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GOLD 2025: COPD and cardiovascular disease¹

New in GOLD 2025: Cardiovascular disease (CVD) in stable COPD

The prevalence of CVD, including arterial hypertension, coronary artery disease, heart failure and arrhythmias is increased in patients with clinically stable COPD1

In the UK, COPD is associated with CVD: Prevalence of hypertension is 35% (n=18346), coronary heart disease 21% (n=10811), stroke or transient ischaemic attack 8% (n=4307), atrial fibrillation 6% (n=3065) and heart failure 6% (n=3344) in patients with COPD2

In a cross-sectional data analysis of 1,272,685 adults in Scotland from 314 primary care practices comparing patients with and without COPD.

COPD, CV risk and CVD

Adapted from Rabe KF et al, 2018.3

New in GOLD 2025: COPD exacerbations significantly increase the risk of an acute CV (cardiovascular) event1

During a COPD exacerbation, the risk of MI, arrhythmias and stroke increases, especially for severe exacerbations that require hospitalisation1

3.8

3.8 times increased risk of a CV event in the first 30 days after an acute exacerbation in patients with COPD and CVD or risk factors for CVD compared with pre-AECOPD baseline period4

(95% confidence interval [CI],2.7–5.5, n=16,485). In a post-hoc analysis. Number of participants with exacerbations from day 1 to day 30 = 4,639. Number of participants with exacerbation and adjudicated CVD event from day 1 to day 30 = 32

pre-AECOPD: pre-acute exacerbation of chronic obstructive pulmonary disease

10

Risk of CV event is nearly 10 times greater in the first 30 days after an exacerbation requiring hospitalization compared with pre-AECOPD baseline period4

In a post hoc analysis of a randomized clinical trial with 16,485 patients with COPD and CVD or risk factors for CVD. Number of participants with exacerbation requiring hospitalisation from day 1 to day 30 =1243. Number of participants with exacerbation requiring hospitalisation and adjudicated CVD event from day 1 to day 30 = 24. Hazard ratio 9.9 (95% CI, 6.6-14.9) for cardiovascular death, myocardial infarction, stroke, unstable angina, and transient ischemic attack after an acute exacerbation of COPD requiring hospitalisation

1 year

Risk of a CV event is doubled from 91 days up to 1 year after an acute COPD exacerbation requiring hospitalisation compared with pre-AECOPD baseline period4

In a post hoc analysis of a randomized clinical trial with 16,485 patients with COPD and CVD or increased risk of CVD. Number of participants with exacerbation requiring hospitalisation from day 91 to 1 year =862. Hazard ratio 2.0 (95% CI, 1.3-3.0) for cardiovascular death, myocardial infarction, stroke, unstable angina, and transient ischemic attack after an acute exacerbation of COPD requiring hospitalisation

GOLD underscores the importance of reducing COPD exacerbations in all COPD patients to reduce CV events1

Learn more about how GOLD 2025 and NICE treatment recommendations align

Read more

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) was proven to significantly reduce hospitalised COPD exacerbations vs. Anoro Ellipta (umeclidinium/vilanterol) in a pre-specified analysis (p<0.001)5

The annual rate of severe exacerbations during treatment was a pre-specified secondary endpoint (n=10,355).

Anoro is indicated as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Anoro is not licensed for COPD exacerbations.6

Trelegy Ellipta is indicated as maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS/LABA or LAMA/LABA.

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IMPACT: Designed to compare Trelegy Ellipta with two dual maintenance therapies5

Phase 3, randomised, double-blind, parallel-group, global multicentre study (10,355 patients)5,7

IMPACT trial design

The primary efficacy outcome was the annual rate of moderate or severe exacerbations during treatment (including 1 day after the last dose was administered).5

Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.6

Anoro Ellipta and LAMA/LABAs are not licensed for COPD exacerbations.

Adapted from Lipson DA, et al (2018).5
CAT, COPD Assessment Test; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; UMEC, umeclidinium; VI, vilanterol.

IMPACT: Superior reduction in the annual rate of moderate/severe exacerbations with Trelegy Ellipta vs. a ICS/LABA (FF/VI) and a LAMA/LABA (UMEC/VI) (p<0.001)5

Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.6

Anoro Ellipta and LAMA/LABAs are not licensed for COPD exacerbations.

Annual rate of moderate/severe exacerbations
(primary endpoint)

IMPACT annual rate of moderate/severe exacerbations

Trelegy Ellipta vs. Anoro Ellipta : 0.91/year vs. 1.21/year respectively; rate ratio 0.75; 95% CI: 0.70, 0.81; p<0.001
Trelegy Ellipta vs. Relvar Ellipta: 0.91/year vs. 1.07/year respectively; rate ratio 0.85; 95% CI: 0.80, 0.90; p<0.001

Adapted from: Lipson DA, et al (2018).5
ARR, absolute risk reduction; CI, confidence interval; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; UMEC, umeclidinium; VI, vilanterol.

IMPACT: Trelegy Ellipta was proven to significantly reduce hospitalised COPD exacerbations vs. a LAMA/LABA (UMEC/VI) in a pre-specified analysis (p<0.001)5

Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.6

Anoro Ellipta and LAMA/LABAs are not licensed for COPD exacerbations.

