Time-Specific Differences in Stated Preferences for Health in the United States.

BACKGROUND: Changes over time in health state values from a societal perspective may be an important reason to consider updating societal value sets for preference-based measures of health. OBJECTIVE: The aim was to examine whether stated health preferences are different between 2002 and 2017, controlling for demographic changes in the United States. METHODS: Data from 2002 and 2017 US EQ-5D-3L valuation studies were combined. The primary analysis compared valuations of better-than-dead (BTD) states only, as both studies used the same time trade-off (TTO) method for these states. For worse-than-dead (WTD) states, the 2017 study used the lead-time TTO and the 2002 study used the conventional TTO, which necessitated transformation. Regression models were fitted to BTD values to estimate time-specific differences, adjusting for respondent characteristics. Secondary analyses examined models that fitted WTD values (using linear and nonlinear transformations of the 2002 data) and all values. RESULTS: The adjusted BTD-only model showed mean values were higher for 2017 compared with 2002 (ßY2017=0.05, P<0.001). WTD-only models showed negative changes over time but that were dependent on the transformation method (linear ßY2017=-0.72; nonlinear ßY2017=-0.35; both P<0.001). Using all values, 2017 mean valuations were lower using a linear transformation (ßY2017=-0.11; P<0.001) but did not differ with the nonlinear transformation. CONCLUSIONS: Individuals in 2017 are generally less willing to trade quantity for quality of life compared with 2002. This study provides evidence of time-specific differences in a society's preferences, suggesting that the era in which values were elicited may be an important reason to consider updating societal value sets.

Similar burden of type 2 diabetes among adult patients with sickle cell disease relative to African Americans in the U.S. population: a six-year population-based cohort analysis.

Conflicting evidence exists on the epidemiology of type 2 diabetes mellitus (T2DM) among patients with sickle cell disease (SCD). This study measured the prevalence, incidence and clinical outcomes associated with T2DM in a large US population of commercially-insured adults aged ≥20 years with SCD between 2009 and 2014. Among 7070 patients with SCD, the mean age (median) was 39 (37) years and 60·8% were female. The standardized prevalence of T2DM among patients with SCD showed a modest increase, from 15·7% to 16·5% (P trend = 0·026), and was comparable to African-American respondents to the National Health and Nutrition Examination Survey (18·2%). Over 17 024 person-years, the crude incidence rate for T2DM was 25·4 per 1000 person-years. Incident T2DM was associated with comorbid hypertension (hazard ratio [HR] = 1·45, 95% confidence interval [CI] 1·14-1·83), and dyslipidaemia (HR = 1·43, 95%CI 1·04-1·96). Compared to SCD patients without T2DM, more SCD patients with T2DM had diagnoses of nephropathy (28·0% vs. 9·5%; P < 0·001), neuropathy (17·7% vs. 5·2%; P < 0·001) and stroke (24·1% vs. 9·2%; P < 0·001). Prevalence of T2DM in SCD patients is similar to the general African American population with an increasing trend in recent years. These trends support routine screening for T2DM in aging patients with SCD, especially those with comorbid hypertension and/or dyslipidaemia.

Lifestyle-related attitudes: do they explain self-rated health and life-satisfaction?

