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Factors Associated With PCSK9 Inhibitor Initiation Among US Veterans.

ABSTRACT: Background Few adults at high risk for atherosclerotic cardiovascular disease events use a PCSK9i (proprotein convertase subtilisin/kexin type 9 inhibitor). Methods and Results Using data from the US Veterans Health Administration, we identified veterans who initiated a PCSK9i between January 2018 and December 2019, matched 1:4 to veterans who did not initiate this medication over this time period (case-cohort study). Two cohorts of veterans were analyzed: (1) atherosclerotic cardiovascular disease, with a most recent low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL; and (2) severe hypercholesterolemia (ie, familial hypercholesterolemia or any prior LDL-C ≥190 mg/dL, with most recent LDL-C ≥100 mg/dL). Conditional logistic regression was used to analyze factors associated with PCSK9i initiation, adjusting for all factors, simultaneously. There were 2394 initiators and 9576 noninitiators in the atherosclerotic cardiovascular disease cohort (median LDL-C, 141 and 96 mg/dL, respectively; P<0.001). Factors associated with a higher likelihood of PCSK9i initiation included age 65 to <75 versus <65 years, highest versus lowest quartile of median area-level income, familial hypercholesterolemia, former statin use, and current ezetimibe use. PCSK9i initiation was lower among veterans of a race/ethnicity other than non-Hispanic White. There were 245 initiators and 980 noninitiators in the severe hypercholesterolemia cohort (median LDL-C, 183 and 151 mg/dL, respectively; P<0.001). Age ≥75 versus <65 years, history of chronic kidney disease, former statin use, and current ezetimibe use were associated with a higher likelihood of PCSK9i initiation. Conclusions Several patient-level factors, including age, sex, and race/ethnicity, were significantly associated with PCSK9i initiation, suggesting an unmet treatment need in several patient groups.

SUBMITTER: Derington CG

PROVIDER: S-EPMC8174184 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Factors Associated With PCSK9 Inhibitor Initiation Among US Veterans.

Derington Catherine G CG Colantonio Lisandro D LD Herrick Jennifer S JS Cook James J King Jordan B JB Rosenson Robert S RS Poudel Bharat B Monda Keri L KL Navar Ann Marie AM Mues Katherine E KE Stevens Vanessa W VW Nelson Richard E RE Vanneman Megan E ME Muntner Paul P Bress Adam P AP

Journal of the American Heart Association 20210406 8

Background Few adults at high risk for atherosclerotic cardiovascular disease events use a PCSK9i (proprotein convertase subtilisin/kexin type 9 inhibitor). Methods and Results Using data from the US Veterans Health Administration, we identified veterans who initiated a PCSK9i between January 2018 and December 2019, matched 1:4 to veterans who did not initiate this medication over this time period (case-cohort study). Two cohorts of veterans were analyzed: (1) atherosclerotic cardiovascular dise ...[more]

PMID: 33821686

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Project description:BackgroundInclisiran (ALN-PCSsc) is a long-acting RNA interference (RNAi) therapeutic agent that inhibits the synthesis of proprotein convertase subtilisin-kexin type 9 (PCSK9), a target for the lowering of low-density lipoprotein (LDL) cholesterol.MethodsIn this phase 1 trial, we randomly assigned healthy volunteers with an LDL cholesterol level of at least 100 mg per deciliter in a 3:1 ratio to receive a subcutaneous injection of inclisiran or placebo in either a single-ascending-dose phase (at a dose of 25, 100, 300, 500, or 800 mg) or a multiple-dose phase (125 mg weekly for four doses, 250 mg every other week for two doses, or 300 or 500 mg monthly for two doses, with or without concurrent statin therapy); each dose cohort included four to eight participants. Safety, the side-effect profile, and pharmacodynamic measures (PCSK9 level, LDL cholesterol level, and exploratory lipid variables) were evaluated.ResultsThe most common adverse events were cough, musculoskeletal pain, nasopharyngitis, headache, back pain, and diarrhea. All the adverse events were mild or moderate in severity. There were no serious adverse events or discontinuations due to adverse events. There was one grade 3 elevation in the γ-glutamyltransferase level, which was considered by the investigator to be related to statin therapy. In the single-dose phase, inclisiran doses of 300 mg or more reduced the PCSK9 level (up to a least-squares mean reduction of 74.5% from baseline to day 84), and doses of 100 mg or more reduced the LDL cholesterol level (up to a least-squares mean reduction of 50.6% from baseline). Reductions in the levels of PCSK9 and LDL cholesterol were maintained at day 180 for doses of 300 mg or more. All multiple-dose regimens reduced the levels of PCSK9 (up to a least-squares mean reduction of 83.8% from baseline to day 84) and LDL cholesterol (up to a least-squares mean reduction of 59.7% from baseline to day 84).ConclusionsIn this phase 1 trial, no serious adverse events were observed with inclisiran. Doses of 300 mg or more (in single or multiple doses) significantly reduced levels of PCSK9 and LDL cholesterol for at least 6 months. (Funded by Alnylam Pharmaceuticals and the Medicines Company; ClinicalTrials.gov number, NCT02314442 .).

