Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler® Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Study Design
2.3. Study Outcomes
2.4. Statistical Analysis
3. Results
3.1. Demographic and Other Baseline Characteristics
3.2. Comorbidities in Study Participants
3.3. Improvement in Lung Function at 6 and 12 Months in Patients with and without Comorbidities
3.4. Improvement in Lung Function at 6 and 12 Months According to COPD Severity
3.5. Improvement in Dyspnea (mMRC) in Patients with and without Comorbidities
3.6. Satisfaction from the Elpenhaler® Device as Assessed by the FSI-10 Questionnaire
3.7. Safety Data
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
References
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Demographics | (Ν, %) |
---|---|
Age—years | N = 1016 |
Mean ± SD | 69.5 ± 9.5 |
Gender—no. (%) | N = 1016 |
Female | 264 (26) |
BMI—kg/m2 | N = 1016 |
Mean ± SD | 28.6 ± 5.3 |
Years with COPD | N = 1016 |
Mean ± SD | 7.3 ± 6.0 |
mMRC dyspnea scale—no. (%) | N = 1016 |
Stage 0 | 7 (0.7) |
Stage 1 | 190 (18.7) |
Stage 2 | 457 (45) |
Stage 3 | 321 (31.6) |
Stage 4 | 41 (4) |
Classification according to GOLD spirometric stages—no. (%) | N = 1016 |
GOLD 1 (Mild) | 0 (0) |
GOLD 2 (Moderate) | 471 (46.4) |
GOLD 3 (Severe) | 483 (47.5) |
GOLD 4 (Extremely severe) | 62 (6.1) |
Classification according to GOLD 2020 Groups—no. (%) | N = 1016 |
Group A | 56 (5.5) |
Group B | 286 (28.1) |
Group C | 326 (32.1) |
Group D | 348 (34.3) |
Previous COPD treatment | (N, %) |
No. (%) of patients with no past COPD treatment | 199 (19.6) |
No. (%) of patients with at least one past COPD treatment | 817 (80.4) |
Previous COPD maintenance treatment *—no. (%) | N = 817 |
LABA | 66 (8.1) |
LAMA | 244 (29.8) |
LABA + LAMA | 322 (39.4) |
Roflumilast | 29 (3.5) |
Theophylline | 18 (2.2) |
Other treatment ** | 174 (21.3) |
Comorbidities | (Ν, %) |
---|---|
No. (%) of patients with no comorbidities | 238 (23.4) |
No. (%) of patients with at least one comorbidity | 778 (76.6) |
Number of comorbidities per patient—no. (%) | |
1 | 256 (32.9) |
2 | 233 (29.9) |
>2 | 289 (37.2) |
Number of patients per comorbidity category—no. (%) * | N = 778 |
Cardiovascular diseases | 653 (83.9) |
Coronary artery disease | 175 (22.5) |
Arterial hypertension | 557 (71.6) |
Cardiac failure | 122 (15.7) |
Peripheral arterial disease | 41 (5.3) |
Pulmonary embolism | 9 (1.2) |
Other | 88 (11.3) |
Metabolic diseases | 373 (47.9) |
Diabetes Mellitus Type ΙΙ | 169 (21.7) |
Dyslipidemia | 265 (34.1) |
Other | 33 (4.2) |
Psychiatric diseases | 160 (20.6) |
Depression | 83 (10.7) |
Anxiety disorder | 88 (11.3) |
Other | 11 (1.4) |
Malignancies | 56 (7.2) |
Lung | 13 (1.7) |
Lymphoma | 0 (0) |
Breast | 9 (1.2) |
Other | 32 (4.1) |
Other diseases | 132 (17) |
Osteoporosis | 47 (6) |
Other | 84 (10.8) |
No. (%) of patients with cardiovascular and metabolic diseases | 711 (91.4) |
Spirometry | Baseline (Day 0) N = 1016 | Visit 1 (6 Months) N = 792 | Visit 2 (12 Months) N = 746 |
---|---|---|---|
FEV1 predicted L— | |||
Mean ± SD | 1.35 ± 0.37 | 1.50 ± 0.42 | 1.56 ± 0.45 |
FEV1% predicted—% | |||
Mean ± SD | 48.43 ± 8.61 | 54.17 ± 10.87 | 56.47 ± 11.82 |
Change of FEV1 (L) from baseline (Mean ± SD, p-value) | - | 0.15 ± 0.22, <0.0001 | 0.21 ± 0.25, <0.0001 |