BACKGROUND: Strategies to improve public health may benefit from targeting specific lifestyles associated with poor health behaviors and outcomes. The aim of this study was to characterize and examine the relationship between health and lifestyle-related attitudes (HLAs) and self-rated health and life-satisfaction. METHODS: Secondary analyses were conducted on data from a 2012 community wellness survey in Kirklees, UK. Using a validated HLA tool, respondents (n = 9130) were categorized into five segments: health conscious realists (33%), balanced compensators (14%), live-for-todays (18%), hedonistic immortals (10%), and unconfident fatalists (25%). Multivariate regression was used to examine whether HLAs could explain self-rated health using the EQ-5D visual analog scale (EQ-VAS) and life-satisfaction. Health conscious realists served as the reference group. RESULTS: Self-rated health differed by HLA, with adjusted mean EQ-VAS scores being significantly higher (better) among balanced compensators (1.15, 95% CI 0.27, 2.03) and lower scores among unconfident fatalists (- 9.02, 95% CI - 9.85, - 8.21) and live-for-todays (- 1.96, 95% CI - 2.80, - 1.14). Balanced compensators were less likely to report low life-satisfaction (OR 0.75, 95% CI 0.62, 0.90), while unconfident fatalists were most likely to have low life-satisfaction (OR 3.51, 95% CI 2.92, 4.23). SIGNIFICANCE: Segmentation by HLA explained differences in self-rated health and life-satisfaction, with unconfident fatalists being a distinct segment with significantly worse health perceptions and life-satisfaction. Health promotion efforts may benefit from considering the HLA segment that predominates a patient group, especially unconfident fatalists.

High number of newly initiated direct oral anticoagulant users switch to alternate anticoagulant therapy.

Real-world evidence focusing on medication switching patterns amongst direct oral anticoagulant (DOACs) has not been well studied. The objective of this study is to evaluate patterns of prescription switching in non-valvular atrial fibrillation (NVAF) patients initiated on a DOAC and previously naïve to anticoagulation (AC) therapy. Data was obtained from Truven Health MarketScan® Commercial and Medicare Supplemental database (2009-2013). AC naïve (those without prior anticoagulant use) NVAF patients initiated on a DOAC, with 6 months of continuous health plan enrollment before and after treatment initiation and maintained on continuous therapy for a minimum of 6 months were included. Of 34,022 AC naïve NVAF patients initiating a DOAC, 6613 (19.4%) patients switched from an index DOAC prescription to an alternate anticoagulant and 27,409 (80.6%) remained on the DOAC [age: 68.5 ± 11.7 vs. 67.1 ± 12.7 years, p < 0.001; males: 3781 (57.2%) vs. 17,160 (62.6%), p < 0.001]. Amongst those that switched medication, 3196 (48.3%) did so within the first 6 months of therapy. Overall, 2945 (44.5%) patients switched to warfarin, 2912 (44.0%) switched to another DOAC and 756 (11.4%) switched to an injectable anticoagulant. The highest proportion of patients switched from dabigatran to warfarin (N = 2320; 42.5%) or rivaroxaban (N = 2252; 41.3%). The median time to switch from the index DOAC to another DOAC was 309.5 days versus 118.0 days (p < 0.001) to switch to warfarin. In NVAF patients newly initiated on DOAC therapy, one in five patients switch to an alternate anticoagulant and one of every two patients do so within the first 6 months of therapy. Switching from an initial DOAC prescription to traditional anticoagulants occurs as frequently as switching to an alternate DOAC.

The impact of capping health system cost savings on the projected cost-effectiveness of etranacogene dezaparvovec compared with factor IX prophylaxis for the treatment of hemophilia B.

This viewpoint discusses cost-effectiveness estimates for EtranaDez, a gene therapy for hemophilia B, using the Institute for Clinical and Economic Review's (ICER) framework for single and short-term therapies (SSTs). EtranaDez offers long-term benefits from a single administration, in contrast to the high costs and frequent dosing required by current factor IX prophylaxis. However, the projected gains in health from EtranaDez are small relative to the cost implications of the therapy, and consequently, how the cost offsets associated with EtranaDez are counted has a substantial impact on assessing its cost-effectiveness. Strategies for assessing cost offsets used in the ICER SST framework include a 50/50 cost-sharing model between the health care system and the manufacturer and a cap of $150,000 annually on health care cost offsets. Results from the standard full cost-offset analysis as reported by ICER depicted EtranaDez as a dominant therapy with substantial cost savings compared with factor IX prophylaxis. However, while considering the ICER SST framework, particularly the $150,000 annual cap scenario, the cost-effectiveness was significantly reduced. The incremental cost-effectiveness ratio varied notably between these scenarios, challenging the conventional perception of value of gene therapy in health care. These cost-sharing scenarios highlight the potential of the ICER SST framework to help curtail inefficient health care spending. In cases in which the cost of existing treatment is exceedingly high, the application of such frameworks would improve efficiency in resource allocation, fostering a balance between incentives for innovation and economic sustainability in managed care systems.

