Abstract

Background: Chronic obstructive pulmonary disease (COPD) is characterized by progressive airflow constraint and is highly prevalent disease which may cause functional disability. The use of dual bronchodilator plays major role in the management of chronic obstructive pulmonary disease. Both short acting and long acting bronchodilator combinations are very effective for moderate to severe COPD. Cardiovascular changes in patients with chronic obstructive pulmonary disease (COPD) with the use of these combination drugs are important for improving treatment decisions.

Objectives: To check the cardiovascular risk and safety of using combination therapy with long acting β₂ - agonist and long acting anticholinergics in COPD patients. To evaluate the adherence while using inhaler and educate about inhaler technique.

Method: It is a prospective observational study, patients aged more than 18 years who were diagnosed with COPD and those who received inhalation therapy included glycopyrronium and indacaterol included in the study.

Results: A total of 50 patients included in the study. The main parameters were monitored included ECG, Heart rate, Blood pressure. The patient’s blood pressure level mainly in the prehypertensive level. By considering the heart rate level of patient variation of heart rate in each visit can be seen. The comparison of each visits shows the significant changes for the heart rate variation. Out of 50 patients majority of patients are having abnormal ECG (88%). The main abnormality found in the ECG findings was sinus tachycardia (26%). The adherence of patients during each visit by showing the video of inhaler technique, among 50 patients 44 were counseled by video demonstration and rest of 6 patients by orally. The improvement of patients adherence level by showing the significant value (0.000).

Conclusion: The cardiovascular safety of this combination drug is harmless to an extent. The changes in blood pressure, heart rate and ECG is appear to safely tolerated and slight changes in these parameters are due to weakness and the effect of the drug in related to the response of patient’s different body characteristics. Proper inhalation technique gives the patients to take the inhaler confidently by knowing the better way of its usage.

