Efficacy and safety of saxagliptin, a dipeptidyl peptidase-4 inhibitor, in hemodialysis patients with diabetic nephropathy: A randomized open-label prospective trial

Abe, Masanori; Higuchi, Terumi; Moriuchi, Masari; Okamura, Mitsu; Tei, Ritsukou; Nagura, Chinami; Takashima, Hiroyuki; Kikuchi, Fumito; Tomita, Hyoe; Okada, Kazuyoshi

doi:10.1016/j.diabres.2016.04.034

Cited by 14 publications

(24 citation statements)

References 20 publications

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“…Saxagliptin, in contrast, has been reported for use in patients with moderate CKD with type 2 diabetes mellitus and ESRD [13,27,30]. In particular, the SAVOR-TIMI53 study, which included large-scale clinical trials that followed approximately 16,000 patients for an average of 2.1 years, reported that the safety of Saxagliptin is not significantly different from placebo in chronic kidney disease (CKD) patients not on dialysis [34].…”

Section: Discussionmentioning

confidence: 99%

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Efficacy of Saxagliptin versus Mitiglinid in patients with type 2 diabetes and end-stage renal disease

Sakai

Sakai²,

Mugishima

et al. 2017

Ren Replace Ther

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Background: There are very few oral antidiabetic drugs recommended for patients on dialysis. Saxagliptin is known for its potent effect and long duration of action. In this study, we compared the efficacy of Saxagliptin with Mitiglinid for diabetes control and renal anemia in hemodialysis patients with type 2 diabetes mellitus. Methods: We performed a 6-month prospective, open-label, parallel group study of 41 patients with type 2 diabetes mellitus undergoing hemodialysis who took alpha-glucosidase inhibitors or meglitinides and did not use insulin. Saxagliptin and Mitiglinid were administered at 2.5 and 5 mg/day, respectively. The primary outcomes were changes in hemoglobin A1c (HbA1c) and glycated albumin (GA). Other efficacy assessments included changes in Hb, darbepoetin alpha (DA) dose, and erythropoietin responsiveness index (ERI). Results: No patient required an increase in Saxagliptin or Mitiglinid dose, and there were no cases of hypoglycemia with symptoms. HbA1c and GA values were not significantly different between both groups. For HbA1c, the gradient of the regression line of the Saxagliptin and Mitiglinid groups were Y = −7.144e-005*X + 6.023 and Y = −0. 02604*X + 6.292, respectively, and no significant difference was found (p = 0.3281). However, for GA, the regression line of the Saxagliptin group significantly decreased (Y = −0.5036*X + 19.34 and Y = −0.2346*X + 18.79, p = 0.0371). Both groups did not have a significant change in the DA dose through the observation period. However, the DA dose of the Saxagliptin group significantly decreased when we compared the regression lines (Y = −0.8304*X + 21. 06 and Y = 0.6286*X + 16.12, p = 0.0019) of both groups. Furthermore, ERI did not change significantly but showed a significant difference when regression lines were compared (Y = −0.2030*X + 6.654 and Y = 0.1116*X + 5.288, p = 0.0082).

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Section: Discussionmentioning

confidence: 99%

“…Furthermore, few randomized controlled trials have compared antihyperglycemic agents in these patients [30].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Saxagliptin versus Mitiglinid in patients with type 2 diabetes and end-stage renal disease

Sakai

Sakai²,

Mugishima

et al. 2017

Ren Replace Ther

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“…Of particular note, these observations also extend to T2DM patients with CKD, where insulin therapy is widely used, and where other drugs may be inappropriate or contra‐indicated (Table ). As described above, DPP‐4 inhibitors have been widely studied in patients with impaired renal function, many of whom were treated with insulin (Table ). In specific analyses of the sub‐groups on insulin, the addition of a DPP‐4 inhibitor improved HbA1c levels irrespective of renal function without increasing the incidence or severity of hypoglycaemia or the number of renal adverse events …”