Migration of patients between five urban teaching hospitals in Chicago.

To quantify the extent of patient sharing and inpatient care fragmentation among patients discharged from a cohort of Chicago hospitals. Admission and discharge dates and patient ZIP codes from 5 hospitals over 2 years were matched with an encryption algorithm. Admission to more than one hospital was considered fragmented care. The association between fragmentation and socio-economic variables using ZIP-code data from the 2000 US Census was measured. Using validation from one hospital, patient matching using encrypted identifiers had a sensitivity of 99.3 % and specificity of 100 %. The cohort contained 228,151 unique patients and 334,828 admissions. Roughly 2 % of the patients received fragmented care, accounting for 5.8 % of admissions and 6.4 % of hospital days. In 3 of 5 hospitals, and overall, the length of stay of patients with fragmented care was longer than those without. Fragmentation varied by hospital and was associated with the proportion of non-Caucasian persons, the proportion of residents whose income fell in the lowest quartile, and the proportion of residents with more children being raised by mothers alone in the zip code of the patient. Patients receiving fragmented care accounted for 6.4 % of hospital days. This percentage is a low estimate for our region, since not all regional hospitals participated, but high enough to suggest value in creating Health Information Exchange. Fragmentation varied by hospital, per capita income, race and proportion of single mother homes. This secure methodology and fragmentation analysis may prove useful for future analyses.

Quantifying weight loss program preferences of men working in trade and labor occupations: A discrete choice experiment.

Objective: Men who work in skilled and unskilled trades and labor occupations (i.e., blue-collar occupations), have high rates of obesity and associated comorbidities but are underrepresented in weight loss programs. A first step in engaging this group is to better understand their preferences for weight loss programs. Methods: Respondents were men working in trade and labor occupations, with overweight/obesity, and an interest in losing weight. A discrete choice experiment was developed, and the data were analyzed using mixed logit model. Respondent characteristics were tested as effect modifiers. Results: Respondents (N = 221, age (M ± SD) 45.0 ± 12.6, BMI 33.3 ± 6.3, 77% non-Hispanic white) working in a variety of occupations (construction 31%, manufacturing 30%, transportation 25%, maintenance/repair 14%) participated in this study. Results indicate preferences for programs that encourage making smaller dietary changes, are delivered online, and do not incorporate competition. Results were consistent across sensitivity analyses and most respondent groups. Conclusions: The results suggest specific ways to make weight loss programs more appealing to men in trade and labor occupations. Using experimental methods to quantify preferences using larger, more representative samples would further assist in tailoring behavioral weight loss programs for under-reached populations.

Quantitative revenue estimates and qualitative assessments of innovative fundraising sources for treating rare diseases in Colombia.

Background: Like many developing countries, Colombia faces difficulties in financing health-care services as well as programs for health promotion and health education and there is evidence that its health-care system is underperforming. Objective: To provide evidence-based estimates of potential funding levels and assess the strengths, weaknesses, and viability of innovative funding mechanisms with a focus on treating rare diseases in Colombia. Methods: The strategy involved evidence-based projections of potential funding levels and a qualitative viability assessment using an expert panel. Results: Crowdfunding, corporate donation, and social impact bonds (SIBs) were deemed to be the most viable of numerous potential strategies. Expected funding levels over 10 years for rare diseases in Colombia from crowdfunding, corporate donations, and SIBs were roughly $7,200, $23,000, and $12,400, respectively. Conclusions: Based on the combination of projected funding potential along with expert consensus regarding viability and operability, crowdfunding, corporate donations, and SIBs, especially in combination, have the potential to substantially improve funding for vulnerable patient populations in Colombia.