Keywords: COPD; Bronchodilator; Inhalers; Combination Drug; ECG

References

1. Gershon A., et al. “Cardiovascular Safety of Inhaled Long-Acting Bronchodilators in Individuals with Chronic Obstructive Pulmonary Disease”. JAMA Internal Medicine 13 (2013): 1175-1184.
2. Maele BV., et al. “Cardiovascular Safety of QVA149, a Combination of Indacaterol and NVA237, in COPD Patients”. COPD: Journal of Chronic Obstructive Pulmonary Disease 7 (2010): 418-427.
3. Parvaiz A Koul. “Chronic obstructive pulmonary disease: Indian guidelines and the road ahead”. Lung India3 (2013): 175-177.
4. GBD 2015 Mortality and Causes of Death Collaborators. “Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015 GBD 2015 Chronic Respiratory Disease Collaborators”. Lancet Respiratory Medicine 5 (2017): 691-706.
5. Vincken W., et al. “Efficacy and safety of co administration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study”. International Journal of COPD 9 (2014): 215-228.
6. Spannella F., et al. “Combination Therapy of Inhaled Indacaterol/Glycopyrronium for Chronic Obstructive Pulmonary Disease in the Very Elderly: Is It Safe?” An Electrocardiographic Evaluation”. Journal of Respiration1 (2018): 22-29.
7. Jadwiga A Wedzicha., et al. “Pooled safety analysis of the fixed-dose combination of indacaterol and glycopyrronium (QVA149), its monocomponents, and tiotropium versus placebo in COPD patients”. Respiratory Medicine 108 (2014): 1498-1507.
8. Rogliani P., et al. “LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review”. International Journal of COPD 13 (2018): 3115-3130.
9. Indacaterol, inhaled/glycopyrrolate inhaled (Rx) (2019).
10. Product Monograph: Onbrez Breezhaler. Long-acting beta. Novartis Pharmaceuticals Canada Inc. Montreal, Canada (2015).
11. Samp J C., et al. “Risk of Cardiovascular and Cerebrovascular Events in COPD Patients Treated With Long-Acting β2 Agonist Combined With a Long-Acting Muscarinic or Inhaled Corticosteroid”. Annals of Pharmacotherapy (2017): 1-9.
12. Andreas S., et al. “Effect of long-acting β2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients”. Pulmonary Pharmacology and Therapeutics 52 (2018): 1-6.
13. Ferguson GT., et al. “Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials”. Respiratory Medicine 143 (2018): 67-73.
14. Hohlfeld J M., et al. “Effect of Indacaterol/Glycopyrronium on Pulmonary Perfusion and Ventilation in Hyper inflated COPD Patients (CLAIM): a double-blind, randomized, crossover trial”. American Journal of Respiratory and Critical Care Medicine (2018): 1-11.
15. Worth H., et al. “Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomized, crossover, placebo-controlled, single-centre trial”. Lancet of respiratory Medicine 105 (2011): 571-579.
16. Kardos P., et al. “Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD”. International Journal of COPD 11 (2016): 2885-2895.
17. Calzetta L., et al. “A systematic review with meta-analysis of dual bronchodilation with LAMA/LABA for the treatment of stable chronic obstructive pulmonary disease”. Journal of Chest (2016): 1330-1346.
18. Buhl R., et al. “Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease”. Journal of Respiratory Medicine (2016): 1491-1501.
19. Reisner C., et al. “Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed dose combination of glycopyrronium/formoterol fumarate dehydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects”. Pulmonary Pharmacology and Therapeutics 53 (2018): 33-38.
20. Onishi K . “Total management of chronic obstructive pulmonary disease (COPD) as an independent risk factor for cardiovascular disease”. Journal of Cardiology 70 (2017): 128-134.
21. Zhao D., et al. “Efficacy and safety of tiotropium bromide combined with budesonide/formoterol in the treatment of moderate to severe chronic obstructive pulmonary disease”. Experimental and Therapeutic Medicine 16 (2018): 4578-4584.
22. Chen W., et al. “Risk of cardiovascular co morbidity in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis”. Lancet Respiratory Medicine (2015): 155-172.
23. Suissa S., et al. “Long-acting bronchodilator initiation in COPD and the risk of adverse cardio-pulmonary events: A population-based comparative safety study”. Journal of CHEST (2016): 319-369.
24. Yee K C and Knobloach J. “Cardiovascular safety of new inhaled medications for asthma and chronic obstructive pulmonary disease: a critical review from pharmacist perspective”. International Journal of Research in Medical Sciences6 (2016): 1814-1829.
25. Kumar A., et al. “Assessment of cardiovascular changes among chronic obstructive pulmonary disease patients at rural tertiary care center of Northern India”. International Journal of Medical Science and Public Health8 (2017): 1320-1324.
26. Gupta N K., et al. “Echocardiographic evaluation of heart in chronic obstructive pulmonary disease patient and its co-relation with the severity of disease”. Lung India2 (2011): 105-109.
27. Materaet MG. “Safety Considerations with Dual Bronchodilator Therapy in COPD: An Update”. Springer International Publishing Switzerland (2016): 259-267.
28. Smid D E., et al. “Impact of cardiovascular co morbidities on COPD Assessment Test (CAT) and its responsiveness to pulmonary rehabilitation in patients with moderate to very severe COPD: protocol of the Chance study”. British Medical Journal 5 (2015): 122.
29. Hersh C P., et al. “Family History Is a Risk Factor for COPD”. Journal of Chest 2 (2011): 343-350.
30. Guillien A., et al. “Prevalence and risk factors for COPD in farmers: across-sectional controlled study”. European Respiratory Journal 47 (2016): 95-103.
31. Byrd J B., et al. “Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial”. European Heart Journal (2018): 1-7.
32. Kardos P and Peinz IH. “The impact of indacaterol/glycopyrronium fixed dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study – the Favor study”. International Journal of COPD 13 (2018): 69-77.
33. Buhl R., et al. “Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD”. Europian Respiratory Journal4 (2011): 797-803.
34. Lehmann S., et al. “A randomized trial to determine the impact of indacaterol/glycopyrronium on nighttime oxygenation and symptoms in patients with moderate-to-severe COPD: the Duosleep study”. International Journal of COPD 14 (2019): 199-210.
35. Abdulsalim S., et al. “Structured Pharmacist-led Intervention Programme to Improve Medication Adherence in COPD Patients: A randomized controlled study”. European Respiratory Journal 10 (2018): 909-914.
36. Montes de Oca M., et al. “Adherence to inhaled therapies of COPD patients from seven Latin American countries: The LASSYC study”. Journal Plose One (2017): 1-14.
37. Kim SH., et al. “Chronic obstructive pulmonary disease is independently associated with hypertension in men A survey design analysis using nationwide survey data”. Journal of Medicine19 (2017): 1-7.

Citation

Citation: Dhandapani Chidambaram., et al. “Assessment of Safety in COPD Patients Receiving Long Acting β2- agonist in Addition to Long Acting Anticholinergics". Acta Scientific Microbiology 3.6 (2020): 69-79.

Copyright

Copyright: © 2020 Dhandapani Chidambaram., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.