Real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes in Spain: The Dapa-ON multicenter retrospective study.

OBJECTIVE: To assess real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes mellitus (T1DM). METHODS: We conducted a multicenter retrospective study in Spain including data from 250 people living with T1DM receiving dapagliflozin as add-on therapy to insulin (80.8 % on-label use). The number of diabetic ketoacidosis (DKA) events was calculated over a 12-month follow-up (primary outcome). Changes in body weight, HbA1c, total daily insulin dose, and continuous glucose monitoring (CGM) metrics from baseline (at dapagliflozin prescription) to 12 months were also evaluated. RESULTS: A total of five DKA events (2.4 % [95 % CI 0.3;4.5] were reported in patients with a 12-month follow-up, n = 207): two events related to insulin pump malfunction, two events related to concomitant illnesses, and one event related to insulin dose omission. DKA events were more frequent among insulin pump users than among participants on multiple daily injections (7.7 % versus 1.2 %). Four of the reported DKA events occurred within the first six months after initiation of dapagliflozin. No deaths or persistent sequelae due to DKA were reported. No severe hypoglycemia episodes were reported. Significant reductions in mean body weight (-3.3 kg), HbA1c (-0.6 %), and total daily insulin dose (-8.6 %), P < 0.001, were observed 12 months after dapagliflozin prescription. Significant improvements in TIR (+9.3 %), TAR (-7.2 %), TBR (-2.5 %), and coefficient of variation (-5.1 %), P < 0.001, were also observed in the subgroup of patients with available CGM data. Finally, an improvement in urinary albumin-to-creatinine ratio (UACR) was found among participants with UACR ≥ 30 mg/g at baseline (median decrease of 99 mg/g in UACR, P = 0.001). CONCLUSION: The use of dapagliflozin in people living with T1DM has an appropriate safety profile after careful selection of participants and implementation of strategies to reduce the risk of DKA (i.e., prescribed according to the recommendations of the European Medicines Agency), and also leads to clinical improvements in this population.

Ultrarapid Insulin Use Can Reduce Postprandial Hyperglycemia and Late Hypoglycemia, Even in Delayed Insulin Injections: A Connected Insulin Cap-Based Real-World Study.

Objectives: Reaching optimal postprandial glucose dynamics is a daily challenge for people with type 1 diabetes (T1D). This study aimed to analyze the postprandial hyperglycemic excursion (PHEs) and late postprandial hypoglycemia (LPH) risk according to prandial insulin time and type. Research Design and Methods: Real-world, retrospective study in T1D using multiple daily injections (MDI) analyzing 5 h of paired continuous glucose monitoring and insulin injections data collected from the connected cap Insulclock®. Meal events were identified using the rate of change detection methodology. Postprandial glucometrics and LPH (glucose <70 mg/dL 2-5 h after a meal) were evaluated according to insulin injection time and rapid (RI) or ultrarapid analog, Fiasp® (URI), use. Results: Meal glycemic excursions (n = 2488), RI: 1211, 48.7%; UR: 1277, 51.3%, in 82 people were analyzed according to injection time around the PHE: -45 to -15 min; -15 to 0 min; and 0 to +45 min. In 63% of the meals, insulin was injected after the PHE started. Lower PHE was observed with URI versus RI (glucose peak-baseline; mg/dL; mean ± standard deviation): 106.7 ± 35.2 versus 111.2 ± 40.3 (P = 0.003), particularly in 0/+45 injections: 111.6 ± 40.2 versus 118.1 ± 43.3; (P = 0.002). One third (29.1%) of participants added a second (correction) injection. The use of URI and avoiding a second injection were independently associated with less LPH risk, even in delayed injections (0/+45), (-36%, odds ratio [OR] 0.641; confidence interval [CI]: 0.462-0.909; P = 0.012) and -56% (OR 0.641; CI: 0.462-0.909 P = 0.038), respectively. Conclusions: URI analog use as prandial insulin reduces postprandial hyper- and hypoglycemia, even in delayed injections.

Mediterranean Diet and Cardiodiabesity: A Systematic Review through Evidence-Based Answers to Key Clinical Questions.

