Suboptimally Controlled Research Articles

Assessing disease control in inflammatory bowel disease: a real world cross-sectional study in the UK (PODCAST-IBD)

Objective Proportion Of suboptimal Disease Control And Strategy of Treatment in IBD (PODCAST-IBD) was an international real-world study which aimed to quantify disease control in IBD using STRIDE-II recommendations. Design/Method Cross-sectional assessment of IBD patients attending routine clinic appointments in four UK centers October 2022 to January 2023. Clinician-reported outcomes, patient-reported outcomes and retrospective data from medical chart review were used to assess IBD control against red flags aligned to STRIDE-II. Results Data were available from 198 UK patients. IBD was suboptimally controlled in 52.4% (54/103) of patients with Crohn’s disease (CD) and 45.3% (43/95) with ulcerative colitis (UC). Impaired quality of life (QOL), defined as Short inflammatory bowel disease questionnaire (SIBDQ) score <50, was the main contributor to suboptimal disease control. Suboptimal disease control has a detrimental impact on fatigue and disability with significantly lower mean Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score in suboptimally controlled disease (CD: 81.5 vs 125, UC: 87.4 vs 122.8) and IBD Disk. Suboptimal disease control results in higher health care resource use (HCRU) (CD: £4,746 vs £1,924; UC: £2,428 vs £1,121) and higher rates of work productivity loss (CD: 41.7% vs 11.9%, UC: 38.0% vs 22.6%). Conclusion IBD was suboptimally controlled in around one-half of patients. Impaired QOL was the most common contributor (64%, 62/97) to suboptimal control. Suboptimal control had a considerable economic impact; HCRU more than doubled and productivity fell. Physicians could consider regular QOL assessments to prompt timely disease monitoring to enable identification of early active disease and appropriate treatment.

Suboptimally Controlled Diabetes in Pregnancy: A Review to Guide Antepartum and Delivery Management.

Diabetes mellitus is one of the most common complications in pregnancy with adverse maternal and neonatal risks proportional to the degree of suboptimal glycemic control, which is not well defined. Literature guiding providers in identifying and managing patients at highest risk of complications from diabetes is lacking. This article reviews the definition, epidemiology, and pathophysiology of suboptimal control of diabetes in pregnancy, including "diabetic fetopathy"; explores proposed methods of risk stratification for patients with diabetes; outlines existing antepartum management and delivery timing guidelines; and guides direction for future research. Original research articles, review articles, and professional society guidelines on diabetes management in pregnancy were reviewed. The reviewed available studies demonstrate worsening maternal and neonatal outcomes associated with suboptimal control; however, the definition of suboptimal based on parameters followed in pregnancy such as blood glucose, hemoglobin A1c, and fetal growth varied from study to study. Studies demonstrating specific associations of adverse outcomes with defined suboptimal control were reviewed and synthesized. Professional society recommendations were also reviewed to summarize current guidelines on antepartum management and delivery planning with respect to diabetes in pregnancy. The literature heterogeneously characterizes suboptimal glucose control and complications related to this during pregnancy in individuals with diabetes. Further research into antepartum management and delivery timing for patients with varying levels of glycemic control and at highest risk for diabetic complications is still needed.

Determinants of sub-optimal glycemic control among patients enrolled in a medicine dispensing programme in KwaZulu-Natal: A cohort study, 2018-2021.

The Central Chronic Medicines Dispensing and Distribution (CCMDD) programme facilitates clinically stable patients to collect their chronic medication from community-based pick-up points. We determined baseline glycaemic control and rates and predictors of becoming sub-optimally controlled for type 2 diabetes mellitus (T2DM) CCMDD-enrolled patients. The setting of the study was eThekwini, KwaZulu-Natal, South Africa. We performed a cohort study (April 2018- December 2021). We linked T2DM CCMDD-enrolled patients to glycated haemoglobin (HbA1c) data from the National Health Laboratory Service. We selected patients optimally controlled at their baseline HbA1c, with ≥ 1 repeat-test available. We used Kaplan-Meier analysis to assess survival rates and extended Cox regression to determine associations between time to sub-optimal control (HbA1c 7%) and predictors. Adjusted hazard ratios (aHRs), 95% confidence interval (CI), andp-values are reported. Of the 41145 T2DM patients enrolled in the CCMDD programme, 7960 (19%) had a HbA1c result available. Twenty-seven percent (2147/7960) were optimally controlled at their baseline HbA1c. Of those controlled at baseline, 695 (32%) patients had a repeat test available, with 35% (242/695) changing to sub-optimal status. The HbA1c testing frequency as per national guidelines was associated with a lower hazard of sub-optimal glycaemic control (aHR: 0.46; 95% CI: 0.24-0.91;p-value = 0.024). Patients prescribed dual-therapy had a higher hazard of sub-optimal glycaemic control (aHR: 1.50; 95% CI: 1.16-1.95;p-value = 0.002) versus monotherapy. The HbA1c monitoring, in-line with testing frequency guidelines, is needed to alert the CCMDD programme of patients who become ineligible for enrolment. Patients receiving dual-therapy require special consideration.Contribution:Addressing identified shortfalls can assist programme implementation.

