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ANORO IMPROVED HEALTH-RELATED QUALITY OF LIFE VS PLACEBO, AS MEASURED BY THE SGRQ1,2*

The St. George’s Respiratory Questionnaire (SGRQ) is a respiratory disease–specific, patient-reported instrument containing 76 items that measures3:

ACTIVITIES

ACTIVITIES

SYMPTOMS

SYMPTOMS

IMPACT ON DAILY LIFE

IMPACT ON
DAILY LIFE

The SGRQ responder rate at end of study for ANORO was 49% (188/381) compared with 34% (86/254) for placebo with odds ratio of 2.0 (95% CI: 1.4, 2.8)1

The SGRQ responder rate at end of study for ANORO was 51% (123/239) compared with 40% (94/236) for placebo with odds ratio of 1.6 (95% CI: 1.1, 2.3)2§

Of clinically meaningful improvement* in health-related quality of life for patients taking ANORO vs placebo1,2

 

What could an improvement in health-related quality of life mean for your patients with COPD?

ANORO demonstrated an improvement in health-related quality of life as measured by a decrease from baseline in mean SGRQ total score of:

  • -5.51 unit difference (-8.07 vs -2.56)1
  • -4.03 unit difference (-6.15 vs -2.12)2II

*Studied in patients with moderate or worse COPD (GOLD 2–4).
Defined as a decrease of at least 4 units from baseline.
Compared with placebo on Day 168; not adjusted for multiplicity.
§Compared with placebo on Day 84; not adjusted for multiplicity.
IICompared with placebo on Day 84 (P<0.001).

Description of studies

Study DB21133731,4

A 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy and safety of ANORO ELLIPTA (n=413), placebo (n=280), and other treatment arms, each administered once daily by the ELLIPTA inhaler, in patients with COPD. For the primary endpoint, ANORO improved trough FEV1 by 167 mL (P<0.001) vs placebo at Day 169. Health outcomes assessments in this study included SGRQ total score and proportion of responders to SGRQ at Week 24.

The SGRQ responder rate* at end of study for ANORO was 49% (188/381) compared with 34% (86/254) for placebo with odds ratio of 2.0 (95% CI: 1.4, 2.8). ANORO demonstrated an improvement in health-related quality of life as measured by a decrease from baseline in mean SGRQ total score of -5.51 unit difference (-8.07 vs -2.56).

Study 2012112,4

A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy and safety of ANORO ELLIPTA (n=248) compared with placebo (n=248) in patients with COPD. The primary endpoint was the SGRQ total score at Week 12. Proportion of responders to SGRQ at Week 12 was an Other endpoint.

The SGRQ responder rate at end of study for ANORO was 51% (123/239) compared with 40% (94/236) for placebo with odds ratio of 1.6 (95% CI: 1.1, 2.3). ANORO demonstrated an improvement in health-related quality of life as measured by a decrease from baseline in mean SGRQ total score of -4.03 unit difference (-6.15 vs -2.12).§

*Defined as a decrease of at least 4 units from baseline.
Compared with placebo on Day 168; not adjusted for multiplicity.
Compared with placebo on Day 84; not adjusted for multiplicity.
§Compared with placebo on Day 84 (P<0.001).

CI=confidence interval; GOLD=Global Initiative for Chronic Obstructive Lung Disease.

References: 1. Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013;107(10):1538-1546. 2. Siler TM, Donald AC, O’Dell D, et al. A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:971-979. 3. Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31. 4. Data on file, GSK.