Medicines and the internet

The internet has been a major revolution in enhancing the accessibility of information and goods to the public challenging well-established healthcare practices. The Internet Pharmacy is now an integral part of these searches giving enhanced access to medicines to the public. It has become a global multibillion dollar market and brings with it threats and opportunities which could not have been foreseen. A Rogue Internet Pharmacy is a very real threat to the patient and healthcare professional. Of serious concern is the increase in distribution of counterfeit medicines through these sites. The EU is currently preparing legislation to regulate Internet Pharmacy Services to protect patients.peer-reviewe

The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With at Least Two Tyrosine Kinase Inhibitors

Asciminib is an allosteric high-affinity tyrosine kinase inhibitor (TKI) of the BCR-ABL1 protein kinase. This kinase is translated from the Philadelphia chromosome in chronic myeloid leukemia (CML). Marketing authorization for asciminib was granted on August 25, 2022 by the European Commission. The approved indication was for patients with Philadelphia chromosome-positive CML in the chronic phase which have previously been treated with at least 2 TKIs. Clinical efficacy and safety of asciminib were evaluated in the open-label, randomized, phase III ASCEMBL study. The primary endpoint of this trial was major molecular response (MMR) rate at 24 weeks. A significant difference in MRR rate was shown between the asciminib treated population and the bosutinib control group (25.5% vs. 13.2%, respectively, P=.029). In the asciminib cohort, adverse reactions of at least grade 3 with an incidence≥5% were thrombocytopenia, neutropenia, increased pancreatic enzymes, hypertension, and anemia. The aim of this article is to summarize the scientific review of the application which led to the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.</p

Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective

Since the implementation of the EU Orphan Regulation in 2000, the Committee for Orphan Medicinal Products at the European Medicines Agency has been evaluating the benefits of proposed orphan medicines vs. satisfactory treatment methods. This type of evaluation is foreseen in the Orphan Regulation as the orphan designation criterion called the "significant benefit." In this article, based on 20 years of experience, we provide a commentary explaining what is considered a satisfactory method of treatment in the context of the EU Orphan Regulation and for the purpose of the assessment of significant benefit. We discuss the challenges posed by continuously changing clinical practise, which is associated with the increasing number of treatment options, evolving nature of medicinal therapeutic indications and our understanding of them

Efeito do estresse sobre a secreção de glicocorticoides como causa da infertilidade: The effect of stress on glucocorticoid secretion as a cause of infertility

Evidências sugerem que a patogênese de desordens reprodutivas, tais como a infertilidade, pode envolver perturbações no eixo hipotalâmico relacionadas ao estresse físico ou emocional. Este estudo se refere a uma revisão bibliográfica que busca reunir informações acerca do funcionamento dos hormônios reprodutivos sob condições de estresse como possível causa psicossomática da infertilidade

Comparison of Anthropometric Profile and Cognitive Performance of Elite and Non-Elite Beach Volleyball Athletes

To compare the anthropometric profile and cognitive performance of elite and non-elite beach volleyball athletes. Comparative and descriptive study. The sample was composed by 8 athletes, divided in 2 groups: elite (n = 4) and non-elite (n = 4). They were evaluated in anthropometric parameters age, weight and height, and the variables of the cognitive performance evaluated by the battery of computerized tests CogState® (Brief Battery): Detection (Simple Reaction Time); Identification (Choice Reaction Time); One Back Speed (Working Memory); One Back Acuracy (Short Term Memory). Data were classified as non-parametric with the dispersion curve analysis performed by the Shapiro Wilk test. Anthropometric profile and cognitive performance variables were compared with the Mann Whitney U test between the groups. The procedures were performed with a significance level of p < 0.05 using the Statistical Package for the Social Science - SPSS®, Version 25.0. It was observed that there was significant difference in the anthropometric profile in the variable age (sig = 0.029) and in the cognitive performance significant differences occurred in the variables Detec (sig = 0.029) and Indent (sig = 0.029) of elite and not elite athletes of the beach volleyball modality. Elite and non-elite beach volleyball athletes present significant differences in the anthropometric variable (Age) and in the variables of cognitive performance (Detection and Identification) where elite athletes have a better cognitive performance than the non- elite athletes

A Lifetime Modelled Economic Evaluation Comparing Pioglitazone and Rosiglitazone for the Treatment of Type 2 Diabetes Mellitus in the UK

Introduction: Adding pioglitazone or rosiglitazone to existing therapy are alternative treatment options for patients with type 2 diabetes mellitus who have insufficient glycaemic control while receiving the maximal tolerated dose of metformin monotherapy. Our objective was to develop a lifetime model of type 2 diabetes mellitus and its sequelae in order to compare the costs and benefits of pioglitazone versus rosiglitazone in combination with metformin. Methods: A decision-analytic model employing a first order Monte Carlo simulation of a Markov process was constructed. The model incorporated surrogate outcome measures from a large randomised controlled trial (RCT) [n_=_802] that compared the glycaemic and lipid control of pioglitazone and rosiglitazone monotherapy. These efficacy data were used with a recently validated and peer-reviewed UKPDS (UK Prospective Diabetes Study) algorithm to simulate the progression of these surrogate outcomes to final health outcomes, including quality of life (QOL) and mortality, and to calculate the risks of diabetic complications and death. The model perspective was of the UK NHS and included direct healthcare costs only (Lstg , 2004/5 values). Patient outcomes measured in the model included life-expectancy (LE) and QALYs. The base-case analysis was run for 56-year-old male Caucasions with a haemoglobin A1c (HbA1c) of 7.57% and a body mass index of 33.14 kg/m2. Results: Patients treated with pioglitazone experienced a reduction in the total cholesterol to high-density lipoprotein-cholesterol (TC___HDL-C) ratio of 0.34, whereas the TC___HDL-C ratio increased by 0.65 in those receiving rosiglitazone (p_Cost-effectiveness, Cost-utility, Pioglitazone, Rosiglitazone, Type-2-diabetes-mellitus

The orphan drug pipeline in Europe

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