Section: Combinations Of Dpp‐4 Inhibitors and Insulinmentioning

confidence: 99%

“…Because of their good tolerability and low risk of causing hypoglycaemia (due to their glucose-dependent antihyperglycaemic mechanism of action), DPP-4 inhibitors are particularly suited for use in patients with impaired renal function, who are inherently at greater risk of hypoglycaemia. A number of RCTs, specifically examining patients with kidney disease, have consistently shown that DPP-4 inhibitors provide efficacious glycaemic control without unduly increasing the risk of hypoglycaemia irrespective of the degree of renal impairment, [40][41][42][43][44] also in those with end-stage renal disease (ESRD) on dialysis, 43,[45][46][47] with the magnitude of the improvements in HbA1c as well as overall tolerability (Table 4) being similar to what is seen in patients without renal disease.…”

Section: Heart Failurementioning

confidence: 99%

A review of dipeptidyl peptidase‐4 inhibitors. Hot topics from randomized controlled trials

Deacon

2018

Diabetes Obesity Metabolism

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The first clinical study to investigate effects of dipeptidyl peptidase-4 (DPP-4) inhibition was published in 2002, and since then, numerous randomized controlled trials (RCTs) have shown that DPP-4 inhibitors are efficacious, safe and well-tolerated. This review will focus upon RCTs which have investigated DPP-4 inhibitors in patient groups which are often under-represented or excluded from typical phase 3 clinical trials. Large cardiovascular (CV) safety outcome trials in patients with established CV disease have confirmed that DPP-4 inhibitors are not associated with any additional CV risk in these already-at-high-risk individuals, while raising awareness of any uncommon adverse events, such as heart failure hospitalization seen in one of the trials. Studies in patients with kidney disease have shown DPP-4 inhibitors to be efficacious without increasing the risk of hypoglycaemia, irrespective of the degree of renal impairment, while data from the large CV trials as well as smaller RCTs have even pointed towards potential renoprotective effects such individuals. The use of DPP-4 inhibitors with insulin when therapy requires intensification may be beneficial without affecting the incidence or severity of hypoglycaemia, with these effects also being replicated in patients with chronic kidney disease, for whom other agents may not be suitable. Attention is now turning towards exploring the potential utility of DPP-4 inhibitors in other circumstances, including for in-hospital management of hyperglycaemia and in other metabolic disorders. Together, these RCTs raise the possibility that in the future, DPP-4 inhibitors may have a broader use which may extend beyond glycaemic control in the typical type 2 diabetes mellitus (T2DM) patient seen in general practice and may encompass conditions other than T2DM.

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“…Особливо небезпечною є гіпоглікемія, що може розвива-тися під час процедури гемодіалізу, внаслідок видалення глюкози із кровотоку. Використан-ня глюкозовмісних розчинів, постійний моні-торинг рівня глюкози в крові під час сеансів рекомендовані для зниження ризику розвитку гіпоглікемічних станів у хворих на цукровий діабет, які перебувають в умовах хронічного гемодіалізу [5,6]. Крім того, для контролю ефективності процедури гемодіалізу та для зменшення часу перебування пацієнта в не-зручних умовах, необхідний постійний контр-оль основних уремічних токсинів -сечовини та креатиніну [7][8][9].…”

Section: вступunclassified

MULTIBIOSENSOR SYSTEM BASED ON pH-SENSITIVE FIELD-EFFECT TRANSISTORS FOR SIMULTANEOUS DETERMINATION OF GLUCOSE, CREATININE AND UREA

Солдаткін¹,

Марченко²,

Кукла³

et al. 2018

SEMST

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Efficacy and safety of saxagliptin, a dipeptidyl peptidase-4 inhibitor, in hemodialysis patients with diabetic nephropathy: A randomized open-label prospective trial

Abstract: UMIN000018445.

Cited by 14 publications

References 20 publications

Efficacy of Saxagliptin versus Mitiglinid in patients with type 2 diabetes and end-stage renal disease

Efficacy of Saxagliptin versus Mitiglinid in patients with type 2 diabetes and end-stage renal disease

A review of dipeptidyl peptidase‐4 inhibitors. Hot topics from randomized controlled trials

MULTIBIOSENSOR SYSTEM BASED ON pH-SENSITIVE FIELD-EFFECT TRANSISTORS FOR SIMULTANEOUS DETERMINATION OF GLUCOSE, CREATININE AND UREA

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