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      Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis

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          Abstract

          Objective To provide a comprehensive overview of the risk of venous thrombosis in women using different combined oral contraceptives.

          Design Systematic review and network meta-analysis.

          Data sources PubMed, Embase, Web of Science, Cochrane, Cumulative Index to Nursing and Allied Health Literature, Academic Search Premier, and ScienceDirect up to 22 April 2013.

          Review methods Observational studies that assessed the effect of combined oral contraceptives on venous thrombosis in healthy women. The primary outcome of interest was a fatal or non-fatal first event of venous thrombosis with the main focus on deep venous thrombosis or pulmonary embolism. Publications with at least 10 events in total were eligible. The network meta-analysis was performed using an extension of frequentist random effects models for mixed multiple treatment comparisons. Unadjusted relative risks with 95% confidence intervals were reported. The requirement for crude numbers did not allow adjustment for potential confounding variables.

          Results 3110 publications were retrieved through a search strategy; 25 publications reporting on 26 studies were included. Incidence of venous thrombosis in non-users from two included cohorts was 1.9 and 3.7 per 10 000 woman years, in line with previously reported incidences of 1-6 per 10 000 woman years. Use of combined oral contraceptives increased the risk of venous thrombosis compared with non-use (relative risk 3.5, 95% confidence interval 2.9 to 4.3). The relative risk of venous thrombosis for combined oral contraceptives with 30-35 µg ethinylestradiol and gestodene, desogestrel, cyproterone acetate, or drospirenone were similar and about 50-80% higher than for combined oral contraceptives with levonorgestrel. A dose related effect of ethinylestradiol was observed for gestodene, desogestrel, and levonorgestrel, with higher doses being associated with higher thrombosis risk.

          Conclusion All combined oral contraceptives investigated in this analysis were associated with an increased risk of venous thrombosis. The effect size depended both on the progestogen used and the dose of ethinylestradiol.

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          Most cited references58

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          Incidence and mortality of venous thrombosis: a population-based study.

          I Naess, S C Christiansen, P. Romundstad … (2007)
          Estimates of the incidence of venous thrombosis (VT) vary, and data on mortality are limited. We estimated the incidence and mortality of a first VT event in a general population. From the residents of Nord-Trøndelag county in Norway aged 20 years and older (n = 94 194), we identified all cases with an objectively verified diagnosis of VT that occurred between 1995 and 2001. Patients and diagnosis characteristics were retrieved from medical records. Seven hundred and forty patients were identified with a first diagnosis of VT during 516,405 person-years of follow-up. The incidence rate for all first VT events was 1.43 per 1000 person-years [95% confidence interval (CI): 1.33-1.54], that for deep-vein thrombosis (DVT) was 0.93 per 1000 person-years (95% CI: 0.85-1.02), and that for pulmonary embolism (PE) was 0.50 per 1000 person-years (95% CI: 0.44-0.56). The incidence rates increased exponentially with age, and were slightly higher in women than in men. The 30-day case-fatality rate was higher in patients with PE than in those with DVT [9.7% vs. 4.6%, risk ratio 2.1 (95% CI: 1.2-3.7)]; it was also higher in patients with cancer than in patients without cancer [19.1% vs. 3.6%, risk ratio 3.8 (95% CI 1.6-9.2)]. The risk of dying was highest in the first months subsequent to the VT, after which it gradually approached the mortality rate in the general population. This study provides estimates of incidence and mortality of a first VT event in the general population.
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            Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis

            Paul Ronksley, Susan E Brien, Barbara Turner … (2011)
            Objective To conduct a comprehensive systematic review and meta-analysis of studies assessing the effect of alcohol consumption on multiple cardiovascular outcomes. Design Systematic review and meta-analysis. Data sources A search of Medline (1950 through September 2009) and Embase (1980 through September 2009) supplemented by manual searches of bibliographies and conference proceedings. Inclusion criteria Prospective cohort studies on the association between alcohol consumption and overall mortality from cardiovascular disease, incidence of and mortality from coronary heart disease, and incidence of and mortality from stroke. Studies reviewed Of 4235 studies reviewed for eligibility, quality, and data extraction, 84 were included in the final analysis. Results The pooled adjusted relative risks for alcohol drinkers relative to non-drinkers in random effects models for the outcomes of interest were 0.75 (95% confidence interval 0.70 to 0.80) for cardiovascular disease mortality (21 studies), 0.71 (0.66 to 0.77) for incident coronary heart disease (29 studies), 0.75 (0.68 to 0.81) for coronary heart disease mortality (31 studies), 0.98 (0.91 to 1.06) for incident stroke (17 studies), and 1.06 (0.91 to 1.23) for stroke mortality (10 studies). Dose-response analysis revealed that the lowest risk of coronary heart disease mortality occurred with 1–2 drinks a day, but for stroke mortality it occurred with ≤1 drink per day. Secondary analysis of mortality from all causes showed lower risk for drinkers compared with non-drinkers (relative risk 0.87 (0.83 to 0.92)). Conclusions Light to moderate alcohol consumption is associated with a reduced risk of multiple cardiovascular outcomes.
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              Hormonal contraception and risk of venous thromboembolism: national follow-up study

