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Quick reference for prescribing Onglyza

  • +Indications and use
    Onglyza is approved for the treatment of patients with Type 2 diabetes as monotherapy* or as add-on therapy to metformin, a SU, a TZD, metformin plus a SU or insulin (with or without metformin), when these alone, together with diet and exercise, do not provide adequate glycaemic control.1 More on Onglyza indications available here.

    *In patients inadequately controlled by diet or exercise for whom metformin is inappropriate due to contraindications or intolerance.

    When Onglyza is used in combination with insulin or a SU, a lower dose of insulin or the SU may be required to reduce the risk of hypoglycaemia.1
  • +Dosing and administration Onglyza is taken as one 5 mg tablet anytime, with or without food. For patients with Type 2 diabetes and moderate or severe renal impairment, Onglyza is taken as one 2.5 mg tablet anytime, with or without food.1 More on Onglyza dosing available here.
  • +Contraindications Onglyza is contraindicated in patients with a hypersensitivity to the active substance or to any of the excipients, or with a history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any DPP4 inhibitor.1 More on Onglyza contraindications available here.
  • +Known drug interactions There is a low risk of clinically meaningful interactions.1 More on drug interactions available here.
  • +Adverse-event profile Onglyza is generally well tolerated and has a well-characterised adverse event profile.1 More on Onglyza tolerability available here.

Full Onglyza prescribing information available here.

SAVOR: Onglyza's CV safety profile demonstrated in a broad spectrum of high-CV-risk patients20

In the largest CV outcomes trial to date, Onglyza added to standard of care has demonstrated no increased risk versus placebo added to standard of care for CV death, non-fatal MI or non-fatal ischaemic stroke in 16,492 adult patients with Type 2 diabetes who are at high risk for CV events.20

  • Study design

    SAVOR was a multicentre, randomised (1:1), double-blind trial of Onglyza added to standard of care versus placebo added to standard of care. The study involved 16,492 patients with HbA1c of 6.5–12.0% with established CVD or multiple CV risk factors (men aged ≥55 years or women aged ≥60 years and at least one of the following: Dyslipidaemia, hypertension, current smoking). A subgroup of patients had moderate-to-severe renal impairment (estimated glomerular filtration rate ≤50 mL/min).20

    Watch a short video on the
    diverse SAVOR patient
    population

    • A total of 28 patients were lost to follow-up and 388 withdrew consent20

    Adapted from Scirica BM,et al. N Engl J Med 2013.20

    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes with HbA1c 6.5% to 12.0% and at high risk for CV events. Onglyza was administered as 5 mg once daily (or 2.5 mg once daily in patients with estimated glomerular filtration rate ≤50 mL/min).

    Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

  • Endpoints

    SAVOR assessed the CV outcomes with Onglyza added to standard of care versus placebo added to standard of care in patients with Type 2 diabetes at high CV risk.20

    Primary endpoint:20

    • A composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke

    Onglyza did not increase the risk of CV death, non-fatal MI or non-fatal ischaemic stroke versus placebo20

    Watch a short video
    summarising the key
    findings
    from SAVOR

    Adapted from Scirica BM,et al. N Engl J Med 2013.20

    SOC, standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20


    Secondary safety endpoint20

    • Primary composite endpoint plus hospitalisation for heart failure, coronary revascularisation or unstable angina

    There was no increased risk for the secondary composite endpoint of MACE (CV death, MI or ischaemic stroke) or hospitalisation* for Onglyza added to standard of care versus placebo added to standard of care at 2 years20

    *Hospitalisation for unstable angina, coronary revascularisation or heart failure.

    SOC, standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.

    Adapted from Scirica BM,et al. N Engl J Med 2013.20

    • One component of the composite secondary endpoint, hospitalisation for heart failure, occurred at a greater rate with Onglyza added to standard of care (3.5%) versus placebo added to standard of care (2.8%; p=0.007 )*20
    • There was no imbalance in CV deaths due to heart failure (0.5% in each group according to 2-year Kaplan-Meier estimates)20

    *Experience in NYHA Class III–IV is still limited. Therefore, caution is warranted in these patients. In the SAVOR trial, a small increase in the rate for hospitalisation for heart failure was observed in the Onglyza-treated patients compared to placebo. Additional analysis did not indicate a differential effect among NYHA classes.1
    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes with HbA1c 6.5% to 12.0% and at high risk for CV events. Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.

  • Glycaemic control

    During the study, therapy for the management of the patient’s Type 2 diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

    • At Years 1 and 2, Onglyza delivered significantly greater reductions in HbA1c versus placebo when either was added to standard of care, even though the trial was not designed to show differences in glycaemic control20

    • With Onglyza, significantly more patients achieved HbA1c <7% at 2 years versus placebo when either was added to standard of care (40.0% vs 30.3%, p<0.001)20
    • Fewer patients required a dose increase or addition of another antidiabetes treatment with Onglyza added to standard of care versus placebo added to standard of care over 2 years20

     

    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes at high CV risk. Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

  • Safety and tolerability profile

    In the largest Type 2 diabetes CV outcomes trial to date, Onglyza safety and tolerability profile has been characterised in a large patient pool.20

    *p values were calculated with the use of a Chi-square test or Fisher's exact test.

    Hypoglycaemia

    The incidence of hypoglycaemia was actively documented throughout the study. Overall rates of hypoglycaemia were higher with Onglyza added to standard of care (15.3%) versus placebo added to standard of care (13.4%).20

    • More patients reported at least one hypoglycaemic event in the Onglyza group (15.3%) than the placebo group (13.4%; p<0.001) when either was added to standard of care:20
      • In combination with metformin monotherapy, Onglyza did not increase the incidence of hypoglycaemia over placebo1
      • The increased risk of overall and major hypoglycaemia with Onglyza versus placebo occurred primarily in patients treated with SU at baseline and not in those receiving insulin or metformin monotherapy at baseline1
      • Hospitalisation for hypoglycaemia occurred infrequently, and the rate was similar in the two groups at 0.6% (53 patients) with Onglyza and 0.5% (43 patients) with placebo (HR=1.22; 95% CI, 0.82 to 1.83; p=0.33)*20

    *According to 2-year Kaplan-Meier estimates.
    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes at high CV risk. Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

    Pancreatitis and pancreatic cancer

    • Independently adjudicated incidence of pancreatitis was similar when Onglyza or placebo were added to standard of care (0.3% for both; p=0.77)20
    • Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza added to standard of care group (five patients) than the placebo added to standard of care group (12 patients)20

    *p values are calculated with the use of Fisher's exact test.
    Patients may have had more than one type of event.

     

    Development and progression of microalbuminuria

    • Compared with those on placebo, patients on Onglyza were more likely to experience an improvement in progression of microalbuminuria and less likely to worsen over 2 years20

                                                                                                                                                                     

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Working Together In Diabetes

Welcome to the international Onglyza® (saxagliptin)
website for healthcare professionals

This website is an international information resource intended for international healthcare professionals with an interest in Onglyza (saxagliptin) and the treatment of type 2 diabetes. Please choose which site you require.

While the internet serves a global community, the pharmaceutical industry is subject to country-specific regulatory considerations. This means that the registration status and approved product labels of Onglyza (saxagliptin) may not be the same in different countries. Information on this site is based on the Summary of Product Characteristics (SmPC) for Onglyza (saxagliptin) in the EU. Please refer to your local Prescribing Information for full details.

Access the international Onglyza (saxagliptin) website for healthcare professionals

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