Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial

WOS: 000450142800014PubMed ID: 30074294Background and objective Combination long-acting beta(2)-agonist/long-acting muscarinic antagonist (LABA/LAMA) has demonstrated superior clinical outcomes over LABA/inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD) patients; however, data from blinded randomized controlled trials on direct switching from LABA/ICS to LABA/LAMA are lacking. FLASH (Assessment of switching salmeterol/Fluticasone to indacateroL/glycopyrronium in A Symptomatic COPD patient coHort) investigated if direct switch, without a washout period, from salmeterol/fluticasone (SFC) to indacaterol/glycopyrronium (IND/GLY) in COPD patients improves lung function and is well tolerated. Methods In this 12-week, multicentre, double-blind study, patients with moderate-to-severe COPD and up to one exacerbation in previous year, receiving SFC for >= 3 months, were randomized to continue SFC 50/500 mu g twice daily (bd) or switch to IND/GLY 110/50 mu g once daily (od). Primary endpoint was pre-dose trough forced expiratory volume in 1 s (FEV1) at Week 12. Results In total, 502 patients were randomized (1:1) to IND/GLY or SFC. Patients switched to IND/GLY demonstrated superior lung function (pre-dose trough FEV1) versus SFC at Week 12 (treatment difference (Delta) = 45 mL; P = 0.028). IND/GLY provided significant improvements in pre-dose trough forced vital capacity (FVC; Delta = 102 mL; P = 0.002) and numerical improvements in transition dyspnoea index (TDI; Delta = 0.46; P = 0.063). Rescue medication use and COPD assessment test (CAT) scores were comparable between groups. Both treatments had similar safety profiles. Conclusion FLASH demonstrated that a direct switch to IND/GLY from SFC improved pre-dose FEV1 and FVC in COPD patients with up to one exacerbation in the previous year. No new safety signals were identified.NovartisNovartis; Good Publication Practice (GPP3) guidelinesThe authors would like to thank the patients, investigators and staff at participating centres in this study (a full list of principal investigators and centres is provided in Appendix S3 (Supplementary Information)). Authors also thank Peggy Hours-Zesiger (Novartis) for contribution to the conduct of the study. The authors thank Geetika Kainthla (M. Sc) and M. Fahad Haroon (PhD), Novartis, Hyderabad, India, for providing medical writing support/editorial support, which was funded by Novartis, in accordance with Good Publication Practice (GPP3) guidelines

Middle East observational study in metastatic soft tissue sarcoma: an epidemiological study on the treatment patterns (MOON)

WOS: 000448279900016PubMed ID: 30105512PurposeSoft tissue sarcomas (STS) are a heterogeneous group of rare mesenchymal neoplasms, accounting for <1% of all newly diagnosed malignancies. These tumors can occur in almost any anatomic site though they most frequently occur in the extremities. The objective of the study was to describe the epidemiology, treatment paradigm, and real-world outcomes in the clinical management of metastatic STS (mSTS) in the Middle East and North Africa (MEA) region.MethodsMOON was an observational, multicenter, retrospective patient chart review study which included 200 patients with mSTS in the final analysis. The primary objective of the study is exploratory, so it is presented using descriptive statistics.ResultsAt the time of presentation, 62.0% patients had metastatic disease, 27.5% had received only their primary diagnosis and 10.0% had experienced a local recurrence. The most frequent STS localizations were lower extremities (74%), trunk (28.5%) and upper extremities (10.5%). Primary tumor was staged as T2b in the majority (60%) of patients. Surgical treatment was performed most often for the primary disease, whereas radiation therapy and chemotherapy were predominantly administered with palliative intent. A total of 38 patients received treatment with pazopanib. Thirteen adverse events (AEs) were attributed to pazopanib in eight patients.ConclusionAdult patients treated for STS have al most equal gender ratio and mostly are middle aged. The majority of patients have metastatic disease and disease progression, and half of the patients died from the disease during the period of evaluation. This study obtained real-life data on the clinical management of STS in MEA countries which could be shared with the medical community.Novartis Pharma AGThis study was funded by Novartis Pharma AG. We thank Haritha Nekkanti (Novartis Healthcare Pvt Ltd) for providing medical editorial assistance