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Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). It does not require routine monitoring with laboratory testing which may have an adverse impact on adherence. We aimed to describe adherence to dabigatran in the first year after initiation and assess the association between non-adherence to dabigatran and clinical outcomes in a large integrated healthcare system. We studied a national cohort of 5,376 patients with NVAF, initiated on dabigatran between October-2010 and September-2012 at all Veterans Affairs hospitals. Adherence to dabigatran was calculated as proportion of days covered (PDC) and association between PDC and outcomes was assessed using standard regression techniques. Mean age of the study cohort was 71.3 ± 9.7 years; 98.3% were men and mean CHADS2 score was 2.4 ± 1.2 (mean CHA2DS2VASc score 3.2 ± 1.4). Median PDC was 94% (IQR 76%-100%; mean PDC 84% ± 22%) over a median follow-up of 244 days (IQR 140-351). A total of 1,494 (27.8%) patients had a PDC <80% and were classified as non-adherent. After multivariable adjustment, lower adherence was associated with increased risk for combined all-cause mortality and stroke (HR 1.13, 95% CI 1.07–1.19 per 10% decrease in PDC). Adherence to dabigatran was not associated with non-fatal bleeding or myocardial infarction. In the year after initiation, adherence to dabigatran for a majority of patients is very good. However, 28% of patients in our cohort had poor adherence. Furthermore, lower adherence to dabigatran was associated with increased adverse outcomes. Concerted efforts are needed to optimize adherence to NOACs.

Little is known regarding the effectiveness of tixagevimab/cilgavimab in preventing SARS-CoV-2 infection in vaccinated immunocompromised patients, particularly after the emergence of the Omicron variant. In this retrospective cohort study with exact matching and propensity score adjustment within the U.S. Department of Veterans Affairs (VA) healthcare system, we selected immunocompromised veterans age ≥18 years as of 1 January 2022, receiving VA healthcare. We compared a cohort of 1,878 patients treated with at least one dose of intramuscular tixagevimab/cilgavimab to 7,014 matched controls selected from patients who met study criteria but were not treated. Patients were followed through 15 June 2022, or until death, whichever occurred earlier. The primary outcome was a composite of SARS-CoV-2 infection, COVID-19-related hospitalization, and all-cause mortality. We used Cox proportional hazards modeling to estimate the hazard ratios (HRs) and 95% CI for the association between receipt of tixagevimab/cilgavimab and outcomes. Most (73%) tixagevimab/cilgavimab recipients were ≥65 years old, and 80% had ≥3 mRNA vaccine doses or two doses of Ad26.COV2. Compared to matched controls, recipients had a lower incidence of the composite COVID-19 outcome (49/1,878 [2.6%] versus 312/7,014 [4.4%]; HR 0.35; 95% CI, 0.24–0.52), and individually SARS-CoV-2 infection (HR 0.44; 95% CI, 0.22–0.88), COVID-19 hospitalization (HR 0.24; 95% CI, 0.10–0.59), and all-cause mortality (HR 0.32; 95% CI, 0.19–0.55). In conclusion, tixagevimab/cilgavimab was associated with lower rates of SARS-CoV-2 infection and severe COVID-19 during the Omicron BA.1, BA.2, and BA.2.12.1 surge. SARS-CoV-2 remains an ongoing global health crisis that justifies continued efforts to validate and expand, when possible, knowledge on the efficacy of available vaccines and treatments. Clinical trials have been limited due to fast tracking of medications for mitigation of the COVID-19 pandemic for the general population. We present a real-world analysis, using electronic health record data, of the effectiveness of tixagevimab/cilgavimab for the prevention of COVID-19 infection in the unique population of U.S. veterans. Unlike those in the PROVENT clinical trial from which the emergency use authorization for tixagevimab/cilgavimab as a preventative treatment arose, the veterans population is highly immunocompromised and nearly 96% totally vaccinated. These demographics allowed us to analyze the effectiveness of tixagevimab/cilgavimab in preventing COVID-19 under different conditions in a more fragile population than that of the initial clinical trial.

