Abstract Background Adults with atherosclerotic cardiovascular disease are recommended to take a statin to reduce their risk for future cardiovascular events. Prior studies suggest that statins are being taken by most adults with coronary heart disease (CHD). However, there are few data on the use of statins among adults with peripheral artery disease (PAD). Purpose To compare the use of statins among US adults with a history of PAD versus those with a history of CHD. Methods We conducted a retrospective cohort study among US adults ≥19 years of age with commercial or government health insurance who had a history of CHD or PAD as of December 31, 2014 (n=1,006,451, mean age 63 years, 47% male). We used pharmacy claims between January 1 and December 31, 2014 to identify use of any statin and of a high-intensity statin (i.e., atorvastatin 40–80 mg, rosuvastatin 20–40 mg, simvastatin 80 mg). Patients with a history of CHD without PAD (CHD only), both CHD and PAD, and PAD without CHD (PAD only) were analysed. Prevalence ratios for use of any statin and a high-intensity statin among those taking a statin were calculated after multivariable adjustment for sociodemographics and cardiovascular risk factors. Results Overall, 69.1% of patients included in the current analysis had CHD only, 21.4% had both CHD and PAD, and 9.5% had PAD only. Overall, 66.0%, 68.2% and 47.5% of patients with CHD only, CHD and PAD, and PAD only were taking a statin. After multivariable adjustment and compared to patients with CHD only, the prevalence ratio for statin use was 1.02 (95% CI 1.01, 1.02) for those with both CHD and PAD and 0.82 (95% CI 0.82, 0.83) for those with PAD only. Among patients taking a statin, 29.4% of those with CHD only, 28.6% of those with both CHD and PAD, and 17.3% of those with PAD only were taking a high-intensity dosage. Compared to patients with CHD only, the multivariable adjusted prevalence ratio for taking a high-intensity dosage was 1.05 (95% CI 1.04, 1.06) for those with both CHD and PAD and 0.71 (95% CI 0.70, 0.73) for those with PAD only. Conclusion Adults with PAD receive less intensive statin therapy compared with their counterparts who have CHD. Interventions aimed to increase statin use among patients with PAD are warranted. Acknowledgement/Funding This study was supported through a research grant from Amgen, Inc. (Thousand Oaks, CA, USA).
Head-to-head studies comparing COVID-19 mRNA vaccine effectiveness in immunocompromised individuals, who are vulnerable to severe disease are lacking, as large sample sizes are required to make meaningful inferences. This observational comparative effectiveness study was conducted in closed administrative claims data from the US HealthVerity database (December 11, 2020-January 10, 2022, before omicron). A 2-dose mRNA-1273 versus BNT162b2 regimen was assessed for preventing medically-attended breakthrough COVID-19 diagnosis and hospitalizations among immunocompromised adults. Inverse probability of treatment weighting was applied to balance baseline characteristics between vaccine groups. Incidence rates from patient-level data and hazard ratios (HRs) using weighted Cox proportional hazards models were calculated. Overall, 57,898 and 66,981 individuals received a 2-dose regimen of mRNA-1273 or BNT161b2, respectively. Among the weighted population, mean age was 51 years, 53 % were female, and baseline immunodeficiencies included prior blood transplant (8%–9%), prior organ transplant (7%), active cancer (12%–13%), primary immunodeficiency (5–6%), HIV (20%–21%), and immunosuppressive therapy use (60%–61%). Rates per 1,000 person-years (PYs; 95% confidence intervals [CI]s) of breakthrough medically-attended COVID-19 were 25.82 (23.83–27.97) with mRNA-1273 and 30.98 (28.93, 33.18) with BNT162b2 (HR, 0.83; 95% CI, 0.75–0.93). When requiring evidence of an antigen or polymerase chain reaction test before COVID-19 diagnosis, the HR for medically-attended COVID-19 was 0.78 (0.67–0.92). Breakthrough COVID-19 hospitalization rates per 1,000 PYs (95% CI) were 3.66 (2.96–4.51) for mRNA-1273 and 4.68 (3.91–5.59) for BNT162b2 (HR, 0.78; 0.59–1.03). Utilizing open and closed claims for outcome capture only, or both cohort entry/outcome capture, produced HRs (95% CIs) for COVID-19 hospitalization of 0.72 (0.57–0.92) and 0.66 (0.58–0.76), respectively. Among immunocompromised adults, a 2-dose mRNA-1273 regimen was more effective in preventing medically-attended COVID-19 in any setting (inpatient and outpatient) than 2-dose BNT162b2. Results were similar for COVID-19 hospitalization, although statistical power was limited when using closed claims only. NCT05366322.
The risk for subsequent major cardiovascular (CV) events among patients with very high-risk (VHR) atherosclerotic CV disease (ASCVD) remains to be fully elucidated.We assessed the characteristics and major CV event rates of patients with VHR versus non-VHR ASCVD in a real-world setting in the United States (US), hypothesizing that patients with VHR ASCVD would have higher CV event rates.This was a retrospective cohort study conducted from January 01, 2011, to June 30, 2018, in the US using the Prognos LDL-C database linked to the IQVIA PharMetrics Plus® database supplemented with the IQVIA prescription claims (Dx/LRx) databases. Patients were ≥18 years old and had ≥2 non-ancillary medical claims in the linked databases at least 30 days apart. The study was conducted in 2 stages: (1) identification of patients with ASCVD who met the definition of VHR ASCVD and a matched cohort of non-VHR ASCVD patients using the incidence density sampling (IDS) approach; (2) estimation of the occurrence of major CV events.Among patients with ≥1 major ASCVD event (N=147,679), most qualified as VHR ASCVD (79.5%). There were 115,460 patients each in IDS-matched VHR and non-VHR ASCVD cohorts. The composite myocardial infarction/ischemic stroke event rates in the VHR and non-VHR ASCVD cohorts were 8.04 (95% confidence interval [95% CI]: 7.87-8.22) and 0.82 (95% CI: 0.77-0.88) events per 100 patient-years, respectively, during the 1-year post-index period.Most patients with ≥1 previous major ASCVD event treated in real-world US clinical practice qualified as VHR ASCVD. Patients with VHR ASCVD had much higher rates of major CV events versus non-VHR ASCVD patients.
