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  1. Article ; Online: Impact of Elexacaftor/Tezacaftor/Ivacaftor on Healthcare Resource Utilization and Associated Costs Among People With Cystic Fibrosis in the US: A Retrospective Claims Analysis.

    Schechter, Michael S / Sabater-Anaya, Natalia / Oster, Gerry / Weycker, Derek / Wu, Hongsheng / Arteaga-Solis, Emilio / Bagal, Sukirti / McGarry, Lisa J / Van Brunt, Kate / Geiger, Jessica Morlando

    Pulmonary therapy

    2023  Volume 9, Issue 4, Page(s) 479–498

    Abstract: Introduction: Cystic fibrosis (CF) is a life-limiting genetic disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a CFTR modulator (CFTRm) that targets the ...

    Abstract Introduction: Cystic fibrosis (CF) is a life-limiting genetic disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a CFTR modulator (CFTRm) that targets the underlying cause of CF. Based on safety and efficacy demonstrated in clinical trials, ELX/TEZ/IVA is approved in the US for the treatment of CF in people aged ≥ 2 years who have ≥ 1 F508del-CFTR mutation or a CFTR mutation that is responsive to ELX/TEZ/IVA based on in vitro data. While ELX/TEZ/IVA demonstrated unprecedented improvements in lung function and dramatic reductions in pulmonary exacerbations (PEx) and associated hospitalizations in clinical trials, a limited number of studies have examined the impact of ELX/TEZ/IVA on healthcare resource utilization (HCRU) and associated costs in a real-world setting. The aim of this retrospective study was to evaluate changes in PEx, HCRU, and associated non-CFTRm healthcare costs following initiation of ELX/TEZ/IVA among people with CF aged ≥ 12 years in the US.
    Methods: We evaluated the rates of PEx, HCRU, and associated costs before and after initiation of ELX/TEZ/IVA in people with CF aged ≥ 12 years using data from the Merative MarketScan® Commercial Claims and Encounters Database and the Merative Multi-State Medicaid Database from April 21, 2019 to December 31, 2020. Because the study period included time following the onset of the COVID-19 pandemic, we limited our primary analysis to the period prior to the pandemic (October 21, 2019 to March 12, 2020). Outcomes following the onset of the pandemic (March 13 to December 31, 2020) were examined in an exploratory analysis.
    Results: In both commercially insured and Medicaid-insured people with CF, ELX/TEZ/IVA was associated with reductions in PEx, hospitalizations, and associated costs prior to the COVID-19 pandemic, and these reductions were maintained following the onset of the pandemic.
    Conclusions: These findings suggest that ELX/TEZ/IVA reduces the burden and costs associated with PEx and hospitalizations in people with CF.
    Language English
    Publishing date 2023-10-24
    Publishing country United States
    Document type Journal Article
    ISSN 2364-1746
    ISSN (online) 2364-1746
    DOI 10.1007/s41030-023-00241-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: EFFECT OF ELEXACAFTOR/TEZACAFTOR/IVACAFTOR ON ANNUAL RATE OF LUNG FUNCTION DECLINE IN PEOPLE WITH CYSTIC FIBROSIS.

    Lee, Tim / Sawicki, Gregory S / Altenburg, Josje / Millar, Stefanie J / Geiger, Jessica Morlando / Jennings, Mark T / Lou, Yiyue / McGarry, Lisa J / Van Brunt, Kate / Linnemann, Rachel W

    Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

    2022  Volume 22, Issue 3, Page(s) 402–406

    Abstract: Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was shown to be safe and efficacious in people with cystic fibrosis (CF) with ≥ 1 F508del-CFTR allele in Phase 3 clinical trials. ELX/TEZ/IVA treatment led to improved lung function, with increases in ... ...

