Progestin-Only Contraceptives and the Risk of Venous Thromboembolism: Systematic Review and Meta-Analysis,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3344-3344
Author(s):  
Simon Mantha ◽  
Vidya Raghavan ◽  
Rebecca Karp ◽  
Norma Terrin ◽  
Kenneth A. Bauer ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Risk Ratio ◽  
Meta Analysis ◽  
Control Group ◽  
Thrombotic Risk ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Estimated Risk

Abstract Abstract 3344 Background: Combined oral contraceptives (COC) containing estrogens and progestins are associated with a 2 to 4-fold increased risk of venous thromboembolic events. Progestin-only contraceptives are commonly prescribed to women with a higher risk for thrombosis, although a lower thrombotic risk than COC has not been clearly established. We performed a systematic review and meta-analysis of published studies to estimate the risk ratio of venous thromboembolism (VTE) in women taking progesterone for the purpose of contraception. Materials and methods: We performed a literature search of cohort, case-control and randomized studies including women treated with progestin-only contraception compared with a no-hormone control group. All administration routes (oral, injectable and intra-uterine) were considered. The primary endpoint was the corrected risk ratio of VTE analyzed using a random effects model. Results: 1150 references were retrieved; 7 studies were retained for analysis. The summary estimate of the adjusted risk ratio of VTE for women taking a progestin for contraception versus no hormone was 1.02 (95% CI=0.76–1.37, p=0.89). Heterogeneity between studies was minimal (Q-value=7.1, I2=15.49 and p=0.31). An analysis combining the unadjusted odds ratios of VTE gave a similar result (OR=1.24, 95% CI=0.93–1.66, p=0.14). Analysis by subgroup suggests a higher risk of thrombotic events for individuals using an injectable progestin, with an estimated risk ratio of VTE equal to 2.67 (95% CI=1.29–5.53, p=0.008), compared to 0.87 (95% CI=0.53–1.42, p=0.58) for oral administration. Conclusions: Progestin-only oral formulations used for contraception do not appear to increase the risk of venous thromboembolic disease, although injectable administration was associated with an increased incidence of VTE relative to women not taking hormones that is comparable to the risk associated with COC. Estimated risk ratio of VTE for progestin versus no hormone, using adjusted values; A, all routes of administration for all studies; B, injectable progestins only, for studies where those results were reported. This publication was supported by Grant Number UL1 RR025752 from the National Center for Research Resources. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCRR. Disclosures: No relevant conflicts of interest to declare.

scholarly journals EXPRESS: Stroke risk following traumatic brain injury: systematic review and meta-analysis

2021 ◽  
pp. 174749302110042
Author(s):  
Grace Mary Turner ◽  
Christel McMullan ◽  
Olalekan Lee Aiyegbusi ◽  
Danai Bem ◽  
Tom Marshall ◽  
...  
Keyword(s):  
Systematic Review ◽  
Stroke Risk ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Cochrane Library ◽  
Control Group ◽  
Large Sample Size ◽  
Hazard Ratios ◽  
Increased Risk ◽  
The Cochrane Library

Aims To investigate the association between TBI and stroke risk. Summary of review We undertook a systematic review of MEDLINE, EMBASE, CINAHL, and The Cochrane Library from inception to 4th December 2020. We used random-effects meta-analysis to pool hazard ratios (HR) for studies which reported stroke risk post-TBI compared to controls. Searches identified 10,501 records; 58 full texts were assessed for eligibility and 18 met the inclusion criteria. The review included a large sample size of 2,606,379 participants from four countries. Six studies included a non-TBI control group, all found TBI patients had significantly increased risk of stroke compared to controls (pooled HR 1.86; 95% CI 1.46-2.37). Findings suggest stroke risk may be highest in the first four months post-TBI, but remains significant up to five years post-TBI. TBI appears to be associated with increased stroke risk regardless of severity or subtype of TBI. There was some evidence to suggest an association between reduced stroke risk post-TBI and Vitamin K antagonists and statins, but increased stroke risk with certain classes of antidepressants. Conclusion TBI is an independent risk factor for stroke, regardless of TBI severity or type. Post-TBI review and management of risk factors for stroke may be warranted.

