‡The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au. High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years.3,4
Adapted from Gyldenkerne C et al. 2023.8
†Myocardial infarction, stroke, and fatal CVD;8 #Accounting for the competing risk of noncardiovascular death;8 ^Data from a cohort study with all Danish patients with T2D diagnosed between 2006 and 2013 (n =142,587) and sex- and age-matched individuals from the general population (n=388,410), all without prior atherosclerotic CVD with a median follow-up of 8.1 years.8
DECLARE-TIMI 58: largest primary prevention
patient population to date, within SGLT2i CVOTs1,9-11
Representing the patients you see in everyday practice1,9
The primary safety outcome, MACE (defined as cardiovascular death, myocardial infarction, or ischaemic stroke): FORXIGA® met the prespecified criterion for noninferiority1,9
Co-primary efficacy outcomes:
Key secondary outcome:
‡‡Because FORXIGA® resulted in a statistically significantly lower rate in the composite of CV death^ or hHF vs placebo (both + SoC) but did not result in a statistically significantly lower rate of MACE, analyses of additional outcomes (including secondary outcomes) are hypothesis-generating.9
§§In the DECLARE study, risk factors for cardiovascular disease included: age ≥55 years in men or ≥60 years in women and one or more of dyslipidaemia, hypertension or current tobacco use, without having had a CV event at baseline.2 §MACE was defined as cardiovascular death, myocardial infarction, or ischaemic stroke.9
Adding FORXIGA® provides significant reductions in HbA1c1,12¥
¥In T2D patients uncontrolled on metformin alone, FORXIGA® + metformin demonstrated HbA1c reduction from baseline of -0.84% vs -0.30% with placebo + metformin; P<0.0001 at 24 weeks; baseline HbA1c of 7.92% (FORXIGA®, n=135) and 8.11% (placebo, n=137)1,12
With the additional benefit of weight loss1,12††***
††In T2D patients uncontrolled on metformin alone, FORXIGA® + metformin demonstrated body weight reduction from baseline of -2.86kg vs -0.89kg with placebo + metformin; P<0.0001 at 24 weeks; baseline body weight of 86.28kg (FORXIGA®, n=135) and 87.74kg (placebo, n=137)1,12
***Body weight change was a secondary endpoint. FORXIGA® is not indicated for weight loss.1,12
Reductions in weight were mainly attributable to body fat loss, rather than lean tissue or fluid loss1,13
FORXIGA®: One 10mg tablet,
once daily, with no titration1
PBS Authority Required (STREAMLINED)3
15311 – 1mth In combination with at least one: metformin, sulfonylurea, insulin
15265 – 2mth (The condition must be stable)
16220 – 1mth In combination with metformin; patients must have CVD OR high risk of a CV event, OR identify as Aboriginal or Torres Strait Islander
16164 – 2mth (The condition must be stable)
XIGDUO® XR: Taken once daily,
generally with an evening meal2
PBS Authority Required (STREAMLINED)3
15289 – 1mth Inadequately responsive to metformin
15267 – 2mth (The condition must be stable)
16158 – 1mth In combination with metformin; patients must have CVD OR high risk of a CV event, OR identify as Aboriginal or Torres Strait Islander
16162 – 2mth (The condition must be stable)
Refer to the PBS Schedule for full information.
For patient resources and clinical tools to support care of patients with cardiovascular, renal and/or metabolic disease, visit:
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Selected Safety Information: FORXIGA® and XIGDUO® XR
KETOACIDOSIS – There have been reports of ketoacidosis, including DKA, a serious life-threatening condition requiring urgent hospitalisation in patients taking dapagliflozin and other SGLT2is. Fatal cases of ketoacidosis have been reported in patients taking dapagliflozin. Appropriate precautions for DKA for patients need to be taken during treatment with SGLT2i. Ketoacidosis and glucosuria may be prolonged after discontinuation of SGLT2i; consider monitoring even if drug treatment has been interrupted or discontinued.1,2 VOLUME DEPLETION AND/OR HYPOTENSION – Dapagliflozin induces osmotic diuresis which may lead to a modest decrease in blood pressure. Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk.1,2 RENAL IMPAIRMENT – There is limited experience with initiating treatment with FORXIGA® in patients with eGFR <25 mL/min/1.73 m2. Initiating treatment with FORXIGA® in these patients is not recommended. The glucose lowering efficacy of FORXIGA® is dependent on renal function and is reduced where eGFR is <45 mL/min/1.73 m2; if eGFR falls below this, additional glucose-lowering treatment should be considered in patients with diabetes mellitus. XIGDUO® XR should not be used for the treatment of diabetes in patients with eGFR persistently below 45 mL/min/1.73 m2. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with eGFR <60 mL/min/1.73 m2.1,2 INCREASED HAEMATOCRIT – Has been observed with dapagliflozin. Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.1,2
PBS Information: FORXIGA®: Authority Required (STREAMLINED): Type 2 Diabetes, Chronic Heart Failure and Chronic Kidney Disease.
Refer to PBS Schedule for full Authority Required Information.
PBS Information: XIGDUO® XR: Authority Required (STREAMLINED). Type 2 diabetes. Refer to PBS Schedule for full Authority Required Information.
