Health-related quality of life and lifestyle changes in patients with chronic kidney disease and hyperkalaemia: Real-world data from the US, five European countries and China.

BACKGROUND: Chronic kidney disease patients have impaired health-related quality of life and an increased risk of hyperkalaemia. AIMS: The objective was to evaluate the impact of hyperkalaemia on health-related quality of life, and investigate lifestyle change recommendations, in these patients. METHODS: The Adelphi Real World Chronic Kidney Disease Specific Programme™ was used. Data were collected from physicians and patients with non-dialysis dependent stage 3a, 3b and 4 chronic kidney disease from the US, France, Germany, Spain, Italy, the UK and China. Patients completed the Kidney Disease Quality of Life Instrument and EuroQol-5D-3L. Analyses compared data between hyperkalaemic (serum potassium >5.0 mmol/L) and normokalaemic (serum potassium 3.5-5.0 mmol/L) patients. RESULTS: Overall, 1149 patients were included (hyperkalaemic: n = 216, normokalaemic: n = 933; US: n = 376, Europe: n = 490, China: n = 283). Hyperkalaemic vs normokalaemic patients experienced more symptoms (P < .001) and had numerically lower scores, indicating poorer health-related quality of life, in all Kidney Disease Quality of Life domains, with significant differences for three/five domains. Hyperkalaemic patients reported numerically lower EuroQol-5D-3L utility index and visual analogue scores, indicating poorer health status, than normokalaemic patients. A higher proportion of hyperkalaemic than normokalaemic patients were recommended to reduce dietary potassium (P < .05). More normokalaemic than hyperkalaemic patients reported making a radical change in five/six recommended lifestyle changes, with the difference significant for four/six recommendations. CONCLUSIONS: Hyperkalaemia is associated with an incremental impairment of the health-related quality of life in chronic kidney disease patients. A better understanding of the impact of hyperkalaemia in these patients could improve patient outcomes.

Associations between serum potassium and adverse clinical outcomes: A systematic literature review.

BACKGROUND AND OBJECTIVES: Despite the growing body of evidence characterising the association between serum potassium levels and adverse clinical outcomes, a contemporary summary of available evidence is currently lacking. The objective of this study, therefore, was to undertake a systematic literature review to identify all relevant evidence assessing risk factors associated with the incidence of hyperkalaemia (HK) and also quantifying the effect of serum potassium levels on risk of adverse clinical outcomes. METHODS: PubMed (Medline and Medline In-Process), Embase and the Cochrane Library were searched for studies published between January 2002 and November 2018. Search inclusion criteria included studies describing either the incidence of HK events and any associated risk factors, or associations between HK or serum potassium concentration and adverse clinical outcomes including mortality, hospitalisation, major adverse cardiac events (MACE) and renin-angiotensin-aldosterone system inhibitors (RAASi) discontinuation in adult patients with chronic kidney disease (CKD), heart failure (HF), type 2 diabetes (T2DM) or hypertension. RESULTS: The search identified 1,897 publications. From these, a total of 123 studies met the inclusion criteria and were included in the review. The most commonly identified risk factors associated with HK events were the presence of CKD or renal impairment, T2DM, HF, hypertension, RAASi use and mineralocorticoid receptor antagonist use. Potassium levels both above and below the normal range were consistently associated with adverse clinical outcomes, with relative and absolute risks of outcomes increasing with severity of hyper- or hypokalaemia. These associations were consistently reported across a broad range of patient population types and study types. CONCLUSION: The current body of published evidence is compelling in its confirmation of the associations between serum potassium levels and adverse clinical outcomes. This review further highlights the importance of avoiding both hyper- and hypokalaemia, in order to reduce risk of mortality, hospitalisation, MACE and RAASi discontinuation or down-titration.

Evidence in support of hyperkalaemia management strategies: A systematic literature review.