The Mediterranean Diet (MedDiet) has been promoted as a means of preventing and treating cardiodiabesity. The aim of this study was to answer a number of key clinical questions (CQs) about the role of the MedDiet in cardiodiabesity in order to provide a framework for the development of clinical practice guidelines. A systematic review was conducted to answer five CQs formulated using the Patient, Intervention, Comparison, and Outcome (PICO) criteria. Twenty articles published between September 2013 and July 2016 were included, adding to the 37 articles from the previous review. There is a high level of evidence showing that MedDiet adherence plays a role in the primary and secondary prevention of cardiovascular disease (CVD) and improves health in overweight and obese patients. There is moderate-to-high evidence that the MedDiet prevents increases in weight and waist circumference in non-obese individuals, and improves metabolic syndrome (MetS) and reduces its incidence. Finally, there is moderate evidence that the MedDiet plays primary and secondary roles in the prevention of type 2 diabetes mellitus (T2DM). The MedDiet is effective in preventing obesity and MetS in healthy and at-risk individuals, in reducing mortality risk in overweight or obese individuals, in decreasing the incidence of T2DM and CVD in healthy individuals, and in reducing symptom severity in individuals with T2DM or CVD.

Adherence Of Spanish Primary Physicians And Clinical Practise To The Mediterranean Diet.

BACKGROUND/OBJECTIVES: The primary objective of this study was to explore physicians' adherence to the dietary pattern known as the Mediterranean diet (MD). As a secondary objective we assessed physicians' awareness on the benefits of the MD and of the possibility of prescribing it. SUBJECTS/METHODS: Physicians' adherence to the MD was evaluated through the Spanish associations SEMERGEN and CAMFIC, who sent the validated PREDIMED screener to their affiliates. The results reflected a high, medium, low or very low level of adherence depending on total score. The sample was drawn between 2014 and 2016. The second questionnaire evaluated the physicians' knowledge of the MD and their opinion about recommending it. RESULTS: The PREDIMED test was answered by 422 Spanish physicians. In 8 out of 14 questions, more than 50% of the individuals scored only 1 point. However, 3 questions resulted in 1 point being scored by almost all physicians. Thus, on average, 55% of questions obtained 1-point scoring. The second questionnaire was answered by 212 physicians; 70% of them considered themselves to be aware of the benefits of the MD. More than 60% said they could invest 5 min of their time to recommend the MD. CONCLUSIONS: Primary care physicians do not show a high level of adherence to the MD and emphasize the need for creating tools to evaluate it in their patients. This research can be useful as both a database and a justification for the creation of a new protocol to help physicians increase their own and their patients' MD adherence.

Anestesia epidural para realizar gastrostomía abierta en paciente con esclerosis lateral amiotrófica / Epidural anesthesia for open gastrostomy in a patient with amyotrophic lateral sclerosis

Abstract Amyotrophic lateral sclerosis is characterized by the progressive degeneration of motor neurons, causing a constellation of symptoms that include muscle weakness, atrophy, fasciculations, spasticity, and hyperreflexia. Currently, Rulizol is the only treatment that has been shown to delay its progression, though to a very small extent. Disease prognosis is grim, with death caused mainly by respiratory failure secondary to muscle weakness, making anesthetic management of these patients a true challenge. The use of muscle relaxants must be avoided as much as possible because of the high risk of ventilatory depression, considering that these patients have an abnormal unpredictable response as a result of heightened sensitivity related to the lower number of acetylcholine receptors. If muscle relaxants are required during the surgery, rocuronium, among nondepolarizing muscle relaxants, is the drug of choice because of its short half-life, while depolarizing relaxants such as succinylcholine are contraindicated because of the risk of lethal hyperkalemia. In terms of intraoperative hypnotics and analgesics, propofol and remifentanil are ideal because of their short half-life. Regarding neuroaxial anesthesia, despite widespread reluctancy to use it, its benefits and rather uncommon adverse effects lead many anesthetists to consider it as an important alternative when it comes to deciding between general or neuroaxial anesthesia, because it reduces airway manipulation significantly, thus reducing respiratory complications as described in this clinical case.

