Incidence of venous thrombotic events and events of special interest in a retrospective cohort of commercially insured US patients

Weller, Susan C.; Porterfield, Laura; Davis, John W.; Wilkinson, Gregg S.; Chen, Lu; Baillargeon, Jacques

doi:10.1136/bmjopen-2021-054669

Cited by 13 publications

(21 citation statements)

References 21 publications

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“…It may be explained by the rapidly aging population and higher prevalence of cardiovascular disease and cancer. However, most studies demonstrated the incidence of women during childbearing ages of 20–40 is higher than that in men [ 14 , 15 ], and the over 13 million enrollees from the USA for the 5-year pre-pandemic period (2015–2019) indicates that VTE incidence tended to increase with age and was higher for women under 55 [ 16 ]. However, VTE can be prevented in clinical practice, and it is of great significance to screen high-risk population for VTE.…”

Section: Epidemiologymentioning

confidence: 99%

Elevated Risk of Venous Thromboembolism in People Living with HIV

Zhang

Peng

et al. 2022

Viruses

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Human immunodeficiency virus (HIV) has been generally considered as a highly adaptive and rapidly evolving virus. It still constitutes a major public health problem all over the world despite an effective outcome in the prevention and reversal of the development and prognosis by using antiretroviral therapy. The salient question lies in the more frequent emergence of a series of comorbidities along with the prolongation of the life, which deeply affects the survival in such group. Venous thromboembolism (VTE) has been recognized to be the third most common cardiovascular condition within people living with HIV (PWH). In terms of its mechanism of action, the occurrence of VTE is quite multifactorial and complex in HIV. Prior exploration concerning the etiology of VTE in PWH identifies general, disease-specific, and miscellaneous factors for explaining its occurrence and development. VTE has constituted an important role in PWH and may increase its all-cause mortality. Therefore, it is quite necessary to understand VTE from the following aspects of epidemiology, pathophysiology, molecular mechanisms, and therapeutic interventions so as to balance the risks and benefits of anticoagulation and optimize corresponding treatment.

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Section: Epidemiologymentioning

confidence: 99%

Elevated Risk of Venous Thromboembolism in People Living with HIV

Zhang

Peng

et al. 2022

Viruses

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Section: Samplementioning

confidence: 99%

“…For example, dydrogesterone, a lower risk progestin, is unavailable and US incidence of VTE is much higher than in Europe. [18] The WHI and HERS results vastly reduced use of MHT, [14][15][16] but approximately eight percent of US women 50 and older continue to use non-contraceptive estrogens, [16] and little data exist as to how many additional women in this age range use hormonal contraceptives. Common indications for MHT include hot flashes, vaginal dryness, disruptions in sleep patterns, and inability to concentrate.…”

Section: Hormone Exposure and Venous Thromboembolism In Commercially-...mentioning

confidence: 99%

“…All statistical analyses were performed with SAS Version 9.4. [24] Number needed to harm (NNH) [25] was estimated assuming a population VTE incidence of 180/100,000 for women in this age range [18] and the adjusted odds ratios from conditional logistic regression models.…”

Section: Datamentioning

confidence: 99%

“…From the base cohort of women, 20,359 incident cases of acute VTE met inclusion criteria and were matched with 203,590 controls (Figure 1). Among cases, 76% were primary diagnoses, 89.37% (18,194) received anticoagulant therapy, 12.00% (2,444) had an IVC filter placed, and 5.88% (1197) died within 30 days of diagnosis. There were 10,995 (54.01%) cases of PE (with or without DVT) and 9,364 (45.99%) cases of DVT (without PE).…”

Section: Samplementioning

confidence: 99%

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Hormone Exposure and Venous Thromboembolism in Commercially-Insured Women 50 to 64 Years of Age

