. A microarray analysis of whole blood mRNA levels of 200 genes involved in OS-dependant pathway was also performed. Results Levels of zinc, vitamin E and antibodies to oxidized low-density lipoproteins (LDLs) were not significantly different between the two groups. On the other hand, significant increases in the mean levels of lipid peroxides (+176%, p 2 fold change=+ 0.45, p 2 fold change=���0.24, p Conclusions The recently introduced combination of ethinylestradiol and Drospirenone induced the heightening of lipid peroxidation correlated with high levels of copper, a situation that could be associated with increased cardiovascular risk.
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a comparative investigation of contraceptive reliability cycle control and tolerance of two monophasic oral contraceptives containing either Drospirenone or desogestrel
2000Co-Authors: Jeanmichel Foidart, W Wuttke, Christoph Gerlinger, G M Bouw, R HeitheckerAbstract:Objective To assess the contraceptive reliability, cycle control and tolerance of a new monophasic oral contraceptive (Yasmin®) containing 30 μg ethinylestradiol and 3 mg Drospirenone and compare it with a preparation containing an equal dose of ethinylestradiol combined with 150 μg desogestrel (Marvelon®).Methods A multicenter, open-label, randomized study was carried out in 26 European centers. Contraceptive efficacy, cycle control and tolerance (including body weight, blood pressure and heart rate) were assessed over 26 cycles, plus a 3-month follow-up period.Results Of 900 women who were randomized, 887 started treatment and 627 completed the 26 cycles plus follow-up (310 in the ethinylestradiol/Drospirenone group and 317 in the ethinylestradiol/desogestrel group). Both study preparations were found to be effective with regard to contraceptive reliability and cycle control was good. There were six pregnancies (three in each group), but none were considered to have been the result of method failures. T...
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efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and Drospirenone
2000Co-Authors: J Huber, Jeanmichel Foidart, W Wuttke, G S Merkifeld, Christoph Gerlinger, Ilka Schellschmidt, R HeitheckerAbstract:Objective To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg Drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands).Methods A randomized, open-label, 13–cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter.Results Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/Drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23 000 evaluable cycle...
Kristian B Filion - One of the best experts on this subject based on the ideXlab platform.
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Drospirenone containing oral contraceptive pills and the risk of venous thromboembolism a systematic review of observational studies
2017Co-Authors: Kristian B Filion, Natasha Larivee, Samy Suissa, Farzin Khosrowkhavar, Vicky TagalakisAbstract:Background The effects of fourth-generation Drospirenone-containing combined oral contraceptives (COCs) on the risk of venous thromboembolism (VTE) are controversial. Objectives To assess the methodological strengths and limitations of the evidence on the VTE risk of these COCs. Search strategy We searched CINAHL, the Cochrane Library, EMBASE, HealthStar, Medline, and the Science Citation Index. Selection criteria Studies were included if they were cohort and case–control studies, reported a venous thrombotic outcome, had a comparator group, reported an effect measure of the association of interest, and were published in English or French. Data collection and analysis We assessed study quality using the ROBINS-I tool and assessed the presence of four common sources of bias: prevalent user bias, inappropriate choice of comparator, VTE misclassification, and confounding. Main results Our systematic review included 17 studies. The relative risks of VTE associated with Drospirenone- versus second-generation levonorgestrel-containing COCs ranged from 1.0 to 3.3. Based on ROBINS-I, three studies had a moderate risk, ten had a serious risk, and four had a critical risk. Nine studies included prevalent users, four included inappropriate comparators, four had VTE misclassification, and five did not account for two or more important confounding factors. The three highest quality studies had relative risks ranging from 1.0 to 1.57. Author's conclusions As a result of the methodological limitations of the individual studies, the VTE risk of Drospirenone-containing COCs remains unknown. The highest quality studies suggest there are no or slightly increased harmful effects, but their confidence limits do not rule out an almost doubling of the risk. Tweetable abstract Systematic review of Drospirenone: best studies show no or slightly increased VTE risk (versus levonorgestrel).
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Drospirenone containing oral contraceptive pills and the risk of venous thromboembolism an assessment of risk in first time users and restarters
2017Co-Authors: Kristian B Filion, Natasha Larivee, Samy Suissa, Vicky Tagalakis, Janie CoulombeAbstract:Introduction The effects of Drospirenone-containing combined oral contraceptives (COCs) on the risk of venous thromboembolism (VTE) remain controversial due to the challenge in distinguishing between first-time users and restarters, and their different underlying VTE risks, in healthcare databases.
