A New Treatment Option for Weight ManagementFriday, January 09, 2015
Novo Nordisk's Saxenda (liraglutide) is a glucagon-like peptide-1 receptor agonist that has been approved by the FDA as a treatment option for weight management alongside diet and exercise.
While Saxenda and Victoza contain the same active ingredient, liraglutide, it is important to note that Saxenda is not indicated for type 2 diabetes treatment in improving blood sugar levels because the safety and efficacy have not been established for this dosage.
Saxenda is given at a dose of 3 mg and is indicated for the treatment of obesity, in contrast to Victoza, which is formulated to a 1.2 or 1.8 mg dosage and is indicated for type 2 diabetes treatment.
Saxenda is approved for use in obese adults with a body mass index (BMI) of 30 or greater or overweight adults with a BMI of 27 or greater who have at least one weight-related condition, such as hypertension, or high cholesterol.
The FDA approved Saxenda with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the risks associated with Saxenda. The FDA is requiring the following post-marketing studies for Saxenda:
- Clinical trials to evaluate dosing, safety, and efficacy in pediatric patients;
- Study to assess potential effects on growth, sexual maturation, and central nervous system development and function in immature rats;
- An medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Saxenda; and
- An evaluation of the potential risk of breast cancer with Saxenda in ongoing clinical trials.
Saxenda’s safety and efficacy were evaluated in 3 clinical trials that included approximately 4800 obese and overweight patients with and without significant weight-related conditions. Results from a clinical trials showed the following results:
- Enrolled patients without diabetes had an average weight loss of 4.5% from baseline compared to a placebo group after 1 year.
- Enrolled patients with type 2 diabetes had an average weight loss of 3.7 % from baseline compared to a placebo group after 1 year.
- Overall number of patients experiencing weight loss in the trials saxenda>placebo.
Some side effects were reported and are segmented into common and serious. The following is a listing of both:
Common side effects: patients treated with Saxenda during the trials experienced nausea, diarrhea, constipation, vomiting, hypoglycemia, and decreased appetite.
Most serious side effects: patients treated with saxenda reported pancreatitis, gallbladder disease, and renal impairment.
Studies have shown that Saxenda can also increase heart rate. It is recommended for the medication to be discontinued in patients who experience a sustained increase in resting heart rate.
Saxenda is accompanied by a boxed warning states that while thyroid C-cell tumors have been observed in rodent studies with the drug, it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Saxenda should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2.
Another recommendation is that once the medication is prescribed, patients using Saxenda should be evaluated after 16 weeks to determine the effectiveness of the treatment. If a patient has not lost at least 4% of baseline body weight by this point, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Saxenda presents as an option for many patients that are struggling with weight loss. Used in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, I believe it will improve weight loss for many patients who are not successful on other weight loss medications or programs. However, as a clinician who has seen many type 2 patients on Victoza, I believe that nausea, due to the medication’s effect on gut motility, may be an adverse effect that may prevent some patients from compliance with the regimen. Since the nausea experienced is reported to be transient, I expect many patients who can tolerate the nausea to benefit from this new option for weight loss.
To read more about the medication, go to Novo's website here.