The effectiveness and value of gene therapy for hemophilia: A Summary from the Institute for Clinical and Economic Review's California Technology Assessment Forum.

DISCLOSURES: Dr Tice and Mr Sarker received ICER grants during the conduct of the study. Dr Moradi, Ms Herce-Hagiwara, Dr Faghim, Dr Agboola, Dr Rind, and Dr Pearson reports grants from Arnold Ventures, grants from Blue Cross Blue Shield of MA, grants from California Healthcare Foundation, grants from The Commonwealth Fund, grants from The Peterson Center on Healthcare, during the conduct of the study; other from Aetna, other from America's Health Insurance Plans, other from Anthem, other from AbbVie, other from Alnylam, other from AstraZeneca, other from Biogen, other from Blue Shield of CA, other from Cambia Health Services, other from CVS, other from Editas, other from Express Scripts, other from Genentech/Roche, other from GlaxoSmithKline, other from Harvard Pilgrim, other from Health Care Service Corporation, other from Health Partners, other from Johnson & Johnson (Janssen), other from Kaiser Permanente, other from LEO Pharma, other from Mallinckrodt, other from Merck, other from Novartis, other from National Pharmaceutical Council, other from Premera, other from Prime Therapeutics, other from Regeneron, other from Sanofi, other from Spark Therapeutics, other from United Healthcare, other from HealthFirst, other from Pfizer, other from Boehringer-Ingelheim, other from uniQure, other from Evolve Pharmacy Solutions, other from Humana, other from Sun Life, outside the submitted work.

Comparative effectiveness of paricalcitol versus cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis.

BACKGROUND/AIMS: Parathyroidectomies are performed when medical therapy fails to control secondary hyperparathyroidism in hemodialysis patients. The objective of this study was to compare parathyroidectomy rates in secondary hyperparathyroidism patients treated with paricalcitol or cinacalcet. METHODS: Retrospective cohort study using health insurance claims from January 2001 through June 2007 for adult hemodialysis patients who were new users of paricalcitol or cinacalcet. Subjects had a minimum of 12 months' enrollment prior to initiation of treatment and at least 30-day follow-up. RESULTS: We identified 1,387 paricalcitol- and 1,317 cinacalcet-treated patients. The parathyroidectomy incident rate was 74% lower in the paricalcitol (0.58 per 100 patient-years) compared to the cinacalcet (2.24 per 100 patient-years) cohort, with an unadjusted rate ratio of 0.26 (95% CI 0.12-0.52). The time to parathyroidectomy from medication initiation was longer for paricalcitol than cinacalcet; however, it was not statistically significant (535 vs. 443 days, p = 0.377). A Cox proportional hazard model that adjusted for age, gender, obesity, significantly different comorbidities, and duration of hemodialysis resulted in an adjusted risk reduction for parathyroidectomy of 79% (HR = 0.21, 95% CI 0.10-0.46) for paricalcitol compared to cinacalcet. CONCLUSION: These data suggest that long-term treatment with paricalcitol is associated with fewer parathyroidectomies when compared to cinacalcet. Further comparative studies are needed to validate these results.

An initial evaluation of expanded hemodialysis on hospitalizations, drug utilization, costs, and patient utility in Colombia.

