On December, 23rd, 2014 the United States FDA approved Saxenda(liraglutide) 3mg, a powerful new injectable weight loss medication. At a lower dose of 1.2mg and 1.8mg, liraglutide(Victoza) has been FDA approved for treatment of diabetes and the medication has long been know to help people lose weight. The good news is that at a higher dose of 3mg, liraglutide has been shown to melt pounds faster and more efficiently than any of the other weight loss medications currently on the market.
Although physicians have been using Victoza off label for weight loss for a long time, Saxenda is specifically approved for weight loss and a person does not need to a diabetic to try this new medication. Approved for anybody with a body mass index of 30 or over with at least one weight related comobordity such as diabetes, high blood pressure, cholesterol problems, sleep apnea etc.
The drug is also approved for adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).
When approving this new weight loss medication Saxenda, 2nd in the year 2014 after Contrave, the FDA's acting deputy director, James Smith, MD said "obesity is a public health concern and threatens the overall well-being of patients,”
“Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management.
Compared to its rival medications including the other new weight loss medications Contrave, Belviq and Qsymia, over 50% of patients who tried Saxenda lost 5% or more of their body almost twice as effective as the other weight loss medications.
New class of weight loss medications
Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes. Containg the same active ingreding liraglutide, Saxenda and Victoza contain the active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively).
Although the same ingredient as in the diabetes medication Victoza albeit at a higher dose, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.
Studies supporting use of Saxenda for weight loss
The safety and effectiveness of Saxenda were evaluated in three clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related comborbid conditions. All patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity in addition to Saxenda.
Fabulous weight loss results
Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo at one year.
In this trial, 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with placebo.
12 week trial of Saxenda for weight loss
Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working. If a patient has not lost at least 4 percent of baseline body weight, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Warnings and precautions
Saxenda has a boxed warning stating that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Saxenda but that 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 (a disease in which patients have tumors in more than one gland in their body, which predisposes them to MTC).
Side effects of Saxenda
Serious side effects reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate.
In clinical trials, the most common side effects observed in patients treated with Saxenda were
- low blood sugar (hypoglycemia), and
- decreased appetite.
Other related medications are also in the pipeline including once a week dosing type medications and are awaiting the FDA approval.
Liraglutide, with diet and exercise, maintained weight loss achieved by caloric restriction and induced further weight loss over 56 weeks. Improvements in some cardiovascular disease-risk factors were also observed. Liraglutide, prescribed as 3.0 mg per day, holds promise for improving the maintenance of lost weight.
Other similar weight loss medications
AstraZeneca's evenatide (Byetta, Bydureon), has also been found to aid weight loss although not yet approved directly for weight loss. Recently, the FDA approved albiglutide (Tanzeum), GlaxoSmithKline's GLP-1 contender, that is dose once a weeek injected subcutaneously.
Impressive weight loss results
When used along with diet and exercise, Liraglutide, maintained weight loss achieved by caloric restriction and induced further weight loss over 56 weeks in a research study which also showed improvements in some cardiovascular disease-risk factors were also observed. Liraglutide, prescribed as 3.0 mg per day, holds promise for improving the maintenance of lost weight.