Weller

Davis

Porterfield

et al. 2022

Preprint

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ObjectiveDetermine whether hormone-associated venous thromboembolism (VTE) risk varies by exposure route and formulation in 50-64 year-old US women.DesignNested case-control study.SettingLarge US commercially-insured population with patient-level claims data.ParticipantsWomen aged 50-64 years with at least one year of enrollment. Controls were matched to incident cases (10:1) on VTE date and case’s age (+/− 2yrs). Exclusions included prior VTE, intravascular vena cava (IVC) filter within twelve months, and anticoagulant exposure within 14 days.ExposuresAll estrogen and progestogen prescriptions (with route and formulation) filled within 12 months prior to index date were coded as current (0-60 days), past (61-365 days), or none. Contraceptives were categorized separately.OutcomeAcute VTE cases were identified with ICD codes plus anticoagulant, IVC filter, or death within 30 days.ResultsConditional logic regression analyses controlled for differences between cases (n=20,359) and controls (n=203,590) in Elixhauser comorbidities and VTE risk factors. Odds ratios (OR) were as follows: for current oral, unopposed estradiol 1.24 (95% CI: 1.09 to 1.40) or conjugated equine estrogen (CEE) 1.46 (95% CI: 1.28 to 1.68); for progestogens with estradiol 1.14 (95% CI: 0.95 to 1.37), with CEE 1.52 (95% CI: 1.25 to 1.84), or with ethinyl estradiol 2.35 (95% CI: 1.71 to 3.25). Current transdermal estradiol had the lowest ORs, whether unopposed, 0.70 (95% CI: 0.59 to 0.83) or combined with progestogens, 0.73 (95% CI: 0.56 to 0.96), but varied by progestogen. The OR for estrogen-progestogen contraceptives was 5.22 (95% CI: 4.67 to 5.84) compared to no exposure and 4.24 (95% CI: 3.64 to 4.98) compared to combined MHT.ConclusionsIn 50-64-year-old women, transdermal menopausal hormone therapy (estradiol with or without progestogens) did not elevate VTE risk. In contrast, contraceptives markedly increased VTE risk.Summary BoxesWhat is already known on this topic?Randomized controlled trials indicate that relative risk for venous thromboembolism (VTE) is approximately twice as high with menopausal hormone therapy (MHT) containing conjugated equine estrogen (CEE) with or without medroxyprogesterone acetate compared to no hormone exposure.Recent large, observational studies in the UK and Europe suggest that estradiol is lower risk than CEE and transdermal estradiol does not raise VTE risk compared to no hormone exposure, but results may not generalize to the United States because of differences in formulary, prescribing patterns, and background VTE incidence.What this study addsUsing a large medical record database for US commercially-insured women 50-64 years of age, results confirmed that VTE risk was higher for oral compared to transdermal MHT and transdermal MHT (unopposed estrogen or combined with a progestogen) did not increase risk for VTE compared to no hormone exposure. However, unique US prescribing patterns included MHT with transdermal estradiol plus oral progestogens and MHT with ethinyl estradiol.MHT estrogen formulation affected VTE risk: ethinyl estradiol had higher risk than CEE, and CEE had higher risk than estradiol.Combined hormonal contraceptives (oral, vaginal, transdermal) had a markedly higher increase in VTE compared to MHT.

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Statin Use and the Risk of Venous Thromboembolism in Women Taking Hormone Therapy

Davis,

Weller,

Porterfield

et al. 2023

JAMA Netw Open

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ImportanceAlthough hormone therapy (HT) in perimenopausal women is associated with increased risk for venous thromboembolism (VTE), it is unclear to what extent statins may mitigate this HT-associated risk.ObjectiveTo estimate VTE risk in women aged 50 to 64 years taking HT with or without statins.Design, Setting, and ParticipantsThis nested case-control study analyzed data from a commercially insured claims database in the US. Eligible participants included women aged 50 to 64 years with at least 1 year of continuous enrollment between 2008 and 2019. Data analysis occurred from January 2022 to August 2023.ExposureFilled prescriptions for estrogens, progestogens, and statins were recorded in the 12 months prior to index. Recent HT was defined as any estrogen or progestogen exposure within 60 days before the index date. Current statin exposure was defined as 90 or more days of continuous exposure prior to and including the index date. Statin intensity was defined by the statin exposure 30 days prior to index.Main Outcomes and MeasuresCases were identified with VTE diagnoses (diagnostic codes) preceded by at least 12 months without VTE and followed within 30 days by anticoagulation, an inferior vena cava filter placement, or death. Controls were matched to cases (10:1) on date and age. Conditional logistic regression models estimated risk for HT and statin exposures with odds ratios (OR), adjusted for comorbidities. Conditional logistic regression models were used to estimate VTE risk for HT and statin exposures with odds ratios (ORs), adjusted for comorbidities. Intensity of statin therapy was measured as a subgroup analysis.ResultsThe total sample of 223 949 individuals (mean [SD] age, 57.5 [4.4] years) included 20 359 cases and 203 590 matched controls. Of the entire sample, 19 558 individuals (8.73%) had recent HT exposure and 36 238 individuals (16.18%) had current statin exposure. In adjusted models, individuals with any recent HT exposure had greater odds of VTE compared with those with no recent HT exposure (OR, 1.51; 95% CI, 1.43-1.60). Individuals receiving current statin therapy had lower odds of VTE compared with those with no current statin exposure (OR, 0.88; 95% CI, 0.84-0.93). When compared with those not recently taking HT or statins, the odds of VTE were greater for those taking HT without statins (OR, 1.53; 95% CI, 1.44-1.63) and for those taking HT with statins (OR, 1.25; 95% CI, 1.10-1.43), but were lower for those taking statins without HT (OR, 0.89; 95% CI, 0.85-0.94). Individuals taking HT with statin therapy had 18% lower odds of VTE than those taking HT without statins (OR, 0.82; 95% CI, 0.71-0.94) and there was greater risk reduction with higher intensity statins.Conclusions and RelevanceIn this case-control study, statin therapy was associated with reduced risk of VTE in women taking HT, with greater risk reduction with high-intensity statins. These findings suggest that statins may reduce risk of VTE in women exposed to HT and that HT may not be contraindicated in women taking statins.

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Incidence of venous thrombotic events and events of special interest in a retrospective cohort of commercially insured US patients

Cited by 13 publications

References 21 publications

Elevated Risk of Venous Thromboembolism in People Living with HIV

Elevated Risk of Venous Thromboembolism in People Living with HIV

Hormone Exposure and Venous Thromboembolism in Commercially-Insured Women 50 to 64 Years of Age

Statin Use and the Risk of Venous Thromboembolism in Women Taking Hormone Therapy

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