Prevalence of renal and bone risk factors among individuals prescribed oral pre-exposure prophylaxis for HIV.

Objectives: The only available oral pre-exposure prophylaxis (PrEP) regimens approved in the United States to prevent HIV infection during the period covered by this study were emtricitabine/tenofovir alafenamide (F/TAF) and emtricitabine/tenofovir disoproxil fumarate (F/TDF). Both agents have similar efficacy, however F/TAF exhibits improved bone and renal health safety endpoints over F/TDF. In 2021, the United States Preventive Services Task Force recommended individuals have access to the most medically appropriate PrEP regimen. To understand the impact of these guidelines, the prevalence of risk factors to renal and bone health was evaluated among individuals prescribed oral PrEP. Methods: This prevalence study utilized the electronic health records of people prescribed oral PrEP between January 1, 2015 and February 29, 2020. Renal and bone risk factors (age, comorbidities, medication, renal function, and body mass index) were identified using International Classification of Diseases (ICD) and National Drug Code (NDC) codes. Results: Among 40 621 individuals prescribed oral PrEP, 62% had ≥1 renal risk factor and 68% had ≥1 bone risk factor. Comorbidities were the most frequent (37%) class of renal risk factors. Concomitant medications were the most prominent (46%) class of bone-related risk factors. Conclusions: The high prevalence of risk factors suggests the importance of their consideration when choosing the most appropriate regimen for individuals who may benefit from PrEP.

Asthma controller delay and recurrence risk after an emergency department visit or hospitalization.

BACKGROUND: Patients who have asthma-related emergency department (ED) visits or hospitalizations are at risk for recurrent exacerbation events. Our objectives were to assess whether receiving a controller medication at discharge affects risk of recurrence and whether delaying controller initiation alters this risk. METHODS: Asthma patients with an ED visit or inpatient (IP) stay who received a controller dispensing within 6 months were identified from healthcare claims. Cox proportional hazards of the time to first recurrence of an asthma-related ED or IP visit in the 6-month period following the initial event were constructed, with time following discharge without controller medication as the primary predictor. RESULTS: A total of 6139 patients met inclusion criteria, 78% with an ED visit and 22% with an IP visit; 15% had a recurrence within 6 months. The adjusted hazard ratio (HR) associated with not having controller medication at discharge was 1.79 (95% confidence interval [CI], 1.42-2.25). The controller-by-time interaction was significant (P<0.001), with hazard rising as time-to-controller initiation increased. Delaying initiation by 1 day approximately tripled the risk (HR 2.95; 95%CI 1.48-5.88). Sensitivity analyses, including accounting for controller fills prior to the index event, did not substantially alter these results. CONCLUSIONS: This observational study shows that the risk of a recurrent asthma-related ED visit or IP stay increased as the time to initiate a controller increased. Our findings support the importance of early controller initiation following an asthma-related ED or IP visit in reducing risk of recurrence.

Costs and outcomes of noncardioembolic ischemic stroke in a managed care population.

PURPOSE: To evaluate the clinical outcomes and incremental health care costs of ischemic stroke in a US managed care population. PATIENTS AND METHODS: A retrospective cohort analysis was done on patients (aged 18+ years) hospitalized with noncardioembolic ischemic stroke from January 1, 2002, through December 31, 2003, identified from commercial health plan administrative claims. New or recurrent stroke was based on history in the previous 12 months, with index date defined as first date of indication of stroke. A control group without stroke or transient ischemic attack (TIA) was matched (1:3) on age, sex, and geographic region, with an index date defined as the first medical claim during the patient identification period. Patients with atrial fibrillation or mitral value abnormalities were excluded. Ischemic stroke and control cohorts were compared on 4-year clinical outcomes and 1-year costs. RESULTS: Of 2180 ischemic stroke patients, 1808 (82.9%) had new stroke and 372 (17.1%) had a recurrent stroke. Stroke patients had higher unadjusted rates of additional stroke, TIA, and fatal outcomes compared with the 6540 matched controls. Recurrent stroke patients had higher rates of adverse clinical outcomes compared with new stroke patients; costs attributed to recurrent stroke were also higher. Stroke patients were 2.4 times more likely to be hospitalized in follow-up compared with controls (hazard ratio [HR] 2.4, 95% confidence interval [CI]: 2.2, 2.6). Occurrence of stroke following discharge was 21 times more likely among patients with index stroke compared with controls (HR 21.0, 95% CI: 16.1, 27.3). Stroke was also predictive of death (HR 1.8, 95% CI: 1.3, 2.5). Controlling for covariates, stroke patients had significantly higher costs compared with control patients in the year following the index event. CONCLUSION: Noncardioembolic ischemic stroke patients had significantly poorer outcomes and higher costs compared with controls. Recurrent stroke appears to contribute substantially to these higher rates of adverse outcomes and costs.

An observational study of fixed dose combination fluticasone propionate/salmeterol or fluticasone propionate alone on asthma-related outcomes .

OBJECTIVE: To identify the relationship between resource utilization and treatment of asthma in subjects who were first time users of controller therapies, either fluticasone propionate (FP) and salmeterol delivered in a single Diskus device (FSC) or FP monotherapy. METHODS: A retrospective, observational cohort analysis evaluated pharmacy and medical claims from subjects from a commercial managed-care database, which is similar in makeup to the US privately insured population, with a diagnosis of asthma and ≥1 prescription for FSC or FP dispensed from 1/1/2001 to 4/30/2005. Outcomes of interest were asthma-related emergency department (ED) visits, inpatient (IP) visits, and a combined outcome (IP or ED visits). Predicted rates of asthma-related and all-cause intubations were also reported for each cohort. Multivariate analysis of events was conducted using logistic regression and Cox proportional hazard regression. All outcomes were adjusted for differences in baseline characteristics. RESULTS: There were 58 270 subjects identified (FSC, n = 42 466; FP, n = 15 804). Mean age was 37.65 years and 35.75% was female. The use of FSC was associated with lower risk of having an asthma-related ED visit (adjusted OR 0.79; 95% CI, 0.72-0.87) and an asthma-related ED/IP visit (OR 0.80; 95% CI, 0.73-0.88). Asthma-related ED and ED/IP rates were also significantly lower for FSC than for FP. There were no differences observed in post-index asthma-related intubations rates. CONCLUSION: In this observational study using a large managed-care database, subjects treated with FSC were at significantly less risk for developing serious asthma exacerbations and had lower resource utilization than a cohort of subjects treated with FP. This is clinically meaningful despite the inherent limitations of these types of observational studies.