Now indicated in patients with type 2 diabetes and established cardiovascular disease
November 17, 2017
Victoza® can be used in adults with type 2 diabetes and established cardiovascular disease to reduce the incidence of cardiovascular death1
Victoza® is indicated as an adjunct to diet, exercise and standard of care therapy to reduce the incidence of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.1
LEADER study included in Victoza® Product Monograph
November 17, 2017
See below for results from the LEADER study
The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results trial (LEADER) was a multicentre, international, randomized, double-blind, placebo controlled cardiovascular outcomes trial.
The trial looked at type 2 diabetes patients at least 50 years of age and with established cardiovascular disease (concomitant cardiovascular, cerebrovascular, peripheral vascular disease, chronic renal failure or chronic heart failure; n=7598) or at least 60 years of age and other specified risk factors of vascular disease (n=1742).
Patients were randomized to either Victoza® 1.8 mg once daily and standard of care (n=4668) or placebo once daily and standard of care (n=4672) with a median duration of exposure was 3.5 years and up to a maximum of 5 years.
The primary endpoint was the time from randomization to first occurrence of any major adverse cardiovascular events (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. If non-inferiority was met for the primary endpoint, superiority was also tested. 1,7
When added to the standard of care in adults with type 2 diabetes and established cardiovascular disease, Victoza® significantly reduced the incidence of cardiovascular death by 26% as a secondary endpoint (estimated hazard ratio 0.74 [95% CI; 0.61-0.89]; ARR=1.7%) and significantly reduced the time to first MACE versus placebo, corresponding to a relative risk reduction of 17% (estimated hazard ratio 0.83 [95% CI; 0.74-0.93], ARR=2.7%).1
Victoza® can be used without dose adjustment in adults with type 2 diabetes and severe, moderate or mild renal insufficiency1
There is no dose adjustment required in adults with type 2 diabetes and severe renal (creatinine clearance <30 mL/min), moderate (30-59 mL/min) or mild renal insufficiency (60-90 mL/min).1
There is very limited or no clinical experience with Victoza® in patients with end-stage renal disease; use of Victoza® in these patients is not recommended.1
There have been post-marketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease.
Victoza® for use in monotherapy for type 2 diabetes
Victoza® can be used in combination with diet and exercise in adults with type 2 diabetes for whom
metformin is inappropriate due to contraindication or intolerance.
In a study, 746 patients with type 2 diabetes were randomized to Victoza® 1.2 mg
(n=251), Victoza® 1.8 mg (n=247), or glimepiride 8 mg (n=248) in the 52-week,
multicentre, double-blind, double-dummy, randomized, parallel, active-controlled
LEAD™ 3 trial. These patients had previously been treated with diet/exercise (n=272)
or not more than half-maximal OAD monotherapy (n=474) for at least 2 months.
At 52 weeks, patients on Victoza® 1.8 mg saw mean A1C reductions of 1.1% (p<0.05)
and those on Victoza® 1.2 mg saw a mean reduction on 0.8% (p<0.0001) versus 0.5%
for glimepiride 8 mg (all baseline 8.2%).
The secondary endpoint of mean weight change showed a 2.5 kg reduction with
Victoza® 1.8 mg (baseline 92.6 kg), a 2.1 kg reduction with Victoza® 1.2 mg
(baseline 92.1 kg), and a 1.1 kg increase in weight with glimepiride 8 mg (baseline
The percentage of patients achieving an A1C target of <7% was 51% with Victoza®
1.8 mg, 43% with Victoza® 1.2 mg, and 28% with glimepiride 8 mg.1
June 2017 Product Monograph update
June 15, 2017
Victoza® can be used without dose adjustment in adults with type 2 diabetes with hepatic insufficiency1
There is limited clinical experience in adults with type 2 diabetes and mild, moderate or severe hepatic insufficiency. No dose adjustment is required for patients with hepatic insufficiency.1
This June 2017 Product Monograph update remains unchanged in the latest November 2017 Product Monograph update.
January 26, 2017
Victoza® added to innoviCares program
1.5 million Canadians already use the innoviCares payment assistance card to
save on prescription medications.
All your patient needs do is to present their innoviCares card and Victoza®
prescription at their local pharmacy. The innoviCares card will automatically cover
a portion of the drug acquisition cost of their Victoza® prescription.
The LIRA-SWITCH™ trial was a phase 4, 26-week, randomized, multicentre,
parallel-group, double-blind, double-dummy, active-controlled trial studying patients
18 years or over with a BMI of 20 kg/m2 or over and A1C between 7.5% and 9.5%
who were inadequately controlled on stable sitagliptin and metformin.
At 26 weeks, patients who were inadequately controlled on sitagliptin and metformin achieved statistically significant A1C reductions on a regimen of Victoza® and metformin versus continuing sitagliptin and metformin (-1.1% for Victoza® 1.8 mg + MET + oral placebo, n=204 vs. -0.54% for sitagliptin 100 mg + MET + placebo injection, n=203; p<0.0001).5‡
In secondary endpoints, also in patients inadequately controlled on sitagliptin and metformin: Victoza® and metformin showed statistically significant weight reductions versus continuing sitagliptin and metformin (-3.3 kg for Victoza® 1.8 mg + MET + oral placebo, n=204 vs. -1.6 kg for sitagliptin 100 mg + MET + placebo injection, n=203; p<0.0001); and Victoza® and metformin showed a statistically significant proportion of patients achieved target A1C <7% versus continuing sitagliptin and metformin (50.6% for Victoza® 1.8 mg + MET + oral placebo, n=204 vs. 26.9% for sitagliptin 100 mg + MET + placebo injection, n=203; p<0.0001).5‡
‡Baseline values for Victoza® + MET/sitagliptin + MET arm:
A1C (%): 8.3/8.2; body weight (kg): 88.9/91.2.
Victoza® is indicated for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic
control in combination with:
Metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control.
Metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not
achieve adequate glycemic control.
Metformin and a basal insulin, when diet and exercise plus dual therapy with Victoza® and metformin do not achieve
adequate glycemic control.
Victoza® is indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the incidence of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.
Not a substitute for insulin. Should not be used in type 1 diabetes. Victoza® is not indicated for use in pediatric patients.
Contraindications in patients with personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) and pregnant or breast-feeding women
A serious warning on risk of thyroid C-cell tumours including medullary thyroid carcinoma in humans
Other relevant warnings and precautions relating to cardiovascular effects (increased heart rate, PR interval prolongation, decreased blood pressure), treatment of diabetic ketoacidosis, intravenous or intramuscular administration, hypoglycemia in combination with a sulfonylurea or insulin, individual pen use, pancreatitis, recent MI, stroke and congestive heart failure, hepatic and renal impairment, gastrointestinal disease and adverse reactions, hypersensitivity, thyroid disease and adverse reactions, and acute gallbladder disease
Conditions of clinical use, adverse reactions, drug interactions and dosing instructions
See Product Monograph for complete dosing and administration. The Product Monograph is also available by calling us at 1-800-465-4334.
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The latest Victoza® Product
Monograph dated November 17, 20171.