Predictors, Disparities, and Facility-Level Variation: SGLT2 Inhibitor Prescription Among US Veterans With CKD.

RATIONALE & OBJECTIVE: Sodium/glucose cotransporter 2 (SGLT2) inhibitors are recommended for type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease (CKD) or atherosclerotic cardiovascular disease (ASCVD). We evaluated factors associated with SGLT2 inhibitor prescription, disparities by race and sex, and facility-level variation in prescription patterns. STUDY DESIGN: Retrospective cohort. SETTING & PARTICIPANTS: A national sample of US veterans with comorbid T2DM, CKD, and ASCVD with a primary care visit between January 1 and December 31, 2020. EXPOSURE: Race, sex, and individual Veterans Affairs (VA) location. OUTCOME: SGLT2 inhibitor prescription. ANALYTICAL APPROACH: Multivariable logistic regression assessed associations of race and sex with SGLT2 inhibitor prescription. Facility-level variation in SGLT2i prescription was quantified by median rate ratios (MRR), which express the likelihood that 2 randomly selected facilities differ in their use of SGLT2 inhibitor among similar patients. RESULTS: Of 174,443 patients with CKD, T2DM, and ASCVD, 20,024 (11.5%) were prescribed an SGLT2 inhibitor. Lower odds of SGLT2 inhibitor prescription were seen in Black or African American patients compared with White patients (OR, 0.87 [95% CI, 0.83-0.91]) and among women compared with men (OR, 0.59 [95% CI 0.52-0.67]). The adjusted MRR for SGLT2 inhibitor prescription was 1.58 (95% CI 1.48-1.67) in the total cohort, indicating an unexplained 58% variation in treatment between VA facilities, independent of patient and facility characteristics. Facility-level variation was evaluated among Black or African American patients (MRR, 1.55 [95% CI 1.41-1.68]), White patients (MRR, 1.57 [95% CI 1.47-1.66]), women (MRR, 1.40 [95% CI 1.28-1.51]), and men (MRR, 1.57 [95% CI 1.48-1.67]). LIMITATIONS: Albuminuria was not assessed. CONCLUSIONS: Prescription for SGLT2 inhibitors was low among likely eligible patients, with evident disparities by sex and race and between individual VA facilities. Efforts are needed to study and address the reasons for these disparities to improve equitable adoption of these important medications.

Documented Adverse Drug Reactions and Discontinuation of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in Chronic Kidney Disease.

INTRODUCTION: Angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs) are frequently discontinued in patients with chronic kidney disease (CKD). Documented adverse drug reactions (ADRs) in medical records may provide insight into the reasons for treatment discontinuation. METHODS: In this retrospective cohort of US veterans from 2005 to 2019, we identified individuals with CKD and a current prescription for an ACEi or ARB (current user group) or a discontinued prescription within the preceding 5 years (discontinued group). Documented ADRs in structured datasets associated with an ACEi or ARB were categorized into 17 pre-specified groups. Logistic regression assessed associations of documented ADRs with treatment discontinuation. RESULTS: There were 882,441 (73.0%) individuals in the current user group and 326,794 (27.0%) in the discontinued group. There were 26,434 documented ADRs, with at least one documented ADR in 7,520 (0.9%) current users and 9,569 (2.9%) of the discontinued group. ADR presence was associated with treatment discontinuation, aOR 4.16 (95% CI: 4.03, 4.29). The most common documented ADRs were cough (37.3%), angioedema (14.2%), and allergic reaction (10.4%). ADRs related to angioedema (aOR 3.81, 95% CI: 3.47, 4.17), hyperkalemia (aOR 2.03, 95% CI: 1.84, 2.24), peripheral edema (aOR 1.53, 95% CI: 1.33, 1.77), or acute kidney injury (aOR 1.32, 95% CI: 1.15, 1.51) were associated with treatment discontinuation. CONCLUSION: ADRs leading to drug discontinuation were infrequently documented. ADR types were differentially associated with treatment discontinuation. An understanding of which ADRs lead to treatment discontinuation provides an opportunity to address them at a healthcare system level.

Significant Facility-Level Variation in Utilization of and Adherence with Secondary Prevention Therapies Among Patients with Premature Atherosclerotic Cardiovascular Disease: Insights from the VITAL (Veterans wIth premaTure AtheroscLerosis) Registry7.

