Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study—a randomised controlled trial

نویسندگان

  • Peter A Frith
  • Philip J Thompson
  • Rajeev Ratnavadivel
  • Catherina L Chang
  • Peter Bremner
  • Peter Day
  • Christina Frenzel
  • Nicol Kurstjens
  • Ainslie Waddell
  • Alexander Daniel
  • Alireza Khoussousi
  • Andrew Springfield
  • Andrew Veale
  • Anthony Neil Graham
  • Brad Gallagher
  • Braj Raj Pande
  • Brendan O'Kane
  • Christopher Jones
  • Claudio Baldi
  • Colin Helm
  • Conor O'Dochartaigh
  • Daniel Chambers
  • Dean Quinn
  • Derek Yull
  • Dhanalakshi Karthigesu
  • Edward Then
  • Frank Graham
  • Fred Faigenbaum
  • Geetha Geddam
  • Gillian Cameron
  • Hans Blom
  • Hershel Goldman
  • Hilary Snell
  • Imagard Chia
  • James Jeong
  • James Liew
  • James Salvaris
  • Jason Pryke
  • Jim Reid
  • John Kolbe
  • John O'Sullivan
  • John Pak
  • John Upham
  • Joseph Feiber
  • Judith O'Malley Ford
  • Kevin Yong
  • Kyle Perrin
  • Lawrence Noonan
  • Len Atlas
  • Louise Murdoch
  • Margaret Pearce
  • Mark Bloch
  • Mark Holmes
  • Michael Chia
  • Michael Epton
  • Michelle Leadston
  • MK Tandon
  • Mohan Chitgopeker
  • Naomi Liebenberg
  • Neil Hendry
  • Olakunle Olaniyi
  • Omesh Singh
  • Peter Kendall
  • Peter Van Niekerk
  • Rodney Willet
  • Ronald Tomlins
  • Salven Pillay
  • Sammy Sharifeh
  • Simon Carson
  • Stephen Bingham
  • Ted Walford
  • Tersia Erasmus
  • Trevor Claridge
  • Zofia Hess
چکیده

BACKGROUND The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease (COPD) is unclear. The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA). METHODS This randomised, blinded, placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium (GLY) 50 µg, once-daily tiotropium (TIO) 18 µg or placebo (PLA), when combined with salmeterol/fluticasone propionate (SAL/FP) 50/500 µg twice daily. The primary objective was to determine the non-inferiority of GLY+SAL/FP versus TIO+SAL/FP on trough FEV1 after 12 weeks. An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone. RESULTS 773 patients (mean FEV1 57.2% predicted) were randomised; 84.9% completed the trial. At week 12, GLY+SAL/FP demonstrated non-inferiority to TIO+SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. There was significant increase in week 12 trough FEV1 with GLY+SAL/FP versus PLA+SAL/FP (LSMdiff 101 mL, p<0.001). At 12 weeks, GLY+SAL/FP produced significant improvement in St George's Respiratory Questionnaire total score versus PLA+SAL/FP (LSMdiff -2.154, p=0.02). GLY+SAL/FP demonstrated significant rescue medication reduction versus PLA+SAL/FP (LSMdiff -0.72 puffs/day, p<0.001). Serious adverse events were similar for GLY+SAL/FP, TIO+SAL/FP and PLA+SAL/FP with an incidence of 5.8%, 8.5% and 5.8%, respectively. CONCLUSIONS GLY+SAL/FP showed comparable improvements in lung function, health status and rescue medication to TIO+SAL/FP. Importantly, addition of GLY to SAL/FP demonstrated significant improvements in lung function, health status and rescue medication compared to SAL/FP. TRIAL REGISTRATION NUMBER NCT01513460.

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عنوان ژورنال:

دوره 70  شماره 

صفحات  -

تاریخ انتشار 2015