Almost at the end of the year 2014, the FDA announced approval of Novo nordisk's Saxenda(liraglutide), a powerful new injectable weight loss drug in addition to diet and exercise to fight the obesity epidemic. Saxenda has the same active ingredient as the diabetes medication Victoza although at a higher dosage of 3.0 mg instead of 1.2 mg or 1.8 mg in Victoza.
Saxenda is the 2 nd weight loss drug to be approved in 2014 by the US FDA after Takeida pharmaceuticals Contrave was approved a few months prior and fourth weight loss drug to be approved since June of 2012 when Arena Pharmaceuticals Belviq and Orexigen's Qsymia were approved.
1. What do you need to know about Saxenda for weight loss?
Saxenda® (liraglutide 3 mg) is new class of medications to be considered for weight loss - a class of drugs known as incretins. Containing glucagon-like peptide-1 (GLP-1) analogue
with 97% similarity to naturally occurring human GLP-1, incretins contain an anologue similar to the GLP-1 hormone that is released in response to food intake. Like human GLP-1, Saxenda® regulates appetite and food intake in humans and many animals alike by decreasing hunger and increasing feelings of fullness and satiety after eating.
2. Who can take Saxenda for weight loss?
Saxenda is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or 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).
Body Mass Index or BMI measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the data from the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
3. How does Saxenda help with weight loss and blood sugar?
Although Saxenda helps control blood glucose levels, it is not known to cause significant hypoglycemia in non-diabetic patients, a key distinction that allows this medication to be used even in those that do not have diabetes.
4. Dual action of Saxenda
\Saxenda® works on both appetite and blood glucose regulation (for adults with prediabetes
or type 2 diabetes) hold therapeutic potential for adults with obesity, both those
with and without type 2 diabetes.
5. Clinical studies reviewed by the FDA advisory committee on Saxenda
According to the statement from the FDA, 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 conditions. All these patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity in addition to Saxenda or placebo.
6. About 62% on Saxenda lost at least 5% of their weight!
In those taking Saxenda 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 study, 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.
7. Diabetics and Saxenda for weight loss
In those that had diabetes taking Saxenda had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this study, 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.
8. 16 week trial of Saxenda for weight loss
Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is effective for weight loss. If a patient taking Saxenda for weight loss 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.
9. Boxed warnings
Although the clinical significance is not yet determined and its counter part Victoza has been relatively popular, Saxenda does have a boxed warning stating that tumors of the thyroid gland (thyroid C-cell tumors) which have been observed in rodent studies. However, it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans.
10. 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 nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.
Why obesity is a serious medical issue suddenly?
Although still debated by some as not a medical condition, it is increasingly being recognized as a serious, albeit chronic, medical condition that is associated with serious
comorbidities including type 2 diabetes, heart disease, obstructive sleep apnoea (OSA),
certain types of cancer and a decreased life expectancy.
It is also recognized that the risk of morbidity and mortality increases with the severity of obesity. It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.
Affecting approximately 35% of adults, or some 100 million people, obesity is common and together with being overweight that affects an additional 36% of the entire adult population, the enormous implications and costs of obesity not hard to imagine. In fact, according to a study from George Washington University, the direct and indirect cost of obesity is determined to be as high as $4879 for a woman, $2646 for a man.
Cost of Saxenda is yet to be announced and the drug is expected to be available early 2015.
Locations for W8MD physicians familiar with use of Saxenda
Pennsylvania
Philadelphia Insurance Weight Loss & Sleep Center: 1718, Welsh Rd, Philadelphia, PA, 19115 Ph: 1-215-676-2334
Our farthest patient comes from Nassau, Bahamas! Testimonials!
King Of Prussia Weight Loss & Sleep Center: 987 Old Eagle School Rd, Ste 712, Wayne, PA, 19087 Ph: 215-676-2334
Our farthest patient comes from Delaware! Testimonials
New York
NYC Insurance Weight Loss & Sleep Center: 2003, Bath Avenue, Brooklyn, NY, 11214 Ph: 1-718-946-5500.
Our farthest patient comes from Dallas, Texas! Testimonials
New Jersey
W8MD medical weight loss program at Vida Sleep Center of Dr. Felix Roque's office at 543, 45th Street, Union City, New Jersey. 543 45th St, Union City, NJ 07087. Phone: (201) 766-6469. This center bills out of network for insurance.
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