Discrete glucose profiles identified using continuous glucose monitoring data and their association with adverse pregnancy outcomes

Continuous glucose monitoring has facilitated the evaluation of dynamic changes in glucose throughout the day and their effect on fetal growth abnormalities in pregnancy. However, studies of multiple continuous glucose monitoring metrics combined and their association with other adverse pregnancy outcomes are limited. This study aimed to (1) use machine learning techniques to identify discrete glucose profiles based on weekly continuous glucose monitoring metrics in pregnant individuals with pregestational diabetes mellitus and (2) investigate their association with adverse pregnancy outcomes. This study analyzed data from a retrospective cohort study of pregnant patients with type 1 or 2 diabetes mellitus who used Dexcom G6 continuous glucose monitoring and delivered a nonanomalous, singleton pregnancy at a tertiary center between 2019 and 2023. Continuous glucose monitoring data were collapsed into 39 weekly glycemic measures related to centrality, spread, excursions, and circadian cycle patterns. Principal component analysis and k-means clustering were used to identify 4 discrete groups, and patients were assigned to the group that best represented their continuous glucose monitoring patterns during pregnancy. Finally, the association between glucose profile groups and outcomes (preterm birth, cesarean delivery, preeclampsia, large-for-gestational-age neonate, neonatal hypoglycemia, and neonatal intensive care unit admission) was estimated using multivariate logistic regression adjusted for diabetes mellitus type, maternal age, insurance, continuous glucose monitoring use before pregnancy, and parity. Of 177 included patients, 90 (50.8%) had type 1 diabetes mellitus, and 85 (48.3%) had type 2 diabetes mellitus. This study identified 4 glucose profiles: (1) well controlled; (2) suboptimally controlled with high variability, fasting hypoglycemia, and daytime hyperglycemia; (3) suboptimally controlled with minimal circadian variation; and (4) poorly controlled with peak hyperglycemia overnight. Compared with the well-controlled profile, the suboptimally controlled profile with high variability had higher odds of a large-for-gestational-age neonate (adjusted odds ratio, 3.34; 95% confidence interval, 1.15-9.89). The suboptimally controlled with minimal circadian variation profile had higher odds of preterm birth (adjusted odds ratio, 2.59; 95% confidence interval, 1.10-6.24), cesarean delivery (adjusted odds ratio, 2.76; 95% confidence interval, 1.09-7.46), and neonatal intensive care unit admission (adjusted odds ratio, 4.08; 95% confidence interval, 1.58-11.40). The poorly controlled profile with peak hyperglycemia overnight had higher odds of preeclampsia (adjusted odds ratio, 2.54; 95% confidence interval, 1.02-6.52), large-for-gestational-age neonate (adjusted odds ratio, 3.72; 95% confidence interval, 1.37-10.4), neonatal hypoglycemia (adjusted odds ratio, 3.53; 95% confidence interval, 1.37-9.71), and neonatal intensive care unit admission (adjusted odds ratio, 3.15; 95% confidence interval, 1.20-9.09). Discrete glucose profiles of pregnant individuals with pregestational diabetes mellitus were identified through joint consideration of multiple continuous glucose monitoring metrics. Prolonged exposure to maternal hyperglycemia may be associated with a higher risk of adverse pregnancy outcomes than suboptimal glycemic control characterized by high glucose variability and intermittent hyperglycemia.

Effect of Suboptimal Disease Control on Patient Quality of Life: Real-World Data from the Observational IBD-PODCAST Canada Trial

BackgroundThe real-world application of STRIDE-II treatment targets to identify whether disease control is optimal in Crohn’s disease (CD) and ulcerative colitis (UC) is not well known.AimsThis study aimed to estimate proportions of patients with suboptimally controlled CD and UC in real-world Canadian healthcare settings and the impact on quality of life (QoL).MethodsThe noninterventional, multicenter, observational IBD-PODCAST Canada study comprised a single study visit involving routine assessments, patient- and clinician-completed questionnaires, and a retrospective chart review. Primary outcomes were proportions of patients with STRIDE-II-based red flags indicative of suboptimal disease control and mean ± standard deviation Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Secondary outcomes included proportions of patients and clinicians subjectively reporting suboptimal control.ResultsAmong 163 enrolled patients from 10 sites, 45/87 patients with CD (51.7%; 95% CI: 40.8%, 62.6%) and 33/76 patients with UC (43.3%; 95% CI: 32.1%, 55.3%) had suboptimal disease control based on STRIDE-II criteria. Suboptimal control was subjectively reported at lower proportions (patients: CD, 15.0%; UC, 18.6%; clinicians: CD, 19.5%; UC, 25.0%). Numerically lower SIBDQ scores were observed with suboptimal control (CD, 43.0 ± 10.8; UC, 42.5 ± 12.0) than with optimal control (CD, 58.2 ± 7.2; UC, 57.8 ± 6.6).ConclusionsApproximately 50% (CD) and 40% (UC) of patients from real-world Canadian practices had suboptimal disease control based on STRIDE-II criteria. Suboptimal control was underestimated by patients and clinicians and accompanied by reduced QoL, suggesting further efforts to implement STRIDE-II treat-to-target strategies are needed.

