Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency

Chan, Juliana C.N.; Scott, Russell S.; Ferreira, Juan Camilo Arjona; Sheng, D.; Gonzalez, Edward J.; Davies, Michael J.; Stein, Peter; Kaufman, Keith D.; Amatruda, John M.; Williams-Herman, Debora

doi:10.1111/j.1463-1326.2008.00914.x

Cited by 224 publications

(206 citation statements)

References 25 publications

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“…With dose adjustment in a 54-week trial, sitagliptin was generally well tolerated and provided effective glycaemic control in patients with T2DM and moderate-to-severe RI, including patients with ESRD on dialysis [83]. However, in a study assessing dose adjustments of glucose-lowering agents in T2DM patients with moderate to end-stage RI from a large outpatients electronic medical records database, only 15% of patients with prescriptions for sitagliptin received dosages of the drug appropriate for their degree of RI.…”

Section: Patients With Renal Impairmentmentioning

confidence: 99%

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

Scheen¹

2012

Diabetes & Metabolism

176

124

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Dipeptidyl peptidase-4 (DPP-4) inhibitors offer new options for the management of type 2 diabetes. Direct comparisons with active glucose-lowering comparators in drug-naive patients have demonstrated that DPP-4 inhibitors exert slightly less pronounced HbA 1c reduction than metformin (with the advantage of better gastrointestinal tolerability) and similar glucose-lowering effects as with a thiazolidinedione (TZD; with the advantage of no weight gain). In metformin-treated patients, gliptins were associated with similar HbA 1c reductions compared with a sulphonylurea (SU; with the advantage of no weight gain, considerably fewer hypoglycaemic episodes and no need for titration) and a TZD (with the advantage of no weight gain and better overall tolerability). DPP-4 inhibitors also exert clinically relevant glucose-lowering effects compared with a placebo in patients treated with SU or TZD (of potential interest when metformin is either not tolerated or contraindicated), and as oral triple therapy with a good tolerability profile when added to a metformin-SU or pioglitazone-SU combination. Several clinical trials also showed a consistent reduction in HbA 1c when DPP-4 inhibitors were added to basal insulin therapy, with no increased risk of hypoglycaemia. Because of the complex pathophysiology of type 2 diabetes and the complementary actions of glucose-lowering agents, initial combination of a DPP-4 inhibitor with either metformin or a glitazone may be applied in drug-naive patients, resulting in greater efficacy and similar safety compared with either drug as monotherapy. However, DPP-4 inhibitors were less effective than GLP-1 receptor agonists for reducing HbA 1c and body weight, but offer the advantage of being easier to use (oral instead of injected administration) and lower in cost. Only one head-tohead trial demonstrated the non-inferiority of saxagliptin vs sitagliptin. Clearly, more trials of direct comparisons between different incretin-based therapies are needed. Because of their pharmacokinetic characteristics, pharmacodynamic properties (glucose-dependent glucose-lowering effect) and good overall tolerability profile, DPP-4 inhibitors may have a key role to play in patients with renal impairment and in the elderly. The role of DPP-4 inhibitors in the therapeutic armamentarium of type 2 diabetes is rapidly evolving as their potential strengths and weaknesses become better defined mainly through controlled clinical trials. Keywords:Clinical trial-DPP-4 inhibitor; Alogliptin; Linagliptin; Saxagliptin; Sitagliptin; Vildagliptin; Type 2 diabetes mellitus; Review Résumé Les inhibiteurs de la DPP-4 dans le traitement du diabète de type 2 : revue critique des essais cliniques contrôlés.Les inhibiteurs de la dipeptidylpeptidase-4 (DPP-4) offrent de nouvelles options pour le traitement du diabète de type 2. Des comparaisons directes avec d'autres médicaments antidiabétiques chez des patients naïfs de tout traitement ont démontré que les inhibiteurs de la DPP-4 étaient un peu moins puissants pour diminuer ...

