As with any medication, Saxenda weight loss injection has risks and benefits. You should discuss with your doctor the risks of using Saxenda® against the expected benefits. While we strive to provide you with some of the most important and accurate non-biased information, remember that this article does not take the place of talking to your doctor.
Approved for weight loss treatment
Manufactured by Novo Nordisk, Saxenda weight loss injection received favourable votes of 14-1 for its approval for weight management from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) panel of US Food and Drug Administration (FDA) in September 2014.
The FDA granted approval for Saxenda for the treatment of chronic weight management, along with reduced-calorie diet and physical activity in December 2014.
How did Saxenda get its approval?
FDA approval for Saxenda was based on results from three Phase III clinical trials known as SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Nondiabetic and Diabetic people) studies, which were conducted for 56 weeks to evaluate safety and efficacy of the drug.
This three Phase III SCALE clinical trials enrolled more than 5,000 participants who were obese or overweight and with or without other weight-related conditions.
The first Phase of this clinical trial was a randomised, double-blind, placebo-controlled study. It enrolled 3,731 patients with obesity. The second Phase III study enrolled 635 patients with type 2 diabetes and with either overweight or obesity, while the third Phase III study enrolled 422 patients with obesity.
Patients were administered with Saxenda 3mg daily dose or a placebo for 56 weeks and were given counselling about lifestyle changes they need to adopt related to a low-calorie diet and regular physical exercise
With what results?
The study results demonstrated that patients treated with Saxenda experienced a statistically significant reduction in weight, compared with a placebo after 56 weeks. Patients treated with Saxenda achieved 5% and 10% weight loss, compared to a placebo.
The most serious side effects reported during the trials in patients treated with Saxenda included pancreatitis, gallbladder disease, renal impairment and suicidal thoughts.
Saxenda weight loss injection works together with life style changes and dietary modifications but it is not without possible side effects.
If you are self injecting, always remember to give timely updates to your doctor especially if there is anything you are not totally sure about.