The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance study on Oral Contraceptives based on 142,475 women-years of observation

Dinger, Jürgen; Heinemann, L.; Kühl-Habich, Dörthe

doi:10.1016/j.contraception.2006.12.019

Cited by 404 publications

(317 citation statements)

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“…The study by Gronich and colleagues 2 adds further evidence of a higher relative risk of venous thromboembolism among women taking this type of oral contraceptive, rela tive to the alternatives of either third-or second-generation oral contraceptives. Although earlier publications did not detect any such relative difference in thrombotic risk, 8 carefully designed evaluations performed more recently have found evidence of such a risk. 9 The industry-funded phase IV European postmarketing surveillance study 8 collected data by mailed questionnaires from women for whom an oral contraceptive had been newly prescribed.…”

mentioning

confidence: 85%

“…Although earlier publications did not detect any such relative difference in thrombotic risk, 8 carefully designed evaluations performed more recently have found evidence of such a risk. 9 The industry-funded phase IV European postmarketing surveillance study 8 collected data by mailed questionnaires from women for whom an oral contraceptive had been newly prescribed. In that study, all subgroups of pill users (categorized by additional risk factors or by drug prescribed) had a similar incidence of venous thromboembolism, which, according to the study design, excluded the possibility of a twofold higher incidence of venous thromboembolism in drospirenone users and provided evidence of non-inferiority.…”

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confidence: 85%

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Risk of venous thromboembolism with oral contraceptives

Solymoss¹

2011

Canadian Medical Association Journal

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T he lifetime incidence of venous thromboembolism for both men and women is estimated at 1 per 1000.1 Increasing our understanding of the precipitating risk factors, as well as optimizing the prevention of this condition in high-risk populations, could help to reduce the burden of venous thromboembolism. A retrospective cohort study by Gronich and colleagues 2 challenges us to weigh the thrombotic risk of various oral contraceptives.Older age, admission to hospital, surgery, cancer and other comorbidities dramatically increase the rate of venous thromboembolism. Conversely, effective thromboprophylaxis is known to substantially reduce the incidence. The difficulty of ensuring good compliance with thromboprophylaxis remains a major barrier to reducing the adverse outcomes associated with venous thromboembolism. 3The absolute rate of venous thromboembolism in young women is low, but the use of combined oral contraceptives increases this rate three-to five-fold, with an even higher rate in the presence of associated risk factors such as thrombophilia. 4 Gronich and colleagues 2 focus our attention on women 12 to 50 years of age taking hormonal contraceptives and attempt to quantify the relative difference in risk of venous thromboembolism attributable to the type of oral contraceptive prescribed.The reported incidence of venous thromboembolism in users of oral contraceptives is about 0.06 per 100 pill-years, 5 significantly lower than the rate of 0.2 per 100 years at risk during pregnancy and the postpartum period. 6 The high contraceptive efficacy of oral contraceptives, despite their thrombotic risk, should be weighed against the risks associated with less effective contraception methods, including the potential thrombotic consequences of an unwanted pregnancy.The aim of numerous previous studies has been to evaluate the differential thrombotic risk of third-generation (containing desogestrel, gestodene or norgestimate) and secondgeneration (containing norgestrel or levonorgestrel) oral contraceptives. Although not completely consistent, the overall findings have substantiated a relatively lesser thrombotic risk with the use of second-generation contraceptives, albeit with heterogeneity among the studies. Drospirenone-containing oral contraceptives, which have become available more recently, have a mineralocorticoid-derived progestational component. The study by Gronich and colleagues 2 adds further evidence of a higher relative risk of venous thromboembolism among women taking this type of oral contraceptive, rela tive to the alternatives of either third-or second-generation oral contraceptives. Although earlier publications did not detect any such relative difference in thrombotic risk, 8 carefully designed evaluations performed more recently have found evidence of such a risk. 9 The industry-funded phase IV European postmarketing surveillance study 8 collected data by mailed questionnaires from women for whom an oral contraceptive had been newly prescribed. In that study, all subgroups of pill users (categoriz...

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confidence: 85%

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confidence: 85%

Risk of venous thromboembolism with oral contraceptives

Solymoss¹

2011

Canadian Medical Association Journal

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“…To date, wrong assumptions exist regarding the safety of hormonal contraception. Moreover, cardiovascular side effects and embolic risks have not been eliminated either before (6,7) or after menopause (7,8). Thus, physicians should provide women with the information about both advantages and risks of contraception (9).…”

Section: Investigation Of the Relationship Between Myocardial Infarctmentioning

confidence: 99%

Investigation of the Relationship between Myocardial Infarction, Angina Pectoris, and Venous Thrombosis and Some Risk Factors in the Women Suffering from Cardiovascular Diseases with a History of Contraceptive Pills Consumption

Akbarzade

Sharifi

Zare

2016

Int Cardiovasc Res J

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A B S T R A C TBackground: Cardiovascular diseases have various etiologies. Previous studies have come to contradictory results regarding the effects of Oral Contraceptive Pills (OCPs) on the risk of myocardial infarction, angina pectoris, and venous thrombosis. Thus, further investigation is required in this area. Objectives: This study aimed to determine the relationship between cardiovascular diseases and some risk factors in the women with a history of contraceptive pills consumption. Patients and Methods:The present case-control study was conducted on 317 women with cardiovascular diseases (myocardial infarction, angina pectoris, and deep venous thrombosis) selected through simple purposive sampling from CCU, ICU, post-ICU, and neurology departments of Nemazee, Faghihi, and Al-Zahra heart hospitals. Also, 371 controls were selected among 20 -60 year-old women without cardiac diseases. The data were collected through questionnaires, interviewing the patients and their firstdegree relatives, and the patients' medical records. The main variables studied in both groups included the history of OCPs consumption, weight gain, blood sugar level, and hypertension. Then, the data were analyzed using chi-square test, correlation coefficient, and odds ratio. Besides, P < 0.05 was considered to be statistically significant. Results: The mean age of the study population was 49.2 ± 13.4 years. Besides, 10.6%, 4%, and 2.7% of the women had used OCPs for 6 -10, 11 -15, and more than 16 years, respectively. There were no significant differences between the two groups in terms of history of using OCPs (47.3% vs. 51.5%, P = 0.8). In addition, no significant relationship was observed between consumption of OCPs and incidence of myocardial infarction (P = 0.202), angina pectoris (P = 0.260), and thrombosis (P = 0.389). However, a significant difference was found between the two groups regarding the frequency of hyperlipidemia, hyperglycemia, and hypertension (P < 0.001). Conclusions:The results showed no significant association between the use of OCPs and cardiovascular diseases. Nevertheless, other risk factors of cardiovascular diseases were higher among the patients with a history of contraceptive pills consumption.

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“…12 Many factors further increase the risk of VTE, including immobility, smoking, hypertension and diabetes, as well as obesity. 14 These should be taken into consideration when deciding which is the most suitable method of contraception, and COCs should be prescribed with caution to obese women (BMI >35).…”

Section: Principal Risksmentioning

confidence: 99%

“…11 The risk is highest in the first year of use and declines thereafter but persists until discontinuation. 12 The natural estrogen in Qlaira and Zoely confers a neutral clotting profile compared to ethinylestradiol. Surveillance data suggest that Qlaira is associated with similar or lower risk compared to ethinylestradiol COCs but there are no data on risks associated with Zoely.…”

Section: Principal Risksmentioning

confidence: 99%