Tolerability of Saxagliptin in Patients with Inadequately Controlled Type 2 Diabetes: Results from 6 Phase III Studies

Davidson, Jaime A.

doi:10.18553/jmcp.2014.20.2.120

Cited by 9 publications

(8 citation statements)

References 36 publications

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“…Pooled data from six phase 3 clinical trials reported no significant increase in confirmed hypoglycemic events for both 2.5 and 5mg of saxagliptin compared to placebo, 0.8%, 0.5% and 0.4% respectively [38]. As an add-on therapy over 24 weeks, similar results were demonstrated [38]. The frequency of confirmed hypoglycemic events was 0% for initial combination therapy with metformin compared to 0.3% with metformin alone.…”

Section: Safety and Tolerabilitymentioning

confidence: 75%

“…The lower risk of hypoglycaemia is related to its glucose-dependant mechanism of action. Pooled data from six phase 3 clinical trials reported no significant increase in confirmed hypoglycemic events for both 2.5 and 5mg of saxagliptin compared to placebo, 0.8%, 0.5% and 0.4% respectively [38]. As an add-on therapy over 24 weeks, similar results were demonstrated [38].…”

Section: Safety and Tolerabilitymentioning

confidence: 85%

“…No increased risk of cardiovascular events were observed with saxagliptin as a monotherapy or add-on therapy (HR, 0.75 [95% CI: 0.46-1.21]) [43]. Although Davidson et al, found a small increased incidence of hypertension and vascular disorders with saxagliptin and metformin compared to metformin monotherapy alone, the number of cardiovascular adverse events was still lower for dual therapy compared to metformin alone [38]. Iqbal et al [42], showed that the incidence rate ratio between those taking saxagliptin and metformin versus those on metformin alone for any adverse cardiovascular event was 0.93 (95% CI: 0.44-1.99) illustrating no increased cardiovascular risk in the 20 trials studied..…”

Section: Cardiovasular Riskmentioning

confidence: 99%

“…The frequency of confirmed hypoglycemic events was 0% for initial combination therapy with metformin compared to 0.3% with metformin alone. The risk of hypoglycaemia in patients on a combination of metformin and sulfonylureas, compared to metformin and saxagliptin is considerably higher with the percentage of patients having one or more hypoglycaemic event over 52 weeks being 36% versus 3% respectively [38].…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

“…However, there is a greater than 1% risk of non-life threatening hypersensitivity reactions and lymphopenia [13]. In a pooled analysis of 6 placebo controlled randomized control trials investigating saxagliptin monotherapy or combined with metformin, Davidson et al [38], showed that saxagliptin had similar adverse events to placebo. As a monotherapy, only 1% of subjects had adverse effects compared to placebo.…”

Section: Other Adverse Eventsmentioning

confidence: 99%

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Pharmacokinetic, pharmacodynamic and clinical evaluation of saxagliptin in type 2 diabetes

Anderson

Hayes

Stephens

2016

Expert Opinion on Drug Metabolism & Toxicology

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Section: Safety and Tolerabilitymentioning

confidence: 75%

Section: Safety and Tolerabilitymentioning

confidence: 85%

Section: Cardiovasular Riskmentioning

confidence: 99%

Section: Safety and Tolerabilitymentioning

confidence: 99%

Section: Other Adverse Eventsmentioning

confidence: 99%

See 3 more Smart Citations

Pharmacokinetic, pharmacodynamic and clinical evaluation of saxagliptin in type 2 diabetes

Anderson

Hayes

Stephens

2016

Expert Opinion on Drug Metabolism & Toxicology

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The Use of Saxagliptin in People with Type 2 Diabetes in France: The Diapazon Epidemiological Study

et al. 2017

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IntroductionSaxagliptin is a potent, reversible inhibitor of dipeptidyl peptidase-4 that is indicated for the treatment of type 2 diabetes. The DIAPAZON study was a multicenter observational study intended to document the effectiveness, safety and patterns of saxagliptin use in France, including the saxagliptin retention rate, over 2 years of follow-up.MethodsA geographically representative sample of 304 French physicians (general practitioners and specialist endocrinologists or diabetologists) recruited 1131 adults with type 2 diabetes into an ambispective cohort; 1033 fulfilled the inclusion criteria. All had started saxagliptin during the previous 6 months or at study inclusion, and follow-up was for 24 ± 3 months after starting saxagliptin.ResultsThe mean age of the study population when starting saxagliptin was 61 years, and the mean HbA1c level was 8.0%; 79% had an HbA1c level ≥7%. Prior to starting saxagliptin treatment, most participants (91%) were receiving treatment with oral glucose-lowering drugs alone. The most commonly prescribed regimen at starting saxagliptin (53% of participants) was a combination of saxagliptin and metformin. The overall saxagliptin retention rate at 2 years was 79%, as estimated by the Kaplan-Meier method. The most common reasons for discontinuation were inadequate glycemic control (52%) and intolerance (22%). During the course of the study, the mean HbA1c level decreased to 7.0%, and the percentage of people with HbA1c <7% increased from 21% to 49%. The mean change in body weight was −1.8 kg. A total of 294 hypoglycemic episodes were reported in 70 participants (6.8%) during the follow-up period. Of these, 143 episodes in 41 participants (4.0%) occurred when saxagliptin was used in combination with agents associated with hypoglycemia, such as insulin, sulfonylureas or glinides.ConclusionSaxagliptin is efficacious and well tolerated in a real-world practice setting, with almost 80% of participants remaining on treatment after 2 years.FundingAstraZeneca, France.

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Saxagliptin: A Review in Type 2 Diabetes

Dhillon

2015

Drugs

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Saxagliptin (Onglyza(®)) is a highly potent, reversible, competitive dipeptidyl peptidase-4 inhibitor indicated for the treatment of patients with type 2 diabetes. Numerous well-designed clinical studies and their extensions showed that saxagliptin as monotherapy or as dual or triple combination therapy with other antihyperglycaemics improved glycaemic control and was generally well tolerated in patients with type 2 diabetes during ≤2 years' therapy. Saxagliptin was generally weight-neutral and had a low risk of hypoglycaemia (unless coadministered with agents that may be associated with hypoglycaemia, such as sulfonylureas or insulin). In addition, at a median follow-up of 2.1 years in the large SAVOR-TIMI 53 study, with the exception of a 27 % greater risk of hospitalization for heart failure, the addition of saxagliptin to standard of care neither reduced nor increased the rate of ischemic cardiovascular events in at-risk patients. Although further long-term data will be beneficial, current evidence indicates that saxagliptin is a useful option for the treatment of patients with type 2 diabetes.

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Tolerability of Saxagliptin in Patients with Inadequately Controlled Type 2 Diabetes: Results from 6 Phase III Studies

Abstract: BACKGROUND: Oral antihyperglycemic drugs used to treat type 2 diabetes mellitus (T2DM) vary in safety and tolerability. Treatment-related hypoglycemia and weight gain can exacerbate underlying disease.

Cited by 9 publications

References 36 publications

Pharmacokinetic, pharmacodynamic and clinical evaluation of saxagliptin in type 2 diabetes

Pharmacokinetic, pharmacodynamic and clinical evaluation of saxagliptin in type 2 diabetes

The Use of Saxagliptin in People with Type 2 Diabetes in France: The Diapazon Epidemiological Study

Saxagliptin: A Review in Type 2 Diabetes

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