    Abstract Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was shown to be safe and efficacious in people with cystic fibrosis (CF) with ≥ 1 F508del-CFTR allele in Phase 3 clinical trials. ELX/TEZ/IVA treatment led to improved lung function, with increases in percent predicted forced expiratory volume in 1 second (ppFEV
    MeSH term(s) Humans ; Cystic Fibrosis/drug therapy ; Cystic Fibrosis/genetics ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Cystic Fibrosis Transmembrane Conductance Regulator/therapeutic use ; Aminophenols/adverse effects ; Benzodioxoles/therapeutic use ; Lung ; Double-Blind Method ; Mutation ; Chloride Channel Agonists/therapeutic use
    Chemical Substances Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6) ; elexacaftor (RRN67GMB0V) ; ivacaftor (1Y740ILL1Z) ; tezacaftor ; Aminophenols ; Benzodioxoles ; Chloride Channel Agonists
    Language English
    Publishing date 2022-12-27
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2084724-5
    ISSN 1873-5010 ; 1569-1993
    ISSN (online) 1873-5010
    ISSN 1569-1993
    DOI 10.1016/j.jcf.2022.12.009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Disease burden in people with cystic fibrosis heterozygous for F508del and a minimal function mutation.

    Sawicki, Gregory S / Van Brunt, Kate / Booth, Jason / Bailey, Evan / Millar, Stefanie J / Konstan, Michael W / Flume, Patrick A

    Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

    2021  Volume 21, Issue 1, Page(s) 96–103

    Abstract: Background: People with cystic fibrosis (CF) heterozygous for F508del-CFTR and a minimal function CFTR mutation (F/MF) that results in no CFTR protein or results in CFTR protein that is not responsive to tezacaftor, ivacaftor, and tezacaftor/ivacaftor ... ...

    Abstract Background: People with cystic fibrosis (CF) heterozygous for F508del-CFTR and a minimal function CFTR mutation (F/MF) that results in no CFTR protein or results in CFTR protein that is not responsive to tezacaftor, ivacaftor, and tezacaftor/ivacaftor in vitro comprise a sizeable percentage of the US CF population. This retrospective, cross-sectional, observational study aimed to characterize CF burden in this subpopulation.
    Methods: People ≥2 years of age in the US CF Foundation Patient Registry with a CF diagnosis, F/MF genotype, and ≥1 encounters in 2017 were included. Descriptive analyses assessed lung function, nutritional parameters, microbiology, hospitalization and pulmonary exacerbation rates, and CF-related complications. Results were stratified by age group; select characteristics were summarized by percent predicted FEV
    Results: 5348 people met inclusion criteria. Rates of positive bacterial cultures, pulmonary exacerbations, and hospitalizations were generally higher in older age groups. Prevalence of prescribed symptomatic CF therapies was substantial and also generally higher in older age groups. ppFEV
    Conclusions: People with F/MF genotypes have substantial disease burden that worsened in older age groups consistent with the progressive nature of CF, indicating need for additional treatment options in this subpopulation.
    MeSH term(s) Adolescent ; Adult ; Child ; Child, Preschool ; Cost of Illness ; Cross-Sectional Studies ; Cystic Fibrosis/genetics ; Cystic Fibrosis/therapy ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Disease Progression ; Female ; Genotype ; Humans ; Male ; Mutation ; Registries ; Retrospective Studies ; Young Adult
    Chemical Substances CFTR protein, human ; Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6)
    Language English
    Publishing date 2021-07-19
    Publishing country Netherlands
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2084724-5
    ISSN 1873-5010 ; 1569-1993
    ISSN (online) 1873-5010
    ISSN 1569-1993
    DOI 10.1016/j.jcf.2021.07.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Non-respiratory health-related quality of life in people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor.

