Safety of SinEcch™ Demonstrated in 3-Year Clinical Study
SinEcch™ was used in a 3-year Post Marketing Surveillance (PMS) Study in South Korea, which was required for SinEcch™ to receive permanent approval by the South Korean FDA. The purpose of this study was to establish the safety and efficacy of SinEcch™.1
Many variables within the patient population had to be taken into consideration when assessing the possibility of adverse effects from using SinEcch™: 650 patients were involved in this study over the course of the 3-year period – 410 were women and 240 were men. The age range of these patients was 15 to over 65 years. 57 kinds of surgery were performed in 19 institutions including university hospitals, general hospitals, and plastic surgery clinics. 62% of the patients took concomitant medications.
All adverse effects observed during the Study were recorded regardless of whether they could be associated with SinEcch™ or not, including those that may have occurred after the SinEcch™ dosing regimen had been completed.
The PMS Report states, “Statistical analysis method of Chi-square test or Fisher’s Exact test was used. The analysis item was adjusted according to the contents of survey material and survey condition, and presence of statistical significance. In order to surmise factors that affect adverse event expression rate, logistic regression analysis was performed, and other surveying items were analyzed using suitable statistical methods. During final report, all of the adverse events investigated during re-examination period were analyzed and 95% confidence interval was proposed” (p. 16).
After taking all factors into consideration and analyzing the results, no adverse effects were attributed to SinEcch™ (Table 11), demonstrating that SinEcch™ is safe as well as effective to use for recovering from surgery.