BACKGROUND: Hyperkalaemia is a potentially life-threatening condition that can be managed with pharmacological and non-pharmacological approaches. With the recent development of new hyperkalaemia treatments, new information on safe and effective management of hyperkalaemia has emerged. OBJECTIVES: This systematic literature review (SLR) aimed to identify all relevant comparative and non-comparative clinical data on management of hyperkalaemia in adults. Our secondary aim was to assess the feasibility of quantitatively comparing randomised controlled trial (RCT) data on the novel treatment sodium zirconium cyclosilicate (ZS) and established pharmacological treatments for the non-emergency management of hyperkalaemia, such as the cation-exchangers sodium/calcium polystyrene sulphonate (SPS/CPS). METHODS: MEDLINE, Embase and the Cochrane Library were searched on 3rd April 2017, with additional hand-searches of key congresses and previous SLRs. Articles were screened by two independent reviewers. Eligible records reported interventional or observational studies of pharmacological or non-pharmacological management of hyperkalaemia in adults. RESULTS: Database searches identified 2,073 unique records. Two hundred and one publications were included, reporting 30 RCTs, 29 interventional non-RCTs and 43 observational studies. Interventions investigated in RCTs included ZS (3), SPS/CPS (3), patiromer (4) and combinations of temporising agents (6 RCTs). A robust and meaningful indirect treatment comparison between ZS and long-established cation-binding agents (SPS/CPS) was infeasible because of heterogeneity between studies (including time points and dosing) and small sample size in SPS/CPS studies. CONCLUSIONS: Despite hyperkalaemia being associated with several chronic diseases, there is a paucity of high-quality randomised evidence on long-established treatment options (SPS and CPS) and a limited evidence base for hyperkalaemia management with these agents.

Association of Weight Loss and Medication Adherence Among Adults With Type 2 Diabetes Mellitus: SHIELD (Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes).

BACKGROUND: Adherence to prescribed diabetes medications is suboptimal, which can lead to poor glycemic control and diabetic complications. Treatment-related weight gain is a side effect of some oral antidiabetic agents and insulin, which may negatively affect adherence to therapy. OBJECTIVE: This study investigated whether adults with type 2 diabetes mellitus (T2DM) who lost weight had better medication adherence than those who gained weight. METHODS: Weight change over 1 year (2007 to 2008) was assessed among respondents in the US Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD). Weight loss of >1.0%, ≥3%, and ≥5% of weight was compared with weight gain of ≥1.0%. Medication adherence was assessed using the Morisky 4-item questionnaire for medication-taking behavior, with lower scores representing better adherence. RESULTS: There were 746 T2DM respondents who lost >1.0%, 483 who lost ≥3%, 310 who lost ≥5%, and 670 who gained ≥1.0% of weight. Each weight-loss group had significantly lower Morisky scores than the weight-gain group; mean scores of 0.389 versus 0.473 (P = 0.050) for the >1.0% weight-loss group, 0.365 versus 0.473 (P = 0.026) for the ≥3% weight-loss group, and 0.334 versus 0.473 (P = 0.014) for the ≥5% weight-loss group. Significantly fewer respondents who lost weight had received insulin, sulfonylurea, or thiazolidinedione therapy (57%) compared with respondents who gained weight (64%) (P = 0.002). Demographics, exercise habits, and dieting were similar between weight-loss and weight-gain groups. CONCLUSIONS: T2DM respondents with weight loss had significantly better medication adherence and were less likely to be on treatment regimens that increase weight than T2DM respondents with weight gain. These findings suggest that strategies that lead to weight loss, including use of diabetes medications associated with weight loss, may improve medication adherence.

Change in health status (EQ-5D) over 5 years among individuals with and without type 2 diabetes mellitus in the SHIELD longitudinal study.

BACKGROUND: Health-related quality of life studies among adults with type 2 diabetes mellitus, using the EQ-5D, have been short term and have not assessed change over years. This study assessed the change in health status and health-related quality of life over 5 years among individuals with and without diabetes. METHODS: Respondents to the US Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) completed the EuroQol-5D (EQ-5D) at baseline (2004) and 5 years later (2009). Visual analog scale (VAS) score and health index score were computed at baseline and year 5, and the change over 5 years was measured for individuals with type 2 diabetes mellitus (T2DM) and those without diabetes, and T2DM adults with and without diabetic complications. Linear regression models were used to determine change in EQ-5D score, controlling for age, gender, race, education, household income, and body mass index (BMI). RESULTS: There was significantly greater decline in the EQ-5D index score in the T2DM group (-0.031 [SD 0.158]), compared with those without diabetes (-0.016 [0.141], p = 0.001). Compared with respondents without diabetes, those with T2DM had a larger reduction in EQ-5D index score, after controlling for demographics (p = 0.001). EQ-5D VAS score declined over 5 years for both groups: -1.42 (18.1) for the T2DM group, and -0.63 (15.8) for the group without diabetes, but the between-group difference was not significant either before (p = 0.09) or after (p = 0.12), controlling for demographics. T2DM respondents with diabetic complications had a greater decline in EQ-5D scores than T2DM respondents without complications (p < 0.05). CONCLUSION: Over a 5-year period, health status of respondents with T2DM declined significantly compared with those with no diabetes, indicating that the burden of the disease has a long-term detrimental impact. This decline in health status is likely to impact utility scores (fewer quality-adjusted life years) for economic evaluations.

Understanding Patient Perspectives of the Impact of Anemia in Chronic Kidney Disease: A United States Patient Survey.

Anemia in chronic kidney disease (CKD) is associated with reduced health-related quality of life and physical functioning. This study investigated knowledge and awareness of anemia in patients with CKD in the United States (US) through an online, quantitative survey administered to patients aged ≥18 years with self-reported CKD, with or without anemia. Of 446 patients included, 255 (57.2%) were diagnosed with anemia and 191 (42.8%) were in the non-anemia cohort. In patients with anemia, 71.0% were aware of the relationship between CKD and anemia versus 52.9% in the non-anemia cohort. In the anemia cohort, 46.3% of patients were aware of their hemoglobin level, versus 27.2% in the non-anemia cohort. Despite 67.4% of patients with anemia believing their condition was well/very well managed, only 50% reported being informed about different treatments without prompting healthcare providers. In the US, patients with anemia and CKD perceived that anemia had a negative impact on physical health and emotional wellbeing. Results emphasize a lack of disease awareness, suggesting patients would benefit from further education on anemia in CKD.

Race/Ethnicity and gender differences in health intentions and behaviors regarding exercise and diet for adults with type 2 diabetes: a cross-sectional analysis.

BACKGROUND: Self-management is the cornerstone of diabetes control and prevention of complications; however, it is undetermined whether differences in intention to adopt healthy lifestyles and actual healthy behavior exist across race/ethnic groups. This study evaluated the differences across racial-ethnic groups in self-reported medical advice received and health intentions and behaviors among adults with type 2 diabetes mellitus. METHODS: A cross-sectional analysis of the 2007 SHIELD US survey ascertained self-reported health intentions and behaviors for regular exercise, diet, and weight management among Non-Hispanic Caucasian (n = 2526), Non-Hispanic African-American (n = 706), and Hispanic (n = 179) respondents with type 2 diabetes. RESULTS: A similar proportion of respondents from each race-gender group (43%-56%) reported receiving healthcare advice to increase their exercise (P = 0.32). Significantly more minorities reported an intention to follow the exercise recommendation compared with Non-Hispanic Caucasians (P = 0.03). More Non-Hispanic African-American (29%) and Hispanic (27%) men reported exercising regularly compared with other race-gender groups (P = 0.02). Significantly more Non-Hispanic Caucasian women (74%) and Hispanic women (79%) reported trying to lose weight compared with other groups (P < 0.0001). CONCLUSIONS: Differences in health intentions and healthy behaviors were noted across race-gender groups. More Non-Hispanic African-American men reported an intention to follow advice on exercising and self-report of exercising regularly was also higher compared with other race-gender groups. More Hispanic men reported high physical activity levels than other groups. Despite an increased willingness to follow healthcare recommendations for diet, >50% of respondents were obese among all race-gender groups.

Understanding Patient Perspectives and Awareness of the Impact and Treatment of Anemia with Chronic Kidney Disease: A Patient Survey in China.

BACKGROUND: Anemia is a common complication of chronic kidney disease (CKD) that may reduce patients' health-related quality of life (HRQoL). This study explored the experience and knowledge of patients with CKD, with and without anemia, in China. METHODS: A quantitative online survey was administered to 500 consenting Chinese patient volunteers aged ≥18 years with self-reported CKD, with or without anemia, between August 29, and September 17, 2018. Patients with cancer were excluded. The 27-question survey explored knowledge of anemia, HRQoL, anemia management, and interactions with healthcare providers. RESULTS: Of 456 evaluable patients, 148 (32.5%) reported having anemia and 262 (57.5%) did not. Knowledge of anemia and its symptoms varied, and approximately half of all patients did not know their hemoglobin level. Patients with anemia expressed an adverse impact of anemia on HRQoL, most commonly lack of energy (65.5%), sadness/depression (54.1%), and feeling ill (50.0%). The most frequently reported treatments among these patients were dietary advice (68.9%), iron supplements (63.5%), and oral medications (53.4%). Although 89.2% of patients with anemia trusted their healthcare providers above other information sources, only 29.0% reported seeking information from them; this was despite 92.6% reporting wanting further information and support about managing conditions like anemia. CONCLUSION: Our findings suggest that patients with CKD, both with and without anemia, would benefit from increased awareness of anemia and more in-depth discussions with healthcare providers in order to facilitate better management of CKD and optimization of treatment plans.