    Fajac, Isabelle / Daines, Cori / Durieu, Isabelle / Goralski, Jennifer L / Heijerman, Harry / Knoop, Christiane / Majoor, Christof / Bruinsma, Bote G / Moskowitz, Samuel / Prieto-Centurion, Valentin / Van Brunt, Kate / Zhang, Yaohua / Quittner, Alexandra

    Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

    2022  Volume 22, Issue 1, Page(s) 119–123

    Abstract: Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was shown to be safe and efficacious in people with cystic fibrosis (CF) heterozygous for F508del and a minimal function mutation (F/MF) or homozygous for F508del (F/F) in two pivotal Phase 3 trials, ... ...

    Abstract Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was shown to be safe and efficacious in people with cystic fibrosis (CF) heterozygous for F508del and a minimal function mutation (F/MF) or homozygous for F508del (F/F) in two pivotal Phase 3 trials, significantly improving percentage predicted forced expiratory volume in 1 second, Cystic Fibrosis Questionnaire-Revised, Respiratory Domain (CFQ-R RD) scores, and sweat chloride concentration. Here, we analyzed the 11 non-respiratory domains (non-RDs) of the CFQ-R, which assess general health-related quality of life (i.e., Physical Functioning, Role Functioning, Vitality, Health Perceptions, Emotional Functioning, and Social Functioning) and quality of life impacted by CF (i.e., Body Image, Eating Problems, Treatment Burden, Weight, and Digestive Symptoms), for participants in these two Phase 3 trials. ELX/TEZ/IVA treatment led to higher scores in all CFQ-R non-RDs, with improvements in most domains compared with control treatments. These findings demonstrate that ELX/TEZ/IVA improves a range of CF-specific symptoms and general functioning and well-being.
    MeSH term(s) Humans ; Aminophenols ; Benzodioxoles ; Chloride Channel Agonists ; Cystic Fibrosis/diagnosis ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Mutation ; Quality of Life
    Chemical Substances Aminophenols ; Benzodioxoles ; Chloride Channel Agonists ; Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6) ; elexacaftor (RRN67GMB0V) ; ivacaftor (1Y740ILL1Z) ; tezacaftor
    Language English
    Publishing date 2022-09-14
    Publishing country Netherlands
    Document type Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2084724-5
    ISSN 1873-5010 ; 1569-1993
    ISSN (online) 1873-5010
    ISSN 1569-1993
    DOI 10.1016/j.jcf.2022.08.018
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Behaviours, thoughts and perceptions around mealtime insulin usage and wastage among people with type 1 and type 2 diabetes mellitus: A cross-sectional survey study.

    Van Brunt, Kate / Pedersini, Riccardo / Rooney, Jillian / Corrigan, Sheila M

    Diabetes research and clinical practice

    2017  Volume 126, Page(s) 30–42

    Abstract: Aims: People with diabetes who use mealtime insulin (MTI) were surveyed about insulin wastage and injection habits when insufficient insulin remains in a disposable prefilled pen/cartridge to administer a full dose in a single injection.: Methods: ... ...

    Abstract Aims: People with diabetes who use mealtime insulin (MTI) were surveyed about insulin wastage and injection habits when insufficient insulin remains in a disposable prefilled pen/cartridge to administer a full dose in a single injection.
    Methods: Cross-sectional, online, self-reported survey of MTI usage/wastage behaviour in 400 adults with type 1 (n=120) or type 2 (n=280) diabetes mellitus administering >20units/day of MTI via 100units/ml prefilled pens/cartridges for ⩾1month, conducted in France, Germany, Italy and UK.
    Results: Participants' mean±standard deviation age was 54.5±12.2years, body mass index was 29.9±7.2kg/m
    Conclusions: Patients taking >20units/day MTI can find transitions between insulin pens challenging. This study highlights the need to identify ways of improving transitions between pens to make transitions easier for insulin users, which could potentially improve adherence to prescribed doses and reduce waste.
    MeSH term(s) Adult ; Aged ; Cross-Sectional Studies ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/psychology ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/psychology ; Female ; France ; Germany ; Health Behavior ; Humans ; Insulin/therapeutic use ; Insulin Infusion Systems ; Italy ; Male ; Meals/psychology ; Medication Adherence/psychology ; Medication Adherence/statistics & numerical data ; Middle Aged ; Perception ; Surveys and Questionnaires ; Thinking ; United Kingdom
    Chemical Substances Insulin
    Language English
    Publishing date 2017-04
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 632523-3
    ISSN 1872-8227 ; 0168-8227
    ISSN (online) 1872-8227
    ISSN 0168-8227
    DOI 10.1016/j.diabres.2016.12.002
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  6. Article ; Online: Treating Type 1 Diabetes Mellitus with a Rapid-Acting Analog Insulin Regimen vs. Regular Human Insulin in Germany: A Long-Term Cost-Effectiveness Evaluation.