To examine new evidence linking expanded hemodialysis (HDx) using a medium cut-off (MCO) membrane with hospitalizations, hospital days, medication use, costs, and patient utility. This retrospective study utilized data from Renal Care Services medical records database in Colombia from 2017 to 2019. Clinics included had switched all patients from high flux hemodialysis (HD HF) to HDx and had at least a year of data on HD HF and HDx. Data included demographic characteristics, comorbidities, years on dialysis, hospitalizations, medication use, and quality of life measured by the 36 item and Short Form versions of the Kidney Disease Quality of Life survey at the start of HDx, and 1 year after HDx, which were mapped to EQ-5D utilities. Generalized linear models were run on the outcomes of interest with an indicator for being on HDx. Annual cost estimates were also constructed. The study included 81 patients. HDx was significantly associated with lower dosing of erythropoietin stimulating agents, iron, hypertension medications, and insulin. HDx was also significantly associated with lower hospital days per year (5.94 on HD vs. 4.41 on HDx) although not with the number of hospitalizations. Estimates of annual hospitalization costs were 23.9% lower using HDx and patient utilities did not appear to decline. HDx was statistically significantly associated with reduced hospitalization days and lower medication dosages. Furthermore, this preliminary analysis suggested potential for HDx being a dominant strategy in terms of costs and utility and should motivate future work with larger samples and better controls.

The effectiveness and value of emicizumab and valoctocogene roxaparvovec for the management of hemophilia A without inhibitors.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Agboola, Rind, Herron-Smith, and Pearson are employed by ICER. Walton and Quach, through the University of Illinois at Chicago, received funding from ICER for development of the economic model described in this report.

Protocol for a randomized controlled trial of low-intensity physical activity for frail older adults: Promoting seniors' health with home care aides (Pro-Home).

Regular participation in physical activity benefits older adults physically and mentally. However, the availability and assessment of physical activity programs that are safe and appropriate for homebound older adults at risk for nursing home admission are limited. Here we describe the protocol for a randomized controlled trial that examines the effectiveness of a gentle physical activity program. Delivered by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home, this program is implemented in a real-world context of caregiver-client dyads in a Medicaid-funded home care program. The trial uses a two-group repeated measures design (baseline, Month 4, and Month 8) with 300 pairs of eligible home care clients and their home care aides. The results from this trial could provide evidence and guidelines for a new model of home care, which would facilitate the working together of older home care clients and their home care aides to maintain or improve the functional status of nursing home-eligible older adults.

Statistical implications of utility weighted and equally weighted HRQL measures: an empirical study.

The utility-based approach to health measurement, exemplified by EQ-5D and Health Utilities Index (HUI), has been challenged on a theoretical basis, but the statistical implications of such an approach have received little attention. To empirically investigate this issue, psychometric properties and statistical efficiency of the EQ-5D and HUI Mark 3 (HUI3) classifiers were compared when scored using preference weighted (WPS) and equally weighted summary scores using two longitudinal datasets (n(stroke)=124; n(rehabilitation)=264). Test-retest reliability, construct validity, responsiveness, and relative efficiency (RE) ratios (with bootstrapped 95% confidence intervals) were examined. WPS had slightly lower test-retest reliability, particularly for EQ-5D (intraclass correlation coefficient=0.61 vs 0.72). For known-groups comparisons, WPS had greater inferential power for both EQ-5D and HUI3 (RE>1). No significant differences in sensitivity to change were observed for EQ-5D [0.71 (95% CI: 0.29,1.33) < or = RE < or = 0.96(95% CI: 0.69,1.32)] or HUI3 [0.97 (95% CI: 0.89,1.03) < or = RE < or = 1.23 (95% CI: 0.98,1.72)]. Implications of weighted scoring will depend on whether the weights are greater or less than equal weights where patients fall along the health state classifier continuum. Because utility weights can affect the statistical properties and significance of results, the summary score selected should be appropriate to the purpose of the study and population of interest.

Evaluating a remote patient monitoring program for automated peritoneal dialysis.