The Impact of CKD Anaemia on Patients: Incidence, Risk Factors, and Clinical Outcomes-A Systematic Literature Review.

Anaemia is a common consequence of chronic kidney disease (CKD); however, the risk factors for its development and its impact on outcomes have not been well synthesised. Therefore, we undertook a systematic review to fully characterise the risk factors associated with the presence of anaemia in patients with CKD and a contemporary synthesis of the risks of adverse outcomes in patients with CKD and anaemia. We searched MEDLINE, EMBASE, and the Cochrane Library from 2002 until 2018 for studies reporting the incidence or prevalence of anaemia and associated risk factors and/or associations between haemoglobin (Hb) or anaemia and mortality, major adverse cardiac events (MACE), hospitalisation, or CKD progression in adult patients with CKD. Extracted data were summarised as risk factors related to the incidence or prevalence of anaemia or the risk (hazard ratio (HR)) of outcome by Hb level (<10, 10-12, >12 g/dL) in patients not on dialysis and in those receiving dialysis. 191 studies met the predefined inclusion criteria. The risk factor most associated with the prevalence of anaemia was CKD stage, followed by age and sex. Mean HRs (95% CI) for all-cause mortality in patients with CKD on dialysis with Hb <10, 10-12, and >12 g/dL were 1.56 (1.43-1.71), 1.17 (1.09-1.26), and 0.91 (0.87-0.96), respectively. Similar patterns were observed for nondialysis patients and for the risks of hospitalisation, MACE, and CKD progression. This is the first known systematic review to quantify the risk of adverse clinical outcomes based on Hb level in patients with CKD. Anaemia was consistently associated with greater mortality, hospitalisation, MACE, and CKD progression in patients with CKD, and risk increased with anaemia severity. Effective treatments that not only treat the anaemia but also reduce the risk of adverse clinical outcomes are essential to help reduce the burden of anaemia and its management in CKD.

Atherosclerosis profile and incidence of cardiovascular events: a population-based survey.

BACKGROUND: Atherosclerosis is a chronic progressive disease often presenting as clinical cardiovascular disease (CVD) events. This study evaluated the characteristics of individuals with a diagnosis of atherosclerosis and estimated the incidence of CVD events to assist in the early identification of high-risk individuals. METHODS: Respondents to the US SHIELD baseline survey were followed for 2 years to observe incident self-reported CVD. Respondents had subclinical atherosclerosis if they reported a diagnosis of narrow or blocked arteries/carotid artery disease without a past clinical CVD event (heart attack, stroke or revascularization). Characteristics of those with atherosclerosis and incident CVD were compared with those who did not report atherosclerosis at baseline but had CVD in the following 2 years using chi-square tests. Logistic regression model identified characteristics associated with atherosclerosis and incident events. RESULTS: Of 17,640 respondents, 488 (2.8%) reported having subclinical atherosclerosis at baseline. Subclinical atherosclerosis was associated with age, male gender, dyslipidemia, circulation problems, hypertension, past smoker, and a cholesterol test in past year (OR = 2.2) [all p < 0.05]. Incident CVD was twice as high in respondents with subclinical atherosclerosis (25.8%) as in those without atherosclerosis or clinical CVD (12.2%). In individuals with subclinical atherosclerosis, men (RR = 1.77, p = 0.050) and individuals with circulation problems (RR = 2.36, p = 0.003) were at greatest risk of experiencing CVD events in the next 2 years. CONCLUSION: Self-report of subclinical atherosclerosis identified an extremely high-risk group with a >25% risk of a CVD event in the next 2 years. These characteristics may be useful for identifying individuals for more aggressive diagnostic and therapeutic efforts.

Perceived body image in men and women with type 2 diabetes mellitus: correlation of body mass index with the figure rating scale.