    Valentine, William J / Van Brunt, Kate / Boye, Kristina S / Pollock, Richard F

    Applied health economics and health policy

    2018  Volume 16, Issue 3, Page(s) 357–366

    Abstract: Objective: The aim of the present study was to evaluate the cost effectiveness of rapid-acting analog insulin relative to regular human insulin in adults with type 1 diabetes mellitus in Germany.: Methods: The PRIME Diabetes Model, a patient-level, ... ...

    Abstract Objective: The aim of the present study was to evaluate the cost effectiveness of rapid-acting analog insulin relative to regular human insulin in adults with type 1 diabetes mellitus in Germany.
    Methods: The PRIME Diabetes Model, a patient-level, discrete event simulation model, was used to project long-term clinical and cost outcomes for patients with type 1 diabetes from the perspective of a German healthcare payer. Simulated patients had a mean age of 21.5 years, duration of diabetes of 8.6 years, and baseline glycosylated hemoglobin of 7.39%. Regular human insulin and rapid-acting analog insulin regimens reduced glycosylated hemoglobin by 0.312 and 0.402%, respectively. Compared with human insulin, hypoglycemia rate ratios with rapid-acting analog insulin were 0.51 (non-severe nocturnal) and 0.80 (severe). No differences in non-severe diurnal hypoglycemia were modeled. Discount rates of 3% were applied to future costs and clinical benefits accrued over the 50-year time horizon.
    Results: In the base-case analysis, rapid-acting analog insulin was associated with an improvement in quality-adjusted life expectancy of 1.01 quality-adjusted life-years per patient (12.54 vs. 11.53 quality-adjusted life-years). Rapid-acting analog insulin was also associated with an increase in direct costs of €4490, resulting in an incremental cost-effectiveness ratio of €4427 per quality-adjusted life-year gained vs. human insulin. Sensitivity analyses showed that the base case was driven predominantly by differences in hypoglycemia; abolishing these differences reduced incremental quality-adjusted life expectancy to 0.07 quality-adjusted life-years, yielding an incremental cost-effectiveness ratio of €74,622 per quality-adjusted life-year gained.
    Conclusions: Rapid-acting analog insulin is associated with beneficial outcomes in patients with type 1 diabetes and is likely to be considered cost effective in the German setting vs. regular human insulin.
    MeSH term(s) Adolescent ; Adult ; Child ; Cost-Benefit Analysis ; Diabetes Mellitus, Type 1/drug therapy ; Female ; Germany ; Humans ; Insulin, Short-Acting/administration & dosage ; Insulin, Short-Acting/economics ; Male ; Outcome Assessment (Health Care) ; Quality-Adjusted Life Years ; Young Adult
    Chemical Substances Insulin, Short-Acting
    Language English
    Publishing date 2018-03-07
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 2171420-4
    ISSN 1179-1896 ; 1175-5652
    ISSN (online) 1179-1896
    ISSN 1175-5652
    DOI 10.1007/s40258-018-0379-5
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  7. Article ; Online: Attributes Influencing Insulin Pen Preference Among Caregivers and Patients With Diabetes Who Require Greater Than 20 Units of Mealtime Insulin.

