Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract 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. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

Are we helping or harming our insulin-treated diabetic patients during ambulatory treatment?

Introduction. Correctness of insulin treatment depends on both the experience and skills of the doctor and knowledge and behaviour of the patient. Objective. Evaluation the adequacy of insulin doses administered to diabetes patients in ambulatory conditions. Material and methods. The treatment of 59 patients hospitalized in the Diabetology Ward was evaluated at admission, discharge and 3 months after hospitalization. Results. The mean daily doses of insulin significantly differed at times of evaluation and were: 53.90, 39.31 and 43.34 units, respectively (p≈0.000001). A significant reduction of body weight, 90.86 vs. 88.25 kg (p≈0.000001), was obtained only during hospitalization, and was maintained 3 months after discharge (87.86 kg). Significant differences were also noted in the body mass index (33.44 vs. 32.48 vs. 32.37 kg/m2, p≈0.000001). The change in waist circumference was not statistically significant (107.87 vs. 104.89 cm; p≈0.06). A decrease in the number of hypoglycaemia episodes was observed, but were statistically insignificant (25 vs. 23; p≈0.7). Three months after hospitalization an insignificant decrease of HbA1c level was noted (8.41% vs. 8.03%; p≈0.07). Conclusions. During treatment in the Diabetology Ward the procedure of choice was more frequently a reduction than an increase in insulin doses. This management led to the reduction of the patients’ body weight, improvement of glycaemia, without any significant effect on the diabetes control determined by the HbA1c level

Medical and socio-demographic determinants of depressive disorders in diabetic patients

Introduction. Diabetes is a civilisation disease creating a serious challenge for public health. In Poland, approximately 2 million people suffer from diabetes, of which about 25% are unaware of their illness. A considerable part of persons with diabetes experience complications related with the disease. Objective. The aim of the study was to determine the relationship between elements of the state of health and socio-demographic characteristics of diabetic patients treated in the Diabetes Clinic at the Institute of Rural Health (IMW) in Lublin, eastern Poland, and the occurrence of depressive symptoms in these patients. Materials and method. The study was conducted in 2017–2018 among patients treated in the Diabetes Clinic at the Institute of Rural Health in Lublin, by the method of a diagnostic survey using the Beck’s Depression Inventory and an author-constructed questionnaire, as well as data from the patients’ medical records. The study included 314 patients from the Diabetes Clinic who expressed their informed consent to participate in the research. Results. The study showed that diabetes is a disease which predisposes for the occurrence of depression. The occurrence of depressive symptoms of various degrees of intensity was confirmed in more than a half of the examined patients. Among the factors which exerted a significant effect on the occurrence of depressive symptoms were: diabetic neuropathy, type 2 diabetes, high BMI value, lack of occupational activity, poor material standard, and the need to obtain assistance in daily functioning due to the fact of being ill with diabetes. Conclusions. It is necessary to implement routinely performed examinations into the diagnostic-therapeutic process to assess the state of psychological health of diabetic patients, which would allow sufficiently early application of appropriate psychological or psychiatric intervention