BACKGROUND: Body mass index (BMI) is often used as an objective surrogate estimate of body fat. Increased BMI is directly associated with an increase in metabolic disease, such as type 2 diabetes mellitus (T2DM). The Stunkard Figure Rating Scale (FRS) is a subjective measure of body fat, and self-perceptions of body image conceivably impact the development and treatment of T2DM. This study examined the self-perception of body image to various levels of BMI among those with T2DM. METHODS: Respondents (n = 13,887) to the US Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) 2006 survey self-reported their weight and height for BMI calculation. On the gender-specific Stunkard FRS, respondents selected the figure most closely resembling their body image. Spearman correlation was computed between perceived body image and BMI for men and women separately. Student's t-test analysis compared the mean BMI differences between respondents with and without T2DM. RESULTS: Men with T2DM did not significantly differ from men without diabetes mellitus in mean BMI per body image figure except at the extremes in body figures. Women with T2DM had a significantly higher BMI for the same body figure compared with women without diabetes mellitus for most figures (p < 0.05). CONCLUSIONS: Individuals, particularly women, with T2DM may differ in their perception of body image compared with those without diabetes mellitus. It is unclear if these perceived differences increase the risk of T2DM, or if the diagnosis of T2DM alters body image perceptions.

Impact of obesity on work productivity and role disability in individuals with and at risk for diabetes mellitus.

PURPOSE: Evaluate work absence, work productivity, and disruption of work, social, and family life among individuals of varying body mass index (BMI) with or at risk for diabetes mellitus. DESIGN: Cross-sectional analysis of survey data. SETTING: Community-based U.S. population. SUBJECTS: Respondents (n = 15,132; n = 7338 working adults) participating in the U.S. Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) study were stratified by combinations of BMI (i.e., > or = 30 kg/m2 [obese], 25 to 29.9 kg/ m2 [overweight], and < 25 kg/m2 [normal weight]) and diabetes (i.e., type 2 diabetes mellitus [T2DM], type 1 diabetes mellitus [T1DM], and high risk [HR] or low risk [LR] of T2DM). MEASURES: Work impairment was measured using the Work Productivity and Activity Impairment Questionnaire: General Health. Disruption in life was measured using the Sheehan Disability Scale. HR was defined as 3 to 5 of the following factors: abdominal obesity, BMI > or = 28 kg/m2, reported diagnosis of "cholesterol problems,"reported diagnosis of "hypertension, "or history of coronary heart disease or stroke. LR was defined as < or = 2 of these factors. RESULTS: Percentage of work impairment and proportion with severe disruption of work, family, and social life increased systematically from normal weight to obese (p < .001). Obese individuals had the greatest impairment at work (11%-15% of work time), greatest impairment of daily activities (20 %-34% of time), and greatest overall impairment (11%-15% of time) in the LR, HR, and T2DM groups. Obesity and T2DM were independent predictors of overall work impairment and life disruption (p < .001). Between 5% and 7% of total variance was explained in the regression models with BMI category, diabetes/risk group, age, gender, race, income, and household size as variables. CONCLUSION; Greatest impairment of work and daily activities was evident among obese individuals for all groups.

EQ-5D visual analog scale and utility index values in individuals with diabetes and at risk for diabetes: Findings from the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD).

BACKGROUND: The EQ-5D was used to compare burden experienced by respondents with diabetes and those at risk for diabetes. METHODS: A survey including the EQ-5D was mailed to individuals with self-reported diabetes, as well as those without diabetes but with the following risk factors (RFs): (1) abdominal obesity, (2) body mass index > or = 28 kg/m2, (3) dyslipidemia, (4) hypertension, and (5) cardiovascular disease. Non-diabetes respondents were combined into 0-2 RFs and 3-5 RFs. Mean EQ-5D scores were compared across groups using analysis of variance. Multivariable linear regression modeling identified factors affecting respondents' EQ-5D scores. RESULTS: Complete responses were available from >75% of each cohort. Mean EQ-5D index scores were significantly lower for respondents with type 2 diabetes and 3-5 RFs (0.778 and 0.792, respectively) than for those with 0-2 RFs (0.870, p < 0.001 for each); score for respondents with type 2 diabetes was also significantly lower than for those with 3-5 RFs (p < 0.001). Similar patterns were seen for visual analog scale (VAS). For both VAS and index scores, after adjusting for other characteristics, respondents reported decreasing EQ-5D scores as status moved from low to high risk (-6.49 for VAS score and -0.045 for index score) to a diagnosis of type 2 diabetes (-9.75 for VAS score and -0.054 for index score; p < 0.001 vs. 0-2 RFs for all). CONCLUSION: High-risk and type 2 diabetes groups had similar EQ-5D scores, and both were substantially lower than in low-risk respondents.