    Wang, Tao / Conrad, Kenneth A / van Brunt, Kate / Rees, Tina M

    Journal of diabetes science and technology

    2016  Volume 10, Issue 4, Page(s) 923–931

    Abstract: Background: This study compared patient preference for Humalog® KwikPen™ 200 units/mL (insulin lispro; hereafter, IL 200 pen; Eli Lilly and Company, Indianapolis, IN) versus the Humalog KwikPen 100 units/mL (insulin lispro; hereafter, IL 100 pen; Eli ... ...

    Abstract Background: This study compared patient preference for Humalog® KwikPen™ 200 units/mL (insulin lispro; hereafter, IL 200 pen; Eli Lilly and Company, Indianapolis, IN) versus the Humalog KwikPen 100 units/mL (insulin lispro; hereafter, IL 100 pen; Eli Lilly and Company, Indianapolis, IN) in patients with diabetes requiring >20 units of mealtime insulin and diabetes caregivers. This study also determined which attributes had the greatest influence on pen preference selection.
    Methods: In this 2-period, crossover, simulated-use study, 106 participants were randomized to 1 of 8 sequences that varied the pen order (IL 100 pen or IL 200 pen) and dosing order (15 units = low dose or 50 units = high dose) for a total of 4 simulated injections. Participants then completed a self-administered questionnaire to select their overall preference between the 2 pens and then rated the importance of 11 pen attributes in contributing to their overall preference.
    Results: Of the 90 participants expressing an overall preference, significantly more preferred the IL 200 pen to the IL 100 pen (IL 200 pen: 80 respondents; IL 100 pen: 10 respondents; 95% confidence interval [0.81, 0.94], P < .0001). The total amount of insulin in the pen, the ease in pressing the injection button, and the amount of fluid injected were key attributes influencing IL 200 pen preference.
    Conclusions: Based on these key attributes, the IL 200 pen was significantly preferred over the IL 100 pen by patients with diabetes who require >20 daily mealtime insulin units or diabetes caregivers and may improve the injection experience for these patients.
    MeSH term(s) Adult ; Aged ; Cross-Over Studies ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 2/drug therapy ; Female ; Humans ; Hypoglycemic Agents/administration & dosage ; Injections, Subcutaneous/instrumentation ; Insulin/administration & dosage ; Male ; Middle Aged ; Patient Preference ; Surveys and Questionnaires
    Chemical Substances Hypoglycemic Agents ; Insulin
    Language English
    Publishing date 2016-07
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ISSN 1932-2968
    ISSN (online) 1932-2968
    DOI 10.1177/1932296816633232
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  8. Article ; Online: Patient-Reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9).

    Yu, Maria / Brunt, Kate Van / Milicevic, Zvonko / Varnado, Oralee / Boye, Kristina S

    Clinical therapeutics

    2017  

    Abstract: Purpose: This 28-week, randomized, double-blind study compared a once-weekly injection of dulaglutide 1.5 mg to placebo, both added to titrated once-daily insulin glargine (with or without metformin), in patients with type 2 diabetes mellitus and ... ...

