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      The Real-Life Effectiveness and Care Patterns of Diabetes Management Study for Balkan Region (Slovenia, Croatia, Serbia, Bulgaria): A Multicenter, Observational, Cross-Sectional Study

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          Recent large randomized controlled trials highlighted the clinical significance of hypoglycemic episodes in the treatment of diabetes. The present survey was conducted to provide information from real-life practice on the incidence of hypoglycemia in type 2 diabetic patients treated with sulfonylureas.


          This multicenter, observational, cross-sectional study collected data on incidence of side effects of sulfonylurea-based therapy in type 2 diabetic patients in four countries of the Balkan region (Slovenia, Croatia, Serbia, Bulgaria) from October 2014 to June 2015.


          Of the 608 who participated in the study, 573 patients (mean age 67.2 years, mean body mass index 29.9 kg/m 2) met the inclusion/exclusion criteria. More than 90% of the patients were treated with the newer generation sulfonylureas—gliclazide or glimepiride—either as monotherapy or as dual therapy in combination with metformin. In total, 210 patients (36.6%) reported hypoglycemic episode(s) in the last 6 months. Mild episodes were reported by 132 patients (62.8%), moderate by 66 (31.2%), severe by 8 patients (4.0%), and very severe by 4 patients (2%), respectively. Overall, 171 patients (28.2%) reported body weight increase during the previous year. The mean reported body weight gain in this group of patients was 4.2 kg (SD 2.7, median 3). Among them, 68.1% gained less than 5 kg, 25.0% gained 5–9 kg, and the rest gained more than 10 kg.


          Although newer generation sulfonylureas are generally considered safe in terms of hypoglycemia, our data indicates their use is associated with substantial risk of hypoglycemia and weight gain. Clinicians should be mindful of these findings when prescribing SUs and inform patients about the risk of hypoglycemia.


          Merck Sharp & Dohme.

          Electronic supplementary material

          The online version of this article (doi:10.1007/s13300-017-0288-x) contains supplementary material, which is available to authorized users.

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          Most cited references 22

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          Fear of hypoglycemia: quantification, validation, and utilization.

          Hypoglycemia can lead to various aversive symptomatic, affective, cognitive, physiological, and social consequences, which in turn can lead to the development of possible phobic avoidance behaviors associated with hypoglycemia. On the other hand, some patients may inappropriately deny or disregard warning signs of hypoglycemia. This study presents preliminary reliability and validity data on a psychometric instrument designed to quantify this fear: the hypoglycemic fear survey. The instrument was found to have internal consistency and test-retest stability, to covary with elevated glycosylated hemoglobin, and to be sensitive to a behavioral treatment program designed to increase awareness of hypoglycemia.
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            Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study.

            This study was undertaken to evaluate (i) factors associated with patient-reported hypoglycaemia; (ii) association of patient-reported hypoglycaemic symptoms with treatment satisfaction and barriers to adherence and (iii) association between treatment satisfaction, adherence and glycaemic control among patients with type 2 diabetes who added a sulphonylurea or a thiazolidinedione to ongoing metformin. This observational, cross-sectional, multicentre study was conducted in seven countries (Finland, France, Germany, Norway, Poland, Spain and UK) from June 2006 to February 2007. Patients with type 2 diabetes who added a sulphonylurea or a thiazolidinedione to ongoing metformin therapy on a date (index date) from January 2001 through January 2006 and who had at least one haemoglobin A1C (HbA1C) measurement in the 12-month period before the visit date were eligible. Questionnaires were used to ascertain patients' reports of hypoglycaemic symptoms, treatment satisfaction, and treatment adherence. The Treatment Satisfaction Questionnaire for Medication was used to measure patients' treatment satisfaction. An adherence and barriers questionnaire was used to measure patients' adherence to treatment. Glycaemic control was based on documented HbA1C measurements within the prior 12 months. The mean +/- s.d. age was 62.9 +/- 10.6 years, and the mean +/- s.d. duration of diabetes was 7.8 +/- 5.1 years. HbA1C in this population of patients who had failed metformin monotherapy and were treated with oral antihyperglycaemic agents was below the International Diabetes Federation goal of 6.5% in only 477 (27.9%) patients. Approximately 38% of patients reported hypoglycaemic symptoms during the past year. Hypoglycaemia was significantly more likely in patients with a history of macrovascular complications of diabetes (OR = 1.346; 95% CI = 1.050-1.725) and with no regular physical activity (OR = 1.295; 95% CI = 1.037-1.618). Patients reporting hypoglycaemia had significantly lower treatment satisfaction scores (71.6 +/- 17.6 vs. 76.3 +/- 16.8; p < 0.0001 for global satisfaction). Compared with their counterparts reporting no hypoglycaemic symptoms, patients with such symptoms were also significantly more likely to report barriers to adherence, including being unsure about instructions (37.0 vs. 30.5%; p = 0.0057). Patients at HbA1C goal had significantly higher treatment satisfaction and adherence compared with those who were not. Patients' reports of hypoglycaemic symptoms are common in European outpatients with type 2 diabetes and are associated with significantly lower treatment satisfaction and with barriers to adherence. In addition, being at HbA1C goal is associated with treatment satisfaction and adherence.
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              The impact of hypoglycaemia on quality of life and related patient-reported outcomes in Type 2 diabetes: a narrative review.

              As a common side effect of insulin treatment for diabetes, hypoglycaemia is a constant threat and can have far-reaching and potentially devastating consequences, including immediate physical injury as well as more pervasive cognitive, behavioural and emotional effects. Moreover, as a significant limiting factor in achieving optimal glycaemic control, exposure to hypoglycaemia can influence diabetes self-management. Although hypoglycaemia is known to occur in Type 2 diabetes, its morbidity and impact on the individual are not well recognized. The aim of the current review is to examine published evidence to achieve a synthesis of the scope and significance of the potential detriment caused by hypoglycaemia to individuals with Type 2 diabetes. The implications of these observations for treatment and research have also been considered. A narrative review was performed of empirical papers published in English since 1966, reporting the effect of hypoglycaemia on quality of life and related outcomes (including generic and diabetes-specific quality of life, emotional well-being and health utilities) in Type 2 diabetes. Research demonstrates the potential impact of hypoglycaemia on the lives of people with Type 2 diabetes, from an association with depressive symptoms and heightened anxiety, to impairment of the ability to drive, work and function in ways that are important for quality of life. Few studies consider hypoglycaemia as an explanatory variable in combination with quality of life or related primary endpoints. As a consequence, there is a pressing need for high-quality research into the overall impact of hypoglycaemia on the lives of people with Type 2 diabetes. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

                Author and article information

                Diabetes Ther
                Diabetes Ther
                Diabetes Therapy
                Springer Healthcare (Cheshire )
                10 July 2017
                10 July 2017
                August 2017
                : 8
                : 4
                : 929-940
                [1 ]ISNI 0000 0004 0397 736X, GRID grid.412210.4, Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Internal Medicine, , University Hospital Rijeka, ; Rijeka, Croatia
                [2 ]ISNI 0000 0004 0571 7705, GRID grid.29524.38, Department of Endocrinology, Diabetes and Metabolic Diseases, , University Medical Centre Ljubljana, ; Ljubljana, Slovenia
                [3 ]MHAT 5 Sofia EAD, Sofia, Bulgaria
                [4 ]Novi Beograd Health Center, Belgrade, Serbia
                [5 ]Family General Practice, Petra Preradovica 25, Varazdin, Croatia
                © The Author(s) 2017
                Funded by: Merck Sharp and Dohme
                Original Research
                Custom metadata
                © Springer Healthcare Ltd. 2017


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