Affecting behavior change in individuals with diabetes: findings from the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD).

PURPOSE: This study evaluated whether health knowledge, attitudes, and behaviors of individuals with type 1 (T1DM) or type 2 (T2DM) diabetes mellitus and those at high or low risk of T2DM were reflected in healthy behaviors and whether these attributes differed for T2DM respondents who did or did not see a health educator. METHODS: SHIELD, a U.S. population-based study, included respondents (> or =18 years of age) with T1DM (n = 366), T2DM (n = 3897), high risk (HR, n = 5449) defined as > or =3 of the following: abdominal obesity, high body mass index, dyslipidemia, hypertension, cardiovascular disease, and low risk (LR, n = 5725) defined as < or =2 factors. RESULTS: T2DM respondents were more likely to receive health care professional recommendations to change their lifestyle habits (56%-62%) during their average 11 visits annually than the other groups (P < .0001). More T2DM and HR respondents tried losing weight, but fewer exercised regularly than T1DM and LR (P < .0001). T2DM respondents who saw a dietitian or health educator reported better current health and expectations for better future health, tried to make healthy food choices, and followed a prescribed eating plan than those who did not see these providers (P < .01). However, < or =30% of these T2DM respondents exercised regularly, or maintained desired weight. CONCLUSIONS: SHIELD findings show that respondents know and understand that improving their diet or exercise will affect their health, but the majority of respondents have not translated it into a behavior. Interaction with health educators and patient-empowering support may improve the transition to behavior change.

Glucose Control and Weight Change Associated with Treatment with Exenatide Compared with Basal Insulin: A Retrospective Study.

INTRODUCTION: The aim of the study was to compare glycemic and weight change outcomes for type 2 diabetes patients treated with either exenatide once-weekly (EQW) or exenatide twice-daily (EBID) with those patients treated with basal insulin (BI). METHODS: Retrospective data (2010-2014) were extracted from the Clinical Practice Research Datalink, a UK primary care database. Patients previously naïve to injectable therapy initiating EQW, EBID, or BI were extracted and matched by propensity score within two analyses (EQW vs BI and EBID vs BI). Absolute and relative change in HbA1c and weight from baseline and the proportion of patients achieving HbA1c ≤ 7.0% (53 mmol/mol) combined with weight reduction targets of (1) any weight loss or (2) ≥ 5.0% from baseline were compared at 6 and 12-24 months. RESULTS: A total of 485 patients initiated EQW, 3573 EBID, and 13,503 BI. In the propensity matched EQW versus BI analysis, mean HbA1c decreased with changes of - 1.33% (- 14.5 mmol/mol) and - 1.24% (- 13.5 mmol/mol) at 6 months and - 1.19% (- 13.0 mmol/mol) and - 1.17% (- 12.8 mmol/mol) at 12-24 months, respectively. Respective weight change was - 3.7 kg versus + 1.2 kg (p < 0.001) and - 3.2 kg versus + 2.5 kg (p < 0.001). Significantly more EQW patients achieved the combined HbA1c ≤ 7.0% (53 mmol/mol) and weight loss target (22.4% versus 9.9% at 6 months and 18.2% versus 8.0% at 12-24 months, respectively) and HbA1c ≤ 7.0% (53 mmol/mol) and minimum 5% weight loss (11.8% versus 3.7% at 6 months, and 8.0% versus 0.0% at 12-24 months). For EBID versus BI, similar results were found. CONCLUSION: In this real-world data analysis, exenatide QW and exenatide BID were associated with similar glycemic control and greater weight reduction compared with basal insulin.

Prevalence of self-reported diagnosis of diabetes mellitus and associated risk factors in a national survey in the US population: SHIELD (Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes).

