Yao, Xiaoxi

ObjectivesTo report patterns and patient characteristics associated with initiation of and persistence with medical therapies for uterine fibroid‐related heavy menstrual bleeding.DesignRetrospective cohort study.SettingUS commercial insurance claims database.Population41 561 women aged 18–54 years with uterine fibroids and heavy menstrual bleeding who initiated medical therapies from January 2000 through December 2013.MethodMultinomial logistic regression was used to assess patient characteristics associated with initiation and persistence. Cox proportional hazards regression was used on propensity score‐matched cohorts to examine change from index medication.Main outcomes measuresInitiation of and persistence with four first‐line medical therapies: short‐ and long‐acting reversible contraceptive steroids, leuprolide acetate, and tranexamic acid.ResultsMost women (79.4%) took short‐acting reversible contraceptive steroids as first‐line therapy (index medication), whereas 9.5%, 8.5%, and 2.7% used long‐acting reversible contraceptive steroids, leuprolide acetate, and tranexamic acid, respectively. During follow‐up, 16 594 women (39.9%) switched to nonindex medication (18.4%) or procedural treatment (81.6%). In comparison with women taking short‐acting steroids, those receiving long‐acting steroids were less likely to switch [hazard ratio (HR) 0.84, 95% CI 0.79–0.91], whereas women taking leuprolide acetate (HR 2.44, 95% CI 2.27–2.62) or tranexamic acid (HR 1.44, 95% CI 1.26–1.65) were more likely to switch. Older age, emergency department visits, anaemia, and inflammatory disease diagnoses at baseline were associated with increased probability of discontinuing the index medication or switching to another therapy.ConclusionsWomen with uterine fibroid‐related heavy menstrual bleeding were more likely to persist with their initial therapy of long‐acting reversible contraceptive steroid compared with other medical options.Tweetable Abstract80% women with fibroid‐related heavy menstrual bleeding use SARC, but LARC users are more persistent.

OBJECTIVETo examine temporal trends in utilization of glucose-lowering medications, glycemic control, and rate of severe hypoglycemia among patients with type 2 diabetes (T2DM).RESEARCH DESIGN AND METHODSUsing claims data from 1.66 million privately insured and Medicare Advantage patients with T2DM from 2006 to 2013, we estimated the annual 1) age- and sex-standardized proportion of patients who filled each class of agents; 2) age-, sex-, race-, and region-standardized proportion with hemoglobin A1c (HbA1c) <6%, 6 to <7%, 7 to <8%, 8 to <9%, ≥9%; and 3) age- and sex-standardized rate of severe hypoglycemia among those using medications. Proportions were calculated overall and stratified by age-group (18–44, 45–64, 65–74, and ≥75 years) and number of chronic comorbidities (zero, one, and two or more).RESULTSFrom 2006 to 2013, use increased for metformin (from 47.6 to 53.5%), dipeptidyl peptidase 4 inhibitors (0.5 to 14.9%), and insulin (17.1 to 23.0%) but declined for sulfonylureas (38.8 to 30.8%) and thiazolidinediones (28.5 to 5.6%; all P < 0.001). The proportion of patients with HbA1c <7% declined (from 56.4 to 54.2%; P < 0.001) and with HbA1c ≥9% increased (9.9 to 12.2%; P < 0.001). Glycemic control varied by age and was poor among 23.3% of the youngest and 6.3% of the oldest patients in 2013. The overall rate of severe hypoglycemia remained the same (1.3 per 100 person-years; P = 0.72), declined modestly among the oldest patients (from 2.9 to 2.3; P < 0.001), and remained high among those with two or more comorbidities (3.2 to 3.5; P = 0.36).CONCLUSIONSDuring the recent 8-year period, the use of glucose-lowering drugs has changed dramatically among patients with T2DM. Overall glycemic control has not improved and remains poor among nearly a quarter of the youngest patients. The overall rate of severe hypoglycemia remains largely unchanged.

Background The introduction of non–vitamin K antagonist oral anticoagulants has been a major advance for stroke prevention in atrial fibrillation; however, outcomes achieved in clinical trials may not translate to routine practice. We aimed to evaluate the effectiveness and safety of dabigatran, rivaroxaban, and apixaban by comparing each agent with warfarin. Methods and Results Using a large US insurance database, we identified privately insured and Medicare Advantage patients with nonvalvular atrial fibrillation who were users of apixaban, dabigatran, rivaroxaban, or warfarin between October 1, 2010, and June 30, 2015. We created 3 matched cohorts using 1:1 propensity score matching: apixaban versus warfarin (n=15 390), dabigatran versus warfarin (n=28 614), and rivaroxaban versus warfarin (n=32 350). Using Cox proportional hazards regression, we found that for stroke or systemic embolism, apixaban was associated with lower risk (hazard ratio [ HR ] 0.67, 95% CI 0.46–0.98, P =0.04), but dabigatran and rivaroxaban were associated with a similar risk (dabigatran: HR 0.98, 95% CI 0.76–1.26, P =0.98; rivaroxaban: HR 0.93, 95% CI 0.72–1.19, P =0.56). For major bleeding, apixaban and dabigatran were associated with lower risk (apixaban: HR 0.45, 95% CI 0.34–0.59, P <0.001; dabigatran: HR 0.79, 95% CI 0.67–0.94, P <0.01), and rivaroxaban was associated with a similar risk ( HR 1.04, 95% CI 0.90–1.20], P =0.60). All non–vitamin K antagonist oral anticoagulants were associated with a lower risk of intracranial bleeding. Conclusions In patients with nonvalvular atrial fibrillation, apixaban was associated with lower risks of both stroke and major bleeding, dabigatran was associated with similar risk of stroke but lower risk of major bleeding, and rivaroxaban was associated with similar risks of both stroke and major bleeding in comparison to warfarin.

