Aims Therapeutic drug monitoring of infliximab can guide clinical decisions in patients with loss of response and in those who can benefit from a de‐intensification. The aim of this study was to determine the impact of therapeutic drug monitoring combined with Bayesian forecasting methodology on clinical response in a real‐world dataset of patients suffering from inflammatory bowel disease. Methods We performed a single‐centre prospective study with one‐group pre‐test/post‐test design in 108 adult inflammatory bowel disease patients treated with model‐based dosing of infliximab maintenance treatment. We recorded clinical activity scores (Harvey‐Bradshaw index and partial Mayo) and inflammatory biomarkers per patient. Results The initial infliximab regimen was maintained in 49 (45.4%) patients and was adjusted in 59 (54.6%) patients (34 treatment intensifications, 9 de‐intensifications and 16 treatment discontinuations or therapy replacements). The median time from intervention to index measurement was 126 (103–160) days. The overall proportion of patients in clinical remission increased from 65.7% to 80.4% (P < .0001) and the median infliximab trough concentrations increased from 3.21 (0.99–5.45) to 5.13 mg/L (3.57–6.53) (P < .0001). In the intensified group, the remission rate increased from 35.3% to 61.8% (P = .001) and the percentage of patients in clinical remission or with mild symptoms increased from 76.5% to 94.1%. In the de‐intensification cohort, no patients experienced an increase in the Harvey‐Bradshaw index or partial Mayo scores, and all patients maintained an infliximab trough concentration of >5 mg/L. Conclusion In our cohort of inflammatory bowel disease patients, Bayes‐based optimized dosing improved the short‐term efficacy of infliximab treatment.
Background Digoxin, the oldest cardiovascular drug, has been used for the treatment of heart failure and in frequency control strategies in atrial fibrillation (AF) patients. American College of Cardiology/American Heart Association (ACC/AHA) guidelines from 2009 and European Society of Cardiology (ESC) guidelines from 2012, on the management of acute and chronic heart failure (CHF), recommend digoxin for symptom relief and reducing hospital admissions. The ESC-recommended serum digoxin levels used for treating of CHF are 0.8–1.5 nmol/l (0.6–1.2 ng/ml) and equivalent ACC/AHA guidelines recommend 0.64–1.2 nmol/l (0.5–0.9 ng/ml). A serum digoxin level ≥3.0 nmol/l (2.5 ng/ml) is considered to be toxic. Purpose The aim of our study was to analyse a patient population admitted to emergencies for digoxin intoxications in a third-level hospital. Materials and methods This was a retrospective single-centre study of patients admitted to Emergencies with the diagnosis of digoxin intoxication from January 2010 to May 2012. Variables collected from medical records: demographic data (sex, age), antecedents (diabetes, acute (ARF) and chronic (CRF) renal failure, hypertension, dyslipidaemia, CHF), digoxin treatment data, reason for intoxication, test results at admission and treatment at discharge. All categorical variables are reported as frequency and percentage, while the continuous variables were reported as mean ± standard deviation. Results 136 out of 237,068 patients admitted to hospital as emergencies had digoxin intoxication (106 women, 81.8 ± 8.7 years). 36.1% diabetic, 53.5% and 35.6% suffered ARF and CRF, 86.7% hypertensive, 45.9% dyslipidaemia and 69.2% CHF). 47.8% were treated with digoxin for AF and 47% for CHF and AF. The mean daily dose of digoxin was 0.163 ± 0.050 mg. The main reasons for digoxin intoxication were ARF (34.5%), acute kidney injury in CRF (22.7%) and no dosage adjustment (21.8%). The mean digoxin serum levels were 3.36 ± 1.29 mcg/L and creatinine 167.9 ± 121.4 μmol/L. Two patients required treatment with anti-digoxin antibody and three were admitted to the ICU. At discharge, digoxin treatment was stopped (53.2%), dose adjusted (23.4%) or changed to another drug (12.9%) in most of the cases. Conclusions According to the results published, we have found that elderly women with impaired renal function are at the greatest risk. Therefore, early recognition is important for close monitoring and to reduce admissions. No conflict of interest.
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