Statins and risk of thromboembolism: A meta-regression to disentangle the efficacy-to-effectiveness gap using observational and trial evidence

Miksza, Joanne; Zaccardi, Francesco; Kunutsor, Setor K; Seidu, Samuel; Davies, Melanie J.; Khunti, Kamlesh

doi:10.1016/j.numecd.2019.06.022

Cited by 7 publications

(6 citation statements)

References 25 publications

(27 reference statements)

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“…Although an association between statin use and reduced incidence of venous thromboembolism has been described in recent years, we did not collect data on statin use and could not therefore control for it. 19,20 Bone marrow biopsy specimens for patients who progressed to MF were not accessed or systematically reviewed by an independent hematopathologist. We also acknowledge the significant range of disease durations before institutional contact present in our sample, which may present unknown biases related to patient treatment history that are not fully accounted for in our multivariable analysis.…”

Section: Study Limitationsmentioning

confidence: 99%

Persistent leukocytosis in polycythemia vera is associated with disease evolution but not thrombosis

Ronner

Podoltsev

Gotlib

et al. 2020

Blood

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There are unresolved questions regarding the association between persistent leukocytosis and risk of thrombosis and disease evolution in polycythemia vera (PV), as much of the published literature on the topic does not appropriately use repeated-measures data or time-dependent modeling to answer these questions. To address this knowledge gap, we analyzed a retrospective database of 520 PV patients seen at 10 academic institutions across the United States. Taking hematologic laboratory data at ∼3-month intervals (or as available) for all patients for duration of follow-up, we used group-based trajectory modeling to identify latent clusters of patients who follow distinct trajectories with regard to their leukocyte, hematocrit, and platelet counts over time. We then tested the association between trajectory membership and hazard of 2 major outcomes: thrombosis and disease evolution to myelofibrosis, myelodysplastic syndrome, or acute myeloid leukemia. Controlling for relevant covariates, we found that persistently elevated leukocyte trajectories were not associated with the hazard of a thrombotic event (P = .4163), but were significantly associated with increased hazard of disease evolution in an ascending stepwise manner (overall P = .0002). In addition, we found that neither hematocrit nor platelet count was significantly associated with the hazard of thrombosis or disease evolution.

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Section: Study Limitationsmentioning

confidence: 99%

Persistent leukocytosis in polycythemia vera is associated with disease evolution but not thrombosis

Ronner

Podoltsev

Gotlib

et al. 2020

Blood

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“…Cohort studies 25 suggest statin exposure may reduce VTE risk by 25%, whereas RCTs indicate a 15% reduction in risk 25 and accentuation by intensity of therapy. 25 , 26 , 43 , 44 Differences between cohort and RCT findings may be attributable to differences in patient populations, 45 as well as duration of statin exposure. Statin effectiveness studies typically have a longer median statin exposure time (approximately 4 years) 25 than in this study, where VTE reduction was observed with 90 or more days.…”

Section: Discussionmentioning

confidence: 99%

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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“…Cohort studies suggest statin exposure may reduce VTE risk by 25%, 25 while RCTs indicate a 15% reduction in risk 25 and accentuation by intensity of therapy. 25,26,43,44 Differences between cohort and RCT findings may be attributable to differences in patient populations, 45 as well as duration of statin exposure. Statin effectiveness studies typically have a longer median statin exposure time (approximately four years) 25 than in this study, where VTE reduction was observed with 90 or more days.…”

Section: Discussionmentioning

confidence: 99%

Statin Use And The Risk Of Venous Thromboembolism In Women Taking Hormone Therapy

Davis

Weller

Porterfield

et al. 2023

Preprint

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Background. Post-menopausal hormone therapy (HT) may elevate the risk of venous thromboembolism (VTE), while statin therapy may lower risk. Purpose. To estimate VTE risk from HT exposure with/without statin therapy in women 50-64 years of age. Methods. A case-control study in a large commercially-insured database matched cases of VTE diagnoses (1:10) to controls without VTE on age +/- 2 yrs. Conditional logistic regression estimated odds ratios (ORs) for recent HT exposure (any estrogen and/or progestogen within 60 days) and current statin therapy (>90 days continuous exposure) controlling for VTE risk factors, comorbidities, and coronary artery disease. Results. In a comparison of cases (n=20,359) and matched controls (n=203,590), 9% (n=19,558) had recent HT exposure and 16% (n=36,238) had current/continuous statin exposure. After adjustment for all covariates, the OR for any recent HT exposure (regardless of statin exposure) was 1.51 (95% CI: 1.43, 1.60) compared to no HT exposure. The OR for current statin therapy (regardless of HT exposure) was 0.88 (95% CI: 0.84, 0.93). For those with HT exposure without statin therapy the OR was 1.53 (95% CI: 1.44, 1.63), for those with HT exposure with statin therapy the OR was 1.25 (95% CI: 1.10, 1.43), and for those exposed to statin therapy without HT exposure the OR was 0.89 (95% CI: 0.85, 0.94), compared those not exposed to either statin or HT. HT with statin therapy had a 18% significantly lower odds ratio than HT without statin therapy (OR=0.82, 95% CI: 0.71, 0.94). High intensity statin therapy showed greater risk reduction. Conclusion. Statin therapy may reduce VTE risk associated with HT.

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Statins and risk of thromboembolism: A meta-regression to disentangle the efficacy-to-effectiveness gap using observational and trial evidence

Cited by 7 publications

References 25 publications

Persistent leukocytosis in polycythemia vera is associated with disease evolution but not thrombosis

Persistent leukocytosis in polycythemia vera is associated with disease evolution but not thrombosis

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

Statin Use And The Risk Of Venous Thromboembolism In Women Taking Hormone Therapy

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