Change of FEV1 (L) between 6 and 12 months * (Mean ± SD, p-value) | - | - | 0.06 ± 0.19, <0.0001 |
FVC predicted L— | |||
Mean ± SD | 2.48 ± 0.72 | 2.59 ± 0.72 | 2.67 ± 0.76 |
FVC % predicted | |||
Mean ± SD | 68.61 ± 14.42 | 71.61 ± 14.07 | 74.19 ± 15.42 |
Change of FVC (L) from baseline (Mean ± SD, p-value) | - | 0.11 ± 0.35, <0.0001 | 0.19 ± 0.41, <0.0001 |
Change of FVC (L) between 6 and 12 months * (Mean ± SD, p-value) | - | - | 0.09 ± 0.38, <0.0001 |
FEV1/FVC ratio | |||
Mean ± SD | 0.58 ± 0.08 | 0.62 ± 0.10 | 0.62 ± 0.11 |
Change of FEV1/FVC from baseline (Mean ± SD, p-value) | - | 0.036 ± 0.07, <0.0001 | 0.039 ± 0.07, <0.0001 |
Change of FEV1/FVC between 6 and 12 months * (Mean ± SD, p-value) | - | - | 0.002 ± 0.08, 0.595 |
Spirometry | ΔFEV1 0–6 Months (Mean ± SD) | ΔFEV1 0–12 Months (Mean ± SD) | ΔFEV1 6–12 Months (Mean ± SD) |
---|---|---|---|
GOLD 2020 Groups | |||
(* p-value) | 0.015 | <0.001 | 0.014 |
Group A | 0.07 ± 0.23 | 0.19 ± 0.25 | 0.12 ± 0.18 |
Group B | 0.17 ± 0.19 | 0.25 ± 0.24 | 0.07 ± 0.15 |
Group C | 0.19 ± 0.22 | 0.26 ± 0.27 | 0.07 ± 0.23 |
Group D | 0.13 ± 0.20 | 0.17 ± 0.23 | 0.03 ± 0.18 |
Variables | Univariate | Multivariate | ||||
---|---|---|---|---|---|---|
β | 95% CI | * p | β | 95% CI | * p | |
Age | −0.030 | −0.003, 0.001 | 0.418 | 0.16 | −0.002, 0.002 | 0.689 |
Gender (female) | −0.026 | −0.055, 0.026 | 0.481 | −0.016 | −0.050, 0.032 | 0.656 |
BMI | 0.085 | 0.001, 0.007 | 0.020 | 0.083 | 0.001, 0.007 | 0.024 |
mMRC | −0.087 | −0.051, −0.005 | 0.018 | −0.072 | −0.050, 0.000 | 0.047 |
Comorbidities | −0.089 | −0.098, −0.010 | 0.015 | −0.078 | −0.092, −0.003 | 0.035 |
GOLD 2020 Groups | −0.093 | −0.046, −0.006 | 0.011 | −0.099 | −0.050, −0.006 | 0.013 |
Baseline FEV1 | 0.018 | −0.037, 0.061 | 0.627 | −0.016 | −0.063, 0.041 | 0.682 |
mMRC Dyspnea Scale | Baseline (Day 0) N = 1016, % | Visit 1 (6 Months) N = 992, % | Visit 2 (12 Months) N = 966, % |
---|---|---|---|
Stage 0 | 7 (0.7) | 24 (2.4) | 67 (6.9) |
Stage 1 | 190 (18.7) | 315 (31.8) | 299 (31) |
Stage 2 | 457 (45) | 466 (47) | 434 (44.9) |
Stage 3 | 321 (31.6) | 172 (17.3) | 148 (15.3) |
Stage 4 | 41 (4) | 15 (1.5) | 18 (1.9) |
Difference in mMRC scale between visits * (p-value) | <0.0001 |
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Steiropoulos, P.; Tryfon, S.; Kyriakopoulos, C.; Bartziokas, K.; Kostikas, K. Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler® Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study. J. Pers. Med. 2021, 11, 1159. https://doi.org/10.3390/jpm11111159
Steiropoulos P, Tryfon S, Kyriakopoulos C, Bartziokas K, Kostikas K. Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler® Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study. Journal of Personalized Medicine. 2021; 11(11):1159. https://doi.org/10.3390/jpm11111159
Chicago/Turabian StyleSteiropoulos, Paschalis, Stavros Tryfon, Christos Kyriakopoulos, Konstantinos Bartziokas, and Konstantinos Kostikas. 2021. "Evaluation of the Clinical Effectiveness of the Salmeterol/Fluticasone Fixed-Dose Combination Delivered via the Elpenhaler® Device in Greek Patients with Chronic Obstructive Pulmonary Disease and Comorbidities: The AEOLOS Study" Journal of Personalized Medicine 11, no. 11: 1159. https://doi.org/10.3390/jpm11111159