PURPOSE: We investigated facility-level variation in the use and adherence with antiplatelets and statins among patients with premature and extremely premature ASCVD. METHODS: Using the 2014-2015 nationwide Veterans wIth premaTure AtheroscLerosis (VITAL) registry, we assessed patients with premature (age at first ASCVD event: males < 55 years, females < 65 years) and extremely premature ASCVD (< 40 years). We examined frequency and facility-level variation in any statin, high-intensity statin (HIS), antiplatelet use (aspirin, clopidogrel, ticagrelor, prasugrel, and ticlopidine), and statin adherence (proportion of days covered ≥ 0.8) across 130 nationwide VA healthcare facilities. Facility-level variation was computed using median rate ratios (MRR), a measure of likelihood that two random facilities differ in use of statins or antiplatelets and statin adherence. RESULTS: Our analysis included 135,703 and 7716 patients with premature and extremely premature ASCVD, respectively. Across all facilities, the median (IQR) prescription rate of any statin therapy, HIS therapy, and antiplatelets among patients with premature ASCVD was 0.73 (0.70-0.75), 0.36 (0.32-0.41), and 0.77 (0.73-0.81), respectively. MRR (95% CI) for any statin use, HIS use, and antiplatelet use were 1.53 (1.44-1.60), 1.58 (1.49-1.66), and 1.49 (1.42-1.56), respectively, showing 53, 58, and 49% facility-level variation. The median (IQR) facility-level rate of statin adherence was 0.58 (0.55-0.62) and MRR for statin adherence was 1.13 (1.10-1.15), showing 13% facility-level variation. Similar median facility-level rates and variation were observed among patients with extremely premature ASCVD. CONCLUSIONS: There is suboptimal use and significant facility-level variation in the use of statin and antiplatelet therapy among patients with premature and extremely premature ASCVD. Interventions are needed to optimize care and minimize variation among young ASCVD patients.

Facility-Level Variation in Reported Statin-Associated Side Effects Among Patients with Atherosclerotic Cardiovascular Disease-Perspective from the Veterans Affair Healthcare System.

PURPOSE: Statin-associated side effects (SASEs) can limit statin adherence and present a potential barrier to optimal statin utilization. How standardized reporting of SASEs varies across medical facilities has not been well characterized. METHODS: We assessed facility-level variation in SASE reporting among patients with atherosclerotic cardiovascular disease receiving care across the Veterans Affairs (VA) healthcare system from October 1, 2014, to September 30, 2015. The facility rates for SASE reporting were expressed as cases per 1000 patients with ASCVD. Facility-level variation was determined using hierarchical regression analysis to calculate median rate ratios (MRR [95% confidence interval]) by first using an unadjusted model and then adjusting for patient, provider, and facility characteristics. RESULTS: Of the 1,248,158 patients with ASCVD included in our study across 130 facilities, 13.7% had at least one SASE reported. Individuals with a history of SASE were less likely to be on a statin at follow-up compared with those without SASE (72.0% vs 80.8%, p < 0.01). The median (interquartile range) facility rate of SASE reported was 140.5 (109.4-167.7) cases per 1000 patients with ASCVD. Significant facility-level variation in the rate of SASE reported was observed: MRR 1.38 (1.33-1.44) in the unadjusted model and MRR 1.56 (1.47-1.65) in the adjusted model. CONCLUSION: Significant facility-level variation in SASE reporting was found within the VA healthcare system suggesting room for improvement in standardized documentation of SASEs among medical facilities. This has the potential to lead to improvement in statin utilization.

Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System.

INTRODUCTION: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. METHODS: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients. RESULTS: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more). CONCLUSION: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

Statin Prescription Rates, Adherence, and Associated Clinical Outcomes Among Women with PAD and ICVD.