scholarly journals Comparing pharmacological venous thromboembolism prophylaxis to intermittent pneumatic compression in acute intracerebral haemorrhage: protocol for a systematic review and network meta-analysis

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e024405 ◽  
Author(s):  
Vignan Yogendrakumar ◽  
Ronda Lun ◽  
Brian Hutton ◽  
Dean A Fergusson ◽  
Dar Dowlatshahi
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Intracerebral Haemorrhage ◽  
Meta Analysis ◽  
Indirect Evidence ◽  
Intermittent Pneumatic Compression ◽  
Qualitative Assessment ◽  
Primary Data ◽  
Thromboembolism Prophylaxis ◽  
Increased Risk

IntroductionPatients with an intracerebral haemorrhage are at increased risk of venous thromboembolism. Pharmacotherapy and pneumatic compression devices are capable of preventing venous thromboembolism, however both interventions have limitations. There are no head-to-head comparisons between these two interventions. To address this knowledge gap, we plan to perform a systematic review and network meta-analysis to examine the comparative effectiveness of pharmacological prophylaxis and mechanical compression devices in the context of intracerebral haemorrhage.Methods and analysisMEDLINE, PUBMED, EMBASE, CENTRAL, ClinicalTrials.gov and the Internet Stroke Trials Registry will be searched with assistance from an experienced information specialist. Eligible studies will include those that have enrolled adults presenting with spontaneous intracerebral haemorrhage and compared one or more of the respective interventions against each other and/or a control. Primary outcomes to be assessed are occurrence of new venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) and haematoma expansion, defined as a significant enlargement of baseline haemorrhage or new haemorrhage occurrence. Both randomised and non-randomised comparative studies will be included. Data on participant characteristics, study design, intervention details and outcomes will be extracted. Study quality will be assessed using the Cochrane Risk of Bias Tool and the Robins-I tool. Bayesian network meta-analyses will be performed to compare interventions based on all available direct and indirect evidence. If the transitivity assumption for network meta-analysis cannot be met, we will perform a qualitative assessment.Ethics and disseminationFormal ethics is not required as primary data will not be collected. The findings of this study will be disseminated through conference presentations, and peer-reviewed publications. In an area of clinical practice where equipoise exists, the findings of this study may assist in determining which treatment intervention is most effective in venous thromboembolism prevention.PROSPERO registration numberCRD42018090960.

scholarly journals Extended thromboprophylaxis for medically ill patients with cancer: a systemic review and meta-analysis

2021 ◽  
Vol 5 (8) ◽  
pp. 2055-2062
Author(s):  
Soravis Osataphan ◽  
Rushad Patell ◽  
Thita Chiasakul ◽  
Alok A. Khorana ◽  
Jeffrey I. Zwicker
Keyword(s):  
Meta Analysis ◽  
Thromboembolic Events ◽  
Medically Ill ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Extended Duration ◽  
Medically Ill Patients

Abstract Hospitalized medically ill patients with cancer are at increased risk of both venous thromboembolism and bleeding. The safety and efficacy of extended thromboprophylaxis in patients with cancer are unclear. We conducted a systematic review and meta-analysis of the literature using of MEDLINE, EMBASE, and the Cochrane CENTRAL databases to identify cancer subgroups enrolled in randomized controlled trials evaluating extended thromboprophylaxis following hospitalization. The primary outcomes were symptomatic and incidental venous thromboembolic events and hemorrhage (major hemorrhage and clinically relevant nonmajor bleeding). Four randomized controlled trials reported the outcomes of extended thromboprophylaxis in 3655 medically ill patients with active or history of cancer. The rates of venous thromboembolic events were similar between the extended-duration and standard-duration groups (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.61-1.18; I2 = 0%). However, major and clinically relevant nonmajor bleeding occurred significantly more frequently in the extended-duration thromboprophylaxis group (OR, 2.10; 95% CI, 1.33-3.35; I2 = 8%). Extended thromboprophylaxis in hospitalized medically ill patients with cancer was not associated with a reduced rate of venous thromboembolic events but was associated with increased risk of hemorrhage. This study protocol was registered on PROSPERO as #CRD42020209333.

