New Clinical Research Shows the Safety, Tolerability and Efficacy of the Epitomee Capsule
CAESAREA, Israel, Oct. 23, 2018
CAESAREA, Israel, Oct. 23, 2018 /PRNewswire/ -- Research led by Prof. Shirin, and conducted by a group of physicians from the Kamila Gonczarowski Institute of Gastroenterology, Assaf Harofeh Medical Center, and the Sackler Faculty of Medicine, Tel-Aviv University, Israel, was presented today at a UEG meeting in Vienna. It reports an analysis of the Epitomee Capsule that compares the weight, vital signs, and laboratory tests of patients relative to their baseline during and after treatment.
"This was a prospective, 12-week, twice-daily use of the capsule for patients with a BMI of 27-40, controlled hypertension and/or dyslipidemia. A life intervention program, hypocaloric diet and increased physical activity were included, with 52 patients completing the twelve weeks," said Prof. Shirin at the meeting. "Weight, vital signs, laboratory tests and post-treatment endoscopies were performed. Efficacy endpoints were the percentage change in total body weight and proportion of participants who lost at least 5% in total body weight, as well as changes in cardio-metabolic markers. Safety assessments included an evaluation of treatment-related adverse events, vital signs, laboratory and endoscopy findings. We were happy to see that there were no serious treatment-related adverse events and that the treatment was well tolerated."
In this study, 80% of hypertensive patients became normalized at week 12, with average systolic BP reduced from 147 to 126mmHg and diastolic BP improved from 96 to 74mmHg, p<0.02. In 53% of pre-diabetic patients, fasting glucose was reduced from 104 to 92 and HbA1C% from 6.03 to 5.6.
Excess body weight loss was -21.8% with P<0.001. The means total body weight loss after 12 weeks was 4.5% with P<0.001. Moreover, 42% of those who finished the study and 31% of the study population achieved weight loss of more than 5% within 12 weeks of treatment. The average BMI of the entire group declined from 33 to 31, and waist circumference reduced by 4.41cm.
"Thanks to this work we can now go further in our investigations and complete our advanced phase 2. This will bring the Capsule closer to people who seek a safe and simple clinical weight loss solution," said Dr. Dan Hashimsohny, Epitomee's CEO.
SOURCE Epitomee Medical