The n reflects the number of patients included in each analysis from the ITT population. Patients were excluded if they had predefined data missing; this varied according to the analysis.

Annual rate of severe exacerbations resulting in hospitalisation
(prespecificed protocol-defined secondary outcome)

annual rate severe exacerbations

Trelegy Ellipta vs. Anoro Ellipta: 0.13/year vs. 0.19/year respectively; rate ratio 0.66 95% Cl: 0.56, 0.78; p<0.001
Trelegy Ellipta vs. Relvar Ellipta: 0.13/year vs. 0.15/year respectively; rate ratio 0.87 95% Cl: 0.76, 1.01; p=0.06

Adapted from Lipson DA, et al (2018).5
ARR, absolute risk reduction; CI, confidence interval; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; ITT, intention-to-treat; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; NS, not significant; OD, once daily; UMEC, umeclidinium; VI, vilanterol.

IMPACT: On-treatment events across moderate/severe exacerbations and pneumonia8,9

IMPACT: On-treatment events across moderate/severe exacerbations and pneumonia4,8

Anoro Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.6

Anoro Ellipta and LAMA/LABAs are not licensed for COPD exacerbations.

Other AEs including SAEs and AESIs exist. Please consult the Summary of Product Characteristics for a full list of adverse reactions.

IMPACT: on treatment events

†The number of events in the UMEC/VI group has been doubled to account for the 2:2:1 randomisation scheme. Absolute numbers for UMEC/VI group; moderate/severe exacerbations n=1949, on treatment pneumonia AESIs n=104. 
Pneumonia is a special warning for Trelegy Ellipta. Please consult the SmPC for a full list of adverse reactions, precautions, special warnings and contraindications prior to prescribing.
Adapted from Lipson et al. 2018.8
AESI, adverse event of special interest; COPD, chronic obstructive pulmonary disease; FF, fluticasone furoate; ICS, inhaled corticosteroid; UMEC, umeclidinium; VI, vilanterol.

IMPACT: Trelegy Ellipta demonstrated a reduction in the risk of on-treatment all-cause mortality compared with Anoro Ellipta5,8,10

ARR: 0.68; Trelegy Ellipta vs. Anoro Ellipta: 1.20% vs. 1.88% on-treatment deaths (n=50/4151 vs. n=39/2070), respectively; HR 0.58 (95% CI: 0.38, 0.88 (p=0.011))

Data presented are that of the ITT population. On-treatment all-cause mortality was a pre-specified other endpoint of the 52-Week IMPACT trial (N=10,355, ITT). On-treatment events are those that occur between the start, and up to 7 days after the end of study treatment. This endpoint was not corrected for multiplicity. Mortality difference not observed in subgroup who entered study on non-ICS treatment.

IMPACT all-cause mortality

Adapted from Lipson et al. 2020.5
Figure reproduced with permission of the authors and the publisher under a Creative Commons license (CC BY-NC 4.0).

On-treatment adjudicated cause of death8

Summary of on-treatment adjudicated cause of death FF/UMEC/VI (N=4151) UMEC/VI (N=2070)
n (%) Rate (1000 patient years) n (%) Rate (1000 patient years)
Total 50 (1) 13.2 39 (2) 22.5
Primary cause of death
CV 16 (<1) 4.2 15 (<1) 8.7
Respiratory 15 (<1) 4.0 9 (<1) 5.2
Cancer 4 (<1) 1.1 2 (<1) 1.2
Unknown 11 (<1) 2.9 11 (<1) 6.4
Other 4 (<1) 1.1 2 (<1) 1.2

On-treatment definition: A death was defined as “on-treatment” if the actual date of death occurred up to 7 days after the last day of treatment and considered to be “off-treatment” if the actual date of death occurred more than 7 days after the last day of treatment and up to within 7 days of the projected Week 52 date.

CV, cardiovascular disease; FF, fluticasone furoate; ICS, inhaled corticosteroid; ITT, intent-to-treat; UMEC, umeclidinium; VI, vilanterol.