BACKGROUND: The benefits of automated peritoneal dialysis (APD) have been established, but patient adherence to treatment remains a concern. Remote patient monitoring (RPM) programs are a potential solution; however, the cost implications are not well established. This study modeled, from the payer perspective, expected net costs and clinical consequences of a novel RPM program in Colombia. METHODS: Amarkov model was used to project costs and clinical outcomes for APD patients with and without RPM. Clinical inputs were directly estimated from Renal Care Services data or taken from the literature. Dialysis costs were estimated from national fees. Inpatient costs were obtained from a recent Colombian study. The model projected overall direct costs and several clinical outcomes. Deterministic and probabilistic sensitivity analyses (DSA and PSA) were also conducted to characterize uncertainty in the results. RESULTS: The model projected that the implementation of an RPM program costing US$35 per month in a cohort of 100 APD patients over 1 year would save US$121,233. The model also projected 31 additional months free of complications, 27 fewer hospitalizations, 518 fewer hospitalization days, and 6 fewer peritonitis episodes. In the DSA, results were most sensitive to hospitalization rates and days of hospitalization, but cost savings were robust. The PSA found there was a 91% chance for the RPM program to be cost saving. CONCLUSION: The results of the model suggest that RPM is cost-effective in APD patients which should be verified by a rigorous prospective cost analysis.

Estimating the Impact of Food and Drug Administration's Unapproved Drug Initiative on Drug Prices and Sales.

BACKGROUND: The 2006 FDA's Unapproved Drug Initiative (UDI) aimed to improve safety and public health by decreasing the availability of drug products that never obtained FDA approval (unapproved drug products) in the market and incentivizing manufacturers to emphasize that these products must obtain FDA approval. The objective of this study was to measure changes in the prices, sales, and quantities sold of drug products approved under the FDA-UDI. METHODS: Drug products that obtained voluntary approval under FDA-UDI from 2006 to 2015 were identified and trends in prices, sales, and units sold were analyzed using the IQVIA National Sales Perspective database. RESULTS: Eleven drug products were included in the final analysis. Relative to baseline levels 2 years before approval, a steep increase in price and sales was observed 2 years postapproval for all except 2 of the drug categories-with median percent change of 245% (range: -37% to 9618%) for price and 238% (range: -4% to 6707%) for sales. Substantial variance was observed in the changes in units sold. CONCLUSION: A marked increase was seen in postapproval prices and sales for the vast majority of drug products approved in the FDA-UDI with mixed results in changes in units sold. In addition to increased information on safety, the policy's impact on postapproval drug prices and associated effects on units sold should be considered in assessing the policy, especially when substantial price increases and decreases in units sold may negatively impact health.

The Effectiveness and Value of Deflazacort and Exon-Skipping Therapies for the Management of Duchenne Muscular Dystrophy.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, Commonwealth Fund, California Health Care Foundation, National Institute for Health Care Management (NIHCM), New England States Consortium Systems Organization, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, Kaiser Foundation Health Plan, and Partners HealthCare to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Allergan, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Fluetsch, Rind, and Pearson are employed by ICER. Lin reports support from ICER during work on this economic model and grants from Mount Zion Health Fund, National Institutes of Health (National Cancer Institute and National Heart, Lung, and Blood Institute), and the Tobacco-Related Diseases Research Program, unrelated to this work. Walton reports support from ICER for work on this economic model and unrelated consulting fees from Baxter.

Adherence and Persistence with DPP-4 Inhibitors Versus Pioglitazone in Type 2 Diabetes Patients with Chronic Kidney Disease: A Retrospective Claims Database Analysis.

