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Linagliptin treatment in subjects with type 2 diabetes with and without mild-to-moderate renal impairment.

Groop PH, Del Prato S, Taskinen MR, Owens DR, Gong Y, Crowe S, Patel S, von Eynatten M, Woerle HJ - Diabetes Obes Metab (2014)

Bottom Line: In linagliptin-treated subjects, overall adverse event (AE) rates and serious AE rates were similar to placebo.The incidence of hypoglycaemia with linagliptin and placebo was 11.1 versus 6.9%, 11.9 versus 9.0% and 15.9 versus 12.0% in the normal, mild RI and moderate RI categories, respectively.This pooled analysis provides evidence that linagliptin is an effective, well-tolerated and convenient treatment in subjects with T2DM and mild or moderate RI.

View Article: PubMed Central - PubMed

Affiliation: Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.

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Mean change in renal function (eGFR) over time in subjects treated with linagliptin 5 mg or placebo (FAS). Renal function according to MDRD formula; normal, ≥90 ml/min/1.73 m2; mild, 60–<90 ml/min/1.73 m2; moderate, 30–<60 ml/min/1.73 m2. eGFR, estimated glomerular filtration rate; FAS, full analysis set; MDRD, modification of diet in renal disease; s.d., standard deviation.
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fig03: Mean change in renal function (eGFR) over time in subjects treated with linagliptin 5 mg or placebo (FAS). Renal function according to MDRD formula; normal, ≥90 ml/min/1.73 m2; mild, 60–<90 ml/min/1.73 m2; moderate, 30–<60 ml/min/1.73 m2. eGFR, estimated glomerular filtration rate; FAS, full analysis set; MDRD, modification of diet in renal disease; s.d., standard deviation.

Mentions: Linagliptin treatment was generally well-tolerated across the three renal function categories (Table3). In both treatment groups, a slight trend for higher rates of any AEs, SAEs and drug-related AEs was seen in subjects with RI. The incidence of AEs with linagliptin was comparable to placebo in each renal function category. In the moderate RI category, there were no reported drug-related AEs with placebo compared with an incidence rate of 14.5% (n = 10) with linagliptin. Notably, hypoglycaemia was reported by 7 of 10 linagliptin-treated subjects with drug-related AEs in this category. Overall, there was no clustering of any specific type of unexpected AE (Table3). In an analysis of AEs by system organ class (SOC), the incidences of cardiac disorders for linagliptin and placebo were: normal renal function, 1.9 and 1.4%; mild RI, 3.7 and 0.5%; moderate RI, 1.4 and 4.0%. The incidences of AEs relating to renal and urinary disorders were similar for linagliptin and placebo in subjects with normal renal function (2.5 and 4.0%), mild RI (3.8 and 3.2%) and moderate RI (4.3 and 4.0%). There were no drug-related AEs of renal failure. Renal function (eGFR) remained stable over 24 weeks following linagliptin or placebo treatment (Figure 3). Although only one subject (0.2%) developed hyperkalaemia (from the mild RI category and who received linagliptin), no other clinically significant laboratory findings emerged. According to the eCcr categorisation, there was a trend for higher rates of any AEs, SAEs and drug-related AEs in subjects with RI compared with subjects without RI, but overall rates were similar between linagliptin and placebo (Table S3).


Linagliptin treatment in subjects with type 2 diabetes with and without mild-to-moderate renal impairment.

Groop PH, Del Prato S, Taskinen MR, Owens DR, Gong Y, Crowe S, Patel S, von Eynatten M, Woerle HJ - Diabetes Obes Metab (2014)

Mean change in renal function (eGFR) over time in subjects treated with linagliptin 5 mg or placebo (FAS). Renal function according to MDRD formula; normal, ≥90 ml/min/1.73 m2; mild, 60–<90 ml/min/1.73 m2; moderate, 30–<60 ml/min/1.73 m2. eGFR, estimated glomerular filtration rate; FAS, full analysis set; MDRD, modification of diet in renal disease; s.d., standard deviation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4288982&req=5

fig03: Mean change in renal function (eGFR) over time in subjects treated with linagliptin 5 mg or placebo (FAS). Renal function according to MDRD formula; normal, ≥90 ml/min/1.73 m2; mild, 60–<90 ml/min/1.73 m2; moderate, 30–<60 ml/min/1.73 m2. eGFR, estimated glomerular filtration rate; FAS, full analysis set; MDRD, modification of diet in renal disease; s.d., standard deviation.
Mentions: Linagliptin treatment was generally well-tolerated across the three renal function categories (Table3). In both treatment groups, a slight trend for higher rates of any AEs, SAEs and drug-related AEs was seen in subjects with RI. The incidence of AEs with linagliptin was comparable to placebo in each renal function category. In the moderate RI category, there were no reported drug-related AEs with placebo compared with an incidence rate of 14.5% (n = 10) with linagliptin. Notably, hypoglycaemia was reported by 7 of 10 linagliptin-treated subjects with drug-related AEs in this category. Overall, there was no clustering of any specific type of unexpected AE (Table3). In an analysis of AEs by system organ class (SOC), the incidences of cardiac disorders for linagliptin and placebo were: normal renal function, 1.9 and 1.4%; mild RI, 3.7 and 0.5%; moderate RI, 1.4 and 4.0%. The incidences of AEs relating to renal and urinary disorders were similar for linagliptin and placebo in subjects with normal renal function (2.5 and 4.0%), mild RI (3.8 and 3.2%) and moderate RI (4.3 and 4.0%). There were no drug-related AEs of renal failure. Renal function (eGFR) remained stable over 24 weeks following linagliptin or placebo treatment (Figure 3). Although only one subject (0.2%) developed hyperkalaemia (from the mild RI category and who received linagliptin), no other clinically significant laboratory findings emerged. According to the eCcr categorisation, there was a trend for higher rates of any AEs, SAEs and drug-related AEs in subjects with RI compared with subjects without RI, but overall rates were similar between linagliptin and placebo (Table S3).

Bottom Line: In linagliptin-treated subjects, overall adverse event (AE) rates and serious AE rates were similar to placebo.The incidence of hypoglycaemia with linagliptin and placebo was 11.1 versus 6.9%, 11.9 versus 9.0% and 15.9 versus 12.0% in the normal, mild RI and moderate RI categories, respectively.This pooled analysis provides evidence that linagliptin is an effective, well-tolerated and convenient treatment in subjects with T2DM and mild or moderate RI.

View Article: PubMed Central - PubMed

Affiliation: Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.

Show MeSH
Related in: MedlinePlus