Background Incidental mobile thrombi are commonly found on endovascular leads of cardiac implantable electronic devices ( CIED s). Transseptal puncture for catheter ablation of arrhythmia poses a risk for paradoxical embolism. We examined risk of ischemic stroke, transient ischemic attack ( TIA ), or systemic embolism after transseptal ablation in patients with and without CIED s. Methods and Results Using a national administrative claims database, 31 720 patients who underwent a transseptal catheter ablation between January 2004 and September 2014 were identified. Two propensity‐matched cohorts were created by matching demographic variables, administrative variables, Charlson Comorbidity Index, CHA 2 DS 2 ‐Vasc score, and year and indication for ablation (5533 and 11 300 patients with and without CIED s). Incidence rates and Cox proportional hazards models were used to estimate risk of ischemic stroke, TIA , or systemic embolism for patients with and without CIED s. Impact of oral anticoagulation ( OAC ) use on the endpoint was examined. Over a mean follow‐up of 2.1 years, the incidence of the combined endpoint was 1.9 per 100 person‐years in patients with CIED s and 1.5 per 100 person‐years in patients without CIED s ( P =0.03). Among patients not on OAC , presence of a cardiac device was associated with an increased risk (hazard ratio [ HR ], 1.71 [1.24–2.35]; P <0.01), whereas there was no association noted among patients treated with OAC ( HR , 0.98 [0.75–1.28]). Conclusion CIED s are associated with an increased risk of stroke, TIA , or systemic embolism after transseptal ablation, but this risk is attenuated with postablation OAC use. Role of anticoagulation post‐transseptal ablation in patients with CIED warrants further investigation.

Background In comparison to warfarin, non–vitamin K antagonist oral anticoagulants ( NOAC s) have the advantages of ease of dosing, fewer drug interactions, and lack of need for ongoing monitoring. We sought to evaluate whether these advantages translate to improved adherence and whether adherence is associated with improved outcomes in patients with atrial fibrillation. Methods and Results We performed a retrospective cohort analysis by using a large US commercial insurance database to identify 64 661 patients with atrial fibrillation who initiated warfarin, dabigatran, rivaroxaban, or apixaban treatment between November 1, 2010, and December 31, 2014. During a median of 1.1 y of follow‐up, 47.5% of NOAC patients had a proportion of days covered of ≥80%, compared with 40.2% in warfarin patients ( P <0.001). Patients with CHA 2 DS 2 ‐ VAS c (risk based on the presence of congestive heart failure, hypertension age 65–74 y, age ≥75 y, diabetes mellitus, prior stroke or transient ischemic attack, vascular disease, sex category) score ≥4 were at increased risk of stroke when they were not taking anticoagulation ≥1 month versus <1 week (1–3 months: hazard ratio [ HR ] 1.96, 3–6 months: HR 2.64, ≥6 months: HR 3.66; all P <0.001). Patients with CHA 2 DS 2 ‐ VAS c score 2 or 3 were at increased risk of stroke when they were not taking anticoagulation ≥6 months ( HR 2.73, P <0.001). In these patients with CHA 2 DS 2 ‐ VAS c score ≥2, nonadherence was not associated with intracranial hemorrhage. Among patients with CHA 2 DS 2 ‐ VAS c score 0 or 1, time not taking anticoagulation was not associated with stroke, but not taking anticoagulation ≥3 months was associated with a significant reduction of bleeding. Conclusions Adherence to anticoagulation is poor in practice and may be modestly improved with NOAC s. Adherence to therapy appears to be most important in patients with CHA 2 DS 2 ‐ VAS c score ≥2, whereas the benefits of anticoagulation may not outweigh the harms in patients with CHA 2 DS 2 ‐ VAS c score 0 or 1.

Background There is significant practice variation in oral anticoagulation ( OAC ) use following catheter ablation for atrial fibrillation. It is not clear whether the risk of cardioembolism increases after discontinuation of OAC following catheter ablation. Methods and Results We identified 6886 patients within a large national administrative claims database who underwent catheter ablation for atrial fibrillation between January 1, 2005, and September 30, 2014. We assessed the effect of time off of OAC by CHA 2 DS 2 ‐ VAS c score (after adjusting for other comorbidities) on risk of cardioembolism, using Cox proportional hazards models. There was an increase in the use of non–vitamin K OAC after ablation from 0% in 2005 to 69.8% in 2014. OAC discontinuation was high, with only 60.5% and 31.3% of patients remaining on OAC at 3 and 12 months, respectively. The rate of discontinuation was higher in low‐risk patients (82% versus 62.5% at 12 months for CHA 2 DS 2 ‐ VAS c 0–1 versus ≥2, respectively; P <0.001). Stroke occurred in 1.4% of patients with CHA 2 DS 2 ‐ VAS c ≥2 and 0.3% of those with CHA 2 DS 2 ‐ VAS c 0 or 1 over the study follow‐up. The risk of cardioembolism in the first 3 months after ablation was increased among those with any time off OAC (hazard ratio 8.06 [95% CI 1.53–42.3], P <0.05). The risk of cardioembolism beyond 3 months was increased with OAC discontinuation among high‐risk patients (hazard ratio 2.48 [95% CI 1.11–5.52], P <0.05) but not low‐risk patients. Conclusion The overall risk of stroke in postablation patients is low; however, OAC discontinuation after ablation is common and is associated with increased risk of cardioembolism for all patients within the first 3 months and for high‐risk patients in the long term. Continuing OAC for at least 3 months in all patients and indefinitely in high‐risk patients appears to be the safest strategy.