Background: Statins are effective for the primary and secondary prevention of coronary heart disease (CHD) events. However, studies from the early 2000s have suggested that many patients have low adherence to statin therapy. Objective: To analyze trends in adherence among US adults initiating treatment with a statin. Methods: We identified US adults 21-64 years of age with commercial health insurance in Marketscan and ≥65 years of age with government health insurance through Medicare who initiated statin therapy in 2007-2014. Three populations were analyzed, those initiating statin therapy 1) following myocardial infarction (n=52,828 in Marketscan, n=148,745 in Medicare), 2) with diabetes without a history of CHD (n=565,573 in Marketscan, n=42,411 in Medicare), and 3) without diabetes or a history of CHD (n=2,134,501 in Marketscan, n=105,948 in Medicare). Adherence to statin therapy was defined by having a statin available to take for ≥80% of the 365 days following treatment initiation. Results: Adherence to statin therapy increased in each population analyzed ( Figure ). In 2014, 68.1% and 62.7% of patients initiating treatment following myocardial infarction in Marketscan and Medicare, respectively were adherent to their statin. Less than half of patients initiating treatment with diabetes without CHD and without diabetes or CHD in Marketscan and Medicare were adherent to their statin. Adherence to statin therapy in the overall Marketscan and Medicare populations was higher among men (relative risk [95% CI] 1.16 [1.15, 1.18] and 1.10 [1.08, 1.12], respectively), and those with cardiologist visits (1.22 [1.21, 1.24] and 1.27 [1.25, 1.30], respectively), and lower among those with kidney disease diagnosed after treatment initiation (0.89 [0.85, 0.94] and 0.92 [0.88, 0.96], respectively). Conclusion: Adherence to statins improved slightly between 2007 and 2014 but remains suboptimal. Management by a cardiologist is associated with better adherence to statins.
ABSTRACT Recent data have shown elevated infection rates in several subpopulations at risk of SARS-CoV-2 infection and COVID-19, including immunocompromised (IC) individuals. Previous research suggests that IC persons have reduced risks of hospitalization and medically-attended COVID-19 with 2 doses of mRNA-1273 (SpikeVax; Moderna) compared to two doses of BNT162b2 (Comirnaty; Pfizer/BioNTech). The main objective of this retrospective cohort study was to compare real-world effectiveness of third doses of mRNA-1273 versus BNT162b2 at multiple time points on occurrence of COVID-19 hospitalization and medically-attended COVID-19 among IC adults in the US. The HealthVerity (HV) medical and pharmacy claims database, which contains data from >330 million patients, was the data source. Both subgroup and sensitivity analyses were conducted in addition to the core comparisons noted. In propensity score-adjusted analyses, receiving mRNA-1273 vs BNT162b2 as third dose was associated with 32% (relative risk [RR] 0.68; 95% confidence interval [CI] 0.51-0.89), 29% (0.71; 0.57-0.86), and 23% (0.77; 0.62-0.93) lower risk of COVID-19 hospitalization after 90, 180, and 270 days, respectively. Corresponding reductions in medically-attended COVID-19 were 8% (0.92; 0.86-0.98), 6% (0.94; 0.90-0.98), and 2% (0.98; 0.94-1.02), respectively. Our findings suggest a third dose of mRNA-1273 is more effective than a third dose of BNT162b2 in preventing COVID-19 hospitalization and breakthrough medically-attended COVID-19 among IC adults in the US.
Abstract Background Chronic kidney disease (CKD) is a known risk factor of atherosclerotic cardiovascular disease (ASCVD). Per the 2018 American Heart Association/American College of Cardiology cholesterol guidelines, high‐risk ASCVD patients with CKD and low‐density lipoprotein cholesterol (LDL‐C) levels 70 mg/dL should take a high‐intensity statin with ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i). Objective/Methods We examined the changes in use of lipid lowering therapies (LLT) over two years in 3304 patients with ASCVD and CKD in the G etting to an impr O ved U nderstanding of L ow‐ D ensity Lipoprotein Cholesterol and Dyslipidemia Management ( GOULD ) observational cohort study. Results Of those with eGFR <60 ml/min/1.73 m 2 , 21.6% (171/791) had intensification of LLT while 10.4% (82/791) had de‐escalation of LLT. Notably, 61.6% (487/791) had no change in LLT regimen over 2 years. Statin use was 83.2% (785/944) at baseline and 80.1% (634/791) at 2 years. Statin/ezetimibe use increased from 2.9% (27/944) to 4.9% (39/791). Statin discontinuation at 2 years was greater with lower eGFR levels across all cohorts. Conclusion Despite the recommendations of multiscociety guidelines, statin use, while high, is not ubiquitous and rates of high‐intensity statin and ezetimibe use remain low in patients with CKD. There remains a significant opportunity to optimize LLT and achieve atheroprotective cholesterol levels in the CKD population.
