The problem is that older physicians like myself can still remember the last round of miracle drugs that were in vogue twenty or thirty years ago and the damage they caused. From amphetamines to "fen-phen", which caused valvular heart disease, none of them did anything in the long run to ameliorate obesity and its ill effects. Certainly amphetamines resulted in decrease of appetite and hyperactivity, and they certainly made patients feel better, for a while at least. Unless we want to make our already drug addicted society even more drug addicted we should avoid that kind of drug.
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. Saxenda and Victoza contain the same active ingredient (liraglutbide) at different doses (3 mg and 1.8 mg, respectively). However, 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.
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 patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity. 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 (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. 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.
Saxenda has a boxed warning stating that tumors of the thyroid gland have been observed in rodent studies with Saxenda but rats are not human. usually) 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. The most common side effects observed in patients treated with Saxenda were nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.
The FDA is requiring the following post-marketing studies for Saxenda:
- clinical trials to evaluate dosing, safety, and efficacy in pediatric patients;
- a study to assess potential effects on growth, sexual maturation, and central nervous system development and function in immature rats;
- an MTC case registry of at least 15 years duration to identify any increase in MTC incidence related to Saxenda; and
- an evaluation of the potential risk of breast cancer with Saxenda in ongoing clinical trials.
Here are the actual FDA indications for Saxenda:
Indications and Usage for Saxenda
Saxenda is indicated as an adjunct to a reduced-calorie
diet and increased physical activity for chronic weight management in
adult patients with an initial body mass index (BMI) of
- •
- 30 kg/m2 or greater (obese), or
- •
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
- After thirty years of treating obese patients it is difficult to understand how the FDA could approve a potentially dangerous drug for these indications.
- I would never have prescribed this medication for these indications.
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