Project description:BackgroundProprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to be effective and safe in patients with stable angina and previous myocardial infarction. However, evidence for initiating their use in patients hospitalized with acute coronary syndrome (ACS) is limited. This systematic review and meta-analysis was performed to provide more clinical evidence.MethodsPubMed, Embase, OVID, Cochrane Library and ClinicalTrials.gov were systematically searched for eligible randomized controlled trials up to March 20, 2023. The risk ratios, standardized mean differences and 95% confidence intervals were calculated for primary and secondary outcomes. The bias risk of the included studies was assessed using the Cochrane RoB 2 criteria.ResultsAbout 8 randomized controlled trials involving 1255 inpatients with ACS were included. PCSK9 inhibitor treatment significantly reduced low-density lipoprotein cholesterol (LDL-C) (SMD -1.28, 95% CI -1.76 to -0.8, P = .001), triglycerides (TG) (SMD -0.93, 95% CI -1.82 to -0.05, P = .03), total cholesterol (SMD -1.36, 95% CI -2.01 to -0.71, P = .001), and apolipoprotein B (Apo B) (SMD -0.81, 95% CI -1.09 to -0.52, P = .001) within approximately 1 month. PCSK9 inhibitor treatment significantly reduced the total atheroma volume (TAV) (SMD -0.33, 95% CI -0.59 to -0.07, P = .012). It also significantly increased minimum fibrous cap thickness (FCT) (SMD 0.41, 95% CI 0.22-0.59, P = .001) in long-term follow-up (>6 months). PCSK9 inhibitor treatment significantly reduced the risk of readmission for unstable angina (RR 0.32, 95% CI 0.12-0.91, P = .032) in short-term follow-up (<6 months). There were no significant differences in all-cause mortality, cardiovascular death, myocardial infarction, ischemic stroke, coronary revascularization or heart failure. Only nasopharyngitis (RR 1.71, 95% CI 1.01-2.91, P = .047) adverse events were significantly observed in the PCSK9 inhibitor group.ConclusionApplication of a PCSK9 inhibitor in hospitalized patients with ACS reduced lipid profiles and plaque burdens and was well tolerated with few adverse events.