scholarly journals Effects of Selenium Supplementation on Graves’ Disease: A Systematic Review and Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Huijuan Zheng ◽  
Junping Wei ◽  
Liansheng Wang ◽  
Qiuhong Wang ◽  
Jing Zhao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Thyroid Function ◽  
Meta Analysis ◽  
Selenium Supplementation ◽  
Control Group ◽  
Graves Disease ◽  
Cochrane Central Register ◽  
Placebo Administration ◽  
Increased Risk ◽  
Tsh Levels

Low selenium status is associated with increased risk of Graves’ disease (GD). While several trials have discussed the efficacy of selenium supplementation for thyroid function, in GD patients, the effectiveness of selenium intake as adjuvant therapy remains unclear. In this systematic review and meta-analysis, we aimed to determine the efficacy of selenium supplementation on thyroid function in GD patients. Two reviewers searched PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, and four Chinese databases for studies published up to October 31, 2017. RCTs comparing the effect of selenium supplementation on thyroid hyperfunction in GD patients on antithyroid medication to placebo were included. Serum free thyroxine (FT4), free triiodothyronine (FT3), thyrotrophic hormone receptor antibody (TRAb), and thyroid-stimulating hormone (TSH) levels were assessed. Ten trials involving 796 patients were included. Random-effects meta-analyses in weighted mean difference (WMD) were performed for 3, 6, and 9 months of supplementation and compared to placebo administration. Selenium supplementation significantly decreased FT4 (WMD=-0.86 [confidence interval (CI)-1.20 to -0.53]; p=0.756; I2=0.0%) and FT3 (WMD=-0.34 [CI-0.66 to -0.02]; p=0.719; I2=0.0%) levels at 3 months, compared to placebo administration; these findings were consistent at 6 but not 9 months. TSH levels were more elevated in the group of patients taking selenium than in the control group at 3 and 6, but not 9 months. TRAb levels decreased at 6 but not 9 months. At 6 months, patients on selenium supplementation were more likely than controls to show improved thyroid function; however, the effect disappeared at 9 months. Whether these effects correlate with clinically relevant measures remains to be demonstrated.

Is prolonged immobilization a risk factor for symptomatic venous thromboembolism in elderly bedridden patients?

2004 ◽  
Vol 91 (03) ◽  
pp. 538-543 ◽  
Author(s):  
Ora Paltiel ◽  
Michael Bursztyn ◽  
Moshe Gatt
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Early Period ◽  
Thromboembolic Events ◽  
Historical Cohort ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Prolonged Immobilization ◽  
The Impact

SummaryProlonged immobilization and advanced age are considered to be important risk factors for venous thromboembolism (VTE). Nevertheless, the need for VTE prophylaxis in long-term bedridden patients is not known. To assess whether very prolonged immobilization (i.e. over three months) carries an increased risk for clinically apparent VTE, we performed a historical-cohort study of nursing home residents during a ten-year period. Data concerning patient’s mobility and incidence of overt deep vein thrombosis or pulmonary embolism were registered. The mean resident age was 85 ± 8.4 years. Eighteen mobile and eight immobile patients were diagnosed with clinically significant thromboembolic events, during 1137 and 573 patient-years of follow up, respectively. The incidence of venous thromboembolic events was similar in both chronically immobilized and mobile patient groups, 13.9 and 15.8 per thousand patient years, respectively (p = 0.77). The rate ratio for having a VTE event in the immobilized patient group as compared with the mobile group was 0.88 (95% Confidence Interval (CI) 0.33 to 2.13). When taking into account baseline characteristics, risk factors and death rates by various causes, no differences were found between the two groups. In conclusion, chronically immobile bedridden patients are no more prone to clinically overt venous thromboembolic events than institutionalized mobile patients. Until further studies are performed concerning the impact of very prolonged immobilization on the risk of VTE, there is no evidence to support primary prevention after the first three months of immobilization. Evidence for efficacy or cost effectiveness beyond this early period is not available.

