Search results for "dosing"

Patient and ophthalmologist attitudes concerning compliance and dosing in glaucoma treatment.

2005

The aim of this study was to identify research avenues that might improve patient compliance with glaucoma therapy.500 patients and physicians were interviewed by telephone in 5 European countries, and the results were compiled and evaluated by 2 independent physicians.Most physicians believed that pressure reduction is useful (UK (96%), France (94%), Spain (80%), Italy (72%), and Germany (70%), p0.0001). The majority of physicians believed that noncompliance exists in 0%-25% of patients, whereas 34% of patients admitted to noncompliance. Physicians believed patients would prefer once-daily dosing (92%) and that it would help compliance, whereas 60% of patients preferred once-daily dosing, …

External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical set…

2013

Vancomycin is one of the most evaluated antibiotics in neonates using modeling and simulation approaches. However no clear consensus on optimal dosing has been achieved. The objective of the present study was to perform an external evaluation of published models, in order to test their predictive performances in an independent dataset and to identify the possible study-related factors influencing the transferability of pharmacokinetic models to different clinical settings. Published neonatal vancomycin pharmacokinetic models were screened from the literature. The predictive performance of 6 models was evaluated using an independent dataset (112 concentrations from 78 neonates). The evaluati…

Is GH dosing optimal in female patients with adult-onset GH deficiency? An analysis from the NordiNet® International Outcome Study

2017

SummaryObjective To evaluate gender differences in GH dosing, IGF-I and cardiovascular risk markers in adults with GH deficiency (GHD). Design NordiNet® International Outcome Study (NCT00960128), a noninterventional, multicentre study, evaluates the long-term effectiveness and safety of Norditropin® (Novo Nordisk A/S) in the real-life clinical setting. Patients Nondiabetic patients (n = 252; 41·7% female) with adult-onset GHD (age ≥20 years at GH start), ≥4 years’ GH therapy and glycosylated haemoglobin (HbA1c) data at baseline and 4 years. Measurements Effects of gender (adjusted for baseline age and body mass index [BMI], average GH dose, treatment duration and concomitant medication) on …

2021

Abstract Strong evidence suggests that endoplasmic reticulum stress plays a critical role in the pathogenesis of amyotrophic lateral sclerosis (ALS) through altered regulation of proteostasis. Robust preclinical findings demonstrated that guanabenz selectively inhibits endoplasmic reticulum stress-induced eIF2α-phosphatase, allowing misfolded protein clearance, reduces neuronal death and prolongs survival in in vitro and in vivo models. However, its safety and efficacy in patients with ALS are unknown. To address these issues, we conducted a multicentre, randomized, double-blind trial with a futility design. Patients with ALS who had displayed an onset of symptoms within the previous 18 mon…

Breakthrough Cancer Pain: Ten Commandments

2016

The term "breakthrough cancer pain" (BTcP) was introduced about 25 years ago. Peaks of pain intensity reported in patients with cancer had been invariably examined in the past years, providing relevant information for a better knowledge of this phenomenon and its treatment. The aim of this critical review was to provide the golden rules, namely, the 10 commandments, for a correct diagnostic pathway of BTcP and a consequent personalized pharmacological treatment. These are as follows: 1) assessment of background analgesia, 2) drugs used for background analgesia, 3) BTcP is a frequent phenomenon, 4) characteristics of BTcP, 5) diagnosis of BTcP, 6) continuous assessment, 7) tailored pharmacol…

Recent clinical evidence on metronomic dosing in controlled clinical trials: a systematic literature review.

2020

Introduction: Metronomic dosing is used to give continuous chemotherapy at low doses. The low doses have minimal side effects and may enable cancer treatment to be remodeled toward the management o...

NEO1 and NEO-EXT studies: Long-term safety of repeat avalglucosidase alfa dosing for 4.5 years in late-onset Pompe disease patients

2019

Safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of repeat avalglucosidase alfa dosing (5, 10, or 20 mg/kg qow) for 6 months were evaluated in NEO1 (NCT01898364) in late-onset Pompe disease patients either treatment-naive (Naive) or having received alglucosidase alfa for ≥9 months (Switch). In NEO-EXT (NCT02032524), an ongoing NEO1 extension, long-term safety and pharmacokinetics of repeat avalglucosidase alfa dosing will be monitored over 6 years. Interim safety results after 4.5 years of NEO-EXT are reported here. Mean ages at NEO1 enrollment were: Naive: 44.8 (SD:20.3, range:20-78) years and Switch: 46.7 (SD:14.1, range:21-68) years. Of the 24 NEO1 parti…

Antineoplastic dosing in overweight and obese cancer patients: an Associazione Italiana Oncologia Medica (AIOM)/Associazione Medici Diabetologi (AMD)…

2021

Most anticancer molecules are administered in body-size-based dosing schedules, bringing up unsolved issues regarding pharmacokinetic data in heavy patients. The worldwide spread of obesity has not been matched by improved methods and strategies for tailored drug dosage in this population. The weight or body surface area (BSA)-based approaches may fail to fully reflect the complexity of the anthropometric features besides obesity in cancer patients suffering from sarcopenia. Likewise, there is a lack of pharmacokinetic data on obese patients for the majority of chemotherapeutic agents as well as for new target drugs and immunotherapy. Therefore, although the available findings point to the …