Saxenda approved for weight loss!

After just a few months of approving Contrave for weight loss, on december 23rd, 2014 the US FDA approved a powerful new weight loss drug, Saxenda to be manufactured by the Danish pharmaceutical company, Novonordisk, to help fight the obesity epidemic. FDA previously approved Arena Pharmaceutical’s Belviq(Lorcasering) and Vivus Pharmaceutical’s Qsymia(Phentermine and Topiramate) in 2012. 

Saxenda(liraglutide) is a new class of weight loss medications that are in the category callegory called GLP-1 (glucagon-like peptide-1 receptor agonists. Liraglutide is approved for weight loss in addition to diet and exercise in those who are obese with a body mass index of 27 or more with an obesity related comborbid condition or those with a BMI of over 30.

Victoza and Saxenda – two sides of the same coin!

This is a rare situation where the same medication is called different brand names at different doses – a lower dose of the same medication(1.2 mg and 1.8mg) was approved in January 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) (tradename: Victoza) and now Saxenda is liraglutide at 3.0 mg approved for weight loss. While the maximum approved dose for the diabetes indication as Victoza is 1.8 mg daily, administered as a subcutaneous injection, the weight loss dose was 3.0 mg administered similarly.

Not only in those with diabetes

The good news is that with the approval of Saxenda for weight loss indication as opposed to diabetes indication for Victoza, it is expected to become easier to get insurance approval for this medication. Although Victoza has long been known and been used off label for weight loss, it was not officially approved for weight loss thus creating a significant barrier for wide spread use of Victoza for weight loss. With the approval of Saxenda for weight loss, let us hope that the insurances would start approving this medication to help overweight and obese fight this epidemic of obesity.

Advantages of Liraglutide

  • It acts in a glucose-dependent manner, meaning it will stimulate insulin secretion only when blood glucose levels are higher than normal. Consequently, it shows negligible risk of hypoglycemia.
  • It has the potential for inhibiting apoptosis and stimulating regeneration of beta cells (seen in animal studies).
  • It decreases appetite and maintains body weight, as shown in a head-to-head study versus glimepiride.
  • It lowers blood triglyceride levels.

Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) agonist that normally has a short half life – however, it is made to bind to the albumin in the blood in Saxenda, thus increasing the half life and utility of this otherwise very short acting compound.

Liraglutide leads to insulin release in pancreatic beta cells in the presence of elevated blood glucose. This insulin secretion subsides as glucose concentrations decrease and approach euglycemia. It also decreases glucagon secretion in a glucose-dependent manner and delays gastric emptying. Unlike native GLP-1, liraglutide is stable against metabolic degradation by peptidases with a plasma half-life of 13 hours.

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Native GLP-1 is short-lived in the body (the half-life after intramuscular injection is approximately half an hour), so it is not very useful as a therapeutic agent. Since liraglutide binds to albumin, the half-life after subcutaneous injection is increased to 11–15 hours, making it suitable for once-daily dosing.

Clinical trial data supporting Saxenda for weight loss

In clinical trials in patients without diabetes taking liraglutide showed that patients had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo (inactive pill) 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.

In a similar trial in 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.

Effectiveness of Saxenda for weight loss to be assessed in 4 months

Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working which is somewhat similar to the other medications in the class although a bit longer at 16 weeks as opposed to 12 weeks.

After using Saxenda for 16 weeks, 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.

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).

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 nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.

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