Resumen La esclerosis lateral amiotrófica se caracteriza por la degeneración progresiva de las neuronas motoras provocando una constelación de síntomas que incluyen debilidad muscular, atrofia, fasciculaciones, espasticidad e hiperreflexia. Actualmente, el unico tratamiento que ha demostrado retrasar mínimamente su progresión ha sido el Rulizol. Su pronóstico es infausto, falleciendo mayoritariamente por insuficiencia respiratoria secundaria a la debilidad de su musculatura, siendo el manejo anestésico de estos pacientes, un importante desafío. El uso de relajantes neuromusculares deberá evitarse en la medida de lo posible por el riesgo elevado de depresión ventilatoria, ya que estos pacientes tienen una respuesta anormal e impredecible a ellos al presentar una sensibilidad aumentada por el menor número de receptores de acetilcolina; Si la cirugía requiere de ellos, es de elección dentro de los relajantes neuromusculares no despolarizantes, el rocuronio por su vida media corta, contraindicándose el uso de los despolarizantes como la succinilcolina, por el riesgo de hiperkaliemia letal. En cuanto a los hipnóticos y analgésicos que deberemos de usar intraoperatoriamente, el propofol y remifentanilo serían los más ideales por su vida media corta. En cuanto a la anestesia neuroaxial, a pesar de la reticencia extendida a su uso, su beneficio y sus no tan frecuentes efectos adversos, hacen a muchos anestesistas, considerarla como una alternativa de peso a la hora de decidir entre anestesia general o neuroaxial, pues reduce considerablemente la manipulación de la vía aérea, disminuyendo por tanto complicaciones respiratorias posteriores, como referimos en el caso clínico que describiremos a continuación.

Recalcitrant hypocalcaemia in a patient with post-thyroidectomy hypoparathyroidism and Roux-en-Y gastric bypass.

INTRODUCTION: Roux-en-Y gastric bypass (RYGB) places patients at an increased risk of hypocalcaemia due to the reduction in calcium absorption (because the procedure bypasses the duodenum and jejunum) and vitamin D deficiency. Subsequent thyroid surgery increases the risk of severe hypocalcaemia due to potential post-operative hypoparathyroidism. Only a few cases have been published before of this type of treatment-challenging hypocalcaemia. CLINICAL PRESENTATION: We report the case of a 31-year-old woman with a previous RYGB, who suffered severe and symptomatic chronic hypocalcaemia after total thyroidectomy. She required aggressive therapy with oral calcium and calcitriol and frequent calcium infusions, but there was no improvement in serum calcium level. Due to the lack of response to standard therapy, teriparatide treatment was started (first with subcutaneous injections and thereafter with a multipulse subcutaneous infusor) but the results were disappointing. As there was no response to different medical treatments, reversal of RYGB was performed with no complications and a subsequent sustained increase in serum calcium level. CONCLUSIONS: This case shows that patients with postoperative hypoparathyroidism and RYGB have increased risk of severe recalcitrant symptomatic hypocalcaemia. In our case teriparatide was ineffective but, as this is the first patient reported, more results are needed to evaluate properly the effect of teriparatide in this multifactorial hypocalcaemia. Reversal of RYGB should be considered when medical therapy has failed, because surgery restores an adequate absorption of calcium and vitamin D from previously bypassed duodenum and proximal jejunum.

Mediterranean diet and cardiodiabesity: a review.

Cardiodiabesity has been used to define and describe the well-known relationship between type 2 Diabetes Mellitus (T2DM), obesity, the metabolic syndrome (MetS) and cardiovascular disease (CVD). The objective of this study was to perform a scientific literature review with a systematic search to examine all the cardiovascular risk factors combined and their relationship with adherence to the Mediterranean Diet (MedDiet) pattern as primary prevention against cardiodiabesity in a holistic approach. Research was conducted using the PubMed database including clinical trials, cross-sectional and prospective cohort studies. Thirty-seven studies were reviewed: fourteen related to obesity, ten to CVD, nine to MetS, and four to T2DM. Indeed 33 provided strong evidence on the association between adherence to a MedDiet and a reduced incidence of collective cardiodiabesity risk in epidemiological studies. This scientific evidence makes the MedDiet pattern very useful for preventive strategies directed at the general population and also highlights the need to consider all these diet-related risk factors and health outcomes together in daily primary care.