Project description:ImportanceSemaglutide, a novel glucagon-like peptide-1 (GLP-1) receptor agonist medication, was approved for weight management in individuals with obesity in June 2021. There is limited evidence on factors associated with uptake among individuals in this subgroup without diabetes.ObjectiveTo explore factors associated with semaglutide initiation among a population of commercially insured individuals with obesity but no diagnosed diabetes.Design, setting, and participantsThis retrospective observational cohort study used data from the Merative MarketScan Commercial Claims and Encounters Database and included adults in the US aged 18 years or older with a first diagnosis of obesity in an outpatient or inpatient setting between June 5, 2021, and July 1, 2022. Inclusion criteria were no prior antiobesity medication, GLP-1, bariatric surgery, or diabetes-related claim in the 12 months prior to obesity diagnosis, and continuous enrollment in the 12 months preceding and 6 months following obesity diagnosis. Analysis was conducted from February to November 2024.ExposuresMedication classes prescribed, clinical diagnoses, and sociodemographic factors. Exposures were identified within the 12 months prior to obesity diagnosis.Main outcomes and measuresFactors associated with incident semaglutide prescription within 6 months after obesity diagnoses were identified using a 10-fold cross-classified random forest model. The top 20 features of the model feature importance list were ranked in a Shapley Additive Explanations plot and used in a multivariable logistic regression model to quantify associations with semaglutide initiation.ResultsIn this study of 97 456 individuals, 58 124 (59.6%) were female, 26 582 (27.3%) were aged 45 to 54 years, 50 705 (52.0%) resided in the South region, and 49 390 (50.7%) were covered by preferred provider organization plans. Of all participants, 1963 (2.0%) initiated semaglutide within 6 months of their initial obesity diagnosis. The random forest model had an area under the receiver operating characteristic curve of 0.71 (95% CI, 0.69-0.74). The most important exposures identified via Shapley Additive Explanations were sex, use of antidepressants, and employer industry. The top 20 factors were used in the logistic regression model, and significant associations were found with semaglutide initiation, including being female (adjusted odds ratio [aOR], 2.30; 95% CI, 2.05-2.58), use of certain medication classes including antidepressants (aOR,1.62; 95% CI, 1.46-1.78), and being covered by a point-of-service plan (aOR, 1.78; 95% C, 1.42-2.22).Conclusions and relevanceThis cohort study found that key sociodemographic, health care, and clinical factors are associated with receipt of semaglutide in those without diabetes. These findings suggest that insurance plan type and structure may be a crucial intervention point for improving equity in obesity treatment access.

Project description:Background Sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor, received US Food and Drug Administration approval in 2015 for heart failure with reduced ejection fraction (HFrEF). Our objective was to describe the sacubitril/valsartan initiation rate, associated characteristics, and 6-month follow-up dosing among veterans with HFrEF who are renin-angiotensin-aldosterone system inhibitor (RAASi) naïve. Methods and Results Retrospective cohort study of veterans with HFrEF who are RAASi naïve defined as left ventricular ejection fraction (LVEF) ≤40%; ≥1 in/outpatient heart failure visit, first RAASi (sacubitril/valsartan, angiotensin-converting enzyme inhibitor [ACEI]), or angiotensin-II receptor blocker [ARB]) fill from July 2015 to June 2019. Characteristics associated with sacubitril/valsartan initiation were identified using Poisson regression models. From July 2015 to June 2019, we identified 3458 sacubitril/valsartan and 29 367 ACEI or ARB initiators among veterans with HFrEF who are RAASi naïve. Sacubitril/valsartan initiation increased from 0% to 26.5%. Sacubitril/valsartan (versus ACEI or ARB) initiators were less likely to have histories of stroke, myocardial infarction, or hypertension and more likely to be older and have diabetes mellitus and lower LVEF. At 6-month follow-up, the prevalence of ≥50% target daily dose for sacubitril/valsartan, ACEI, and ARB initiators was 23.5%, 43.2%, and 47.1%, respectively. Conclusions Sacubitril/valsartan initiation for HFrEF in the Veterans Administration increased in the 4 years immediately following Food and Drug Administration approval. Sacubitril/valsartan (versus ACEI or ARB) initiators had fewer baseline cardiovascular comorbidities and the lowest proportion on ≥50% target daily dose at 6-month follow-up. Identifying the reasons for lower follow-up dosing of sacubitril/valsartan could support guideline recommendations and quality improvement strategies for patients with HFrEF.