BACKGROUND: Adherence and persistence with diabetes medication play an important role in glycemic control and may differ by medication class. However, there is a lack of research comparing diabetes medications in patients with renal impairment, despite the challenges and higher burden associated with managing this population. OBJECTIVE: To compare adherence and persistence among patients with type 2 diabetes mellitus (T2DM) and nondialysis chronic kidney disease (CKD) treated with dipeptidyl peptidase-4 (DPP-4) inhibitors versus pioglitazone. METHODS: This retrospective cohort study used Truven MarketScan administrative claims databases from 2009 to 2015. One-year adherence for patients with T2DM and nondialysis CKD who initiated therapy with either a DPP-4 inhibitor or pioglitazone was measured by proportion of days covered (PDC) following an initial dispensing, and PDC ≥ 0.80 was coded as adherent. Persistence was calculated as the days between the index date and last day with the index medication on hand, based on the end of the last days supply or the end of follow-up (i.e., 365 days), whichever occurred first. Multivariate logistic regression and Cox proportional hazards models were used to estimate confounder-adjusted differences between the groups for adherence and persistence. RESULTS: The final cohort included 9,019 patients (DPP-4 inhibitors: 7,002; pioglitazone: 2,017). In the adjusted analysis, DPP-4 inhibitor users demonstrated a 1.41 (95% CI = 1.25-1.59) higher odds of being adherent compared with pioglitazone users. Overall adjusted HR for persistence was 0.74 (95% CI = 0.69-0.79), which favored DPP-4 inhibitors compared with pioglitazone. Relative to 2010, persistence with pioglitazone decreased in 2011-2012 and then increased in 2013-2014. In the subgroup analysis, DPP-4 inhibitors first had lower (2010: OR = 0.78, 95% CI = 0.70-0.87; 2011-2012: OR = 0.60, 95% CI = 0.54-0.66) and then similar (2013-2014: OR = 1.03, 95% CI = 0.88-1.19) hazards of nonpersistence compared with pioglitazone. CONCLUSIONS: Among patients with T2DM and nondialysis CKD, the use of DPP-4 inhibitors was associated with better adherence compared with pioglitazone. However, following the approval of generic pioglitazone and associated lower cost sharing after 2012, the magnitude of difference in adherence between the medication classes reduced. Similarly, safety warnings in 2011 and approval of generic products in 2012 may have affected pioglitazone persistence, leading to first higher and then similar hazards for nonpersistence with pioglitazone as compared with DPP-4 inhibitors. These shifts in the results for pioglitazone warrant further investigation and close monitoring of the population initiating this medication. DISCLOSURES: No funding was received for this study. The authors have no conflicts of interest to disclose. An abstract for this study was presented as a podium presentation at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) 2019 Annual Meeting; May 18-22, 2019; New Orleans, LA.

Antidiabetic drug use trends in patients with type 2 diabetes mellitus and chronic kidney disease: A cross-sectional analysis of the National Health and Nutrition Examination Survey.

BACKGROUND: There is little information on medication use, trends across time, and the impact of guidelines on appropriate use of antidiabetic drugs in participants with type 2 diabetes mellitus (T2DM) with chronic kidney disease (CKD). METHODS: A cross-sectional analysis of the National Health and Nutrition Examination Survey (NHANES) from 2005-2016 was carried out for participants with T2DM with and without CKD. Multivariate survey-weighted regression models were used to evaluate trends in antidiabetic drug use across the time periods and CKD severity. Guideline-discordant use of metformin and glyburide were assessed among those with glomerular filtration rate and serum creatinine-based contraindications. RESULTS: Out of 3237 study participants with T2DM, 35.9% had CKD. Comparing 2013-2016 with 2005-2008, use of metformin (non-CKD: 69% vs 83.8%, CKD: 58.6% vs 68.2%) increased, whereas the use of sulfonylureas (non-CKD: 46.3% vs 27.2%, CKD: 54.7% vs 36.6%) and thiazolidinediones (non-CKD: 29.3% vs 3.9%, CKD: 24.6% vs 5.5%) decreased. In combined NHANES cycles and across stages of CKD severity, metformin use decreased (non-CKD, stage 1/2, stage 3, stage 4/5: 78.4%, 69.5%, 54.6%, 4.9%, respectively; P < .01), and insulin use increased (18.5%, 26.8%, 25%, 52.8%, respectively; P < .01) from non-CKD to progressed CKD. Guideline-discordant use of metformin and glyburide was observed in 8.3% and 2.8% of the participants, respectively, in 2013-2016. CONCLUSIONS: Use of particular antidiabetic medications in patients with CKD changed noticeably over the years, most in accordance with guidelines and regulatory decisions. Gaps in quality of care still exist, which warrants increasing awareness and implementing programs to mitigate inappropriate use.