P1145 Assessing disease control in inflammatory bowel disease (IBD) – a real world cross-sectional study in the UK

Abstract Background There is a paucity of data on disease control in patients with inflammatory bowel disease (IBD) in clinical practice. The Proportion Of suboptimal Disease Control And Strategy of Treatment in IBD (PODCAST-IBD) multicentre, non-interventional study aimed to quantify real-world rates of disease control using the STRIDE-II recommendations, explore contributors to, and the economic burden of, suboptimal disease control. Methods Cross sectional assessment of patients with IBD attending routine clinic appointments was carried out in four UK centres between Oct 2022 and Jan 2023. Clinician-reported outcomes, patient-reported outcomes and retrospective data from medical chart review were used to assess IBD control against red flags aligned to the STRIDE-II recommendations (Table). Health care resource utilisation (HCRU) was calculated using NHS reference costs. Results Data was available from 198 patients (Crohn's disease [CD]: 103, ulcerative colitis [UC]: 95) and most were currently receiving long-term IBD-specific treatment (CD: 85%, UC: 78%). IBD was suboptimally controlled in 52.4% (54/103) of patients with CD and 45.3% (49/95) with UC. Impaired quality of life (QOL), defined as Short inflammatory bowel disease questionnaire (SIBDQ) score &amp;lt;50, was the most frequent contributor to suboptimal disease control for both UC and CD. Other frequent contributors were systemic steroid overuse, extraintestinal manifestations (EIM), failure to achieve clinical improvement and perianal disease (Figure). Suboptimal disease control has a detrimental impact on fatigue and disability, demonstrated by lower (indicating more fatigue) mean total FACIT-F score in suboptimally controlled disease (CD: 81.5 vs 125, UC: 87.4 vs 122.8) and IBD Disk, a 10-item self-questionnaire used to assess IBD-related disability. HCRU more than doubled in patients with suboptimal vs optimal control (CD: £4,746 vs £1,924; UC: £2,428 vs £1,121), driven by more hospital admissions and emergency room visits in patients with suboptimal disease control. Patients with suboptimal disease control had higher rates of work productivity loss than those with optimal control (CD: 41.7% vs 11.9%, UC: 38.0% vs 22.6%). Conclusion This UK cross-sectional study found that IBD was suboptimally controlled in around one-half of patients based on STRIDE-II recommendations. Of those with suboptimally controlled disease one-third had impaired QOL making it the most common contributor. Suboptimal control of IBD had a considerable economic impact; HCRU more than doubled and productivity fell. Physicians could consider regular QOL assessments to prompt timely disease monitoring to enable identification of early active disease and ensure appropriate treatment.

P808 Use of intestinal ultrasound influences the proportion of suboptimally controlled patients: IBD Podcast Study results

Abstract Background The IBD-PODCAST study estimates the proportion of patients with Crohn’s disease (CD) and ulcerative colitis (UC) with suboptimal disease control (DC) in a real-world setting. Intestinal ultrasound (IUS) is recommended in international guidelines as a non-invasive tool to assess disease activity and to guide therapeutic decisions in IBD. It is easy to use, inexpensive, can be repeatedly used without limitations and provides an opportunity for immediate patient interaction. The aim of this descriptive analysis was to assess the impact of IUS on the proportion of suboptimal DC in this cohort. Methods IBD PODCAST was a non-interventional, cross-sectional, multi-center study conducted across 103 sites in 10 countries. Criteria for suboptimal DC were based on STRIDE-II. Retrospective data on the frequency of imaging (i.e. endoscopies, MRI/MRE/CT and IUS) in the 12 months prior to assessment were collected. We compared clinical decision making, subjective evaluation of DC by patients and physicians and objective criteria of suboptimal DC at the time of assessment (i.e. index) in patients with (i.e. CD+IUS12, UC+IUS12) and without IUS (CD-IUS, UC-IUS) in the past 12 months. Results 2185 patients (CD: n=1108, UC n=1077) with a mean age (SD) of 44.0 (14.8) years and mean disease duration (SD) of 12.4 (9.2) years were included (52.2% male). Imaging was performed in 43.1% (n=477) of CD and 44.6% (n=480) of UC patients within 12 months prior to index. Endoscopy accounted for 77.6% and 88.8%, MRI/MRE/CT for 21.0% and 6.7%, and IUS for 19% (n=89/477) and 16% (n=77/480) of patients with CD and UC, respectively. The proportion of patients with signs of active inflammation at index was higher in patients where IUS was used (CD+IUS12: 34% vs CD-IUS: 9.5%; UC+IUS12: 22.6% vs UC-IUS: 15.3%; Table 1). For UC only, numerically more patients with parameters indicating clinically active disease at index were further monitored or had their treatment adjusted, when IUS was used within the past 12 months. (UC+IUS12: 58.6% vs UC-IUS: 50.7%). Despite the high number of patients with suboptimal DC based on objective criteria, the use of IUS minorly improved the alignment of subjective evaluation of suboptimal DC between the patient and physician, and only in UC (UC+IUS12: 37.5% vs UC-IUS: 32.7%; Fig 1). Conclusion Only a minority of patients underwent IUS in this cohort. Yet, this non-invasive tool may be useful if used more frequently. Consistent with others, IUS could aid in holistic disease monitoring for the detection of suboptimal treatment response, clinical decision making and the opportunity for alignment with patients on treatment targets.

