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Prescribers should consult the summary of product characteristics (SmPC) in relation to all adverse reactions and safety information.
CREDENCE was a Phase 3 RCT in 4,401 patients with T2DM and established diabetic kidney disease (study duration: 2.6 years).1,2
It compared Invokana 100 mg + standard of care (SoC) to placebo + SoC (SoC included maximum tolerated dose of ACEi or ARB)
Cases of Diabetic Ketoacidosis (DKA) (≥1/10,000 to <1/1,000), Lower Limb Amputation (≥1/1,000 to <1/100) and Fournier’s Gangrene (unknown frequency) have been reported. See the SmPC for further details.1
|System organ class||Very common (≥1/10)||Common (≥1/100 to <1/10)|
|Infections and infestations||Vulvovaginal candidiasis||Balanitis or balanoposthitis, urinary tract infection (pyelonephritis and urosepsis have been reported post-marketing)|
|Metabolism and nutrition disorders||Hypoglycaemia in combination with insulin or sulphonylurea|
|Gastrointestinal disorders||Constipation, thirst, nausea|
|Renal and urinary disorders||Polyuria or pollakiuria|
|Investigations||Dyslipidaemia, haematocrit increased|
Rates of renal and urinary disorders in patients treated with Invokana in four pooled 26-week placebo-controlled trials.
|Placebo (n=646)||Invokana 100 mg (n=833)||Invokana 300 mg (n=834)|
|Polyuria or pollakiuria||0.8%||5.3%||4.6%|
|Urinary tract infection||4.0%||5.9%||4.3%|
Adapted from Usiskin K, et al 2014.3
ACEI: Angiotensin-Converting Enzyme Inhibitors; ARB: Angiotensin II Receptor Blockers; CREDENCE: Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation; CVD: Cardiovascular Disease; DKA: Diabetic Ketoacidosis; HR: Hazard Ratio; LLA: Lower Limb Amputations; RCT: Randomised Controlled Trial; SGLT2i: Sodium-Glucose Co-transporter 2 inhibitor; SmPC: Summary of Product Characteristics; SoC: Standard of Care; T2DM: Type 2 Diabetes Mellitus; UACR: Urinary Albumin/Creatinine Ratio.