Drugs
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial.
The combination of an inhaled corticosteroid (ICS) and a long-acting bronchodilator is recommended in the treatment of patients with chronic obstructive pulmonary disease (COPD) who have frequent exacerbations. Budesonide/formoterol dry powder inhaler (DPI) has demonstrated efficacy and tolerability in patients with COPD. ⋯ Budesonide/formoterol pMDI 320/9 microg demonstrated significantly greater efficacy for pulmonary function on both co-primary endpoints versus the pre-specified comparators (formoterol DPI 9 microg for pre-dose FEV(1) and budesonide pMDI 320 microg for 1-hour post-dose FEV(1)). Budesonide/formoterol pMDI 160/9 microg demonstrated significantly greater efficacy for 1-hour post-dose FEV(1) versus budesonide pMDI 320 microg. Dyspnoea scores and HR-QOL were significantly improved with both budesonide/formoterol pMDI dosage strengths versus both monocomponents and placebo. Both budesonide/formoterol pMDI dosage strengths were well tolerated relative to the monocomponents and placebo.
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A large proportion of patients with congenital heart disease (CHD), in particular those with relevant systemic-to-pulmonary shunts, will develop pulmonary arterial hypertension (PAH) if left untreated. Persistent exposure of the pulmonary vasculature to increased blood flow, as well as increased pressure, may result in pulmonary obstructive arteriopathy, which leads to increased pulmonary vascular resistance that, if it approaches or exceeds systemic resistance, will result in shunt reversal. Eisenmenger's syndrome, the most advanced form of PAH associated with CHD, is defined as CHD with an initial large systemic-to-pulmonary shunt that induces severe pulmonary vascular disease and PAH, with resultant reversal of the shunt and central cyanosis. ⋯ One randomized controlled trial reported favourable short- and long-term outcomes of treatment with the orally active dual endothelin receptor antagonist bosentan in patients with Eisenmenger's syndrome. Lung transplantation with repair of the cardiac defect or combined heart-lung transplantation are options for Eisenmenger's syndrome patients with a poor prognosis. A treatment algorithm based on the one used in the treatment of PAH patients is proposed for patients with PAH associated with corrected and uncorrected congenital systemic-to-pulmonary shunts and Eisenmenger's syndrome.
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We have analysed the published literature on eptacog alfa (recombinant factor VIIa; rFVIIa) for nonhaemophiliac conditions with the aim of determining its current place in therapy. Initial surgical and/or medical management is required for any patient with life-threatening bleeding. In those with continued life-threatening bleeding (i.e. despite maximal surgical and/or medical therapy), eptacog alfa may be considered as additional therapy, in exceptional circumstances. ⋯ In addition to conventional measures to stop bleeding (i.e. surgery and blood transfusion), correction of hypothermia and acidosis, and reversal of anticoagulation are all recommended. The outcomes (effectiveness and safety) of all off-label uses should be systematically evaluated and reported. Adequate data to assess cost effectiveness for eptacog alfa does not exist for most off-label indications.
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Dalbavancin is a semisynthetic glycopeptide antibacterial agent that is active against Gram-positive bacteria associated with complicated skin and skin structure infections (cSSSIs). It is administered as a two-dose regimen intravenously infused over 30 minutes once weekly. The efficacy of dalbavancin (1000 mg on day 1 and 500 mg on day 8) has been examined in two randomized controlled trials in adults with cSSSIs. ⋯ In a randomized, controlled, double-blind, multinational, phase III trial, dalbavancin was noninferior to linezolid, with clinical success rates of 88.9% and 91.2%. In a randomized, open-label, multicentre, phase II trial, clinical success rates were 94% with dalbavancin and 76% with comparator antibacterials. Dalbavancin was generally well tolerated by adult patients with cSSSIs, with most adverse events being of mild or moderate severity.