Rationale Controlled trials have demonstrated successful weight loss associated with certain weight management medications (WMMs). However, there are limited real‐world data on prescribing patterns and efficacy and safety profiles of WMMs in Veterans Affairs (VA) patients. Objective To evaluate: utilization patterns of WMMs liraglutide, naltrexone/bupropion, orlistat, phentermine, phentermine/topiramate, and semaglutide; weight loss at three, six, twelve, and more than 12 months; safety; and treatment barriers. Methods A retrospective, cross‐sectional medication use evaluation (MUE) was conducted using electronic health records of outpatient Veterans newly initiated on WMMs at 37 VA Medical Centers between 1 March 2020 and 31 March 2022. Chart review was used to identify WMM utilization and capture rates of clinical response, defined as 5% and 10% or greater weight loss at the final weight, adverse drug events (ADEs), non‐adherence, and discontinuations. Site‐specific surveys evaluated local practices and barriers. Results Among 1959 eligible Veterans, semaglutide, phentermine/topiramate, and orlistat were most frequently prescribed. The clinical response was highest among phentermine/topiramate, liraglutide, and semaglutide. Naltrexone/bupropion and phentermine demonstrated the highest and lowest ADE rates, respectively. Potential barriers to WMM utilization and successful treatment by site reports were drug shortages, patient perceptions of therapeutic course, personal preferences, and VA WMM use criteria. Conclusions Smaller weight loss and higher discontinuation rates were observed relative to clinical trials. The MUE data allow for better assessment of benefits and risks for Veterans prescribed WMMs.

Background: Linking process and outcomes is critical to accurately estimating healthcare quality and quantifying its benefits. Objectives: The objective of this study was to explore the relationship of guideline-based depression process measures with subsequent overall and psychiatric hospitalizations. Research Design: This is a retrospective cohort study during which we used administrative and centralized pharmacy records for sample identification, derivation of guideline-based process measures (antidepressant dosage and duration adequacy), and subsequent hospitalization ascertainment. Depression care was measured from June 1, 1999, through August 31, 1999. We used multivariable regression to evaluate the link between depression care and subsequent overall and psychiatric hospitalization, adjusting for patient age, race, sex, socioeconomic status, comorbid illness, and hospitalization in the prior 12 months. Subjects: We studied a total of 12,678 patients from 14 Northeastern VHA hospitals. Results: We identified adequate antidepressant dosage in 90% and adequate duration in 45%. Those with adequate duration of antidepressants were less likely to be hospitalized in the subsequent 12 months than those with inadequate duration (odds ratio [OR], .90; 95% confidence interval [CI], .81-1.00). Those with adequate duration of antidepressants were less likely to have a psychiatric hospitalization in the subsequent 12 months than those with inadequate duration (OR, .82; 95% CI, .69-.96). We did not demonstrate a significant link between dosage adequacy and subsequent overall or psychiatric hospitalization. Conclusions: Guideline-based depression process measures derived from centralized data sources offer an important method of depression care surveillance. Their accuracy in capturing depres care quality is supported by their link to healthcare utilization. Further work is needed to assess the effect of implementing these quality indicators on depression care.

Background.. Herpes zoster occurs more commonly in patients taking immunosuppressive medications, although the risk associated with different medications is poorly understood. Methods.. We conducted a retrospective cohort study involving 20,357 patients who were followed in the Veterans Affairs healthcare system and treated for rheumatoid arthritis from October 1998 through June 2005. Cox proportional hazards regression was used to determine risk factors for herpes zoster and herpes zoster–free survival. Chart review was performed to validate the diagnosis of herpes zoster. Results.. The incidence of herpes zoster was 9.96 episodes per 1000 patient-years. In time-to-event analysis, patients receiving medications used to treat mild rheumatoid arthritis were less likely to have an episode of herpes zoster than patients receiving medications used to treat moderate and severe rheumatoid arthritis (P<.001). Independent risk factors for herpes zoster included older age, prednisone use, medications used to treat moderate and severe rheumatoid arthritis, malignancy, chronic lung disease, renal failure, and liver disease. Among patients receiving tumor necrosis factor–α antagonists, etanercept (hazard ratio, 0.62) and adalimumab (hazard ratio, 0.53) were associated with a lower risk of herpes zoster. There was excellent agreement between the International Classification of Diseases, Version 9, Clinical Modification diagnosis of herpes zoster and diagnosis by chart review (k=0.92). Conclusions.. Risk factors for herpes zoster included older age, prednisone use, medications used to treat moderate and severe rheumatoid arthritis, and several comorbid medical conditions. These results demonstrate that the Department of Veterans Affairs' national administrative databases can be used to study rare adverse drug events.

