Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1?year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn?s disease or ulcerative colitis who have achieved clinical remission for ?6?months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1?year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission. Clinical trial reference number: EudraCT 2015-001410-1

Estudio mediante monitorización ambulatoria de la presión arterial del efecto de bata blanca en hipertensos tratados y controlados en atención primaria

Introducción y objetivos. Se considera fenómeno de bata blanca (FBB) cuando la diferencia de presión arterial sistólica/presión arterial diastólica entre la observada en la consulta y la ambulatoria es mayor de 20/10 mmHg, respectivamente. Dichas diferencias absolutas corresponderían a lo que llamamos efecto de bata blanca (EBB), que puede ser la causa de que se considere como hipertensos a normotensos con hipertensión de bata blanca (HBB). En nuestro trabajo analizamos, mediante monitorización ambulatoria de la presión arterial, la prevalencia de la respuesta presora (EBB, FBB, HBB) de los pacientes con hipertensión arterial de grado 1 y/o 2 en fase de realización de su tratamiento farmacológico, así como tras 4 semanas de supresión controlada de la medicación antihipertensiva. Pacientes y método. Se realizaron estudios de monitorización ambulatoria de la presión arterial a 70 pacientes hipertensos con buen control tras el tratamiento, antes de suspender la medicación antihipertensiva (primera fase) y a las 4 semanas de abandonar el tratamiento (segunda fase). Resultados. De los 70 pacientes, 18 (26%) no llegaron a realizarse la segunda monitorización ambulatoria de la presión arterial, ya que tras la retirada de la medicación presentaron valores inaceptables de presión arterial que obligaron a reintroducirla. El EBB fue significativamente más alto en la primera fase, mientras que para el FBB e HBB no hubo diferencias significativas. Al final del estudio, la prevalencia de HBB fue del 33%. Conclusiones. La retirada de la medicación antihipertensiva en pacientes con hipertensión de grado 1 y/o 2 bien controlados no modifica de manera significativa la prevalencia de FBB e HBB, y el EBB es mayor cuando los pacientes están sometidos a tratamiento farmacológico. La tercera parte de estos pacientes están sobrediagnosticados de hipertensión arterial

Could renin-angiotensin-aldosterone system activation explain the amputations associated with canagliflozin? The nitric oxide hypothesis.

One of the most important reported adverse effects events of related to sodium-glucose cotransporter-2 inhibitors (SGLT2i) is lower-limb amputations. While the reasons for the increased rate of these events are still unclear, it is unlikely that an unique explanation may explain the mechanisms by which this undesired effect occurs. In the present article we propose a hypothesis based on the observation of two patients with type 2 diabetes mellitus (DM) who, after receiving dapagliflozin, experienced erectile dysfunction (ED). In both cases the ED did not improve after adding losartan but improved markedly after starting treatment with ramipril, a type 1 angiotensin-converting enzyme inhibitor (ACEi), without the need to remove dapagliflozin. In both patients the ED was evaluated using the internationally validated test IIEF-5 (International Index of Erectile Function 5 items) [1]. Alternative hormonal and pharmacological causes for ED were ruled out