Expert review of clinical pharmacology
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Expert Rev Clin Pharmacol · Dec 2018
Review Comparative StudyMorphine sulfate abuse-deterrent formulations for the treatment of chronic pain.
Abuse-deterrent formulations have been developed to reduce inappropriate opioid use. The aim of this paper is to review existing literature about currently available morphine abuse-deterrent formulations. Areas covered: The US FDA has currently attributed an 'abuse-deterrent formulation' label to two different morphine compounds: an agonist/antagonist combination, and a morphine formulation with physical barrier. ⋯ Expert commentary: Available data from literature suggest that both formulations may offer an alternative with lower abuse potential in the treatment of chronic pain. Nevertheless, current evidence suggests that only a little percentage of abusers may stop abusing drugs as result of reformulation. More post-marketing studies are advocated to evaluate the real impact of abuse-deterrent formulations.
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Expert Rev Clin Pharmacol · Sep 2018
ReviewEfficacy, tolerability, and safety of serotonergic psychedelics for the management of mood, anxiety, and substance-use disorders: a systematic review of systematic reviews.
Mood, anxiety, and substance-use disorders are among the most prevalent psychiatric disorders in the population. Although several pharmacological treatments are available, they are not effective for a significant proportion of patients and are associated with several adverse reactions. Therefore, new treatments should be explored. ⋯ Although the results are promising, several studies were open label, and only few were RCTs, and most had small sample sizes and a short duration. Single or few doses of these drugs seem to be well tolerated, but long-term studies are lacking. New RCTs with bigger samples and longer duration are needed to replicate these findings.
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Expert Rev Clin Pharmacol · Sep 2018
Review Meta Analysis Comparative StudyComparative efficacy of bevacizumab, ranibizumab, and aflibercept for treatment of macular edema secondary to retinal vein occlusion: a systematic review and network meta-analysis.
Anti-vascular endothelial growth factor (VEGF) therapy has become the most commonly used treatment for macular edema secondary to retinal vein occlusion (RVO). Although its superior efficacy as compared to other interventions has been proven, there is a lack of evidence for relative efficacy among anti-VEGF drugs. Areas covered: This work systematically reviewed and compared the efficacy of intravitreal bevacizumab, ranibizumab, and aflibercept for treating macular edema due to RVO. ⋯ Expert commentary: Apparently, bevacizumab, ranibizumab, and aflibercept were significantly superior to sham injection in terms of BCVA improvement and CMT reduction and had good safety profiles. However, there were no statistically significant differences in any outcomes among anti-VEGF drugs. In selecting an anti-VEGF drug for individual patients, other factors including affordability, drug availability, and patient characteristics should be considered.
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In August 2017, the United States Federal Drug Administration (FDA) approved enasidenib (Idhifa, Celgene/Agios) for adults with relapsed and refractory acute myelogenous leukemia (AML) with an IDH2 mutation. Enasidenib targets cells with mutant copies of isocitrate dehydrogenase-2 (IDH2), inhibiting the oncometabolite 2-hydroxyglutarte (2-HG) formed by the mutant IDH2. Areas covered: We review the studies leading to enasidenib's approval, as well as common side effects and safety issues experienced during the clinical trials. ⋯ Enasidenib is beneficial in a patient population that previously had limited treatment options. However, given the fact that enasidenib is a highly specific inhibitor of an early stable mutation, it is questionable whether a strategy of targeting a single mutation or pathway in relapsed AML will allow for better than the 20% complete remission (CR) rate observed with this therapy. The proper role for single mutation targeting in AML needs to be carefully considered.
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Expert Rev Clin Pharmacol · Jul 2018
ReviewRivaroxaban: searching the integral vascular protection.
Residual cardiovascular risk remains high in patients with atherosclerotic cardiovascular disease despite current antithrombotic therapy. On the other hand, patients with atrial fibrillation have an increased risk of myocardial infarction and cardiovascular death. As a result, a new antithrombotic approach appears necessary to reduce this risk. ⋯ The COMPASS trial showed that among patients with stable atherosclerotic vascular disease, the addition of rivaroxaban 2.5 mg twice daily (vascular dose) to aspirin provided a higher cardiovascular protection than aspirin alone. In ROCKET-AF trial, compared with warfarin, rivaroxaban 20 mg once daily (15 mg if moderate renal dysfunction) (anticoagulant dose) was, at least, as effective as warfarin for the prevention of stroke or systemic embolism among patients with nonvalvular atrial fibrillation, with a trend toward a reduction in the risk of cardiovascular outcomes. All these data suggest that rivaroxaban might have a vascular protective effect beyond its stroke/systemic embolism preventive activity.