PURPOSE: This study sought to investigate gender-based disparities in statin prescription rates and adherence among patients with peripheral arterial disease (PAD) and ischemic cerebrovascular disease (ICVD). METHODS: We identified patients with PAD or ICVD seeking primary care between 2013 and 2014 in the VA healthcare system. We assessed any statin use, high-intensity statin (HIS) use, and statin adherence among women with PAD or ICVD compared with men. We also compared proportion of days covered (PDC) as a measure of statin adherence; PDC ≥ 0.8 deemed a patient statin adherent. Association between statin use (or adherence) and odds of death or myocardial infarction (MI) at 12-month follow-up was also ascertained. RESULTS: Our analyses included 192,219 males and 3188 females with PAD and 331,352 males and 10,490 females with ICVD. Women with PAD had lower prescription rates of any statin (68.5% vs. 78.7%, OR 0.68, 95% confidence interval (CI) 0.62-0.75), HIS (21.1% vs. 23.7%, OR 0.88, 95% CI 0.79-0.97), and lower statin adherence (PDC ≥ 0.8: 34.6% vs. 45.5%, OR 0.75, 95% CI 0.69-0.82) compared with men. Similar disparities were seen in ICVD patients. Among female patients with PAD or ICVD, statin adherence was associated with lower odds of MI (OR 0.76, 95% CI 0.59-0.98), while use of any statin (OR 0.71, 95% CI 0.56-0.91) and HIS (OR 0.68, 95% CI 0.48-0.97) was associated with lower odds of death at 12 months. CONCLUSIONS: Women with PAD or ICVD had lower odds of receiving any statins, HIS, or being statin adherent. Targeted clinician- and patient-level interventions are needed to study and address these disparities among patients with PAD and ICVD.

Premature Coronary Heart Disease in South Asians: Burden and Determinants.

PURPOSE OF REVIEW: While the burden of cardiovascular disease (CVD) is on the decline globally, it is on the rise among South Asians. South Asians are also believed to present early with coronary artery disease (CAD) compared with other ethnicities. RECENT FINDINGS: South Asians have demonstrated a higher burden of premature CAD (PCAD) compared with other ethnicities. These findings are not limited to non-immigrant South Asians but have also been found in immigrant South Asians settled around the world. In this article, we first discuss studies evaluating PCAD among South Asians residing in South Asia and among South Asian immigrants in other countries. We then discuss several traditional risk factors that could explain PCAD in South Asians (diabetes, hypertension, dietary factors, obesity) and lipoprotein-associated risk (low HDL-C levels, higher triglycerides, and elevated apolipoprotein B levels). We then discuss several emerging areas of research among South Asians including the role of dysfunctional HDL, elevated lipoprotein(a), genetics, and epigenetics. Although various risk markers and risk factors of CAD have been identified in South Asians, how they impact therapy is not well-known. PCAD is prevalent in the South Asian population. Large-scale studies are needed to identify how this information can be rationally utilized for early identification of risk among South Asians, and how currently available therapies can mitigate this increased risk.

Statin prescription rates and their facility-level variation in patients with peripheral artery disease and ischemic cerebrovascular disease: Insights from the Department of Veterans Affairs.

The 2013 American College of Cardiology/American Heart Association cholesterol guideline recommends moderate to high-intensity statin therapy in patients with peripheral artery disease (PAD) and ischemic cerebrovascular disease (ICVD). We examined frequency and facility-level variation in any statin prescription and in guideline-concordant statin prescriptions in patients with PAD and ICVD receiving primary care in 130 facilities across the Veterans Affairs (VA) health care system between October 2013 and September 2014. Guideline-concordant statin intensity was defined as the prescription of high-intensity statins in patients with PAD or ICVD ≤75 years and at least moderate-intensity statins in those >75 years. We calculated median rate ratios (MRR) after adjusting for patient demographic factors to assess the magnitude of facility-level variation in statin prescribing patterns independent of patient characteristics. Among 194,151 PAD patients, 153,438 patients (79.0%) were prescribed any statin and 79,435 (40.9%) were prescribed a guideline-concordant intensity of statin. PAD patients without ischemic heart disease were prescribed any statin and a guideline-concordant intensity of statin therapy less frequently (69.1% and 28.9%, respectively). Among 339,771 ICVD patients, 265,491 (78.1%) were prescribed any statin and 136,430 (40.2%) were prescribed a guideline-concordant intensity of statin. ICVD patients without ischemic heart disease were prescribed any statin and a guideline-concordant intensity of statin less frequently (70.9% and 30.5%, respectively). MRRs for both PAD and ICVD patients demonstrated a 20% and 28% variation among two facilities in treating two identical patients with statin therapy and guideline-concordant intensity of statin therapy, respectively. The prescription of statins, especially guideline-recommended intensity of statin therapy, is suboptimal in PAD and ICVD patients, with significant facility-level variation not explained by patient-level factors.

Effectiveness of NPs and PAs in managing diabetes and cardiovascular disease.

