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Schernthaner, G, Barnett, A H, Emser, A, Patel, S, Troost, J, Woerle, H-J and von Eynatten, M (2012) Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus. Diabetes, obesity & metabolism, 14 (5). pp. 470-8. ISSN 1463-1326. Available via evidence.nhs.uk for users with a HEFT Athens password
Full text not available from this repository.Abstract
AIMS
To assess the safety and tolerability of the dipeptidyl peptidase-4 inhibitor linagliptin in patients with type 2 diabetes.
METHODS
Data were pooled from eight randomized, double-blind, placebo-controlled Phase III clinical trials lasting ≤24 weeks. Incidences were calculated with descriptive statistics for the overall population and for subgroups of elderly and renally impaired patients.
RESULTS
A total of 2523 patients received linagliptin 5 mg once daily and 1049 patients received placebo. The overall incidence of adverse events (AEs) or serious AEs with linagliptin was similar to placebo (AEs 55.8% vs. 55.0%; serious AEs 2.8% vs. 2.7%). Overall aggregated infection incidence was 19.5% for linagliptin and 21.4% for placebo. Similar or reduced incidence of AEs versus placebo were seen with linagliptin for upper respiratory tract infection (3.3% vs. 4.9%), headache (2.9% vs. 3.1%), urinary tract infection (2.2% vs. 2.7%), blood and lymphatic disorders (1.0% vs. 1.2%), hypersensitivity (0.1% vs. 0.1%), hepatic enzyme increase (0.1% and 0.1%) and serum creatinine increase (0.0% and 0.1%). There was a slight increased frequency of nasopharyngitis (5.9% vs. 5.1%) and cough (1.7% vs. 1.0%) with linagliptin. Hypoglycaemia incidence was 8.2% for linagliptin and 5.1% for placebo; incidence was higher in patients with a background of sulphonylurea therapy (20.7% and 13.3%, respectively). In patients not receiving concomitant sulphonylurea, the hypoglycaemic incidence with linagliptin was very low in both the total population (<1%), and elderly and renally impaired patients (both <1%).
CONCLUSIONS
This pooled analysis shows that linagliptin is well tolerated, with a low risk of hypoglycaemia.
| Item Type: | Article |
|---|---|
| Additional Information: | Available via evidence.nhs.uk for users with a HEFT Athens password |
| Subjects: | WK Endocrine system. Endocrinology |
| Divisions: | Ambulatory Care > Diabetes |
| Related URLs: | |
| Depositing User: | Users 7 not found. |
| Date Deposited: | 23 Jun 2014 09:11 |
| Last Modified: | 23 Jun 2014 09:11 |
| URI: | http://www.repository.uhblibrary.co.uk/id/eprint/300 |
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