Hemibalismo secundario a descompensación hiperglucémica hiperosmolar / Hemiballism due to hyperglycemic hyperosmolar syndrome

El síndrome hiperglucémico hiperosmolar no cetósico (SHNC) se ha asociado con diversas alteraciones neurológicas, incluidos los trastornosd el movimiento. Es la segunda causa más frecuente de hemicoreahemibalismo, que se produce como consecuencia de la afectación delputamen contralateral. Presentamos a una paciente de 95 años con un SHNC que desarrolló un hemibalismo secundario a una lesión putaminal (AU)

Non-ketotic hyperglycemia has occasionally been associated with various neurological abnormalities including movement disorders. Hyperglycemichyperosmolar syndrome (HHS) is the second most common cause of hemiballism-hemichorea, which is due to acontralateral putaminal lesion. We describea 95-year-old woman with HHS who developed hemichorea-hemiballism syndrome due to a putaminal lesión (AU)

Diabetes mellitus y síndrome diarreico en mujer de edad avanzada / Diabetes mellitus and diarrhea in an elderly woman

Entre un 5 y un 10% de los adultos diagnosticados inicialmente de diabetes mellitus tipo 2 (DM2) en realidad tienen diabetes autoinmunitaria de inicio en la edad adulta. Dado el elevado número de pacientes con diagnóstico de DM2, la entidad que ha sido denominada por algunos autores como LADA (latent autoimmune diabetes in adults) podría suponer la mitad de todos los diabéticos con DM1A. Presentamos el caso de una mujer de 75 años de edad, con antecedentes de diabetes mellitus con labilidad en el control glucémico y síndrome de colon irritable, que finalmente fue diagnosticada de diabetes autoinmunitaria con enfermedad celíaca concomitante (AU)

Between 5 and 10% of adults initially diagnosed with type 2 diabetes mellitus (DM) actually have adult-onset autoimmune diabetes. Given the large number of patients diagnosed with DM type 2, the entity called latent autoimmune diabetes in adults (LADA) by some authors could represent half of all diabetics with type 1A diabetes. We report the case of a 75-year-old woman, with a history of brittle diabetes and irritable bowel syndrome, who was finally diagnosed with autoimmune diabetes and celiac disease (AU)

Diabetes and diarrhea in an elderly woman.

Between 5 and 10% of adults initially diagnosed with type 2 diabetes mellitus.(DM) actually have adult-onset autoimmune diabetes. Given the large number of patients diagnosed with DM type 2, the entity called latent autoimmune diabetes in adults (LADA) by some authors could represent half of all diabetics with type 1A diabetes. We report the case of a 75-year-old woman, with a history of brittle diabetes and irritable bowel syndrome, who was finally diagnosed with autoimmune diabetes and celiac disease.

Hemiballism due to hyperglycemic hyperosmolar syndrome.

Non-ketotic hyperglycemia has occasionally been associated with various neurological abnormalities including movement disorders. Hyperglycemic hyperosmolar syndrome (HHS) is the second most common cause of hemiballism-hemichorea, which is due to a contralateral putaminal lesion. We describe a 95-year-old woman with HHS who developed hemichorea-hemiballism syndrome due to a putaminal lesion.

Transformación anaplásica tardía de dos bocios multinodulares / Late anaplastic transformation of two multinodular

El carcinoma anaplásico de tiroides es un tumor muy agresivo con una supervivencia media de 3 a 7 meses. El 50% se desarrolla a partir de bocios multinodulares de larga evolución y el 20-30% coexiste con carcinomas diferenciados. Presentamos los casos de 2 pacientes ancianas con bocio multinodular en seguimiento durante años que sufrieron, de forma brusca, una transformación anaplásica. Ante esta posibilidad, y dado el pronóstico infausto de este tipo de carcinoma, se aconseja realizar un seguimiento de por vida en estos pacientes

Anaplastic thyroid carcinoma is a highly aggressive tumor with a mean survival of 3-7 months. Up to one half of patients have long-standing multinodular goiter and 20-30% have a coexisting differentiated carcinoma. We present two elderly patients under follow-up for multinodular goiters that suddenly showed anaplastic transformation many years after the initial diagnosis. Given the possibility of malignant transformation and the fatal prognosis of this carcinoma, life-long surveillance of these patients is advisable