              Øjvind Lidegaard, Ellen Løkkegaard, Anne Louise Svendsen … (2009)
              Objective To assess the risk of venous thrombosis in current users of different types of hormonal contraception, focusing on regimen, oestrogen dose, type of progestogen, and route of administration. Design National cohort study. Setting Denmark, 1995-2005. Participants Danish women aged 15-49 with no history of cardiovascular or malignant disease. Main outcome measures Adjusted rate ratios for all first time deep venous thrombosis, portal thrombosis, thrombosis of caval vein, thrombosis of renal vein, unspecified deep vein thrombosis, and pulmonary embolism during the study period. Results 10.4 million woman years were recorded, 3.3 million woman years in receipt of oral contraceptives. In total, 4213 venous thrombotic events were observed, 2045 in current users of oral contraceptives. The overall absolute risk of venous thrombosis per 10 000 woman years in non-users of oral contraceptives was 3.01 and in current users was 6.29. Compared with non-users of combined oral contraceptives the rate ratio of venous thrombembolism in current users decreased with duration of use ( 4 years 2.76, 2.53 to 3.02; P<0.001) and with decreasing dose of oestrogen. Compared with oral contraceptives containing levonorgestrel and with the same dose of oestrogen and length of use, the rate ratio for oral contraceptives with norethisterone was 0.98 (0.71 to 1.37), with norgestimate 1.19 (0.96 to 1.47), with desogestrel 1.82 (1.49 to 2.22), with gestodene 1.86 (1.59 to 2.18), with drospirenone 1.64 (1.27 to 2.10), and with cyproterone 1.88 (1.47 to 2.42). Compared with non-users of oral contraceptives, the rate ratio for venous thromboembolism in users of progestogen only oral contraceptives with levonorgestrel or norethisterone was 0.59 (0.33 to 1.03) or with 75 μg desogestrel was 1.12 (0.36 to 3.49), and for hormone releasing intrauterine devices was 0.90 (0.64 to 1.26). Conclusion The risk of venous thrombosis in current users of combined oral contraceptives decreases with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel. Progestogen only pills and hormone releasing intrauterine devices were not associated with any increased risk of venous thrombosis.
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                Author and article information

                Contributors
                Bernardine H Stegeman: Role: research associate
                Marcos de Bastos: Role: research fellow
                Frits R Rosendaal: Role: professor of clinical epidemiology
                A van Hylckama Vlieg: Role: research fellow
                Frans M Helmerhorst: Role: professor of clinical epidemiology of fertility
                Theo Stijnen: Role: professor of medical statistics
                Olaf M Dekkers: Role: research fellow
                Journal
                Journal ID (nlm-ta): BMJ
                Journal ID (iso-abbrev): BMJ
                Journal ID (publisher-id): bmj
                Title: BMJ : British Medical Journal
                Publisher: BMJ Publishing Group Ltd.
                ISSN (Print): 0959-8138
                ISSN (Electronic): 1756-1833
                Publication date Collection: 2013
                Publication date (Print): 2013
                Publication date (Electronic): 12 September 2013
                Volume: 347
                Electronic Location Identifier: f5298
                Affiliations
                [1 ]Department of Epidemiology and Public Health, University College London, London, UK
                [2 ]Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands
                [3 ]Department of Clinical Epidemiology, Department of Thrombosis and Haemostasis, Einthoven Laboratory for Experimental Vascular Medicine, Leiden University Medical Center, Netherlands
                [4 ]Department of Clinical Epidemiology, Einthoven Laboratory for Experimental Vascular Medicine, Leiden University Medical Center, Netherlands
                [5 ]Department of Gynaecology and Reproductive Medicine, Leiden University Medical Center, Netherlands
                [6 ]Department of Medical Statistics, Leiden University Medical Center, Netherlands
                [7 ]Department of Clinical Epidemiology, Department of Endocrinology and Metabolism, Leiden University Medical Center, 2333 ZA Leiden, Netherlands
                Author notes
                Correspondence to: O M Dekkers o.m.dekkers@ 123456lumc.nl
                Article
                Publisher ID: steb011344
                DOI: 10.1136/bmj.f5298
                PMC ID: 3771677
                PubMed ID: 24030561
                SO-VID: 9a16d5f7-6341-44b0-add1-18e5fd471fb5
                Copyright © © Stegeman et al 2013
                License:

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

                History
                Date accepted : 12 August 2013
                Categories
                Subject: Research

                ScienceOpen disciplines: Medicine
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                ScienceOpen disciplines: Medicine

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