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INVOKANA® demonstrated statistically significant reductions in A1C in a dedicated study of patients with moderate renal impairment1,2*

In a placebo-controlled study

Adjusted Mean Change in A1C From Baseline at 26 Weeks (%)


A1C reductions in renal impairment: INVOKANA® vs placeboA1C reductions in renal impairment: INVOKANA® vs placebo

 

  • INVOKANA® 100 mg difference from placebo: –0.30% (95% CI: –0.53, –0.07; P <0.05)
  • INVOKANA® 300 mg difference from placebo: –0.40% (95% CI: –0.64, –0.17; P <0.001)

INVOKANA® 100 mg should be used in patients with moderate renal impairment with an eGFR of 45 to <60 mL/min/1.73 m2.
INVOKANA® should not be initiated in patients with an eGFR <45 mL/min/1.73 m2.

Assessment of renal function is recommended prior to initiation of INVOKANA® therapy and periodically thereafter. INVOKANA® should be discontinued when eGFR is persistently <45 mL/min/1.73 m2

SELECT IMPORTANT SAFETY INFORMATION FROM PRESCRIBING INFORMATION

Symptomatic hypotension can occur after initiating INVOKANA®, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone system (eg, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers), or patients with low systolic blood pressure. Before initiating INVOKANA®, assess volume status. Monitor for signs and symptoms after initiating therapy.1 

Similar overall safety and select adverse events with INVOKANA® vs placebo in patients with moderate renal impairment2,3

Overall Safety and Select Adverse Events and Discontinuation Rates With INVOKANA® vs Placebo Over 26 Weeks2,3

  Placebo (n=90) Discontinuation rate: Placebo (n=90) INVOKANA® 100 mg (n=90) Discontinuation rate: INVOKANA® 100 mg (n=90) INVOKANA® 300 mg (n=89) Discontinuation rate: INVOKANA® 300 mg (n=89)
Any AE
74.4% 5.6% 78.9% 4.4% 74.2% 2.2%
AEs related to study drug 22.2% 2.2% 25.6% 0% 32.6% 1.1%
Serious AEs 17.8% 3.3% 11.1% 2.2% 11.2% 1.1%
Urinary tract infection 5.6% 0% 5.6% 0% 7.9% 0%
Genital mycotic infection
           
Male§ 0% 0% 1.7% 0% 2.1% 0%
Female|| 0% 0% 3.1% 0% 2.4% 0%
           
Increased urine frequency 1.1% 0% 2.2% 0% 4.5% 0%
Increased urine volume 0% 0% 0% 0% 0% 0%
           
Postural dizziness 0% 0% 1.1% 0% 2.2% 0%
Orthostatic hypotension 0% 0% 0% 0% 1.1% 0%
  Placebo (n=90) INVOKANA® 100 mg (n=90) INVOKANA® 300 mg (n=89)
Any AE
74.4% 78.9% 74.2%
AEs related to study drug 22.2% 25.6% 32.6%
Serious AEs 17.8% 11.1% 11.2%
Urinary tract infection 5.6% 5.6% 7.9%
Genital mycotic infection
Male§ 0% 1.7% 2.1%
Female|| 0% 3.1% 2.4%
Increased urine frequency 1.1% 2.2% 4.5%
Increased urine volume 0% 0% 0%
Postural dizziness 0% 1.1% 2.2%
Orthostatic hypotension 0% 0% 1.1%
Discontinuation Rates
Any AE 5.6% 4.4% 2.2%
AEs related to study drug 2.2% 0% 1.1%
Serious AEs 3.3% 2.2% 1.1%
Urinary tract infection 0% 0% 0%
Genital mycotic infection
Male§ 0% 0% 0%
Female|| 0% 0% 0%
Osmotic diuresis–related AEs
Increased urine frequency 0% 0% 0%
Increased urine volume 0% 0% 0%
Volume-related AEs
Postural dizziness 0% 0% 0%
Orthostatic hypotension 0% 0% 0%

All adverse events are reported for regardless of rescue medication, except for osmotic diuresis–related and volume-related AEs, which are reported for prior to initiation of rescue therapy.
Possibly, probably, or very likely related to study drug, as assessed by investigators.
§Placebo, n=57; INVOKANA® 100 mg, n=58; INVOKANA® 300 mg, n=48; including balanitis and balanoposthitis.
||Placebo, n=33; INVOKANA® 100 mg, n=32; INVOKANA® 300 mg, n=41; including vulvovaginal mycotic infection.

Study Design

A randomized, double-blind, placebo-controlled study to evaluate the efficacy of INVOKANA® in 269 patients with moderate renal impairment (eGFR 30 to <50 mL/min/1.73 m2) who were inadequately controlled on their current diabetes therapy. Patients were randomized to the addition of placebo (n=90), INVOKANA® 100 mg (n=90), or INVOKANA® 300 mg (n=89), administered once daily, in combination with their current diabetes treatment (diet or antihyperglycemic agent therapy, with 95% of patients on insulin and/or a sulfonylurea) over 26 weeks. Mean baseline A1C values for placebo, INVOKANA® 100 mg, and INVOKANA® 300 mg were, respectively, 8.0%, 7.9%, and 8.0%. The primary endpoint was the change in A1C from baseline to week 26. Prespecified secondary endpoints included change in fasting plasma glucose, proportion of patients reaching A1C of <7.0%, percent change in body weight, and change in systolic blood pressure.1,2 

See results in OLDER PATIENTS

See the results of INVOKANA® AS MONOTHERAPY, VS JANUVIA®, VS GLIMEPIRIDE, and in OLDER PATIENTS.

References: 1. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Yale JF, Bakris G, Cariou B, et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013;15(5):463-473. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.