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Saxagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus.

Kulasa K, Edelman S - Core Evid (2010)

Bottom Line: Saxagliptin (Onglyza™; Bristol-Myers Squibb Company, Princeton, NJ, USA; AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA) is an oral dipeptidyl peptidase-4 inhibitor, recently approved for the treatment of T2DM.Saxagliptin significantly improves glycemic control vs placebo, as demonstrated by decreasing glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels when used as monotherapy; in initial combination with metformin; and as add-on therapy with metformin, sulfonylurea (SU), or thiazolidinedione (TZD).Saxagliptin also significantly improves β-cell function, is weight neutral, has a low risk for hypoglycemia, and has been shown to have cardiovascular safety.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Metabolism, VA San Diego Healthcare System, University of California, USA;

ABSTRACT

Introduction: The worldwide prevalence of type 2 diabetes mellitus (T2DM) is high, and the chronically poor metabolic control that can result from T2DM is associated with a high risk for microvascular and macrovascular complications. Because of the progressive pathophysiology of T2DM, oral antidiabetic agents often fail to provide sustained glycemic control, indicating the need for new therapies. Saxagliptin (Onglyza™; Bristol-Myers Squibb Company, Princeton, NJ, USA; AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA) is an oral dipeptidyl peptidase-4 inhibitor, recently approved for the treatment of T2DM.

Evidence review: Saxagliptin significantly improves glycemic control vs placebo, as demonstrated by decreasing glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels when used as monotherapy; in initial combination with metformin; and as add-on therapy with metformin, sulfonylurea (SU), or thiazolidinedione (TZD). Saxagliptin also significantly improves β-cell function, is weight neutral, has a low risk for hypoglycemia, and has been shown to have cardiovascular safety.

Place in therapy: The clinical profile for saxagliptin indicates that it is useful as an adjunct to diet and exercise as first-line monotherapy and in combination with metformin; or as add-on treatment for patients who cannot achieve glycemic control with a combination of diet and lifestyle changes and metformin, SU, or TZD.

No MeSH data available.


Related in: MedlinePlus

Postprandial concentrations during the 3-hour oral glucose tolerance test. Effect of saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes. Volume 25 by Rosenstock, et al. © 2009 by Current Medical Research and Opinion.3Notes: aSample size at 120-minute time point. bAdjusted mean change in 120 minute (PPG). cP = 0.007 vs PBO. dP = 0.0009 vs PBO. eP < 0.0001 vs PBO.Abbreviations: PBO, placebo; PPG, postprandial glucose; SAXA, saxagliptin.
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f4-ce-5-023: Postprandial concentrations during the 3-hour oral glucose tolerance test. Effect of saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes. Volume 25 by Rosenstock, et al. © 2009 by Current Medical Research and Opinion.3Notes: aSample size at 120-minute time point. bAdjusted mean change in 120 minute (PPG). cP = 0.007 vs PBO. dP = 0.0009 vs PBO. eP < 0.0001 vs PBO.Abbreviations: PBO, placebo; PPG, postprandial glucose; SAXA, saxagliptin.

Mentions: A randomized, double-blind, placebo-controlled trial of 401 patients with T2DM not controlled with diet and exercise alone (mean baseline HbA1c 7.9%) was conducted. Patients received oral saxagliptin 2.5, 5, or 10 mg once-daily or placebo for 24 weeks. Saxagliptin monotherapy produced clinically meaningful improvements in HbA1c and FPG in treatment-naïve patients at all doses (2.5, 5, and 10 mg) compared with placebo. Saxagliptin (5 and 10 mg) also statistically significantly improved PPG-area under the concentration–time curve (AUC) compared with placebo (P < 0.0002, P < 0.0001, respectively). A separate open-label cohort of 66 patients with HbA1c 10%–12% received saxagliptin 10 mg once-daily for 24 weeks.3 Not surprisingly, clinically meaningful reductions in HbA1c (−1.9%), FPG (−1.83 mmol/L), and PPG-AUC (−615 mmol·min/L) were also observed in the patients with high baseline HbA1c (10%–12%; Figure 4).3 Saxagliptin was more effective than placebo in achieving HbA1c < 7% at week 24.


Saxagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus.

Kulasa K, Edelman S - Core Evid (2010)

Postprandial concentrations during the 3-hour oral glucose tolerance test. Effect of saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes. Volume 25 by Rosenstock, et al. © 2009 by Current Medical Research and Opinion.3Notes: aSample size at 120-minute time point. bAdjusted mean change in 120 minute (PPG). cP = 0.007 vs PBO. dP = 0.0009 vs PBO. eP < 0.0001 vs PBO.Abbreviations: PBO, placebo; PPG, postprandial glucose; SAXA, saxagliptin.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2963920&req=5

f4-ce-5-023: Postprandial concentrations during the 3-hour oral glucose tolerance test. Effect of saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes. Volume 25 by Rosenstock, et al. © 2009 by Current Medical Research and Opinion.3Notes: aSample size at 120-minute time point. bAdjusted mean change in 120 minute (PPG). cP = 0.007 vs PBO. dP = 0.0009 vs PBO. eP < 0.0001 vs PBO.Abbreviations: PBO, placebo; PPG, postprandial glucose; SAXA, saxagliptin.
Mentions: A randomized, double-blind, placebo-controlled trial of 401 patients with T2DM not controlled with diet and exercise alone (mean baseline HbA1c 7.9%) was conducted. Patients received oral saxagliptin 2.5, 5, or 10 mg once-daily or placebo for 24 weeks. Saxagliptin monotherapy produced clinically meaningful improvements in HbA1c and FPG in treatment-naïve patients at all doses (2.5, 5, and 10 mg) compared with placebo. Saxagliptin (5 and 10 mg) also statistically significantly improved PPG-area under the concentration–time curve (AUC) compared with placebo (P < 0.0002, P < 0.0001, respectively). A separate open-label cohort of 66 patients with HbA1c 10%–12% received saxagliptin 10 mg once-daily for 24 weeks.3 Not surprisingly, clinically meaningful reductions in HbA1c (−1.9%), FPG (−1.83 mmol/L), and PPG-AUC (−615 mmol·min/L) were also observed in the patients with high baseline HbA1c (10%–12%; Figure 4).3 Saxagliptin was more effective than placebo in achieving HbA1c < 7% at week 24.

Bottom Line: Saxagliptin (Onglyza™; Bristol-Myers Squibb Company, Princeton, NJ, USA; AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA) is an oral dipeptidyl peptidase-4 inhibitor, recently approved for the treatment of T2DM.Saxagliptin significantly improves glycemic control vs placebo, as demonstrated by decreasing glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels when used as monotherapy; in initial combination with metformin; and as add-on therapy with metformin, sulfonylurea (SU), or thiazolidinedione (TZD).Saxagliptin also significantly improves β-cell function, is weight neutral, has a low risk for hypoglycemia, and has been shown to have cardiovascular safety.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Metabolism, VA San Diego Healthcare System, University of California, USA;

ABSTRACT

Introduction: The worldwide prevalence of type 2 diabetes mellitus (T2DM) is high, and the chronically poor metabolic control that can result from T2DM is associated with a high risk for microvascular and macrovascular complications. Because of the progressive pathophysiology of T2DM, oral antidiabetic agents often fail to provide sustained glycemic control, indicating the need for new therapies. Saxagliptin (Onglyza™; Bristol-Myers Squibb Company, Princeton, NJ, USA; AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA) is an oral dipeptidyl peptidase-4 inhibitor, recently approved for the treatment of T2DM.

Evidence review: Saxagliptin significantly improves glycemic control vs placebo, as demonstrated by decreasing glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels when used as monotherapy; in initial combination with metformin; and as add-on therapy with metformin, sulfonylurea (SU), or thiazolidinedione (TZD). Saxagliptin also significantly improves β-cell function, is weight neutral, has a low risk for hypoglycemia, and has been shown to have cardiovascular safety.

Place in therapy: The clinical profile for saxagliptin indicates that it is useful as an adjunct to diet and exercise as first-line monotherapy and in combination with metformin; or as add-on treatment for patients who cannot achieve glycemic control with a combination of diet and lifestyle changes and metformin, SU, or TZD.

No MeSH data available.


Related in: MedlinePlus