ABSTRACT
AIM: In a world of data overload, clinical practice recommendations are needed to help practitioners and patients to take evidence-based decisions. However, in the field of type 2 diabetes mellitus (T2DM) recommendations on glycemic goals and treatment choice are controversial in spite of being supported by a common body of evidence. We hypothesize that internal and external validity of this body of evidence might not be as sound as expected. The aim of the current study is to appraise the studies supporting recommendations developed by influential medical societies dealing with glycemic goals and the choice of pharmacological treatment in adults with T2DM. METHODS: Clinical practice recommendations and their references were extracted out of eight documents developed by influential scientific societies between 2016 and 2019. Internal and external validity of each study was then appraised with standard tools and in duplicate. RESULTS: A total of 114 recommendations and their underlying 233 citations were extracted. Out of these 233 citations 81 (35%) corresponded to randomized controlled trials (RCT) and 45 (20%) to systematic reviews. After systematical appraisal only four RCT (5%) and eight systematic reviews (17%) were considered to be unflawed. Indirectness (lack of generalizability) was the most common caveat identified in RCTs. Out of the 114 recommendations analyzed (32 dealing with glycemic goals and 82 with treatment choice), only 21 (18.4%) were supported by at least one high-quality study. CONCLUSION: Only one in five recommendations regarding glycemic goals or pharmacological treatment choice in T2DM is based on at least one high-quality study. Clinical practice recommendations dealing with areas of uncertainty should be formulated more transparently to enable real evidence-based decisions.
Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Glycemic Control/standards , Guidelines as Topic , Evidence-Based Medicine , Humans , Societies, MedicalSubject(s)
Canagliflozin , Diabetes Mellitus, Type 2 , Cardiovascular System , Humans , Hypoglycemic Agents , KidneyABSTRACT
El descubrimiento de la etiopatogenia autoinmune de la diabetes mellitus tipo 1 (DM1) junto con la eficacia de diversas estrategias inmunoterapéuticas en modelos animales de DM1 espontánea abrieron, hace ya más de 30 años, la vía de la intervención inmunofarmacológica en esta entidad. Hoy por hoy, los estudios que evalúan la inmunoterapia al comienzo de la DM1 tienen el objetivo de modificar la historia natural de la pérdida de secreción endógena insulínica de una forma segura y aditiva a la obtenida mediante el tratamiento insulínico intensificado. Tras las grandes expectativas levantadas a principios del presente siglo con la publicación de prometedores estudios piloto, en los últimos meses han visto la luz los resultados de ensayos clínicos fase III con resultados insatisfactorios, lo que ha levantado nuevamente entre la comunidad científica el debate sobre los estudios de inmunointervención al comienzo de la DM1
The discovery of type 1 diabetes mellitus' (T1DM) autoimmune etiopathogenesis, as well as the effectiveness of diverse immunotherapeutic strategies in T1DM animal models, opened a scenario of pharmacological immuno-intervention in this disease, more than 30 years ago. The aim of current trials that are evaluating these immune therapies at T1DM onset, is to safely modify the natural history of insulin secretion loss in addition to that obtained with intensive insulin treatment. After the great expectations arised at the beginning of the present century with the publication of promising pilot studies, the results of phase III clinical trials have recently been published, with unsatisfactory results. This has again led to a debate on immunological therapies at T1DM onset in the scientific community
