Safety, tolerability and efficacy of a novel self‐use biodegradable device for management of obesity

Abstract

Summary Objective Obesity is a major public health issue with significant impact on quality of life, morbidity and mortality rates. It is estimated that if the current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. All the current therapies are not optimal due to limited efficacy or safety; thus, there is a need for additional devices for the treatment of obesity. This study aimed to examine the safety, tolerability, and efficacy of a biodegradable encapsulated Epitomee device for weight loss. The technology is based on absorbent pharmaceuticals polymers and bonding materials that self‐expand in the stomach to create a pH‐sensitive super absorbent gel structure for weight loss. Methods A prospective, 12‐week twice daily use of the encapsulated device in patients with body mass index of 27–40 kg m −2 . Efficacy endpoints were the percent total body weight loss (%TBWL), proportion of participants with 5% TBWL and changes in cardio‐metabolic markers. Safety analysis included evaluation of adverse events, laboratory and endoscopic findings. Results Overall, 52 patients completed the study. TBWL per intension‐to‐treat analysis was 3.68 ± 3.07% (3.23 ± 2.69 kg) and 4.52 ± 2.97% (3.95 ± 2.57 kg) per protocol. No device serious adverse effects reported. The most common adverse events were headache (18.1%), viral infection (11.5%), abdominal discomfort (10.1%), bloating (7.9%), nausea and constipation (5% each) and flatulence (4.3%). Endoscopy in 26 patients revealed mild, asymptomatic gastric/duodenal erythema without erosions in five patients. Conclusions Twelve weeks of Epitomee capsules treatment combined with lifestyle counselling resulted in 3.68–4.52% of TBWL. With continued research, the Epitomee capsules have considerable potential to become a non‐invasive, safe and effective treatment option for weight loss.

Recent advances in therapies utilizing superabsorbent hydrogel technology for weight management: A review

“…The ED works as a transient gastric space‐filling device, similar to the pufferfish‐inspired device in development discussed above. Shirin et al 32 . recently reported results from an open‐label, single‐center, single‐arm, phase 2 study (NCT03610958) in patients (aged 25–61 years, BMI 27–40 kg/m 2 , with or without controlled hypertension and/or dyslipidemia) demonstrating that ED treatment combined with lifestyle modification led to 3.7%–4.5% total body weight loss after 3 months.…”

“…The ED works as a transient gastric space-filling device, similar to the pufferfish-inspired device in development discussed above. Shirin et al 32…”

“…ED was highly tolerable with a favorable safety profile. The most commonly reported AEs were headache, viral infection, abdominal discomfort, bloating, nausea, constipation, and flatulence 32 . Results from an endoscopic examination revealed mild, asymptomatic gastric/duodenal erythema without erosions or need for medical intervention in five of 26 patients (19%) 32 .…”

“…Interest is developing around the utilization of superabsorbent hydrogel technologies as a nonsystemic, biodegradable approach for weight management, with the idea that achievable weight loss and maintenance in individuals in the overweight range can prevent development of greater levels of obesity and attendant comorbidities. [32][33][34] The following is a review of the emerging science and description of several approaches utilizing superabsorbent hydrogel technologies at varying stages of preclinical and clinical development.…”

Tecnologias Em Saúde No Manejo Da Obesidade

“…encapsulado biodegradável e aconselhamentos sobre estilo de vida. 14 Aqueles que concluíram as 12 semanas como proposto pelo estudo utilizando o dispositivo EPITOMEE juntamente com os aconselhamentos sobre estilo de vida apresentaram perda de peso clinicamente significativa (≥ 5%). Não houve efeitos adversos graves relacionados ao dispositivo.…”