BACKGROUND: The effectiveness of cardiovascular disease (CVD) and diabetes care delivered by NPs and physician assistants (PAs), and resource use by these providers has not been studied. METHODS: We performed regression analyses of patients with diabetes or CVD with a primary care visit in 130 Veterans Affairs (VA) facilities to assess the association between provider type and effectiveness or resource use. RESULTS: The diabetes cohort consisted of 156,034 patients assigned to NPs and 54,590 assigned to PAs. Glycemic and BP control, statin use, number of primary or specialty care visits, lipid panels, and A1C results were comparable between groups. The CVD cohort consisted of 185,694 patients assigned to NPs and 66,217 assigned to PAs. BP control; use of beta-blockers, statins, or antiplatelets; primary or specialty care visits; lipid panels; and number of stress tests ordered were comparable between groups. CONCLUSION: Effectiveness of care and resource use among patients in both groups were comparable.

Comparative effectiveness of outpatient cardiovascular disease and diabetes care delivery between advanced practice providers and physician providers in primary care: Implications for care under the Affordable Care Act.

BACKGROUND: The objective was to compare quality of diabetes and cardiovascular disease (CVD) care between advanced practice providers (APPs) and physicians in a primary care setting. METHODS: We identified diabetes (n=1,022,588) and CVD (n=1,187,035) patients receiving primary care between October 2013 and September 2014 in 130 Veterans Affairs facilities. We compared glycemic control (hemoglobin A1c <7%) in diabetic patients, blood pressure (BP) <140/90 mmHg in diabetic or CVD patients, cholesterol control (low-density lipoprotein cholesterol<100 mg/dL, receiving a statin) in diabetic or CVD patients, and those receiving a ß-blocker (with history of myocardial infarction in the last 2 years) among patients receiving care from physicians and APPs. We also compared the proportion meeting composite measure (glycemic, BP, and cholesterol control in diabetic patients; BP, cholesterol control, and receipt of ß-blocker among eligible CVD patients). RESULTS: Diabetic patients receiving care from APPs were statistically more likely to have glycemic (50% vs 51.4%, odds ratio [OR] 1.06 [1.05-1.08]) and BP control (77.5% vs 78.4%, OR 1.04 [1.03-1.06]), whereas patients receiving care from physicians were more likely to have cholesterol control (receipt of statin 68% vs 66.5%, OR 0.94 [0.93-0.95]) in adjusted models, although these differences are not clinically significant. Similar results were seen in CVD patients. Few patients met the composite measure (27.1% and 27.6% of diabetic and 54.0% and 54.8% of CVD patients receiving care from physicians and APPs, respectively). CONCLUSIONS: Diabetes and CVD care quality was comparable between physicians and APPs with clinically insignificant differences. Regardless of provider type, there is a need to improve performance on eligible measures in diabetes or CVD patients.

Understanding Prescribing Practices and Patient Experiences with Renin Angiotensin System Inhibitors Use in Chronic Kidney Disease: A Qualitative Study.

INTRODUCTION: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) improve outcomes but are underutilized in patients with chronic kidney disease (CKD). Little is known about reasons for discontinuation and lack of reinitiating these medications. We aimed to explore clinicians' and patients' experiences and perceptions of ACEI/ARB use in CKD. METHODS: A multi-profession sample of health care clinicians and patients with documented ACEI/ARB-associated side effects in the past 6 months. Participants were recruited from 2 Veterans Affairs healthcare systems in Texas and Tennessee. A total of 15 clinicians and 10 patients completed interviews. We used inductive and deductive qualitative data analysis approaches to identify themes related to clinician and patient experiences with ACEI/ARB. Thematic analysis focused on prescribing decisions and practices, clinical guidelines, and perception of side effects. Data were analyzed as they amassed, and recruitment was stopped at the point of thematic saturation. RESULTS: Clinicians prescribe ACEI/ARB for blood pressure control and kidney protection and underscored the importance of these medications in patients with diabetes. While clinicians described providing comprehensive patient education about ACEI/ARB in CKD, patient interviews revealed significant knowledge gaps about CKD and ACEI/ARB use. Many patients were unaware of their CKD status, and some did not know why they were prescribed ACEI/ARB. Clinicians' drug management strategies varied widely, as did their understanding of prescribing guidelines. They identified structural and patient-level barriers to prescribing and many endorsed the development of a decision support tool to facilitate ACEI/ARB prescribing and management. DISCUSSION/CONCLUSION: Our qualitative study of clinicians and providers identified key target areas for improvement to increase ACEI/ARB utilization in patients with CKD with the goal to improve long-term outcomes in high-risk patients. These findings will also inform the development of a decision support tool to assist with prescribing ACEI/ARBs for patients with CKD.