Background: Information on the effectiveness of newer antidepressants like serotonin-norepinephrine reuptake inhibitors in terms of healthcare utilization is limited. Treatment guidelines affect evaluation. Second-line medications are usually prescribed to patients with higher utilization. Objectives: The objective of this study was to compare antidepressants within the Veterans Affairs (VA) healthcare system on the basis of the number of outpatient psychiatric visits for each class of antidepressants. Research Design and Subjects: We conducted a retrospective cohort design using precollected information from VA national databases from 1999 and 2000. The study identified 92,537 patients on serotonin specific reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs). Measures: We stratified individual patients by the number of visits in the baseline year for each medication class. For each stratum, we created a dichotomized variable$Y_{K}:Y_{K}=1$if there is a reduction of K visits or more and 0 if there is no reduction. We calculated the odds of reduction of psychiatric visits among the 3 classes of antidepressants. Results: TCAs and SSRIs were associated with greater odds of reduction compared with SNRIs at the level of 1 through 10 or 11 visits, respectively. SNRIs were associated with greater odds of reduction in visits at the level of 14, 16, or more visits compared with SSRIs and TCAs, respectively (P <0.05). SSRIs were associated with greater odds of reduction compared with TCAs at the level of 1 to 11 visits (P <0.05); there were no significant differences between the 2 classes above 11 visits. Conclusion: Effectiveness research using databases should consider how medications are prescribed within systems. Treatment guidelines result in differences in severity and utilization among users of different medications.

Background Studies of the retreatment with consensus interferon (CIFN) and ribavirin (RBV) of hepatitis C virus (HCV)-infected patients who failed prior pegylated interferon alfa/ribavirin (PEG-IFN/RBV) have found quite variable efficacy and tolerability of this therapy. As such, CIFN/RBV use and efficacy in clinical practice were evaluated within the Department of Veterans Affairs (VA), the largest national, integrated system for HCV care. Aims The purpose of this study was to determine rates of sustained virologic response (SVR) and patterns of CIFN/RBV use in the VA. Methods included retrospective review of national VA data in HCV-infected patients who had previously failed ≥12 weeks of PEG-IFN/RBV and were prescribed CIFN/RBV between October 1, 2003 and September 30, 2006. Results A total of 597 patients met the study criteria. CIFN was primarily dosed as 15 mcg subcutaneously daily combined with standard doses of RBV. Mean treatment duration was 21 weeks; CIFN was discontinued within 4 weeks in 24%. Hematological growth factors were used in 49%. Post-treatment viral loads were available in 385 patients. SVR to CIFN/RBV was achieved in 11%, and was significantly higher in prior PEG-IFN/RBV relapsers compared with nonresponders (31% vs. 6%, respectively; P  < 0.0001). A 2-log 10 or greater drop in HCV RNA after 24 weeks of PEG-IFN/RBV was a predictor of subsequent SVR to CIFN/RBV. Conclusions CIFN/RBV was used frequently in clinical practice for retreatment of PEG-IFN/RBV. In this setting, early treatment discontinuation was common. Overall SVR was low, although response was significantly better in prior PEG-IFN/RBV relapsers and those who had a 2-log 10 or greater decline than in nonresponders.