Project description:BackgroundThis study focuses on factors that may disproportionately affect female veterans' mental health, compared to men, and is part of a larger study assessing the prevalence of mental health disorders and treatment seeking among formerly deployed US military service members.MethodsWe surveyed a random sample of 1,730 veterans who were patients in a large non-VA hospital system in the US. Based on previous research, women were hypothesized to be at higher risk for psychological problems. We adjusted our results for confounding factors, including history of trauma, childhood abuse, combat exposure, deployments, stressful life events, alcohol misuse, psychological resources, and social support.ResultsAmong the veterans studied, 5% were female (n = 85), 96% were White (n = 1,161), 22.9% were Iraq/Afghanistan veterans (n = 398), and the mean age was 59 years old (SD = 12). Compared to males, female veterans were younger, unmarried, college graduates, had less combat exposure, but were more likely to have lifetime PTSD (29% vs. 12%.), depression (46% vs. 21%), suicidal ideation (27% vs. 11%), and lifetime mental health service use (67% vs. 47%). Females were also more likely to have low psychological resilience and to have used psychotropic medications in the past year. Using multivariate logistic regression analyses that controlled for risk and protective factors, female veterans had greater risk for lifetime PTSD, depression, suicidal thoughts, and for lifetime use of psychological services, compared to males. Since 95% of the population in this study were male and these results may have been statistically biased, we reran our analyses using propensity score matching. Results were consistent across these analyses.ConclusionUsing a sample of post-deployment veterans receiving healthcare services from a large non-VA health system, we find that female veterans are at greater risk for lifetime psychological problems, compared to male veterans. We discuss these findings and their implications for service providers.

Project description:ImportanceMost clinical practice guidelines recommend stopping cancer screenings when risks exceed benefits, yet low-value screenings persist. The Veterans Health Administration focuses on improving the value and quality of care, using a patient-centered medical home model that may affect cancer screening behavior.ObjectiveTo understand rates and factors associated with outpatient low-value cancer screenings.Design, setting, and participantsThis cohort study assessed the receipt of low-value cancer screening and associated factors among 5 993 010 veterans. Four measures of low-value cancer screening defined by validated recommendations of practices to avoid were constructed using administrative data. Patients with cancer screenings in 2017 at Veterans Health Administration primary care clinics were included. Excluded patients had recent symptoms or historic high-risk diagnoses that may affect test appropriateness (eg, melena preceding colonoscopy). Data were analyzed from December 23, 2019, to June 21, 2021.ExposuresReceipt of cancer screening test.Main outcomes and measuresLow-value screenings were defined as occurring for average-risk patients outside of guideline-recommended ages or if the 1-year mortality risk estimated using a previously validated score was at least 50%. Factors evaluated in multivariable regression models included patient, clinician, and clinic characteristics and patient-centered medical home domain performance for team-based care, access, and continuity previously developed from administrative and survey data.ResultsOf 5 993 010 veterans (mean [SD] age, 63.1 [16.8] years; 5 496 976 men [91.7%]; 1 027 836 non-Hispanic Black [17.2%] and 4 539 341 non-Hispanic White [75.7%] race and ethnicity) enrolled in primary care, 903 612 of 4 647 479 men of average risk (19.4%) underwent prostate cancer screening; 299 765 of 5 770 622 patients of average risk (5.2%) underwent colorectal cancer screening; 21 930 of 469 045 women of average risk (4.7%) underwent breast cancer screening; and 65 511 of 458 086 women of average risk (14.3%) underwent cervical cancer screening. Of patients screened, low-value testing was rare for 3 cancers, with receipt of a low-value test in 633 of 21 930 of women screened for breast cancer (2.9%), 630 of 65 511 of women screened for cervical cancer (1.0%), and 6790 of 299 765 of patients screened for colorectal cancer (2.3%). However, 350 705 of 4 647 479 of screened men (7.5%) received a low-value prostate cancer test. Patient race and ethnicity, sociodemographic factors, and illness burden were significantly associated with likelihood of receipt of low-value tests among screened patients. No single patient-, clinician-, or clinic-level factor explained the receipt of a low-value test across cancer screening cohorts.Conclusions and relevanceThis large cohort study found that low-value breast, cervical, and colorectal cancer screenings were rare in the Veterans Health Administration, but more than one-third of patients screened for prostate cancer were tested outside of clinical practice guidelines. Guideline-discordant care has quality implications and is not consistently explained by associated multilevel factors.

Dataset Information

Factors Associated With PCSK9 Inhibitor Initiation Among US Veterans.

Publications

Factors Associated With PCSK9 Inhibitor Initiation Among US Veterans.

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