Based on recent guidelines for the management of community-acquired pneumonia, this study was designed to evaluate the effectiveness of a new fluoroquinolone compared with standard antimicrobial regimens, in conditions relating as closely as possible to the real world setting.In this study, 564 patients were randomised to either oral moxifloxacin (400 mg o.d.) or to standard oral therapy (amoxicillin 1 g t.i.d. or clarithromycin 500 mg b.i.d. alone or in combination) for up to 14 days using a double-blind procedure. The choice between the three standard regimens was made by the clinician prior to randomisation. Clinical response, quality of life, symptoms, healthcare resources and safety were assessed.In the per-protocol population, clinical success was reported for 201 of 215 (93.5%) and 217 of 231 (93.9%) in the moxifloxacin and standard groups, respectively, at 7-10 days post-therapy. At 28-35 days follow-up, continued clinical cure was observed in 183 of 192 (95.3%) moxifloxacin and 207 of 221 (93.7%) standard groups. Drug-related adverse events were reported in 55 of 274 (20%) moxifloxacin and 86 of 279 (31%) standard patients with diarrhoea w5%.Oral moxifloxacin monotherapy was as effective as, and better tolerated than, optimal antibiotic strategy represented either by mono-or combination therapy (amoxicillin and/or clarithromycin) in community-acquired pneumonia management.
Recombinant human DNase in management of lobar atelectasis due to retained secretions This report suggests that directly instilled rhDNase may be one altemative to conventional therapy for lobar atelectasis. Its use may be beneficial for the subset of patients with lobar atelectasis due to retained secretions which fail to clear with vigorous coughing, chest physiotherapy, and suctioning. Direct bronchoscopic instillation offers the advantage of concentrating it at the site of obstruction and avoids the delay of waiting for the effects of nebulised administration. Further study is warranted comparing rhDNase by direct instillation and nebulisation with traditional respiratory therapy for lobar collapse due to retained secretions.
Patients with pulmonary arterial hypertension (PAH) who do not have an adequate response to therapy with phosphodiesterase-5 inhibitors (PDE-5i) may have insufficient synthesis of cyclic guanosine monophosphate (cGMP). These patients may respond to a direct soluble guanylate cyclase (sGC) stimulator such as riociguat. RESPITE (NCT02007629) was an open-label, multicenter, uncontrolled, single-arm phase 3b study of riociguat in patients with PAH who demonstrated an insufficient response to treatment with PDE-5i. Insufficient response was defined as World Health Organization functional class (WHO FC) III despite PDE-5i therapy for at least 90 days; 6-min walk distance (6MWD) of 165-440 m, and right-heart catheterization showing mean pulmonary artery pressure >30 mmHg, cardiac index <3.0 L/min/m, and pulmonary vascular resistance >400 dyn s cm. PAH patients with an insufficient response to stable doses of sildenafil or tadalafil-either as monotherapy or in combination with an endothelin receptor antagonist-for at least 90 days were switched to riociguat for 24 weeks. Starting at 1.0 mg TID, the dose of riociguat was increased during the 8-week titration phase in 0.5-mg increments in 2-week intervals if the patient had no signs or symptoms of hypotension. In the ensuing 16-week maintenance phase, riociguat was continued at the optimal individual dose. All efficacy outcomes were exploratory and include change from baseline to 24 weeks in 6MWD, cardiac index, N-terminal pro-brain natriuretic peptide, WHO FC, and quality of life and the proportion of patients with clinical worsening. The following biomarkers were to be measured: cGMP, asymmetric dimethyl arginine, growth-differentiation factor-15, and ST2. Results from RESPITE will help to determine if PAH patients who do not respond to PDE-5i are likely to benefit from treatment with an sGC stimulator. The study may also identify biomarkers that are able to suggest which patients are more likely to respond to sGC stimulators.
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