Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study.

Objectives: DARWIN 3 (ClinicalTrials.gov: NCT02065700) assessed the safety and efficacy of filgotinib in a long-term extension (LTE) of two phase II randomised controlled rheumatoid arthritis (RA) trials.

Methods: Eligible patients completing the 24-week DARWIN 1 (filgotinib plus methotrexate) and DARWIN 2 (filgotinib monotherapy) trials could enrol.

GLPG1205 for idiopathic pulmonary fibrosis: a phase 2 randomised placebo-controlled trial.

Background: GLPG1205 is a selective functional antagonist of G-protein-coupled receptor 84, which plays an important role in fibrotic processes. This study assessed the efficacy, safety and tolerability of GLPG1205 for treatment of idiopathic pulmonary fibrosis (IPF).

Methods: PINTA (ClinicalTrials.

Reporting rates of adverse reactions to specialty care medicines exhibit a direct positive correlation with patient exposure: A lack of evidence for the Weber effect.

Aims: The classical Weber effect describes an increase in adverse reaction (AR) reports after medicinal product authorisation, with a peak in AR reporting at the end of the second year followed by a decline, despite increasing patient exposure. The present study aimed to evaluate the validity of the Weber effect in the context of authorised medicines in a specialty care setting.

Methods: Using 6-monthly sales data as a proxy for exposure, the exposure-adjusted reporting rates for AR reports for 10 selected specialty care medicines were plotted against time.

Angioedema in heart failure patients treated with sacubitril/valsartan (LCZ696) or enalapril in the PARADIGM-HF study.

Background: PARADIGM-HF demonstrated significant clinical benefits for sacubitril/valsartan (LCZ696, an angiotensin receptor neprilysin inhibitor) versus the angiotensin-converting enzyme inhibitor (ACEI) enalapril in patients with heart failure with reduced ejection fraction. As inhibition of ACE, and co-inhibition of ACE and neprilysin, may increase the risk of angioedema, this was an adverse event of special interest.

Methods: Following sequential enalapril and sacubitril/valsartan run-ins, patients were randomized to twice-daily sacubitril/valsartan 200 mg or enalapril 10 mg.

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug.

Comparative evaluation of surgical procedures for trigeminal neuralgia.

Trigeminal neuralgia (TN) is a debilitating ailment. Pharmacotherapy still remains the first line therapy for the management of TN. However, often the patients become refractory to the pharmacotherapy and need surgical interventions.

Computer simulation models are implementable as replacements for animal experiments.

It has become increasingly difficult to perform animal experiments, because of issues related to the procurement of animals, and strict regulations and ethical issues related to their use. As a result, it is felt that the teaching of pharmacology should be more clinically oriented and that unnecessary animal experimentation should be avoided. Although a number of computer simulation models (CSMs) are available, they are not being widely used.