Effect of once-daily fluticasone furoate/vilanterol versus vilanterol alone on bone mineral density in patients with COPD: a randomized, controlled trial.

BACKGROUND: The relationship between inhaled corticosteroids and bone mineral density (BMD) remains uncertain despite extensive research. METHODS: This was an international, multicenter, randomized, double-blind, parallel-group, 3-year noninferiority study. Patients with chronic obstructive pulmonary disease (COPD) (⩾40 years of age; smoking history ⩾10 pack years) and at least one native hip evaluable for BMD were enrolled and randomized 1:1, stratified by sex, to treatment with vilanterol (VI) 25 µg or fluticasone furoate/vilanterol (FF/VI) 100 µg/25 µg. BMD measurements were taken via dual-energy X-ray absorptiometry every 6 months. The primary endpoint was assessment of the noninferiority of change from baseline in total hip BMD per year at the -1% noninferiority level. Change from baseline in BMD at the lumbar spine and BMD measurements by sex were secondary endpoints. Incidences of COPD exacerbations and bone fractures throughout the study were also recorded. RESULTS: Of 283 randomized patients, 170 (60%) completed the study. Noninferiority was demonstrated for FF/VI versus VI with regards to change from baseline in total hip BMD per year, with changes of -0.27% and 0.18%, respectively, and a treatment difference of -0.46% per year [95% confidence interval (CI) -0.97 to 0.06]. The treatment difference for FF/VI versus VI regarding lumbar spine BMD was -0.51% per year (95% CI -1.11 to 0.10). COPD exacerbations and bone fracture rates were similar between treatment groups. CONCLUSION: FF/VI showed noninferiority to VI for change from baseline in total hip BMD per year, when assessed at the -1% noninferiority margin in a combined sample of men and women with COPD.The reviews of this paper are available via the supplemental material section.

Evolution of Patients with Pulmonary Arterial Hypertension Starting Macitentan After the Discontinuation of Other Endothelin-Receptor Antagonists: Results of a Retrospective Study.

BACKGROUND: Macitentan is the latest endothelin-receptor antagonist (ERA) approved for the treatment of pulmonary arterial hypertension (PAH), presenting enhanced properties over previous ERAs. OBJECTIVE: We describe the clinical and echocardiographic evolution of patients with PAH who started macitentan after discontinuing bosentan/ambrisentan. METHODS: This was a retrospective series of patients with different etiologies who started macitentan after the suspension of other ERAs under routine clinical practice at five Spanish hospitals. World Health Organization functional class (WHO-FC), 6-min walk distance (6MWD), levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP), and cardiac imaging data were collected and described at baseline (before macitentan initiation) and after 3, 6, and 12 months, when available. RESULTS: In total, 12 patients (ten women; mean age 65.63 ± 13.27 years) were observed. At baseline, most patients were receiving concomitant PAH medications, and five patients were classed as WHO-FC III. After 3 months of macitentan treatment, WHO-FC had improved in four patients, 6MWD increased in eight patients, and NT-proBNP levels and right atrial area were lowered in seven and eight patients, respectively. Similar results were observed after 6 and 12 months. Macitentan was well-tolerated, with no PAH hospitalizations, septostomies, transplants, or deaths registered. CONCLUSIONS: Our results suggest that switching to macitentan in patients with PAH who discontinued bosentan/ambrisentan was well-tolerated and effective. Further studies are needed to confirm these observations.

Varón con dolor y tumefacción recidivante de tobillos / Male with pain and recurrent swelling of the kness rheumatology

No disponible

Hemiatrofia corporal y lesiones cutáneas / Hemicorporal atrophy and cutaneous lesions

No disponible