Safety and efficacy of Ensifentrine in COPD: A Systemic Review and Meta-analysis

Yappalparvi A 1 , Balaraman AK 2 , Padmapriya G 3 , Gaidhane S 4 , Kaur I 5 , Lal M 6 Show all authors , Iqbal S 7 , Prasad GVS 8 , Pramanik A 9 , Vishwakarma T 10 , Malik P 11 , Sharma P 12 , Punia A 13 , Jagga M 14 , Lingamaiah D 15 , Mehta R 16 , Sah S 17 , Zahiruddin QS 18 , Serhan HA 19 , Shabil M 20 , Bushi G 21

Affiliations 

  • 1 School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, India. Electronic address: ambanna910@gmail.com
  • 2 Research and Enterprise, University of Cyberjaya, Persiaran Bestari, Cyber 11, 63000 Cyberjaya, Selangor, Malaysia. Electronic address: ashok@cyberjaya.edu.my
  • 3 Department of Chemistry and Biochemistry, School of Sciences, JAIN (Deemed to be University), Bangalore, Karnataka, India. Electronic address: g.padmapriya@jainuniversity.ac.in
  • 4 One Health Centre, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education, Wardha, India. Electronic address: shilpa.gaidhane@dmiher.edu.in
  • 5 Department of Allied Healthcare and Sciences, Vivekananda Global University, Jaipur, Rajasthan-303012, India. Electronic address: irwanjotkaur850@gmail.com
  • 6 Department of Medicine, NIMS University, Jaipur, India. Electronic address: Madan.lal1@nimsuniversity.org
  • 7 Chandigarh Pharmacy College, Chandigarh Group of College, Jhanjeri, Mohali - 140307, Punjab, India. Electronic address: Suhaib2956.research@cgcjhanjeri.in
  • 8 Department of Chemistry, Raghu Engineering College, Visakhapatnam, Andhra Pradesh-531162, India. Electronic address: sivaprasad.gv@raghuenggcollege.in
  • 9 School of Applied and Life Sciences, Division of Research and Innovation, Uttaranchal University, Dehradun, India. Electronic address: atreyipram91@gmail.com22
  • 10 IES Institute of Pharmacy, IES University, Bhopal, Madhya Pradesh 462044, India. Electronic address: teena.research@iesuniversity.ac.in
  • 11 New Delhi Institute of Management, Delhi, India. Electronic address: praveen.malik@ndimdelhi.org
  • 12 Department of Microbiology, Graphic Era (Deemed to be University) Clement Town Dehradun-248002, India. Electronic address: promilasharma.bt@geu.ac.in
  • 13 Centre of Research Impact and Outcome, Chitkara University, Rajpura- 140417, Punjab, India. Electronic address: ankit.punia.orp@chitkara.edu.in
  • 14 Chitkara Centre for Research and Development, Chitkara University, Himachal Pradesh-174103, India. Electronic address: megha.jagga.orp@chitkara.edu.in
  • 15 Noida Institute of Engineering and Technology (Pharmacy Institute), Greater Noida, India. Electronic address: lingamdoddolla13@gmail.com
  • 16 Clinical Microbiology, RDC, Manav Rachna International Institute of Research and Studies, Faridabad, Haryana 121004, India; Dr Lal PathLabs - Nepal, Chandol-4, Maharajgunj, Kathmandu 44600, Nepal. Electronic address: mehtarachana89@gmail.com
  • 17 Department of Paediatrics, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune 411018, Maharashtra, India; Department of Public Health Dentistry, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune 411018, Maharashtra, India. Electronic address: sanjitsahnepal561@gmail.com
  • 18 South Asia Infant Feeding Research Network, Division of Evidence Synthesis, Global Consortium of Public Health and Research, Datta Meghe Institute of Higher Education, Wardha, India. Electronic address: zahirquazi@dmiher.edu.in
  • 19 Department of Ophthalmology, Hamad Medical Corporation, Doha, Qatar. Electronic address: habuserhan@hamad.qa
  • 20 University Center for Research and Development, Chandigarh University, Mohali, Punjab, India; Medical Laboratories Techniques Department, AL-Mustaqbal University, 51001 Hillah, Babil, Iraq. Electronic address: mohdshabil99@gmail.com
  • 21 Center for Global Health Research, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, India; Research and Enterprise, University of Cyberjaya, Persiaran Bestari, Cyber 11, 63000 Cyberjaya, Selangor, Malaysia. Electronic address: ganeshbushi313@gmail.com
Respir Med, 2024 Nov 16.
PMID: 39557208 DOI: 10.1016/j.rmed.2024.107863

Abstract

BACKGROUND: Chronic obstructive pulmonary disease (COPD) significantly impacts global health due to persistent airflow limitation and inflammation. Despite standard therapies, symptoms persist. Ensifentrine, targeting both bronchoconstriction and inflammation as a dual phosphodiesterase 3 and 4 inhibitor, offers a promising therapeutic advancement for COPD management. This meta-analysis evaluates the safety and efficacy of ensifentrine in improving lung function, dyspnea, and quality of life in COPD patients.

METHODS: We searched PubMed, Embase, and Web of Science through August 2024 for randomized controlled trials evaluating ensifentrine in COPD patients over a minimum of four weeks. Data extraction and screening utilized Knowledge software, and meta-analyses were performed using R v4.4 with a random-effects model.

RESULTS: From 206 studies identified, four met our inclusion criteria. Ensifentrine improved FEV1 significantly at a dose of 3 mg (LS mean difference: 40.90 mL; 95% CI: 19.65-62.15). It also improved dyspnea as measured by the Transition Dyspnea Index (TDI) (LS mean difference: 0.91; 95% CI: 0.61-1.21) and quality of life according to the St. George's Respiratory Questionnaire-C (SGRQ-C) scores (LS mean difference: -1.92; 95% CI: -3.28 to -0.55). Safety profiles were comparable between the ensifentrine and placebo groups, with no significant increase in treatment-emergent adverse events (TEAEs) (RR: 1.02; 95% CI: 0.94-1.10).

CONCLUSION: Ensifentrine significantly enhances lung function, reduces dyspnea, and improves quality of life in COPD patients, especially at a 3 mg dose. These benefits, coupled with a stable safety profile, support its use as an adjunctive therapy in COPD management.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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