Leveraging structured and unstructured electronic health record data to detect reasons for suboptimal statin therapy use in patients with atherosclerotic cardiovascular disease.

OBJECTIVE: To determine whether natural language processing (NLP) of unstructured medical text can improve identification of ASCVD patients not using high-intensity statin therapy (HIST) due to statin-associated side effects (SASEs) and other reasons. METHODS: Reviewers annotated reasons for not prescribing HIST in notes of 1152 randomly selected patients from across the VA healthcare system treated for ASCVD but not receiving HIST. Developers used reviewer annotations to train the Canary NLP tool to detect and extract notes containing one or more of these reasons. Negative predictive value (NPV), sensitivity, specificity and Area Under the Curve (AUC) were used to assess accuracy at detecting documents containing reasons when using structured data, NLP-extracted unstructured data, or both data sources combined. RESULTS: At least one documented reason for not prescribing HIST occurred in 47% of notes. The most frequent reasons were SASEs (41%) and general intolerance (20%). When identifying notes containing any documented reason for not using HIST, adding NLP-extracted, unstructured data significantly (p<0.05) increased sensitivity (0.69 (95% confidence interval [CI] 0.60-0.76) to 0.89 (95% CI 0.81-0.93)), NPV (0.90 (95% CI 0.87 to 0.93) to 0.96 (95% CI 0.93-0.98)), and AUC (0.84 (95% confidence interval [CI] 0.81-0.88) to 0.91 (95% CI 0.90-0.93)) compared to structured data alone. CONCLUSIONS: NLP extraction of data from unstructured text can improve identification of reasons for patients not being on HIST over structured data alone. The additional information provided through NLP of unstructured free text should help in tailoring and implementing system-level interventions to improve HIST use in patients with ASCVD.

Utilization Rates of SGLT2 Inhibitors and GLP-1 Receptor Agonists and Their Facility-Level Variation Among Patients With Atherosclerotic Cardiovascular Disease and Type 2 Diabetes: Insights From the Department of Veterans Affairs.

OBJECTIVE: There is mounting evidence regarding the cardiovascular benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA) among patients with atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes mellitus (T2DM). There is paucity of data assessing real-world practice patterns for these drug classes. We aimed to assess utilization rates of these drug classes and facility-level variation in their use. RESEARCH DESIGN AND METHODS: We used the nationwide Veterans Affairs (VA) health care system data set from 1 January 2020 to 31 December 2020 and included patients with established ASCVD and T2DM. Among these patients, we assessed the use of SGLT2i and GLP-1 RA and the facility-level variation in their use. Facility-level variation was computed using median rate ratios (MRR), a measure of likelihood that two random facilities differ in use of SGLT2i and GLP-1 RA in patients with ASCVD and T2DM. RESULTS: Among 537,980 patients with ASCVD and T2DM across 130 VA facilities, 11.2% of patients received an SGLT2i while 8.0% of patients received a GLP-1 RA. Patients receiving these cardioprotective glucose-lowering drug classes were on average younger and had a higher proportion of non-Hispanic Whites. Overall, median (10th-90th percentile) facility-level rates were 14.92% (9.31-22.50) for SGLT2i and 10.88% (4.44-17.07) for GLP-1 RA. There was significant facility-level variation among SGLT2i use-MRRunadjusted: 1.41 (95% CI 1.35-1.47) and MRRadjusted: 1.55 (95% CI 1.46 -1.63). Similar facility-level variation was observed for use of GLP-1 RA-MRRunadjusted: 1.34 (95% CI 1.29-1.38) and MRRadjusted: 1.78 (95% CI 1.65-1.90). CONCLUSIONS: Overall utilization rates of SGLT2i and GLP-1 RA among eligible patients are low, with significantly higher residual facility-level variation in the use of these drug classes. Our results suggest opportunities to optimize their use to prevent future adverse cardiovascular events among these patients.

Health care costs associated with primary care physicians versus nurse practitioners and physician assistants.

