Search results for " Side Effects"

Effectiveness and safety of ombitasvir, paritaprevir, ritonavir ± dasabuvir ± ribavirin: An early access programme for Spanish patients with genotype…

2017

Over the last 5 years, therapies for hepatitis C virus (HCV) infection have improved significantly, achieving sustained virologic response (SVR) rates of up to 100% in clinical trials in patients with HCV genotype 1. We investigated the effectiveness and safety of ombitasvir/paritaprevir/ritonavir +/- dasabuvir in an early access programme. This was a retrospective, multicentre, national study that included 291 treatment-naive and treatment-experienced patients with genotype 1 or 4 HCV infection. Most patients (65.3%) were male, and the mean age was 57.5years. The mean baseline viral load was 6.1 log, 69.8% had HCV 1b genotype, 72.9% had cirrhosis and 34.7% were treatment-naive. SVR at 12 w…

Pelvic exenterations for primary rectal cancer: analysis from a 10-year national prospective database

2018

Aim: to identify short-term and oncologic outcomes of pelvic exenterations (PE) for locally advanced primary rectal cancer (LAPRC) in patients included in a national prospective database. Methods: few studies report on PE in patients with LAPRC. For this study, we included PE for LAPRC performed between 2006 and 2017, as available, from the Rectal Cancer Registry of the Spanish Association of Surgeons [Asociación Española de Cirujanos (AEC)]. Primary endpoints included procedure-associated complications, 5-year local recurrence (LR), disease-free survival (DFS) and overall survival (OS). A propensity-matched comparison with patients who underwent non-exenterative surgery for low rectal canc…

[Gadolinium-containing contrast agents: Gadoterat-meglumine is safe in patients with chronic renal failure].

2014

Objective To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients. Methods Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at −15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between base…

When symptoms become side effects: Development of the side effect attribution scale (SEAS)

2021

Objectives\ud \ud Symptom misattribution is a central process in the nocebo effect but it is not accurately assessed in current side effect measures. We have developed a new measure, the Side Effect Attribution Scale (SEAS), which examines the degree to which people believe their symptoms are treatment side effects.\ud \ud \ud \ud Methods\ud \ud The SEAS was tested in three New Zealand studies: a vaccination sample (n = 225), patients with gout or rheumatoid arthritis (n = 102), and patients switching to a generic medicine (n = 69). The internal reliability of the scale was examined using Cronbach's alpha. To assess validity, the Side Effect Attribution Total Score and Side Effect Attributi…

Effectiveness of dapagliflozin versus comparators on renal endpoints in the real world: A multicentre retrospective study.

2019

Aim: To evaluate the changes in renal endpoints in type 2 diabetes patients treated with dapagliflozin versus other glucose-lowering medications in routine clinical practice. Materials and Methods: DARWIN-T2D was a retrospective study conducted at 46 outpatient diabetes clinics in Italy. An automated software collected data on 17 285 patients who received dapagliflozin, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, or gliclazide, 6751 of whom had a follow-up visit. We analysed changes in albumin excretion rate (AER) and estimated glomerular filtration rate (eGFR). Results: Patients who received dapagliflozin (n = 473) were younger, more obese, and had a poore…

Evaluation of 13-valent pneumococcal conjugate vaccine and concomitant meningococcal group C conjugate vaccine in healthy infants and toddlers in Spa…

2013

Abstract Background Given the concurrent administration of multiple vaccines during routine pediatric immunizations, efforts to elucidate the potential interference of any vaccine on the immune response to the concomitantly administered antigens are fundamental to prelicensure clinical research. Methods This phase 3 randomized controlled trial of 13-valent pneumococcal conjugate vaccine (PCV13) versus 7-valent PCV (PCV7) assessed immune responses of concomitantly administered meningococcal group C conjugated to diphtheria toxin cross-reactive material 197 (MnCCV-CRM 197 ) in a 2-dose infant series and 15-month toddler dose. Results 619 subjects were randomized, 315 to PCV13 and 304 to PCV7.…

Medical treatment and medical side effects in urinary incontinence in the elderly

1998

A Model‐Based Workflow to Benchmark the Clinical Cholestasis Risk of Drugs

2021

We present a generic workflow combining physiology-based computational modeling and in vitro data to assess the clinical cholestatic risk of different drugs systematically. Changes in expression levels of genes involved in the enterohepatic circulation of bile acids were obtained from an in vitro assay mimicking 14 days of repeated drug administration for 10 marketed drugs. These changes in gene expression over time were contextualized in a physiology-based bile acid model of glycochenodeoxycholic acid. The simulated drug-induced response in bile acid concentrations was then scaled with the applied drug doses to calculate the cholestatic potential for each compound. A ranking of the cholest…

Predictors of survival in patients with advanced hepatocellular carcinoma who permanently discontinued sorafenib

2015

Treatment with sorafenib of patients with advanced hepatocellular carcinoma is challenged by anticipated discontinuation due to tumor progression, liver decompensation, or adverse effects. While postprogression survival is clearly determined by the pattern of tumor progression, understanding the factors that drive prognosis in patients who discontinued sorafenib for any reason may help to improve patient management and second-line trial design. Patients consecutively admitted to three referral centers who were receiving best supportive care following permanent discontinuation of sorafenib for any reason were included. Postsorafenib survival (PSS) was calculated from the last day of treatmen…

Dabigatran after Short Heparin Anticoagulation for Acute Intermediate-Risk Pulmonary Embolism: Rationale and Design of the Single-Arm PEITHO-2 Study

2017

AbstractPatients with intermediate-risk pulmonary embolism (PE) may, depending on the method and cut-off values used for definition, account for up to 60% of all patients with PE and have an 8% or higher risk of short-term adverse outcome. Although four non-vitamin K-dependent direct oral anticoagulants (NOACs) have been approved for the treatment of venous thromboembolism, their safety and efficacy as well as the optimal anticoagulation regimen using these drugs have not been systematically investigated in intermediate-risk PE. Moreover, it remains unknown how many patients with intermediate-high-risk and intermediate-low-risk PE were included in most of the phase III NOAC trials. The ongo…