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Section: Patients With Renal Impairmentmentioning

confidence: 99%

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

Scheen¹

2012

Diabetes & Metabolism

176

124

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“…However, Park et al [9] reported that sitagliptin showed a much higher efficacy compared to that of vildagliptin and linagliptin. In Table 2 Vital and serum parameters determined before and during the study treating T2DM patients with stages 3 to 5 chronic kidney disease (CKD) including those with end-stage renal disease, sitagliptin has been reported to be effective in controlling plasma glucose levels and maintaining the safety [11][12][13]. However, these reports only discussed the plasma glucose control mainly by measuring HbA1c, and the targets of DPP-4 inhibitors to achieve good glycemic control, such as aGLP-1, have not been discussed.…”

Section: Discussionmentioning

confidence: 99%

“…The sub-analysis of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin study (TECOS) to evaluate cardiovascular outcome in mainly normoalbuminuric T2DM patients receiving sitagliptin showed that mean change of eGFR during 48 months from the baseline was significantly lower in the sitagliptin group than in the placebo group, but the cumulative incidence of microalbuminuria and renal failure was equivalent in two groups [15]. The efficacy and safety of sitagliptin had also been reported in patients with renal failure [11][12][13]. Taking these reports together into consideration, subtle changes in renal function caused by sitagliptin might be generally safe.…”

Section: Discussionmentioning

confidence: 99%

The renoprotective effect and safety of a DPP-4 inhibitor, sitagliptin, at a small dose in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors: REAL trial

Kanozawa

Noguchi

Sugahara³

et al. 2017

Clin Exp Nephrol

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Background We conducted the multicenter, prospective, open-label study in type 2 diabetic (T2DM) patients with renal dysfunction, to clarify the efficacy and the safety in relation to renal function and glycemic control, and the economic effect when other dipeptidyl peptidase-4 (DPP-4) inhibitors were switched to a small dose of sitagliptin depending on their renal function. Methods Vildagliptin, alogliptin, or linagliptin received for more than 2 months were changed to sitagliptin at 25 or 12.5 mg/ day depending on their renal function in 49 T2DMs. Renal function and glycemic control, and the drug cost were assessed during 6 months. Results Estimated glomerular filtration rate was not changed in patients not on hemodialysis (n = 29). The HbA1c levels were not altered in all of the patients including those on hemodialysis (n = 20). The active glucagon-like peptide-1 levels or other renal parameters were not altered significantly. There were no adverse events to be related to the drugs. The daily drug expense was reduced by 88.1 yen per patient. Conclusion Switching to a small dose of sitagliptin according to the renal function in T2DM patients with renal dysfunction demonstrated the same efficacy and safety as those with other full-dose DPP-4 inhibitors, indicating a therapeutic option with a high cost performance.

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“…7 Recent data suggest that sitagliptin is well tolerated and provides effective glycemic control in patients with type 2 diabetes with moderate to severe renal insufficiency, including patients on dialysis. 13 To our knowledge, no data exist examining the potentially inappropriate dosing of sitagliptin based on manufacturer guidelines.…”

Section: ■■ Resultsmentioning

confidence: 99%

Drug Use Evaluation of Sitagliptin Dosing by Pharmacist Versus Nonpharmacist Clinicians in an Internal Medicine Department of a Private Physician-Owned Multispecialty Clinic

McFarland

Cross²,

Gross³

et al. 2009

JMCP

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Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency

Abstract: In this study, sitagliptin was generally well tolerated and provided effective glycaemic control in patients with type 2 diabetes and moderate to severe renal insufficiency, including patients with ESRD on dialysis.

Cited by 224 publications

References 25 publications

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

The renoprotective effect and safety of a DPP-4 inhibitor, sitagliptin, at a small dose in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors: REAL trial

Drug Use Evaluation of Sitagliptin Dosing by Pharmacist Versus Nonpharmacist Clinicians in an Internal Medicine Department of a Private Physician-Owned Multispecialty Clinic

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