Assessment of the impact of type 2 diabetes on the quality of life by Audit of Diabetes-Dependent Quality-of-Life (ADDQoL-19)

Together with the epidemic prevalence of diabetes mellitus (DM), the burden of this chronic metabolic disorder has serious impact on the quality of life of patients and reduces their life span. The objective of this study was to assess the impact of type 2 diabetes mellitus (T2DM) on the Quality of Life (QoL) by Audit of Diabetes-Dependent Quality-of-Life (ADDQoL-19). A cross-sectional study of 540 adults with T2DM was carried out. We collected socio-economic, demographic, health status, therapeutic and metabolic control data. The instrument used to measure the quality of life was the ADDQoL-19. The study included 411 adult patients [216 (52.6%) men; mean age 59.9. years]. T2DM had a negative impact on QoL in 36.7% of the participants, whereas 67.1% believed that their life would have been better without the presence of T2DM. The mean ‘present QoL’ score was: 0.6 (SD: 0.9) and the ‘diabetes-related’ QoL was: −1.8 (SD: 0.8). Diabetes had the most negative average weighted impact on ‘freedom to eat’ −4.0 (SD: 2.6), and ‘family life’ −3.9 (SD: 2.7). The results indicate that T2DM has a significant impact on QoL and its assessment is an important tool in the management of this disease. The negative values reflect the general negative impact of diabetes over all 19 examined aspects. These findings are of importance to health professionals and policy makers to identify and implement appropriate interventions in order to achieve better disease management and ultimately to increase the QoL of patients with T2DM

Bulgarian version of the Audit of Diabetes-Dependent Quality of Life (ADDQoL-19)

<p>The aims of this study were to translate and culturally adapt the UK English Audit of Diabetes-Dependent Quality of Life version 19 (ADDQOL-19) into Bulgarian and explore the psychometric properties of the ADDQoL-19 BUL. The formalized linguistic procedure was used to develop the Bulgarian version of the ADDQoL-19 BUL. The ADDQoL was assessed for the following: internal consistency (Cronbach's alpha); test--retest reliability (intraclass correlation coefficient (ICC)); factor structure and known-groups validity (insulin requiring vs. non-insulin requiring, with vs. without diabetes-related complications, overweight/obese vs. not overweight/obese). A total of 423 adults with type 2 diabetes mellitus (T2DM) participated in the study. The mean age was 59.92 years (standard deviation (SD) 11.60, range 28–88 years), and 52.6% were male. Internal consistency (α = 0.922) and the 3-week test–retest stability (intraclass correlation = 0.99) were high. Confirmatory factor analysis indicated that the one-factor structure of the ADDQoL-19 fits moderately (χ² = 230.63, <i>df</i> = 136, <i>p</i> < 0.001, SRMR (Standardized Root Mean Square Residual) of 0.05, RMSEA (Root Mean Square Error of Approximation) of 0.06, CFI (Comparative Fit Index) of 0.95). Standardized coefficients showed that all domains loaded 0.4, except for one item. The total score was negatively associated with HbA₁c (<i>r</i> = −0.10; <i>p</i> < 0.05), indicating that lower scores were related to poorer glycaemic control. In conclusion, the Bulgarian version of the ADDQoL-19 has good psychometric properties and provides clinicians and researchers with a useful tool for comprehensive assessment of the quality of life in adults with diabetes mellitus.</p

Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. RESULTS: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. CONCLUSION: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk

Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes

BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo