Drugs
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A combination of prolonged-release (PR) oxycodone with PR naloxone (Targin(®), Targiniq(®), Targinact(®)) in one tablet with a fixed 2:1 ratio is available for the treatment of patients with severe pain, which can only be adequately managed with opioid analgesics. The aim of this formulation is to counteract opioid-induced constipation through the local antagonist effect of naloxone in the gut wall, while maintaining analgesia due to the low bioavailability of oral naloxone. Three large, 12-week, randomized, double-blind, phase III trials in patients with moderate to severe, chronic, non-malignant pain, plus a prospectively planned pooled analysis of two of these studies, demonstrated that oxycodone/naloxone PR improved bowel function, as measured by the bowel function index, compared with oxycodone PR. ⋯ Of note, numerically lower rates of constipation were observed in the oxycodone/naloxone PR group compared with the oxycodone PR group. A cost-utility analysis predicted that oxycodone/naloxone PR would be a cost-effective option compared with oxycodone PR in patients with non-malignant pain. Although more comparative data are needed, oxycodone/naloxone PR is an effective option for use in patients with severe chronic pain, particularly among those with opioid-induced constipation.
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QVA149 (indacaterol/glycopyrronium) [Xoterna(®) Breezhaler(®), Ultibro(®) Breezhaler(®)] is an inhaled fixed-dose combination of indacaterol (a long-acting selective β2-adrenergic receptor agonist [LABA]) and glycopyrronium (a long-acting muscarinic receptor antagonist [LAMA]) that has been approved in the EU and Japan for the symptomatic control of chronic obstructive pulmonary disease (COPD) in adults. In phase III studies, QVA149 significantly improved bronchodilation versus indacaterol, glycopyrronium or tiotropium alone and the LABA/inhaled corticosteroid fixed-dose combination salmeterol/fluticasone. These improvements in lung function, which were rapid in onset and maintained during long-term treatment, were generally associated with significant improvements in dyspnoea, health status, COPD exacerbation risk, patient symptoms, and rescue medication use. ⋯ Bronchodilators remain central to the symptomatic management of COPD. When dual bronchodilation is indicated, QVA149 offers the convenience of two bronchodilators in a single inhaler coupled with a simple, once-daily dosing regimen that may encourage better treatment adherence. Therefore, it is a valuable option in the treatment of COPD.
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Alemtuzumab (Lemtrada™) is a humanized therapeutic monoclonal antibody, which has been approved for use in patients with B-cell chronic lymphocytic leukaemia for several years, and has recently become approved in the EU and several other countries for use in adult patients with active relapsing-remitting multiple sclerosis. This article reviews the available pharmacological properties of intravenous infusions of alemtuzumab and its clinical efficacy and tolerability in adult patients with relapsing-remitting multiple sclerosis. Alemtuzumab is an effective treatment for patients with relapsing-remitting multiple sclerosis, and has a generally acceptable tolerability profile. ⋯ There was an increased risk of autoimmunity and infection associated with alemtuzumab in these trials; while these adverse events were generally mild to moderate, some were severe. Alemtuzumab is a highly convenient treatment, requiring hospital attendance for an intravenous infusion for a handful of days on two consecutive years, with no treatment required in between; however, this convenience is counterbalanced by the need for regular monitoring for the increased risk of autoimmunity. More investigation is required before final conclusions can be drawn on the correct placement of alemtuzumab in multiple sclerosis treatment; however, it is of a certainty a welcome addition to the treatment options for these patients.
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Rivaroxaban (Xarelto(®)) is an orally administered highly selective direct inhibitor of factor Xa that has been approved in many countries to reduce the risk of stroke in patients with atrial fibrillation and for the treatment and prevention of venous thromboembolism. More recently, rivaroxaban at a low dosage of 2.5 mg twice daily, co-administered with aspirin alone or aspirin plus either clopidogrel or ticlopidine, was approved for use in the EU for patients with a recent acute coronary syndrome (ACS). The approval of rivaroxaban in ACS was primarily based on findings of the phase III ATLAS ACS 2-TIMI 51 trial, which showed that after a median of 13.1 months of treatment with rivaroxaban 2.5 mg twice daily (combined with aspirin or aspirin plus either clopidogrel or ticlopidine) there was a statistically significant reduction in the rate of the primary composite endpoint, which was death from cardiovascular causes, myocardial infarction or stroke, compared with placebo. ⋯ There was an increase in the risk of major bleeding and intracranial haemorrhage with rivaroxaban 2.5 mg twice daily compared with placebo; however, there was no increase in the risk of fatal bleeding. Aspirin plus either ticagrelor or prasugrel was not evaluated as background dual antiplatelet therapy in ATLAS ACS 2-TIMI 51 and the safety implications of rivaroxaban used in combination with such therapy are unknown. In conclusion, results of the ATLAS ACS 2-TIMI 51 trial suggest a potentially important role for rivaroxaban 2.5 mg twice daily co-administered with aspirin alone or aspirin plus either clopidogrel or ticlopidine in patients with a recent ACS.