Arterial hypertension after liver transplantation.

One of the most prevalent influenceable risk factors for poor cardiovascular outcome is arterial hypertension.This is aprospective analysis of liver transplant recipients in which 24-hour blood pressure (BP) measurement was performed. The primary aim was to identify post-LT (liver transplantation) patients without ahistory of arterial hypertension who meet the criteria for arterial hypertension using 24-hour BP monitoring. Secondary objectives were to determine how many patients with known treated arterial hypertension had suboptimal BP control. The group included 88 patients (men, 52.3%, history of arterial hypertension group: n=56, no history of arterial hypertension group: n=32) with an average age at the time of measurement of 62.4 years±11. The average time since LT at the time of measurement was 45.2 months. De novo arterial hypertension using 24-hour BP monitoring was diagnosed in 28%. Hypertonic changes in the fundus oculi were confirmed as predictor for suboptimally controlled hypertension [OR 5,1265, p=0.0279]. On the other hand, male sex [OR 3.1840, p=0.0311], together with age [OR 1.3347, p=0.0153] and waist circumference [OR 4.3490, p=0.0418] predicted the need of intensification of antihypertensive treatment. Male sex, age and waist circumference should increase the index of suspicion and lead to zoom-in on apossibility of poorly controlled blood pressure. Where automated blood pressure monitoring is unavailable, regular examination of the fundus could serve as an available surrogate marker of suboptimally controlled arterial hypertension (Tab.6, Fig. 1, Ref. 36). Text in PDF www.elis.sk Keywords: liver transplantation, arterial hypertension, automated blood pressure monitoring.

Reductions in inhaler greenhouse gas emissions by addressing care gaps in asthma and chronic obstructive pulmonary disease: an analysis

IntroductionClimate change from greenhouse gas (GHG) emissions represents one of the greatest public health threats of our time. Inhalers (and particularly metred-dose inhalers (MDIs)) used for asthma and chronic obstructive...

Long-Term Effectiveness of Quadruple Combination Therapy with Empagliflozin Versus Basal Long-Acting Insulin Therapy in Patients with Type 2 Diabetes: 3-Year Retrospective Observational Study.

Effective blood glucose control remains a constant problem in patients with type 2 diabetes (T2D), even if they are being properly treated with one or more currently available drugs. The present study was designed as a 3-year retrospective observational study to determine whether the use of either empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, or insulin would provide any improvement in the control of the blood glucose levels in patientswith T2D who were already being treated with a cocktail of three different oral antidiabetic drugs. Adult patients with T2D were enrolled in this study if they exhibited suboptimal glycemic control (HbA1c 7.5-12.0%) despite being continuously treated for at least 3months with metformin, dipeptidyl-peptidase 4 inhibitor, and glimepiride. Empagliflozin (25mg/day, n = 154) or basal long-acting insulin (n = 147) was added as a fourth medication to the existing drug regimen. The major outcomes that were monitored in this study included the measurement of HbA1c, fasting plasma glucose (FPG), and general cardiometabolic and blood markers. After the addition of empagliflozin or basal insulin to the existing oral anti-diabetic agent (OAD) regimen, the baseline levels of HbA1c were reduced after month 36 in both the empagliflozin (8.9 ± 1.0% to 7.4 ± 0.8%, P < 0.01) and insulin (9.0 ± 1.4% to 8.0 ± .1.4%, P < 0.05) groups. The HbA1c reduction was higher in the empagliflozin group to the end of the 36-month study period (7.4 ± 0.8% vs. 8.0 ± 1.4%, empagliflozin vs. insulin, P < 0.05). FPG showed a similar trend in the early period but it was not maintained at the end of study. Body weight decreased (P < 0.01) from baseline (70.4 ± 12.3kg) to month 36 (65.6 ± 11.4kg) in the empagliflozin group but not the insulin group. At 36months, the body weight in the empagliflozin group (65.6 ± 11.4kg) was significantly lower (P < 0.01) than that in the insulin treatment group (70.0 ± 10.9kg). Empagliflozin was shown to perform as well as better than insulin when used as part of a quadruple drug regimen for regulating blood glucose levels in suboptimally controlled patientswith T2D. NCT05103306 (ClinicalTrials.gov).

