Multiple, same-day cryolipolysis treatments don’t adversely affect serum lipids or liver enzymes, either acutely or after 12 weeks.
Among all the lipids measured, only triglycerides showed a significant increase, jumping from a mean 77 mg/dL to 83.4 mg/dL. The just over 6 mg/dL increase was “clinically trivial” and driven by a single patient in the 35-subject study, Kenneth B. Klein, MD, and his colleagues reported in Lasers in Surgery and Medicine.Endpoint, LLC, Bainbridge Island, Wash., and his coinvestigators. Dr. Klein owns the company, which designs clinical trials and advises clients on drug and device development.
Results of the small, prospective study are reassuring, if not surprising, the authors wrote. Even four flank treatments, as performed in this cohort, release only about 160 g of fat, at a rate of less than 2 g/day. “To put this figure in perspective, the typical American diet contains at least 75 g of fat per day. Moreover, it has been shown that consuming as much as 261 grams of fat per day causes no ill effects or laboratory abnormalities.”
The study included 35 men and women with a mean age of 45 years but a range of 20-67 years. The mean body mass index was 24.7 kg/m2, although the range was quite wide, at 18-29.7 kg/m2. All subjects underwent cryolipolysis of the lower abdomen and both flanks. Blood was drawn for analysis at baseline and at weeks 1, 4, and 14 after treatment. One patient didn’t complete the treatment because it was impossible to draw enough flank tissue into the applicator.
Patients experienced the expected procedural side effects of erythema, numbness, and edema, with a few reports of tingling and bruising. All of these resolved spontaneously. Immediately after the procedure, the mean pain score was 4 on a 1-10 scale; by week 12, there were no reports of pain.
Other than the triglyceride change in the single patient, there were no statistically or clinically significant changes from baseline to week 12 in total cholesterol (mean 186.5 mg/dL vs. 189.2 mg/dL), HDL cholesterol (71 mg/dL vs. 73.8 mg/dL), LDL cholesterol (100 mg/dL vs. 102.5 mg/dL), or very low-density cholesterol (15.7 mg/dL vs. 16.8 mg/dL). Although the mean triglyceride change was statistically significant, the final measurement was still well below the upper limit of reference (150 mg/dL).
The only liver enzyme change of note occurred in one patient, who had one sharp increase in aminotransferase. That was related to alcohol consumption the night before the week 12 blood draw.
The study was sponsored by Zeltiq Aesthetics, which manufactures the device used in the trial. Dr. Klein is a consultant to Zeltiq. All three coauthors were paid investigators; in addition, one of them, Eric P. Bachelor, MD, is on the Zeltiq speakers’ bureau.
SOURCE: Klein KB et al. Lasers Surg Med. 2017 Sep;49(7):640-4.