BACKGROUND: Significant primary care provider (PCP) shortage exists in the United States. Expanding the scope of practice for nurse practitioners (NPs) and physician assistants (PAs) can help alleviate this shortage. The Department of Veterans' Affairs (VA) has been a pioneer in expanding the role of NPs and PAs in primary caregiving. PURPOSE: This study evaluated the health care costs associated with VA patients cared for by NPs and PAs versus primary care physicians (physicians). METHODS: A retrospective data analysis using two separate cohorts of VA patients, one with diabetes and the other with cardiovascular disease (CVD), was performed. The associations between PCP type and health care costs were analyzed using ordinary least square regressions with logarithmically transformed costs. RESULTS: The analyses estimated 12% to 13% (US dollars [USD] 2,626) and 4% to 5% (USD 924) higher costs for patients assigned to physicians as compared with those assigned to NPs and PAs, after adjusting for baseline patient sociodemographics and disease burden, in the diabetes and CVD cohort, respectively. Given the average patient population size of a VA medical center, these cost differences amount to a total difference of USD 14 million/year per center and USD 5 million/year per center for diabetic and CVD patients, respectively. IMPLICATIONS FOR PRACTICE: This study highlights the potential cost savings associated with primary caregiving by NPs and PAs. In light of the PCP shortage, the study supports increased involvement of NPs and PAs in primary caregiving. Future studies examining the reasons for these cost differences by provider type are required to provide more scientific evidence for regulatory decision making in this area.

Association of patient, provider and facility related characteristics with statin associated side effects and statin use: Insight from the Veteran's Affairs healthcare system.

BACKGROUND: Statin associated side effects (SASE) are a leading cause of statin discontinuation. OBJECTIVE: We evaluated patient, provider, and facility characteristics associated with SASEs and whether these characteristics impact statin utilization. METHODS: Patients with atherosclerotic cardiovascular disease (ASCVD) receiving care across the Veterans Affairs healthcare system from October 1, 2014 to September 30, 2015 were included. Multivariable logistic regression analyses were performed to determine (a) factors associated with SASE and (b) factors associated with statin use in those with SASE. RESULTS: Our cohort included 1,225,576 patients with ASCVD. Of these, 171,189 (13.7%) had at least 1 reported SASE since year 2000. The most significant odds for SASEs were observed with female sex (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.36, 1.45), White race (OR 1.43, 95% CI 1.41, 1.45), hypertension (OR 1.37, 95% CI 1.33, 1.41) and ischemic heart disease (IHD: OR 1.45, 95% CI 1.43, 1.47). Lower odds were noted with care at a teaching facility (OR 0.89, 95% CI 0.88, 0.90). Factors most associated with being on a statin among patients with SASE included having diabetes (OR 1.18, 95% CI 1.15, 1.20), IHD (OR 1.39, 95% CI 1.35, 1.43) and a higher number of cardiology visits (OR 1.08, 95% CI 1.07, 1.09), while female sex was associated with lower odds (OR 0.65, 95% CI 0.61, 0.69). CONCLUSION: There are significant disparities in statin use by sex, ASCVD type, and comorbidities among secondary prevention patients with SASE, which represent areas for improvement in optimizing statin utilization.

Shared Decisions: A Qualitative Study on Clinician and Patient Perspectives on Statin Therapy and Statin-Associated Side Effects.

Background Despite guideline recommendations and clinical trial data suggesting benefit, statin therapy use in patients with atherosclerotic cardiovascular disease remains suboptimal. The aim of this study was to understand clinician and patient views on statin therapy, statin-associated side effects (SASEs), SASE management, and communication around statin risks and benefits. Methods and Results We conducted qualitative interviews of patients with atherosclerotic cardiovascular disease who had SASEs (n=17) and clinicians who regularly prescribe statins (n=20). We used directed content analysis, facilitated by Atlas.ti software, to develop and revise codebooks for clinician and patient interviews. The most relevant codes were "pile sorted" into 5 main topic domains: (1) SASEs vary in severity, duration, and time of onset; (2) communication practices by clinicians around statins and SASEs are variable and impacted by clinician time limitations and patient preconceived notions of SASEs; (3) although a "trial and error" approach to managing SASEs may be effective in allowing clinicians to keep patients with atherosclerotic cardiovascular disease on a statin, it can be frustrating for patients; (4) outside sources, such as the media, internet, social networks, and social circles, influence patients' perceptions and often impact the risk benefit discussion; and (5) a decision aid would be beneficial in facilitating clinician decision-making around SASEs and discussion of SASEs with the patients. Conclusions Statin use among patients with atherosclerotic cardiovascular disease remains suboptimal because of various patient- and clinician-related factors. The development of a decision aid to facilitate discussion of SASEs, clinician decision-making, and SASE management may improve statin use in this high-risk population.