Expert review of clinical pharmacology
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Expert Rev Clin Pharmacol · Jul 2017
GFF MDI for the improvement of lung function in COPD - A look at the PINNACLE-1 and PINNACLE-2 data and beyond.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally and incidence rates are continuing to rise. Long-acting bronchodilators are the foundation on which current pharmacological approaches to COPD management are built, with long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs) recommended across the spectrum of the disease continuum. Combining LAMAs and LABAs provides additional lung function improvements and relief of patient symptoms compared with either therapy alone. ⋯ Areas covered: This article describes the rationale for the development of the LAMA/LABA FDC of glycopyrrolate and formoterol fumarate, formulated by Co-Suspension™ Delivery Technology and delivered by MDI (GFF MDI). The clinical trial program of GFF MDI, including the pivotal Phase III studies (PINNACLE-1 and PINNACLE-2) that supported regulatory approval, are reviewed, providing insights into interpretation and future directions for research. Expert commentary: LAMA/LABA FDCs are already a crucial part of the COPD treatment paradigm, but additional data are needed in order to maximize their role as maintenance therapies in patients with COPD.
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Expert Rev Clin Pharmacol · May 2017
ReviewPirfenidone for the treatment of idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis (IPF) is a diffuse parenchymal lung disease with no cure. Up until recently, no treatment had been proven to alter its natural history as judged by rate of lung function decline. In 2014 however, the emergence of two novel anti-fibrotic agents, Pirfenidone and Nintedanib revolutionized the management of this condition. ⋯ Areas Covered: This review article focuses on Pirfenidone - a pyridone derivative initially designed as an analgesic and anti-pyretic agent. Here we describe the history of the drug from its inception through to exploratory pre-clinical in-vitro and in-vivo studies where its anti-fibrotic potential was identified, and eventually to large multicenter randomized controlled trials. Expert Commentary: This article also summarizes some of the difficulties surrounding clinical end-point selection in IPF trials and addresses some of the challenges facing the IPF community over the coming years.
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Expert Rev Clin Pharmacol · Apr 2017
ReviewCannabinoids therapeutic use: what is our current understanding following the introduction of THC, THC:CBD oromucosal spray and others?
The complexity of the endocannabinoid (eCB) system is becoming better understood and new drivers of eCB signaling are emerging. Modulation of the activities of the eCB system can be therapeutic in a number of diseases. Research into the eCB system has been paralleled by the development of agents that interact with cannabinoid receptors. ⋯ Clinical trials have confirmed its efficacy and tolerability. Other diseases in which different cannabinoids are currently being investigated include various pain states, Alzheimer's disease, Parkinson's disease, Huntington's disease and epilepsy. The continued characterization of individual cannabinoids in different diseases remains important.
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Expert Rev Clin Pharmacol · Apr 2017
Meta AnalysisCollaborative approach of individual participant data of prospective studies of de-escalation in non-immunosuppressed critically ill patients with sepsis.
There is a concern to conduct de-escalation in very sick patients. ⋯ In our study there was an independent association of de-escalation and decrease mortality rate.
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Expert Rev Clin Pharmacol · Mar 2017
ReviewAsthma phenotypes in children and stratified pharmacological treatment regimens.
Asthma is the most common inflammatory disease in childhood. The interaction of genetic, environmental and host factors may contribute to the development of childhood asthma and defines its progress, including persistence and severity. Until now, various classifications of childhood asthma phenotypes have been suggested based on patient's age during onset of symptoms, type of inflammatory cells, response to treatment and disease severity. ⋯ Areas covered: The current childhood asthma phenotypes and the new therapeutic strategies for each phenotype are reviewed. Expert commentary: There are multiple phenotypes in childhood asthma and it is crucial to define them before the initiation of personalized treatment. Both the therapeutic strategy and monitoring should follow the recent guidelines.