A total of 1,022 patients participated in the trials—514 received ATX-101 and 508 received a placebo. More than 68% of patients reported at least a one-point improvement on a composite of the clinician- and patient-reported Submental Fat Rating Scale, which uses a 0 through 4 scale. That compared with 20.5% in the placebo group (P<.001). Sixteen percent of the treatment group reported an improvement of two points or more, compared with 1.5% in the placebo group (P<.001).
Explore this issue:September 2015
The most common adverse events were pain, swelling, bruising, and numbness, but most were transient and expected due to the nature of the treatment,
researchers reported. In the trials, 4% of patients had facial nerve injury that caused an uneven smile or muscle weakness, but those symptoms resolved.
Kythera, which is expected to be bought by Allergan in a $2.1 billion deal, says the injections should be used with caution in patients with bleeding abnormalities and in those who are on anticoagulants (The Wall Street Journal, August 5, 2015). The company also cautions that it should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.
Ed Williams, MD, founding physician at the Williams Center Plastic Surgery Specialists in Albany, N.Y., and the president-elect of the American Academy of Facial Plastic and Reconstructive Surgery, said he was initially “very skeptical” of Kybella. But after speaking with the company’s founder and becoming a paid trainer, he now thinks the treatment has a place in the field. He has treated approximately 25 patients and, using a topical anesthetic and lidocaine and a thin, 30-gauge needle, has been able to make the procedure pain-free, he said.
“One could say, wouldn’t you be better with liposuction?” he said. “And the answer is, there are a lot of people who just don’t want surgery. They want something nonsurgical.”
He acknowledged that the treatment is “not inexpensive” and that with multiple injections the cost can add up quickly. But some patients will still prefer the procedure over liposuction, he said. “I learned years ago not to get into consumers’ heads, because just when you think you’ve got it figured out, something different happens,” he added.