WARNING: Life-threatening lactic acidosis can occur due to accumulation of metformin. The main risk factor is renal impairment, other risk factors include old age associated with reduced renal function and high doses of metformin above 2g per day.2
PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING. FURTHER INFORMATION
AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342 OR WWW.ASTRAZENECA.COM.AU/PI
Glossary: CV cardiovascular; CVD cardiovascular disease; T2D type 2 diabetes; SGLT2i sodium-glucose co-transporter-2 inhibitor; XR extended release
References: 1. FORXIGA® Approved Product Information. 2. XIGDUO® XR Approved Product Information. 3. The Pharmaceutical Benefits Scheme (PBS). PBS website. https://www.pbs.gov.au. Last accessed December 2024. 4. The Department of Health and Aged Care. Australian Guideline for assessing and managing cardiovascular disease risk. 2023. Available at: https://www.cvdcheck.org.au/. Last accessed November 2024. 5. Australian Institute of Health and Welfare 2024. Diabetes: Australian facts. Available at: https://www.aihw.gov.au/reports/diabetes/diabetes/contents/summary. Accessed November 2024. 6. Australian Institute of Health and Welfare. Aboriginal and Torres Strait Islander Health Performance Framework. 1.05 Cardiovascular disease. Available at: https://www.indigenoushpf.gov.au/measures/1-05-cardiovascular-disease Accessed November 2024. 7. Australian Bureau of Statistics. Heart, stroke and vascular disease. Available at: https://www.abs.gov.au/statistics/health/health-conditions-and-risks/heart-stroke-and-vascular-disease/latest-release Accessed November 2024. 8. Gyldenkerne C et al. J Am Coll Cardiol. 2023;82(16):1583–1594. 9. Wiviott SD et al. N Engl J Med 2019;380:347–357. 10. Zinman B et al. N Engl J Med 2015;373:2117–2128. 11. Cannon CP et al. N Engl J Med. 2020;383(15):1425–1435. 12. Bailey CJ et al. Lancet. 2010;375(9733):2223–2233. 13. Bolinder J et al. J Clin Endocrinol Metab. 2012;97(3):1020–1031.
FORXIGA® and XIGDUO® XR are registered trademarks of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com. AU-24248. August 2026.
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INDICATIONS
FORXIGA® is the only SGLT2i indicated across three inter-related diseases2-4
MECHANISM OF ACTION
Learn more about how FORXIGA® works across T2D
FORXIGA® T2D MOA Video
LANDMARK TRIALS
Studied across three landmark Phase III trials in patients both with and without T2D5,6,8
TRIAL RESULTS
Studied in >26,000 patients across three landmark trials5,6,8cc
Patients in the trials were randomised to FORXIGA® + SoC (n=13107) or placebo + SoC (n=13101)5,6,8
SAFETY
Well-established safety profile demonstrated across three indications2,5,6,8
DOSING
Simple dosing with one tablet, once daily2
HEALTHCARE PROFESSIONAL RESOURCES
PATIENT RESOURCES
BEFORE PRESCRIBING PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE
ON REQUEST FROM ASTRAZENECA ON 1800 805 342 OR www.astrazeneca.com.au/PI
WARNING: XIGDUO XR: Life-threatening lactic acidosis can occur due to accumulation of metformin. The main risk factor is renal impairment, other risk factors include old age associated with reduced renal function and high doses of metformin above 2g per day. |
PBS Information: XIGDUO XR: Authority Required (STREAMLINED). Type 2 Diabetes. |
PBS Information: FORXIGA: Type 2 Diabetes, Chronic Heart Failure and Chronic Kidney Disease: Authority Required (STREAMLINED). |
ACEi=angiotensin-converting enzyme inhibitor; ACR=albumin-to-creatinine ratio; ADS=Australian Diabetes Society; AE=adverse event; ARB=angiotensin receptor blocker; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; hHF=hospitalisation for heart failure; HR=hazard ratio; KHA=Kidney Health Australia; MACE=major adverse cardiovascular events; MOA=mechanism of action; NYHA=New York Heart Association; PBS=Pharmaceutical Benefits Scheme; RRR=relative risk reduction; SGLT2i=sodium–glucose co-transporter-2 inhibitor; SoC=standard of care; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio; UTI=urinary tract infection.
References: 1. The Pharmaceutical Benefits Scheme (PBS). https://www.pbs.gov.au. Last accessed October 2022. 2. FORXIGA® Approved Product Information. 3. JARDIANCE® Approved Product Information. 4. STEGLATRO® Approved Product Information. 5. Heerspink HJL et al. N Engl J Med. 2020; 383(15):1436–1446. 6. McMurray JJV et al. N Engl J Med. 2019; 381(21):1995–2008. 7. Protocol for: McMurray JJV et al. N Engl J Med. 2019; 381:1995–2008. NEJM website. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1911303/suppl_file/nejmoa1911303_protocol.pdf. Last accessed May 2022. 8. Wiviott SD et al. N Engl J Med. 2019; 380:347–357. 9. Petrie MC et al. JAMA. 2020; 323(14):1353-1368. 10. Supplement to: Wiviott SD et al. N Engl J Med. 2019; 380:347-357.
FORXIGA® and XIGDUO® XR are registered trademarks of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com. AU-14833, November 2022.
