The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature

Abstract

Purpose Filgrastim (NEUPOGEN ®) is the originator recombi-nant human granulocyte colony-stimulating factor widely used for preventing neutropenia-related infections and mobilizing he-matopoietic stem cells. This report presents findings of a systematic literature review and meta-analysis of efficacy and safety of originator filgrastim to update previous reports. Methods A literature search of electronic databases, congress abstracts, and bibliographies of recent reviews was conducted to identify English-language reports of clinical trials and observational studies evaluating filgrastim in its US-approved indications up to February 2015. Two independent reviewers assessed titles/abstracts and full texts of publications, and extracted data from studies that compared originator filgrastim vs placebo or no treatment. For outcomes with sufficient homogeneous data reported across studies, meta-analysis was performed and relative risk (RR) determined. Data were summarized descriptively for all other evaluated outcomes. Results A total of 1194 unique articles evaluating originator filgrastim were identified, with 25 meeting eligibility criteria for data extraction: 18 randomized controlled trials , 2 nonrandomized clinical trials, and 5 observational studies. In chemotherapy-induced neutropenia (CIN), filgrastim vs placebo or no treatment significantly reduced febrile neutro-penia incidence (RR 0.63, 95% CI 0.53-0.75) and grade 3 or 4 neutropenia incidence (RR 0.50, 95% CI 0.37-0.68). The most commonly reported adverse event (AE) with filgrastim was bone pain (RR 2.61, 95% CI 1.29-5.27 in CIN). Additional efficacy and safety outcomes are described within indications. Conclusions This systematic literature review and meta-analysis confirms and updates previous reports on the efficacy and safety of originator filgrastim. Bone pain was the commonly reported AE associated with filgrastim use.

Cryolipolysis for the treatment of submental fat: Review of the literature

“…A systemic literature review evaluating the safety and efficacy of cryolipolysis for body contouring showed that only 0.82% reported adverse effects last greater than 4 weeks, with decreased sensation being most common. At 4 months, the mean reduction in subcutaneous fat was 19.6% compared to the control site . To date, four clinical trials and one case series have demonstrated the safety and efficacy of cryolipolysis for treatment of the submental region.…”

“…Cryolipolysis has been studied extensively for its safety and efficacy to reduce nonfacial focal lipodystrophy . There have been no changes in lipid levels or liver function tests and no peripheral nerve damage .…”

A customized approach for arm fat reduction using cryolipolysis

“…Cryolipolysis is based upon the greater susceptibility of lipid-rich adipocytes to cold injury compared to surrounding water-rich cells [1][2][3]. Numerous clinical studies have demonstrated the safety, efficacy, and tolerability of cryolipolysis in multiple areas [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21].…”

Cryolipolysis for Reduction of Arm Fat: Safety and Efficacy of a Prototype CoolCup Applicator With Flat Contour

“…Most commonly used to treat the abdomen and flanks, cryolipolysis is also highly tolerable for treatment of areas including the back, submental area, inner thighs, and outer thighs. 1–12 …”