Hauner H, et al. - This study attempted to assess the utility and safety of increasing doses of cathine (nor-pseudoephedrine) as a weight-lowering agent in patients with obesity. It has been validated that cathine appears to be an effective weight-lowering agent for adjunct treatment of obesity, but additional clinical studies on its efficacy and safety are required.

Methods

• For this study, overweight and obese patients (n = 241, mean BMI 34.6 ± 3.4 kg/m²) were assigned randomly to one of three doses of cathine (16 mg, 32 mg, 53.3 mg) or placebo in addition to a multimodal lifestyle intervention program in a multicenter, double-blind, controlled, dose-finding study for 24 weeks.
• Weight loss was considered as a primary endpoint.

Results

• According to the data, treatment with the 3 doses of cathine resulted in a significantly greater weight loss compared to placebo over 24 weeks: 6.5 ± 4.2 kg for 16 mg cathine, 6.2 ± 4.7 kg for 32 mg cathine, and 9.1 ± 5.4 kg for 53.3 mg cathine versus 2.4 ± 4.4 kg for placebo (each p
• They noted that the percentage of patients losing > 5% / >10% of initial body weight was significantly greater for all doses of cathine than for placebo (each p
They observed that heart rate increased dose-dependently (by 1.2 bpm under 16 mg, 5.8 bpm under 32 mg, and 6.2 bpm under 53.3 mg cathine), but no suspected unexpected serious adverse reactions were noted.
• It was showed that the overall dropout rate was 24.9%, with the highest rate in the placebo group (42.3%).