Studies describe differences between recommendations for hypertension treatment and actual drug use. Antihypertensive use data from the Department of Veterans Affairs (VA) for 1995 to 1999 showed a downward trend for calcium antagonist (CA) use and increased use of beta-blockers (BB) and thiazide diuretics (TD). This study evaluates national VA antihypertensive treatment for 2000 to 2002 and compares these data to treatment data for 1995 to 1999. National VA pharmacy data were used to determine use of BB, TD, CA, angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), and combinations of antihypertensive drugs for 2000 to 2002. Dispensing data were converted to treatment days. In addition to national trends, data were analyzed regionally to examine geographic differences. Pharmacoeconomic analysis estimated the financial impact of medication changes. Antihypertensive drug use in the VA represented more than 1 billion days in 2002. The ACEI were most commonly used, representing 33.4% and 33.5% of treatment days in 2000 and 2002, respectively. Changes from 2000 to 2002 were 21.9% to 24.2% for BB, 29.3% to 24.4% for CA, and 13.2% to 14.2% for TD. Use of ARB increased from 2.1% to 3.7% of treatment days. Analysis of the 21 VA regions showed geographic variation. For example, the proportion of BB treatment days is highest in a northeast VA region (28.6%) and lowest in a southeast region (19.9%). In 2002 the VA has saved an estimated US 8.5 million dollars because of changes in medication use. As a proportion of antihypertensive agent use, CA continues to fall in the VA, whereas BB, TD, and ARB use have increased. However, TD use remains low, despite national guidelines that promote use of this class of agent.

Studies describe differences between recommendations for hypertension treatment and actual drug use. Antihypertensive use data from the Department of Veterans Affairs (VA) for 1995 to 1999 showed a downward trend for calcium antagonist (CA) use and increased use of β-blockers (BB) and thiazide diuretics (TD). This study evaluates national VA antihypertensive treatment for 2000 to 2002 and compares these data to treatment data for 1995 to 1999. National VA pharmacy data were used to determine use of BB, TD, CA, angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), and combinations of antihypertensive drugs for 2000 to 2002. Dispensing data were converted to treatment days. In addition to national trends, data were analyzed regionally to examine geographic differences. Pharmacoeconomic analysis estimated the financial impact of medication changes. Antihypertensive drug use in the VA represented more than 1 billion days in 2002. The ACEI were most commonly used, representing 33.4% and 33.5% of treatment days in 2000 and 2002, respectively. Changes from 2000 to 2002 were 21.9% to 24.2% for BB, 29.3% to 24.4% for CA, and 13.2% to 14.2% for TD. Use of ARB increased from 2.1% to 3.7% of treatment days. Analysis of the 21 VA regions showed geographic variation. For example, the proportion of BB treatment days is highest in a northeast VA region (28.6%) and lowest in a southeast region (19.9%). In 2002 the VA has saved an estimated $8.5 million because of changes in medication use. As a proportion of antihypertensive agent use, CA continues to fall in the VA, whereas BB, TD, and ARB use have increased. However, TD use remains low, despite national guidelines that promote use of this class of agent.

Older studies of antihypertensive treatment have shown that prescribing patterns are not consistent with recommendations from expert national panels. We determined whether prescribing patterns for antihypertensive drugs changed recently in the largest integrated health care system in the United States. Specifically, we determine 1) patterns of antihypertensive medication use at all Department of Veterans Affairs (VA) medical facilities for fiscal years 1997 to 1999, 2) the cost of this care, and 3) savings associated with changes in treatment patterns. Data were aggregated by individual medication as well as by antihypertensive drug class. Estimates of VA national antihypertensive drug costs are based on the median cost and the number of units for each dosage form of each medication dispensed at all facilities. At VA medical facilities, calcium antagonist use went from 33% to 29.3% of antihypertensive treatment days between 1997 and 1999, angiotensin converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) use from 36.4% to 36.8%, β-blockers from 19.1% to 21.1%, and thiazide diuretic use from at 11.5% to 12.8%. If treatment patterns had remained the same between 1997 and 1999 in terms of the proportion of medications from each drug class, an additional six million dollars would have been spent on antihypertensive medications in 1999. Although calcium antagonists and ACE inhibitors/ARB remained the most commonly dispensed antihypertensives at VA facilities from 1997 to 1999, there was a proportional decrease in calcium antagonist use and an increase in the use of thiazide diuretics and β-blockers. These changes were consistent with improved compliance with VA national guidelines. The cost implications of these changes in practice patterns were considerable.