Suboptimally controlled asthma in patients treated with inhaled ICS/LABA: prevalence, risk factors, and outcomes

This observational claims-linked survey study assessed the prevalence of and risk factors for suboptimal asthma control and healthcare utilization in adults with asthma receiving fixed-dose combination (FDC) inhaled corticosteroid/long-acting β2-agonist (ICS/LABA). Commercially insured adults from the Optum Research Database were invited to complete the Asthma Control Test (ACT) and Asthma Control Questionnaire-6 (ACQ-6). Among participants (N = 428), 36.4% (ACT-assessed) and 55.6% (ACQ-6-assessed) had inadequately controlled asthma. Asthma-related quality of life was worse and asthma-related healthcare resource utilization was higher in poorly controlled asthma. Factors associated with ACT-defined suboptimal asthma control in multivariate analysis included: frequent short-acting β2-agonist (SABA) use, asthma-related outpatient visits, lower treatment adherence, and lower education levels. During follow-up, factors associated with asthma exacerbations and/or high SABA use included: inadequately controlled asthma (ACT-assessed), body mass index ≥30 kg/m2, and high-dose ICS/LABA. Approximately 35–55% of adults with asthma were inadequately controlled despite FDC ICS/LABA; poor control was associated with worse disease outcomes.

Switching from one biologic to benralizumab in patients with severe eosinophilic asthma: An ANANKE study post hoc analysis.

BackgroundSevere asthma is a heterogeneous inflammatory disease driven by eosinophilic inflammation in the majority of cases. Despite biologic therapy patients may still be sub-optimally controlled, and the choice of the best biologic is a matter of debate. Indeed, switching between biologics is common, but no official guidelines are available and real-world data are limited.Materials and methodsIn this post hoc analysis of the Italian, multi-center, observational, retrospective study, ANANKE. Patients with severe eosinophilic asthma treated with benralizumab were divided in two groups based on history of previous biologic therapy (biologic-experienced [suboptimal response] vs naïve). Baseline clinical and laboratory characteristics were collected in the 12 months prior to benralizumab treatment. Change over time in blood eosinophils, annualized exacerbation rate (AER), asthma control (ACT), lung function and oral corticosteroid (OCS) use following benralizumab initiation were collected in the two groups.ResultsA total of 147 biologic-naïve and 58 biologic-experienced (34 omalizumab, 19 mepolizumab, and 5 omalizumab-mepolizumab) patients were enrolled. Biologic-experienced patients were more likely to be atopic and have a higher AER despite more frequent OCS use. Similar reductions in AER (>90% in both groups), OCS use (≥49% reduction in dosage and ≥41% able to eliminate OCS), ACT improvement (≥7 points gained in 48 weeks) and lung function (≥300 mL of FEV1 improvement in 48 weeks) were observed after benralizumab introduction within the two groups. There were no registered discontinuations of benralizumab for safety reasons.ConclusionIn this post hoc analysis, patients who were switched to benralizumab because of suboptimal control with a previous biologic therapy were more likely to be atopic and more often treated with omalizumab. Benralizumab is effective in both naïve patients and those previously treated with a biologic.

Remission in Type 2 DM with Personalized Medical Interventions Including Life Style Modification and Appropriate Pharmacotherapy - A Case Report

Introduction: Increase in prevalence of type-2 diabetes in background of increased prevalence of obesity has increased overall health risk and complicates its management. Health benefits of weight loss and strategies for the same have been found to be effective. Caring for people living with diabetes and obesity requires a person-centred approach using the most appropriate evidence based individualized care. This case study discusses diabetes and weight management in a patient with sub-optimally controlled diabetes and a high BMI with potential for reversal of Diabetes. Clinical Problem: Extremely obese (BMI-43.23kg/m2) middle-aged person with hypertension and diabetes as comorbidity with sedentary lifestyle having sub-optimal glycaemic control (HbA1c 11.2%) with fatty liver disease presented for management of his sub-optimal glycaemic control. Management plan and its rationales with outcomes: Proper education about self-management of diabetes and counselling for importance of weight management and its long-term benefits were explained to patient. Low calorie diet with a calorie deficit of 600 calories per day, one-hour moderate intensity exercise day, SGLT-2i (dapagliflozin 10mg daily), Metformin 2000mg daily, GLP1RA (Liraglutide in incremental dose followed by switch over to oral similitude), Saroglitazar (dual PPAR agonist) along with antihypertensive medication and statin was started in this patient.At 4 months of intervention patient has tolerated the treatment very well and lost 26kg of body weight. His glycated HbA1c came down to 4.2% from 11.2%. Reversal of urine albumin to creatinine ratio to normal range was another significant change. Conclusion: Personalized medical interventions including lifestyle changes and appropriate antidiabetic medication was associated with&gt;25% weight loss, which can potentially induce complete remission of type-2 diabetes.