BACKGROUND: Studies derived from continuous national surveys have shown that the prevalence of diagnosed diabetes mellitus in the US is increasing. This study estimated the prevalence in 2004 of self-reported diagnosis of diabetes and other conditions in a community-based population, using data from the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD). METHODS: The initial screening questionnaire was mailed in 2004 to a stratified random sample of 200,000 households in the US, to identify individuals, age > or = 18 years of age, with diabetes or risk factors associated with diabetes. Follow-up disease impact questionnaires were then mailed to a representative, stratified random sample of individuals (n = 22,001) in each subgroup of interest (those with diabetes or different numbers of risk factors for diabetes). Estimated national prevalence of diabetes and other conditions was calculated, and compared to prevalence estimates from the National Health and Nutrition Examination Survey (NHANES) 1999-2002. RESULTS: Response rates were 63.7% for the screening, and 71.8% for the follow-up baseline survey. The SHIELD screening survey found overall prevalence of self-reported diagnosis of diabetes (either type 1 or type 2) was 8.2%, with increased prevalence with increasing age and decreasing income. In logistic regression modeling, individuals were more likely to be diagnosed with type 2 diabetes if they had abdominal obesity (odds ratio [OR] = 3.50; p < 0.0001), BMI > or =28 kg/m2 (OR = 4.04; p < 0.0001), or had been diagnosed with dyslipidemia (OR = 3.95; p < 0.0001), hypertension (OR = 4.82; p < 0.0001), or with cardiovascular disease (OR = 3.38; p < 0.0001). CONCLUSION: The SHIELD design allowed for a very large, community-based sample with broad demographic representation of the population of interest. When comparing results from the SHIELD screening survey (self-report only) to those from NHANES 1999-2002 (self-report, clinical and laboratory evaluations), the prevalence of diabetes was similar. SHIELD allows the identification of respondents with and without a current diagnosis of the illness of interest, and potential longitudinal evaluation of risk factors for future diagnosis of that illness.

Treatment Outcomes and Tolerability Following Initiation of GLP-1 Receptor Agonists Among Type 2 Diabetes Patients in Primary Care Practices in Germany.

BACKGROUND: The aim was to investigate real-world treatment outcomes and tolerability of GLP-1 receptor agonist (GLP-1RA) therapy in patients with type 2 diabetes in Germany. METHODS: Patients from 323 primary care practices who started any GLP-1RA therapy (89 Byetta, 108 Bydureon, 347 Victoza patients) between January 1, 2011, and December 31, 2013 (index date) were analyzed retrospectively (Disease Analyzer database, Germany). Changes from baseline in HbA1c, weight, and hypoglycemia were evaluated in 3 follow-up periods of 0-6, 7-12, and 13-18 months. RESULTS: A total of 544 diabetes patients (mean age: 57.9 years; men: 54%) were eligible for the study. Mean (SD) HbA1c (%) decreased from 8.3 (1.4) at baseline to 7.4 (1.2) in 6 months, 7.6 (1.3) in 7-12 months and 7.6 (1.4) in 13-18 months, respectively ( P < .001 for all), while the proportion of patients with HbA1c <7% increased from 15% at baseline to 38%, 36% and 35% in the corresponding periods ( P < .0001 for all). Multivariate-adjusted beta coefficients corresponding to changes in HbA1c (%) from baseline were -.52, -.44, and -.44, respectively, in the follow-up periods for baseline HbA1c (%) ( P < .0001 for all). The prevalence of hypoglycemia at baseline was 0.7%; this did not change significantly after treatment. CONCLUSIONS: In clinical practice, GLP-1RA treatment was associated with improved glycemic control without increased hypoglycemia for up to 18 months. The higher the baseline HbA1c, the greater the HbA1c reduction recorded.

Discrete Choice Experiment Attribute Selection Using a Multinational Interview Study: Treatment Features Important to Patients with Type 2 Diabetes Mellitus.

INTRODUCTION: Methods for discrete choice experiment (DCE) attribute and attribute-level selection have not yet been firmly established and are rarely reported in detail. This paper describes a qualitative study designed to inform the development of a DCE survey designed to examine preferences for glucagon-like peptide-1 receptor agonist (GLP-1RA) treatments among patients with type 2 diabetes mellitus. METHODS: The study involved a literature review, interviews with clinical experts, and interviews with GLP-1RA-experienced (i.e., exenatide once weekly, liraglutide once daily) and injection-naïve type 2 diabetes patients from Brazil, China, Germany, Japan, and the UK. Interviews followed a semi-structured guide including open-ended questions, and probes to capture the patients' perspective on important aspects of GLP-1RAs and concerns with injectable treatments. Qualitative analyses were performed utilizing MAXQDA version 11. Descriptive statistics were used to summarize the sample. RESULTS: Thirty-two articles were reviewed, including 13 DCE studies. Thirty-one attributes were identified from the DCE studies, and 61 different attributes were identified in the non-DCE studies. Fifty patients completed interviews: 28 (56%) GLP-1RA-experienced and 22 (44%) injection-naïve, 54% were male, and they had a mean age of 52.8 years. Patients considered efficacy, adverse effects, and dosing frequency as the most important treatment-related attributes. From a list of five pre-defined device- or regimen-related attributes, patients considered dosing frequency, needle size, and injection preparation as the three most important attributes. CONCLUSION: This study adds to the DCE literature to inform researchers on attribute selection methodology in an international setting as there is limited published information to guide researchers on best practices for selecting and defining attributes for DCE surveys.