    Abstract Purpose: This 28-week, randomized, double-blind study compared a once-weekly injection of dulaglutide 1.5 mg to placebo, both added to titrated once-daily insulin glargine (with or without metformin), in patients with type 2 diabetes mellitus and inadequate glycemia control (control defined as hemoglobin A
    Methods: Patients not naive to injectable therapy were randomly assigned (1:1) to receive dulaglutide/glargine or placebo/glargine; glargine was titrated to a fasting plasma glucose target of 71 to 99 mg/dL. The Impact of Weight on Self-Perceptions (IW-SP), the EQ-5D-5L (measure of health status), the 18-item Diabetes Health Profile (DHP-18), and the Medication Device Delivery Assessment (MDDAB) instruments for assessing the dulaglutide Single-Use Pen (SUP) and glargine-delivery device were administered at baseline and 28 weeks, and also at 6 or 12 weeks for some measures. A mixed model for repeated measures was used for analyzing changes from baseline scores.
    Findings: At 28 weeks, improvements observed in the transformed total scores on the IW-SP and DHP-18 Disinhibited Eating domain were significantly greater with dulaglutide/glargine compared with placebo/glargine (least squares mean differences, +6.06 [P = 0.019] and -4.50 [P = 0.017], respectively). There were no significant overall between-treatment differences in quality of life as measured by the EQ-5D-5L or the Barriers to Activities and Psychological Distress domains of the DHP-18. Of all patients, 95% reported that overall, the dulaglutide SUP was "easy" or "very easy" to use at 28 weeks. Device-features scores showed that most patients liked the dulaglutide SUP features, with the 3 highest-rated items relating specifically to features of the needle (not having to touch the needle, not having to attach the needle, and automatic insertion). The majority of patients (~90%) "agreed" or "strongly agreed" that they were satisfied with the overall dulaglutide SUP injection experience at 28 weeks.
    Implications: Dulaglutide/glargine-treated patients had greater improvements in weight-related quality-of-life measures compared with placebo/glargine-treated patients, which may be clinically relevant when evaluating treatment options for insulin-requiring patients who often gain weight with insulin monotherapy. Results from the MDDAB indicated overall satisfaction with the dulaglutide SUP injection experience, which may be an important factor in some patients when initiating parenteral therapy. ClinicalTrials.gov identifier: NCT02152371.
    Language English
    Publishing date 2017-10-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 603113-4
    ISSN 1879-114X ; 0149-2918
    ISSN (online) 1879-114X
    ISSN 0149-2918
    DOI 10.1016/j.clinthera.2017.10.002
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  9. Article: The Trend of High-Dose Insulin Usage Among Patients with Diabetes in the UK: A Retrospective Study.

    Idris, Iskandar / Peng, Xiaomei / He, Xuanyao / Liu, Dongju / Balogh, Elemer / Kaushik, Puneet / Van Brunt, Kate

    Diabetes therapy : research, treatment and education of diabetes and related disorders

    2018  Volume 9, Issue 6, Page(s) 2245–2257

    Abstract: Introduction: Many patients with diabetes may require high-dose insulin treatment to achieve target HbA1c level, but the prevalence, disease burden, and patient characteristics of the population remain unclear. We therefore investigated people with ... ...

    Abstract Introduction: Many patients with diabetes may require high-dose insulin treatment to achieve target HbA1c level, but the prevalence, disease burden, and patient characteristics of the population remain unclear. We therefore investigated people with insulin-treated diabetes in the UK from 2009 to 2013, who were prescribed high daily doses (> 200 units/day).
    Methods: A retrospective analysis was conducted using the UK primary care electronic dataset from the Clinical Practice Research Datalink (CPRD). Trends of demographics, insulin dose, clinical characteristics, and annualized incidence rate of the insulin initiators were analyzed. Patients with type 1 (T1D) or type 2 diabetes (T2D) and who were prescribed insulin between 2009 and 2013 were categorized into either a low- or high-dose insulin user group. Two-sample t test and chi-square test were used for comparison of continuous variables and categorical variables, respectively. A multivariable negative binomial regression analysis with (log) person time as an offset was used to assess the impact of different covariates on incidence of high-dose insulin initiation.
    Results: Between 2009 and 2013, 19,631 patients with diabetes were treated with insulin (T1DM, 7620; T2DM, 12,011). In 2013, 415 high-dose insulin initiators were identified (T1DM, N = 170; T2DM, N = 245). More than half were male (T1DM/T2DM, 62.4%/56.3%) and 94.1%/83.7% of T1DM/T2DM patients were prescribed an insulin analogue at high-dose insulin initiation. At 6 months, 43.6% of T1DM and 42.6% of T2DM remained to have suboptimal HbA1c level of ≥ 8% (64 mmol/mol). Overall, 15.9%/63.3% of high-dose insulin initiators (HDII) with T1DM/T2DM took oral antidiabetics. From 2009 to 2013, the estimated glomerular filtration rate worsened in both T1DM and T2DM HDII.
    Conclusion: Despite a number of patients requiring high doses of insulin in the UK, achievement of optimal HbA1c levels remains poor. Early identification of HDII is important in order to plan for alternative/adjuvant antidiabetic and lifestyle strategies to achieve optimal glycemic targets in this patient group.
    Funding: Eli Lilly and Company.
    Language English
    Publishing date 2018-09-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2566702-6
    ISSN 1869-6961 ; 1869-6953
    ISSN (online) 1869-6961
    ISSN 1869-6953
    DOI 10.1007/s13300-018-0515-0
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  10. Article ; Online: Dosing of U-100 insulin and associated outcomes among Medicare enrollees with type 1 or type 2 diabetes.

