The multicenter, open-Label, observational LEAD-Ph study: Real-world safety and effectiveness of liraglutide in Filipino participants with Type 2 Diabetes
https://doi.org/10.15605/jafes.033.02.02
- Author:
Cecilia Jimeno
1
,
2
;
Sjoberg Kho
3
;
Grace Ko de los Santos
4
;
Neslie Buena-Bobis
5
;
Michael Villa
6
Author Information
1. Department of Pharmacology and Toxicology, College of Medicine
2. Section of Endocrinology, Diabetes and Metabolism Department of Medicine, Philippine General Hospital, University of the Philippines
3. Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Santo Tomas Hospital, Philippines
4. Department of Medicine, Far Eastern University-Nicanor Reyes Medical Foundation, Philippines
5. Novo Nordisk Pharmaceuticals (Phils) Bonifacio Global City, Taguig, Philippines
6. Center for Diabetes, Thyroid and Endocrine Disorders, St. Lukes Medical Center, Global City, Taguig, Philippines
- Publication Type:Journal Article
- MeSH:
Glucagon-Like Peptides;
Liraglutide;
Diabetes Mellitus, Type 2;
Safety;
Observational Study
- From:
Journal of the ASEAN Federation of Endocrine Societies
2018;33(2):114-123
- CountryPhilippines
- Language:English
-
Abstract:
Objective:Assess safety and effectiveness of liraglutide among Filipino participants with type 2 diabetes (T2D) in routine clinical practice.
Methodology:A 26-week, prospective, multicenter, open-label, observational study was conducted in adults with T2D prescribed liraglutide (1.2 mg or 1.8 mg) in routine clinical practice in the Philippines. Primary endpoint: incidence rate and type of serious adverse drug reactions (SADRs). Secondary endpoints included other aspects of safety, and effectiveness.
Results:Participants (n=1056) had a mean (standard deviation) age of 53.2 (12.0) years, and glycated hemoglobin (HbA1c) level of 8.8% (2.0). Of 19 ADRs reported in 17 participants, none were SADRs (primary endpoint). No serious adverse events were reported. From baseline to week 26: the proportion of participants with major hypoglycemic episodes (requiring assistance) decreased from 2.0% to 0.2%; and with minor episodes (plasma glucose <3.1 mmol/L [<56 mg/dL]) decreased from 6.1% to 1.5%; serum creatinine remained unchanged. Among secondary effectiveness endpoints, improvements were seen from baseline to week 26 in HbA1c level, fasting and postprandial blood glucose levels, body weight, blood pressure, and fasting lipid profile.
Conclusion:During routine clinical use of liraglutide for T2D in the Philippines, no new safety concerns were identified and blood glucose was lowered effectively.
- Full text:422-Article.pdf
