SESSION TITLE: COPD Treatment
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Sunday, October 26, 2014 at 01:30 PM - 03:00 PM
PURPOSE: UMEC (LAMA) plus VI (LABA) is an approved combination bronchodilator maintenance treatment for COPD in the USA. FSC (ICS/LABA) is indicated as a maintenance therapy for COPD. Two replicate studies (930, 951) compared the efficacy and safety of UMEC/VI inhalation powder with FSC in patients with moderate-to-severe COPD and infrequent COPD exacerbations (defined as none in previous year).
METHODS: In two 12-week, multicentre, double-blind, parallel-group, double-dummy studies, patients with FEV1 ≥30% and ≤70% pred. were randomized 1:1 to UMEC/VI 62.5/25mcg OD (via ELLIPTA™ inhaler) or FSC 250/50µg BD (via DISKUS inhaler™). The primary endpoint was weighted mean (wm) FEV1 over 0-24h on Day 84; trough FEV1 on Day 85 was the secondary endpoint. Other endpoints included symptomatic measures (TDI focal score; SGRQ). Safety assessments included incidence of AEs.
RESULTS: ITT: N=706 (study 930); N=697 (study 951). UMEC/VI significantly improved all lung function measures, including peak, onset and duration over 12 weeks vs FSC. For 0-24h wmFEV1 on Day 84, improvements with UMEC/VI vs FSC were 74mL (95% CI: 38,110) in study 930 and 101mL (95% CI: 63,139) in study 951 (both p<0.001). UMEC/VI improved trough FEV1 on Day 85 vs FSC in study 930 (82mL [95% CI: 45,119]) and in study 951 (98mL [95% CI: 59,137]) (both p<0.001). Both UMEC/VI and FSC demonstrated clinically meaningful improvements in dyspnoea (TDI focal score >1 unit) and quality of life (change from baseline in SGRQ score >4 unit decrease) over 12 weeks in both studies; no treatments differences between UMEC/VI and FSC were observed. Incidence of on-treatment AEs (UMEC/VI, FSC) was 26%, 27% (study 930) and 30%, 31% (study 951). Headache and nasopharyngitis were the most commonly reported AEs. Incidence of on-treatment SAEs was 2%, 3% (study 930) and 3%, 4% (study 951). There was 1 death in study 930 (FSC group; not drug related) and 5 deaths in study 951 (2 UMEC/VI group; 3 FSC group; 1 death (FSC, due to pneumonia) was reported as drug related by the investigator).
CONCLUSIONS: UMEC/VI 62.5/25mcg OD over 12 weeks led to statistically significant and clinically meaningful improvements in lung function vs FSC 250/50mcg BD in patients with moderate-to-severe COPD and infrequent COPD exacerbations. No new safety findings were reported for UMEC/VI or FSC.
CLINICAL IMPLICATIONS: LAMA/LABA therapy with UMEC/VI 62.5/25mcg OD is an effective therapeutic option in this COPD patient population. Funding: GSK (DB2114930 [NCT01817764]; DB2114951 [NCT01879410])
DISCLOSURE: James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Almirall, AstraZeneca, Boehringer Ingelheim, Dey, Elevation Pharmaceuticals, Forest Laboratories, GlaxoSmithKline, Novartis, Pearl Pharmaceuticals, Pfizer and Sunovion, Other: Served as member of Drug Safety Monitoring Boards for: NIH, Novartis, Otsuda, Pearl and Teva Sally Worsley: Employee: GlaxoSmithKline, Shareholder: GlaxoSmithKline Chang-Qing Zhu: Employee: GlaxoSmithKline, Shareholder: GlaxoSmithKline Liz Hardaker: Employee: GlaxoSmithKline, Shareholder: GlaxoSmithKline Alison Church: Employee: GlaxoSmithKline, Shareholder: GlaxoSmithKline
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