    Eby, Elizabeth L / Van Brunt, Kate / Brusko, Cynthia / Curtis, Bradley / Lage, Maureen J

    Clinical interventions in aging

    2015  Volume 10, Page(s) 991–1001

    Abstract: Objective: To examine costs, resource utilization, adherence, and hypoglycemic events among various doses of U-100 insulin regimens among elderly patients (age ≥65 years) diagnosed with diabetes.: Methods: Truven Health Analytics Medicare databases ... ...

    Abstract Objective: To examine costs, resource utilization, adherence, and hypoglycemic events among various doses of U-100 insulin regimens among elderly patients (age ≥65 years) diagnosed with diabetes.
    Methods: Truven Health Analytics Medicare databases from January 1, 2008 through December 31, 2011 were utilized. General linear models with a gamma distribution and log link were used to examine costs, while logistic and negative binomial regressions were used to examine resource utilization and hypoglycemic events. Analyses controlled for patient characteristics, pre-period comorbidities, general health, and use of antidiabetic medications as well as index dose of insulin.
    Results: All-cause inpatient, emergency room, and outpatients costs, as well as diabetes-related inpatient costs, were highest among individuals who were treated with an index dose of 10-100 units/day followed by >300 units/day, while drug costs and total costs generally increased as index dosage increased. Resource utilization generally followed the same pattern as costs, with number of office visits increasing as the dose increased and the highest hospital length of stay, number of hospitalizations, number of emergency room visits, and number of diabetes-related hospitalizations were generally highest among those in the lowest and highest index dose cohorts. Compared to patients who initiated with an index dose of 10-100 units/day, all other patients were significantly less likely to achieve an adherence threshold of 80% based upon index dose range, and while those with an index dose of >100-150 units/day were significantly more likely to experience a hypoglycemic event.
    Conclusion: These results suggest that, for elderly individuals with diabetes, there is a higher patient burden among those who receive the lowest and highest insulin doses.
    MeSH term(s) Age Factors ; Aged ; Aged, 80 and over ; Comorbidity ; Costs and Cost Analysis ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/economics ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/economics ; Dose-Response Relationship, Drug ; Female ; Health Services/economics ; Health Services/utilization ; Humans ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/economics ; Hypoglycemic Agents/therapeutic use ; Insulin/administration & dosage ; Insulin/economics ; Insulin/therapeutic use ; Insurance Claim Review/statistics & numerical data ; Male ; Medicare ; Medication Adherence ; Models, Econometric ; Retrospective Studies ; Sex Factors ; United States
    Chemical Substances Hypoglycemic Agents ; Insulin
    Language English
    Publishing date 2015
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2364924-0
    ISSN 1178-1998 ; 1176-9092
    ISSN (online) 1178-1998
    ISSN 1176-9092
    DOI 10.2147/CIA.S76398
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