8 things to know about the new weight loss drug Saxenda
Saxenda is a new injectable weight-loss drug has been approved by the U.S. Food and Drug Administration on December 23 rd, 2014!
Here are 8 things to know about Saxenda approved for weight loss in addition to diet and exercise!
1. What is Saxenda approved for?
Saxenda (liraglutide) is approved for adults who are obese or for those who are overweight and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol in addition to a low calorie diet and exercise.
2. Who can consider Saxenda for weight loss?
Any eligible adult with a body mass index of 30 or over, or those with a body mass index of 27 or over with at least one weight related comorbid condition!
3. What type of drug is Saxenda?
Saxenda is part of a relatively new class of drugs known as glucagon-like peptide-1 receptor agonists. It works by stimulating insulin production and triggering the release of glucagon (a hormone produced by the body) from the pancreas. The drug also reduces appetite.
4. What is the difference between Saxenda and Victoza?
None, except the dose and probably the price! Both Victoza and Saxenda have exactly the same active ingredient – liraglutide albeit at a different dose. This is one of the very few occasions where the same drug has different brand names from the same manufacturer based on the dosage!
According to the FDA statement, Saxenda should not be used with any other drugs in this class, including Victoza — a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide), but Saxenda contains a larger dose of it.
5. What is the evidence supporting the utility and safety of Saxenda?
Before looking at the evidence for Saxenda for weight loss, let us review some of the criteria that a new weight loss drug has to meet for FDA to consider it. Under the new US FDA rules, a drug can be considered for weight control approval if after clinical trials lasting 1 year either of the following results occur:
- The difference between the average weight loss between those receiving a drug, and an inactive placebo is at least 5% and is statistically significant.
The percentage of subjects who lose more than 5% of their baseline body weigh using the drug, is at least 35% and is approximately double the percentage in the inactive placebo treated group, and the difference is statistically significant.
Three clinical trials assessed the safety and effectiveness of the drug for weight loss. The trials involved roughly 4,800 obese and overweight people with and without other weight-related conditions. All of the participants were counseled about lifestyle changes, such as a low-calorie diet and regular exercise.
One clinical trial that involved patients without diabetes found that patients taking Saxenda had an average weight loss of 4.5 percent after one year. Of the people treated with the drug, 62 percent lost at least 5 percent of their body weight. Meanwhile, only 34 percent of those given an inactive placebo had the same result.
Another clinical trial that included patients with type 2 diabetes found that patients had an average weight loss of almost 4 percent after one year. Of those given Saxenda, 49 percent lost at least 5 percent of their body weight, compared to 16 percent of those who were given a placebo treatment.
Here is the list of various trials of Saxenda for weight loss and their results compared to placebo! The table below shows the clinical trials reviewed by the US FDA for liraglutide (Saxenda) comparing the 3-milligram (mg) daily injection of the drug to a placebo. The trials are identified in the top row according to the manufacturers clinical trial number. The percentage of patients that achieved at least a 5% reduction in body weight is presented for all trials lasting 56 weeks and all trials combined.
|Treatment||Trial 1839||Trial 1922||Trial 1923||Trial 3970||Trial 1807||All 56 Week Long Trials||All Trials Combined|
In comparison to the other new weight loss medications such as Belviq, Contrave, Qsymia, Saxenda results are impressive according to Dr Prab R. Tumpati, MD, a leading obesity medicine physician and founder of W8MD Medical Weight Loss Centers of America, although certain concerns regarding the side effects!
6. How long should I take Saxenda before I know if it is working for me?
According to the FDA, the patients taking Saxenda for weight loss should be examined to determine if Saxenda is working after 16 weeks of treatment. If they do not lose at least 4 percent of their body weight by that time, they should stop taking the medication.
7. What are the most common side effects of Saxenda?
The most common side effects of Saxenda included nausea, diarrhea, constipation, vomiting, low blood sugar and loss of appetite.
Some of the other serious side effects can include pancreatitis (infection of the pancreas), gallbladder disease, lowered kidney function, suicidal thoughts and increased heart rate, the agency noted.
Patients who experience a prolonged increase in their resting heart rate should stop taking Saxenda, the FDA added.
8. What are the concerns regarding thyroid tumors?
Tumors of the thyroid gland were associated with Saxenda treatment in rodent studies. It is unclear, however, if the drug causes thyroid tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans.
Patients who have been diagnosed with MTC or have a family history of the condition should not take Saxenda. Patients with a condition known as multiple endocrine neoplasia syndrome type 2, which increases the risk for MTC, should also not take Saxenda, the agency said.
9. How is Saxenda taken?
Saxenda subcutaneous injection will be available as prefilled multi-dose pens in doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg (6mg/mL, 3mL) in 3- and 5-count cartons and is expected to be available in the first half of 2015. The cost of Saxenda is yet to be made available by the pharmaceutical company!
10. Where can I find weight loss physicians familiar with Saxenda?
W8MD Medical Weight Loss Centers of America offers Saxenda in addition to a reduced calorie diet and exercise to eligible patients at all of its locations!
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
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
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.