Glucagon-Like Peptide-1 Receptor Agonist Treatment Attributes Important to Injection-Experienced Patients with Type 2 Diabetes Mellitus: A Preference Study in Germany and the United Kingdom.

INTRODUCTION: This study assessed the relative importance of treatment-related attributes in influencing patient preferences for glucagon-like peptide-1 receptor agonists (GLP-1RAs) among injection-experienced type 2 diabetes mellitus (T2DM) patients in Germany and the United Kingdom. METHODS: T2DM patients experienced with injecting once-weekly (QW) exenatide or once-daily (QD) liraglutide completed an online discrete-choice experiment (DCE) survey. Patients chose between hypothetical blinded treatment profiles reflecting attributes of GLP-1RAs. The DCE survey included eight attributes: efficacy, side effects, device size, needle size, titration, injection preparation, long-term efficacy/safety, and dosing frequency. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using a conditional logit model indicating the likelihood of choosing a treatment with a given attribute level versus a reference attribute level. RESULTS: 510 GLP-1RA injection-experienced patients completed the survey; 45.3% respondents were being treated with exenatide QW and 54.7% respondents were being treated with liraglutide QD. In terms of GLP-1RA attributes, patients indicated a preference for a treatment with greater efficacy (i.e., a 1.5-point improvement in HbA1c) (OR 2.58; 95% CI 2.37, 2.80; p < 0.001), fewer side effects (OR 2.67; 95% CI 2.52, 2.82; p < 0.001), once-weekly rather than once-daily administration (OR 2.26; 95% CI 2.13, 2.39; p < 0.001), and the preparation required for a multi-use pen (OR 1.71; 95% CI 1.55, 1.88; p < 0.001). Needle size, device size, and titration were not significant drivers of patient preference. CONCLUSIONS: Among GLP-1RA injection-experienced patients, key drivers of treatment preference for a hypothetical GLP-RA profile were side effects, efficacy, dosing frequency, and required preparation. Understanding patient preferences is important for optimizing treatment decision-making and improving treatment adherence. FUNDING: AstraZeneca.

Glucagon-like Peptide-1 Receptor Agonist Treatment Attributes Important to Injection-Naïve Patients with Type 2 Diabetes Mellitus: A Multinational Preference Study.

INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) differ in efficacy, side effects, dosing frequency, and device-related attributes. This study assessed the relative importance of treatment-related attributes in influencing preferences for GLP-1RAs among injection-naïve patients with type 2 diabetes mellitus (T2DM). METHODS: Injection-naïve T2DM patients from five countries completed a Web-based discrete choice experiment (DCE) survey. Patients chose between hypothetical treatment profiles reflecting important and differentiating attributes of GLP-1RAs. Eight attributes were included: efficacy, side effects, device size, needle size, titration, preparation, evidence of long-term efficacy/safety, and dosing frequency. Odds ratios (ORs) and 95% confidence intervals were calculated using a conditional logit model to indicate the likelihood of choosing a treatment with a given attribute level versus a reference attribute level. The influence of individual attributes when considering full treatment profiles was examined using exenatide once weekly (QW) and liraglutide once daily (QD) as case examples. RESULTS: A total of 1482 patients with T2DM completed the DCE survey. Side effects, efficacy, and dosing frequency were the three most important attributes influencing preferences; needle size, device size, and required preparation were least important. Total sample analysis indicated that a profile of GLP-1RA approximating exenatide QW (single pen) was preferred over a profile approximating liraglutide QD (OR 3.36; p < 0.001), when efficacy was assumed to be equal. CONCLUSION: The most influential drivers of treatment preferences for a hypothetical GLP-RA profile were side effects, efficacy, and dosing frequency among injection-naïve T2DM patients. Preference elicitation can promote patient-centered care and inform new generations of T2DM treatments, which can lead to improved adherence and health outcomes.