Risk of venous thromboembolism in cancer patients treated with cisplatin: A systematic review and meta-analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e21016-e21016
Author(s):  
Sonia Maria Seng ◽  
Ziyue Liu ◽  
Sophia Chiu ◽  
Tracey Proverbs-Singh ◽  
Guru Sonpavde ◽  
...  
Keyword(s):  
Relative Risk ◽  
Solid Tumors ◽  
Meta Analysis ◽  
Systemic Review ◽  
Advanced Solid Tumors ◽  
Thromboembolic Events ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic

e21016 Background: Several reports suggest that cisplatin is associated with an increased risk of thromboembolism (TE). However, patients with solid tumors have multiple risk factors for TE and the excess risk of venous thromboembolic events (VTEs) with cisplatin-based chemotherapy as compared with non-cisplatin-based chemotherapy has not been well described. We performed a systemic review and meta-analysis of randomized controlled trials (RCTs) evaluating the incidence and risk of VTE associated with cisplatin-based chemotherapy. Methods: PubMed was searched for articles published from January 1, 1990 until December 31, 2010.The primary aim was to evaluate the association between treatment with cisplatin and VTEs in patients with cancer. Clinical trials that met the following criteria were included in the meta-analysis: (1) prospective randomized phase 2 and 3 trials of patients with cancer; (2) randomization to treatment with cisplatin versus a non-cisplatin containing chemotherapy regimen (3) available data on venous thromboembolic events. Data on all grade venous thromboembolic events was extracted. Study quality was calculated utilizing Jadad scores. Incidence rates, relative risks, and 95% confidence intervals (CIs) were calculated using a random-effects model. Subgroup analyses included the impact of publication year, tumor type, and cisplatin dose. Results: A total of 8216 patients with a variety of advanced solid tumors from 38 RCTs were included for analysis. Among patients treated with cisplatin-based chemotherapy, the summary incidence of VTE was 1.64% (95% CI, 1.06–2.25). Patients treated with cisplatin-based chemotherapy had a significantly increased risk of VTE with a relative risk of 1.65 (95% CI, 1.25–2.18; P = .01) compared with controls. Exploratory subgroup analysis revealed the highest relative risk of VTE in patients receiving a weekly equivalent cisplatin dose >30 mg/m2 (2.64; 95% CI, 1.18–5.77; P = .02) and in studies reported during 2000-2010 (1.70; 95% CI, 1.27–2.28; P = .01). Conclusions: Cisplatin chemotherapy is associated with a significant increase in the risk of VTE in patients with advanced solid tumors compared with non-cisplatin chemotherapy.

scholarly journals Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis

F1000Research ◽  
2019 ◽  
Vol 7 ◽  
pp. 1725 ◽  
Author(s):  
Carl Heneghan ◽  
Jeffrey K. Aronson ◽  
Elizabeth Spencer ◽  
Bennett Holman ◽  
Kamal R. Mahtani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Congenital Malformations ◽  
Meta Analysis ◽  
Case Control ◽  
Control Group ◽  
Case Control Studies ◽  
Renal Anomalies ◽  
Congenital Heart Malformations ◽  
Increased Risk

Background: Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations. Methods: We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies. Results: We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4,209 were exposed to HPTs. Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%). Exposure to HPTs was associated with an increased risk of congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%); nervous system malformations  OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%); gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%); musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%); the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%). Conclusions: This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.

scholarly journals Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Noppacharn Uaprasert ◽  
Krissana Panrong ◽  
Ponlapat Rojnuckarin ◽  
Thita Chiasakul
Keyword(s):  
Systematic Review ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Vaccine Hesitancy ◽  
Bleeding Events ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Hemorrhagic Events ◽  
Estimated Risk ◽  
Low Incidence

Abstract Background Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage. Methods We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic, hemorrhagic events, and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, thrombocytopenia, and thromboembolism/hemorrhage-related death. Results Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95% CI [confidence interval], 0.61–2.14; I2 = 35%), ATE (RR, 0.97; 95% CI, 0.46–2.06; I2 = 21%), VTE (RR, 1.47; 95% CI, 0.72–2.99; I2 = 0%), hemorrhage (RR, 0.97; 95% CI, 0.35–2.68; I2 = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95% CI, 0.16–1.79; I2 = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms. Conclusion Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.

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