Evidence map›Paper›PMID 22003293›Full record

SynthesisInternational journal of chronic obstructive pulmonary disease2011

Safety of indacaterol in the treatment of patients with COPD.

James F Donohue, Dave Singh, Oliver Kornmann, David Lawrence, Cheryl Lassen, Benjamin Kramer

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in International journal of chronic obstructive pulmonary disease, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
9.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Global scientific collaboration in COPD research.International journal of chronic obstructive pulmonary disease · 2017
    Article
  9. Review
  10. Review
  11. A real-world evaluation of indacaterol and other bronchodilators in COPD: the INFLOW study.International journal of chronic obstructive pulmonary disease · 2015
    Observational
  12. Positioning new pharmacotherapies for COPD.International journal of chronic obstructive pulmonary disease · 2015
    Review
  13. Review
  14. New developments in the management of COPD: clinical utility of indacaterol 75 μg.International journal of chronic obstructive pulmonary disease · 2014
    Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 5 countries.

James F DonohueUniversity of North Carolina, Chapel Hill, NC 27599, USA. james_donohue@med.unc.edu
Dave Singh
Oliver Kornmann
David Lawrence
Cheryl Lassen
Benjamin Kramer
Novartis (Switzerland) · CHInstitute of Clinical Cancer Research · DEMedicines Evaluation Unit · GBNovartis (France) · FRUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-agonist for chronic obstructive pulmonary disease (COPD). PATIENTS AND

methodsData were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 μg (n = 449), 150 μg (n = 2611), 300 μg (n = 1157), or 600 μg once daily (n = 547); formoterol 12 μg twice daily (n = 556); salmeterol 50 μg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 μg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs.

resultsThe commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were < 1 for all indacaterol doses. Notable values for vital signs and measures of systemic β(2)-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008).

conclusionIndacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsDrug Administration ScheduleFemaleHumansIndansMaleMiddle AgedPatient SelectionProportional Hazards ModelsPulmonary Disease, Chronic ObstructiveQuinolonesRisk AssessmentRisk FactorsAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsindacaterolIndansQuinolonesformoterolindacaterolsafetysalmeteroltiotropiumtolerability

Identifiers

PMID22003293
PMCPMC3186746
OpenAlexW2071738192

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.