Cost-Effectiveness of iGlarLixi Versus Premix BIAsp 30 in People with Type 2 Diabetes Suboptimally Controlled by Basal Insulin in the US.

IntroductionMany people with type 2 diabetes mellitus (T2DM) experience suboptimal glycemic control and require therapy advancement. This cost-effectiveness analysis was conducted to compare iGlarLixi (insulin glargine 100 U/mL plus lixisenatide) versus BIAsp 30 (biphasic insulin aspart 30) in people with T2DM suboptimally controlled with basal insulin.MethodsThe IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for people with T2DM from a US healthcare payer perspective. Initial clinical data were based on the phase 3 randomized, open-label, active-controlled SoliMix clinical study, which compared the efficacy and safety of once-daily iGlarLixi with twice-daily BIAsp 30. Lifetime costs (US$) and quality-adjusted life-years (QALYs) were predicted, and the incremental cost-effectiveness ratio (ICER) for iGlarLixi versus BIAsp 30 was estimated; the willingness-to-pay threshold was considered to be $50,000. A subgroup analysis considered people with T2DM aged ≥ 65 years.ResultsEstimated QALYs gained were slightly higher with iGlarLixi compared with BIAsp 30 (9.3 vs. 9.2), with lower costs for iGlarLixi ($117,854 vs. $120,109); the ICER for iGlarLixi was therefore considered dominant over BIAsp 30 in the base case. Key drivers for cost savings were the higher dose and twice-daily administration for BIAsp 30 versus once-daily administration for iGlarLixi. The robustness of the base-case results was confirmed by sensitivity and scenario analyses. Results were similar in a subgroup of people with T2DM aged ≥ 65 years.ConclusionIn people with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi confers improved QALYs and reduced costs compared with BIAsp 30.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01300-5.

Clinical and economic burden of uncontrolled severe noneosinophilic asthma.

To quantify the clinical and economic burden of patients with severe asthma with low blood eosinophil counts (BECs) untreated with biologics. Retrospective cohort study in IBM MarketScan claims database. Patients 12 years and older with severe asthma with BEC data were selected between January 1, 2013, and June 30, 2018 (date of the most recent BEC was used as the index date). Inclusion criteria were (1) presence of BEC laboratory test result, (2) continuous enrollment for 12 months preceding and following the index date, (3) meeting the Healthcare Effectiveness Data and Information Set definition of persistent asthma, (4) meeting the Global Initiative for Asthma definition of severe asthma, and (5) an absence of biologic treatment, other respiratory diagnoses, and malignancies 12 months preceding and following the index date. Asthma exacerbations, levels of disease control, and all-cause and asthma-related health care costs were reported during the 12-month postindex period for patients with a BEC less than 300 cells/mcL. The sample included 8073 patients with severe asthma; 78% (n = 6260) presented with a BEC less than 300 cells/mcL. Mean (SD) age of the sample was 54.8 (14.2) years; 64% were female. Eighteen percent of patients had an asthma exacerbation; 19% had either uncontrolled or suboptimally controlled asthma based on the frequency of asthma-related hospital admissions, emergency department visits, or corticosteroid prescription fills. One-year all-cause and asthma-related total health care costs were $25,845 and $2802, respectively. Patients with suboptimally controlled and uncontrolled asthma spent $1471 and $3872 more, respectively, on asthma-related claims compared with patients with controlled asthma. Among patients with severe asthma with low eosinophils untreated with biologics, there is a high burden of disease among those who have suboptimal disease control, highlighting an unmet need in severe asthma treatment.

770-P: Treatment Satisfaction and Fear of Hypoglycemia in the ADAPT Study: A Six-Month, Randomized Controlled Trial Comparing an Advanced Hybrid Closed-Loop System to Multiple Daily Injections (MDI) with Intermittently Scanned CGM (isCGM)