IMPACT: Adverse Events5

Adverse events of special interest in the intention-to-treat population Trelegy Ellipta (FF/UMEC/VI) 92/55/22 mcg OD (N=4,151) n (%), rate [#] Relvar Ellipta (FF/VI) 92/22 mcg OD (N=4,134) n (%), rate [#] Anoro Ellipta (UMEC/VI) 55/22 mcg OD (N=2,070) n (%), rate [#]
Anticholinergic syndrome 184 (4), 60.8 [226] 140 (3), 47.1 [163] 70 (3), 47.7 [81]
Asthma/bronchospasm 27 (<1), 7.5 [28] 34 (<1), 10.1 [35] 16 (<1), 9.4 [16]
Cardiovascular effects 450 (11), 167.2 [621] 430 (10), 157.0 [543] 224 (11), 166.6 [283]
Cardiac arrhythmia 153 (4), 50.9 [189] 161 (4), 51.5 [178] 81 (4), 51.2 [87]
Cardiac failure 138 (3), 42.5 [158] 126 (3), 42.8 [148] 68 (3), 44.8 [76]
Central nervous system haemorrhages and cerebrovascular conditions 41 (<1), 12.1 [45] 28 (<1 ), 9.3 [32] 11 (<1), 6.5 [11]
Hypertension 113 (3), 35.5 [132] 115 (3), 35.0 [121] 54 (3), 34.2 [58]
lschemic heart disease 80 (2), 26.1 [97] 57 (1 ), 18.5 [64] 47 (2), 30.6 [52]
Decreased bone mineral density and associated fractures 98 (2), 32.6 [121] 85 (2), 26.9 [93] 37 (2), 24.7 [42]
Effects on potassium 34 (<1), 9.2 [34] 25 (<1), 7.5 [26] 8 (<1), 4.7 [8]
Gastrointestinal obstruction 9 (<1), 2.7 [10] 10 (<1), 2.9 [10] 2 (<1), 1.2 [2]
Hyperglycemia/new onset diabetes mellitus 152 (4), 47.4 [176] 117 (3), 37.9 [131] 73 (4), 46.5 [79]
Hypersensitivity 196 (5), 61.4 [228] 195 (5), 64.8 [224] 95 (5), 59.5 [101]
LRTI excluding pneumonia 200 (5), 63.0 [234] 199 (5), 69.7 [241] 108 (5), 76.0 [129]
Local steroid effects 337 (8), 114.4 [425] 301 (7), 107.3 [371] 108 (5), 80.1 [136]
Ocular effects 55 (1), 16.7 [62] 45 (1), 14.7 [51] 26 (1), 15.3 [26]
Pneumonia 317 (8), 95.8 [356] 292 (7), 96.6 [334] 97 (5), 61.2 [104]
Tremor 8 (<1), 2.2 [8] 4 (<1), 1.2 [4] 6 (<1), 3.5 [6]
Urinary retention 8 (<1 ), 2.7 [10] 12 (<1), 3.5 [12] 9 (<1 ), 5.3 [9]

This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.
n (%) refers to the number of patients (%), and rate (#) refers to the rate per 1,000 patient-years (number of events). LRTI, lower respiratory tract infection.

Trelegy Ellipta Adverse event information
TRELEGY Ellipta’s tolerability profile is in line with the known profiles of its component molecules.

The most frequently reported adverse reactions observed with Trelegy, as reported in the Summary of Product Characteristics, are nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%). The most common (>1/100 to<1/10) reported adverse event reactions observed with Trelegy as reported in the SmPC, are pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia and back pain.

Pneumonia: in common with other ICS-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with TRELEGY Ellipta, including pneumonia requiring hospitalisation.11

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body-mass index and severe COPD.11 Cardiovascular effects, such as cardiac arrhythmias (e.g., atrial fibrillation and tachycardia), may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including UMEC and VI, respectively. Therefore, TRELEGY Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.11

Anoro Ellipta Adverse Event information
The most frequently reported adverse reactions (≥1/100 to <1/10) observed with Anoro Ellipta, as reported in the Summary of Product Characteristics, are urinary tract infection, sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation, and dry mouth. Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium/vilanterol. Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease6

Relvar ELLIPTA 92/22mcg (fluticasone furoate/vilantero) is indicated for the symptomatic treatment of adults with COPD with a FEV1, <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy Relvar Ellipta (fluticasone furoate/vilanteraol inhalation powder) prescribing information.12 Click here for Relvar ELLIPTA Prescribing information.

Anoro Ellipta (umeclidinium/vilanterol inhalation powder) is indicated for maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease prescribing information. Click here for Anoro ELLIPTA prescribing information.

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is indicated for maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS/LABA or LAMA/LABA. Click here for Trelegy Ellipta prescribing information.

Choose Trelegy Ellipta for your patients with COPD: A triple therapy enabling simplicity in patients with moderate to severe COPD11

For maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS/LABA or LAMA/LABA.11

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References

  1. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD. 2025 Report.
  2. Chetty U et al. B J Gen Prac 2017;67(658):e321-e328.
  3. Rabe KF et al. Eur Respir Rev 2018;27:180057.
  4. Kunisaki KM Am J Respir Crit Care Med 2018;198(1):51-57.
  5. Lipson DA; New England Journal Medicine 2018; 378:1671-80.
  6. Anoro Ellipta, Summary of Product Characteristics.​
  7. Clinicaltrials.gov, NCT02164513. Available at: https://clinicaltrials.gov/study/NCT02164513.
  8. Lipson DA;The New England Journal of Medicine;2018;378;1671-1680. inc. Supplementary Appendix.​
  9. Kew KM;The Cochrane database of systematic reviews;2014;CD010115;1-153
  10. Lipson DA; Am J Respir Crit Care Med 2020;201:1508-1516.
  11. Trelegy Ellipta, Summary of Product Characteristics.​
  12. Relvar Ellipta Summary of Product Characteristics.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to GSK on 0800 221 441 or UKSafety@gsk.com

May 2025 | PM-GB-CPU-WCNT-250001 (V1.0)