Benefits of Vildagliptin Plus Metformin Combination Therapy in Type 2 Diabetes Mellitus (T2DM) from Patient’s Perspective: Quality of Life (QoL) and Hypoglycemia Burden Analysis

Abstract

A447Objectives: Acromegaly is a rare, chronic, hormonal disorder caused by excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1) production resulting predominantly from pituitary adenoma. The objective was to test endocrinologist acceptability of the newly developed SAGIT tool in clinical practice. MethOds: SAGIT (Signs and symptoms -Associated comorbidities -GH concentration level -IGF-1 -Tumour) is a Clinician-Reported Outcomes (ClinROs) tool developed with international experts in acromegaly; it allows patient classification and description in a standardised manner. The tool was pre-tested for acceptability, understanding and ease of use with practicing endocrinologists in France, Germany, UK, Spain, Italy and Brazil (n= 2 per country) using the PRAgmatic Content and face validity Test (PRAC-Test). The endocrinologists completed the SAGIT tool prior to and following an intervention (therapeutics or surgery) for three patients each (n= 36). Once completed, a one-hour phone interview was conducted with each endocrinologist to collect their feedback on the tool. Results: The tool was well accepted and deemed concise (n= 11) and informative (n= 10) by the endocrinologists. Several points were raised that illustrate its usefulness in clinical practice, including the removal of the subjectivity when assessing the disease severity, the possibility of rapid evaluation of the control/progression of acromegaly or of a treatment response, and the possibility for standardisation across countries. Key recommendations for improvements were the need to include: 1) instructions to facilitate the understanding and the use of the tool; 2) definitions of rules and recommendations for patient management; and 3) addition of other signs and symptoms and further details about tumour size to better reflect their clinical cases. cOnclusiOns: SAGIT is a useful tool for endocrinologists to accurately stage and classify acromegaly patients in clinical practice. It is currently being piloted in a cross-sectional study. Validation of scoring rules will confirm the utility of the tool to improve patient management.