Objective: To assess the effect of the MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system compared to MDI with isCGM (MDI+isCGM) therapy on treatment satisfaction (TS) and fear of hypoglycemia (FoH) , in adults with type 1 diabetes (T1D) with above-target baseline glycemic control participating in the ADAPT study. Methods: Participants with T1D who were on MDI+isCGM and who had suboptimal glycemic control (HbA1c≥8%) were randomly assigned to AHCL or to continue MDI+isCGM. Treatment satisfaction was measured with the Diabetes-Treatment-Satisfaction-Questionnaire, status (DTSQs) and change (DTSQc) and FoH with the Hypoglycemia Fear Survey (HFS) . Results: Overall, the decrease in HbA1c was 1.4% greater in the AHCL group vs. MDI+isCGM group (P&amp;lt;0.001) with no difference in hypoglycemia. Mean DTSQs score increased significantly in the AHCL arm after 6 months compared to the MDI+isCGM arm (29.7 vs. 21.9, P=0.0003) , with significant improvement in perceived frequency of hyperglycemia (P&amp;lt;0.001) . There was no difference in the perceived frequency of hypoglycemia. Results were consistent in both DTSQs and DTSQc. Fear of hypoglycemia decreased in both groups, but the decrease was significantly greater in the AHCL group. At 6 months, HFS scores decreased by 10.2 points and 2.7 points from baseline in the AHCL and MDI+isCGM groups, respectively (P=0.04) . Conclusion: AHCL therapy improves patient-reported outcomes with greater treatment satisfaction and reduced FoH compared to MDI+isCGM in sub-optimally controlled participants with T1D. Disclosure S.De portu: Employee; Medtronic. J.Castañeda: Employee; Medtronic. O.Cohen: Employee; Medtronic. Adapt study group: n/a. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. J.Kroeger: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Other Relationship; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Novo Nordisk, Sanofi-Aventis Deutschland GmbH, Tandem Diabetes Care, Inc., Research Support; Medtronic. C.Thivolet: Board Member; Insulet Corporation, Medtronic, Research Support; Abbott Diabetes, Lilly Diabetes, Novo Nordisk A/S, Sanofi. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. R.Ré: Employee; Medtronic. L.Vorrink de groot: Employee; Medtronic. J.Shin: Employee; Medtronic. A.Habteab ghebretinsae: None. Funding Medtronic

Clinical and Demographic Profile of Diabetic Patients from Central India - Results from Diabetes Registry.

This study was done to analyse the demographic profile and presentation of diabetes in Central India. Data was collected for this cross-sectional study from an electronic diabetes registry from 2014 to 2019. Demographic details, patient history and presence or absence of co-morbid conditions, duration of diabetes, age of onset of diabetes, drug history, personal history, presence of micro and/or macrovascular complications and investigations done were obtained. The association between each factor and the outcome was studied in terms of prevalence ratio (PR) using the R-3.0.0 programming (R Foundation for Statistical Computing, Vienna, Austria) language. Statistical significance was evaluated at a 5% level. Among 12,434 patients, 54.95% were below 50 years and 45.05% were above 50 years. 50.21% were females and 49.79% were males. The mean age was 47.49 ± 14.78 years and the mean body mass index (BMI) was 26.85 ± 5.19 kg/m2 with 62.29% of obese patients (>25 kg/m2). The mean overall duration of diabetes was 7.64 ± 7.63 years. Mean Glycosylated Haemoglobin (HbA1c) in patients <=50 years was 8.60 ± 2.63 and 8.90 ± 1.91 for over 50. 65.59% had uncontrolled blood sugars. 25.19% of patients had hypertension and 18.1% had dyslipidaemia. Coronary artery disease (CAD), nephropathy, neuropathy and retinopathy were observed in 21.49%, 9.60%, 33.65% and 14.65%, respectively. The adjusted PR of cardiovascular disease (CVD) was 5.374 times higher for patients over 50 (P < 0.0001); 3.775 times higher for males (P < 0.0001), 1.64 times higher for patients with BMI >25 kg/m2 (P < 0.0001) and 3.643 times higher in hypertensive cases (P < 0.0001). Similar associations were observed with nephropathy, neuropathy and retinopathy. From a large population study on diabetes, it was found a majority of the type 2 diabetes mellitus (T2DM) cases (65%) are sub-optimally controlled with HbA1c levels. Also, microvascular complications were related to the sub-optimal glycaemic control, but not the macro-vascular complications.

Treatment Satisfaction, Patient Preferences, and the Impact of Suboptimal Disease Control in Rheumatoid Arthritis Patients in Greece: Analysis of the Greek Cohort of SENSE study.