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Drospirenone containing oral contraceptive pills and the risk of venous and arterial thrombosis a systematic review
2013Co-Authors: Sonia M Grandi, Kristian B Filion, Haim A Abenhaim, Lawrence Joseph, Mark J EisenbergAbstract:Background Previous studies have provided conflicting results regarding the effect of Drospirenone-containing oral contraceptive pills (OCPs) on the risk of venous and arterial thrombosis. Objectives To conduct a systematic review to assess the risk of venous thromboembolism (VTE), myocardial infarction (MI), and stroke in individuals taking Drospirenone-containing OCPs. Search strategy We systematically searched CINAHL, the Cochrane Library, Dissertation & Abstracts, EMBASE, HealthStar, Medline, and the Science Citation Index from inception to November 2012. Selection criteria We included all case reports, observational studies, and experimental studies assessing the risk of venous and arterial thrombosis of Drospirenone-containing OCPs. Data collection and analysis Data were collected independently by two reviewers. Main results A total of 22 studies [six case reports, three case series (including 26 cases), and 13 comparative studies] were included in our systematic review. The 32 identified cases suggest a possible link between Drospirenone-containing OCPs and venous and arterial thrombosis. Incidence rates of VTE among Drospirenone-containing OCP users ranged from 23.0 to 136.7 per 100 000 woman-years, whereas those among levonorgestrel-containing OCP users ranged from 6.64 to 92.1 per 100 000 woman-years. The rate ratio for VTE among Drospirenone-containing OCP users ranged from 4.0 to 6.3 compared with non-users of OCPs, and from 1.0 to 3.3 compared with levonorgestrel-containing OCP users. The arterial effects of Drospirenone-containing OCPs were inconclusive. Author's conclusions Our systematic review suggests that Drospirenone-containing OCP use is associated with a higher risk for VTE than both no OCP use and levonorgestrel-containing OCP use.
Richard Lynen - One of the best experts on this subject based on the ideXlab platform.
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premenstrual dysphoric disorder symptom cluster improvement by cycle with the combined oral contraceptive ethinylestradiol 20 mcg plus Drospirenone 3 mg administered in a 24 4 regimen
2011Co-Authors: Joachim Marr, Minoo Niknian, Lee P Shulman, Richard LynenAbstract:Abstract Background A combined oral contraceptive comprising ethinylestradiol (EE) 20 mcg/Drospirenone 3 mg in a 24/4 regimen has been clinically shown to alleviate the symptoms associated with premenstrual dysphoric disorder (PMDD). However, previous studies did not report data according to cycle-by-cycle improvement. Study design This was a subanalysis of a Phase III, double-blind, multicenter, United States-based study. Women with confirmed PMDD were randomized to EE 20 mcg/Drospirenone 3 mg 24/4 or placebo for three treatment cycles. Ten of the 21 emotional and physical items on the Daily Record of Severity of Problems scale were grouped to define three symptom clusters: (a) negative emotions, (b) food cravings and (c) water retention-related symptoms. The change from baseline at each treatment cycle was compared between groups using a weighted analysis of covariance model. Results The full analysis set comprised 449 women. Daily Record of Severity of Problems scores for each symptom cluster were significantly reduced from baseline with both EE 20 mcg/Drospirenone 3 mg 24/4 and placebo (p Conclusion Ethinylestradiol 20 mcg/Drospirenone 3 mg 24/4 improved commonly recognizable PMDD symptom clusters relating to negative emotions, food cravings and water retention-related symptoms to a significantly greater extent than placebo during all three cycles of treatment.
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original research article premenstrual dysphoric disorder symptom cluster improvement by cycle with the combined oral contraceptive ethinylestradiol 20 mcg plus Drospirenone 3 mg administered in a 24 4 regimen
2010Co-Authors: Joachim Marr, Minoo Niknian, Lee P Shulman, Richard LynenAbstract:Background: A combined oral contraceptive comprising ethinylestradiol (EE) 20 mcg/Drospirenone 3 mg in a 24/4 regimen has been clinically shown to alleviate the symptoms associated with premenstrual dysphoric disorder (PMDD). However, previous studies did not report data according to cycle-by-cycle improvement. Study design: This was a subanalysis of a Phase III, double-blind, multicenter, United States-based study. Women with confirmed PMDD were randomized to EE 20 mcg/Drospirenone 3 mg 24/4 or placebo for three treatment cycles. Ten of the 21 emotional and physical items on the Daily Record of Severity of Problems scale were grouped to define three symptom clusters: (a) negative emotions, (b) food cravings and (c) water retention-related symptoms. The change from baseline at each treatment cycle was compared between groups using a weighted analysis of covariance model. Results: The full analysis set comprised 449 women. Daily Record of Severity of Problems scores for each symptom cluster were significantly reduced from baseline with both EE 20 mcg/Drospirenone 3 mg 24/4 and placebo (pb.0001 for all). The greatest symptom improvements were achieved within the first cycle of treatment and continued throughout cycles 2 to 3. The mean between-treatment difference was significant in favor of EE 20 mcg/Drospirenone 3 mg 24/4 for all three symptom clusters in all three treatment cycles (p≤.0001 vs. placebo in percent change from baseline). Conclusion: Ethinylestradiol 20 mcg/Drospirenone 3 mg 24/4 improved commonly recognizable PMDD symptom clusters relating to negative emotions, food cravings and water retention-related symptoms to a significantly greater extent than placebo during all three cycles of treatment.