Objectives:SENSE was an international, non-interventional cross-sectional study that assessed treatment satisfaction in patients with suboptimally controlled active rheumatoid arthritis (RA) who were under treatment with any approved agent exposed to ≤ 2 biological disease-modifying anti-rheumatic drugs (DMARDs) at the time of enrolment. The current publication concerns the subanalysis of the results from the Greek cohort.Methods:Treatment satisfaction was assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), with good treatment satisfaction defined as TSQM global ≥80. Adherence to therapy was recorded on a visual analogue scale (VAS) and treatment expectations were assessed on a 7-point numerical rating scale.Results:Of 121 patients, 82.6% were women, of mean age 64.8 years and mean time from diagnosis 8.4 years. Patients had active disease (mean DAS28-ESR 4.5) and compromised functional status (mean [SD] HAQ-DI 1.1 [0.7]) while on treatment (43.8% on biologics and 5% on steroids). The mean TSQM global was 66.9. Treatment expectations were “general improvement of arthritis” and “less joint pain” (mean score [SD], 4.9 [1.8] each), “more joint flexibility” (4.8 [1.9]), and “lasting relief of RA symptoms” (4.8 [2.1]). Oral administration was preferred by 65.3% of patients. Good self-reported adherence (≥80%) was recorded in 93.4% of the patients. Treatment switch to another DMARD was planned by treating rheumatologist for only 49.6% of the participants, despite suboptimal RA control.Conclusion:Patients with suboptimally controlled RA in Greece have low treatment satisfaction and poor self-reported outcomes, albeit high self-reported treatment adherence. Similarly to the global SENSE study results, the need for patient-centric treatment approaches in order to improve disease outcomes is emphasised.

Glycated haemoglobin (HbA1c) use and glycaemic control in patients living with diabetes mellitus attending public healthcare facilities in KwaZulu-Natal Province, South Africa.

Ideal control of diabetes mellitus (DM) remains a global goal, which has not yet been reached. As part of an integrated public healthcare strategy, data with subsequent analysis of diabetes control achieved in patients living with DM (PLWD) need to be available. Diabetes control data from KwaZulu-Natal (KZN) Province, South Africa, are scarce. Smaller studies conducted in public and private healthcare sectors of KZN have shown suboptimal DM control. To identify the percentage of glycated haemoglobin (HbA1c) tests done in KZN public healthcare facilities, and to provide a glimpse into diabetes control being achieved in each KZN district municipality. Data regarding the number of HbA1c tests performed, number of patients with an HbA1c ≤7% and number of diabetes visits were accessed from the KZN Department of Health Information Systems and analysed. The majority of HbA1c tests were performed in the metro municipality of eThekwini (p&lt;0.001). Approximately two-thirds (64.5%) of PLWD in whom HbA1c tests had been performed, were suboptimally controlled. In 5 of the 11 KZN district municipalities more than two-thirds of PLWD had an HbA1c &gt;7%. Most of the patients in 9 of the 11 district municipalities showed suboptimal control of their DM. The total number of HbA1c tests performed in KZN represents approximately one-tenth of the total number of diabetes treatment visits. This trend was prevalent in all 11 district municipalities, where the incidence of DM was on an upward trajectory. Our study demonstrated that the majority of PLWD visiting public healthcare facilities in KZN have suboptimal glycaemic control. They are at increased risk of developing diabetes-related complications, further burdening the healthcare fiscus of low- to middle-income countries. We also showed that the number of HbA1c tests being performed, in the presence of suboptimal control, was well below par. This finding serves to emphasise the need for strategies to be implemented to increase awareness of HbA1c testing for the monitoring of glycaemic control, and for making point-of-care HbA1c testing readily available in these healthcare facilities.

Cost-Effectiveness of iGlarLixi in People with Type 2 Diabetes Mellitus Suboptimally Controlled on Basal Insulin Plus Metformin in the UK.

IntroductionA cost-effectiveness analysis was conducted comparing a fixed-ratio combination (FRC) of insulin glargine 100 units/mL plus lixisenatide (iGlarLixi) versus the FRC of insulin degludec plus liraglutide (iDegLira) and the free-combination comparators insulin glargine plus dulaglutide (iGlar plus Dula) and basal insulin plus liraglutide (BI plus Lira).MethodsThe IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for a cohort of patients with type 2 diabetes mellitus (T2DM) from the UK healthcare perspective. Initial clinical data for iGlarLixi were based on the randomized, controlled LixiLan-L trial and the relative treatment effects for comparators were based on an indirect treatment comparison using data from the AWARD-9 (iGlar plus Dula), LIRA ADD2 BASAL (BI plus Lira), and DUAL V (iDegLira) trials. Costs were derived from publicly available sources. Lifetime costs (in British Pound Sterling [£]) and quality-adjusted life-years (QALYs) were predicted; net monetary benefit (NMB) for iGlarLixi versus comparators was derived using a willingness-to-pay threshold of £20,000. Extensive scenario and sensitivity analyses were conducted.ResultsEstimated costs were lowest with iGlarLixi (£31,295) compared with iGlar plus Dula (£38,790), iDegLira (£40,179), and BI plus Lira (£42,467). Total QALYs gained were identical with iGlarLixi and iDegLira (8.438), and comparable with iGlar plus Dula (8.439) and BI plus Lira (8.466). NMB for iGlarLixi was positive versus all comparators (£10,603.86 vs. BI plus Lira; £7,466.24 vs. iGlar plus Dula; £8.874.11 vs. iDegLira).ConclusionIn patients with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi provides very similar outcomes and substantial cost savings, compared with other fixed and free combinations of insulins plus glucagon-like peptide-1 receptor agonists.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01159-y.