The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial
Aim. To evaluate the clinical efficacy and safety of Dietressa at a dose of 6 tablets per day for 24 weeks in the treatment of patients with Class 1 obesity. To compare the clinical efficacy of two treatment regimens (1 tablet 6 times per day and 2 tablets 3 times per day) for 24 weeks in the treatm...
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"Consilium Medicum" Publishing house
2021
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oai:doaj.org-article:dcf0ff956e4d49f68ae5f3edce4a3cd02021-12-01T12:22:36ZThe use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial0040-36602309-534210.26442/00403660.2021.08.200898https://doaj.org/article/dcf0ff956e4d49f68ae5f3edce4a3cd02021-08-01T00:00:00Zhttps://ter-arkhiv.ru/0040-3660/article/viewFile/79513/60138https://doaj.org/toc/0040-3660https://doaj.org/toc/2309-5342Aim. To evaluate the clinical efficacy and safety of Dietressa at a dose of 6 tablets per day for 24 weeks in the treatment of patients with Class 1 obesity. To compare the clinical efficacy of two treatment regimens (1 tablet 6 times per day and 2 tablets 3 times per day) for 24 weeks in the treatment of patients with Class 1 obesity. Materials and methods. A clinical trial included 493 patients with Class 1 obesity from 18 to 65 years. The proportion of patients who lose greater than or equal to 5 percent of baseline body weight, an average decrease of body weight, a change in waist circumference, dynamics of the quality of life, and the safety of the therapy were assessed. Results. A weight decrease was established among patients without regard to the studied regimens of Dietressa (in a daily dose of 6 tablets with a six- or three-time intake). The goals were achieved by 49% [53%] of patients in the first treatment regimen (statistically significant compared to placebo therapy: p=0.04) [р=0.018]), 48% (51%) in the second (p=0.004 [р=0.0004]) and 48% [52%] of patients in the combined Dietressa group (p=0.0007 [р0.0001]). The average absolute weight loss was -4.44.2 [-4.84.2] kg in the Dietressa-1 group (p=0.0001 [р0.0001]) and -4.44.4 [-4.74.4] kg in the Dietressa-2 group (p0.0001) [р0.0001]). Against the background of the conducted therapy mental component was improved on week 4 (p0.0001) and 24 (p=0.006) as well as parameter of physical health on week 4 (p=0,003) and 12 (p=0,006). Waist circumference significantly decreased every 4 weeks in patients receiving Dietressa (p0.0001 for three comparisons between weeks). A 6-month course of Dietressa therapy demonstrated a favorable safety profile. The frequency of adverse events had no significant differences between Dietressa and Placebo groups. Conclusion. The monotherapy with Dietressa is safe, and it leads to at least 5 percent reduction in body weight during 24 weeks of therapy in patients with Class 1 obesity.Tatiana Y. DemidovaElena I. Krasil’nikovaSergey V. Vorob’evTatiana V. MorugovaTatiana V. Adasheva"Consilium Medicum" Publishing housearticleobesitydietressabody mass indexvarious treatment schemesMedicineRRUТерапевтический архив, Vol 93, Iss 8, Pp 904-915 (2021) |
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DOAJ |
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RU |
| topic |
obesity dietressa body mass index various treatment schemes Medicine R |
| spellingShingle |
obesity dietressa body mass index various treatment schemes Medicine R Tatiana Y. Demidova Elena I. Krasil’nikova Sergey V. Vorob’ev Tatiana V. Morugova Tatiana V. Adasheva The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| description |
Aim. To evaluate the clinical efficacy and safety of Dietressa at a dose of 6 tablets per day for 24 weeks in the treatment of patients with Class 1 obesity. To compare the clinical efficacy of two treatment regimens (1 tablet 6 times per day and 2 tablets 3 times per day) for 24 weeks in the treatment of patients with Class 1 obesity.
Materials and methods. A clinical trial included 493 patients with Class 1 obesity from 18 to 65 years. The proportion of patients who lose greater than or equal to 5 percent of baseline body weight, an average decrease of body weight, a change in waist circumference, dynamics of the quality of life, and the safety of the therapy were assessed.
Results. A weight decrease was established among patients without regard to the studied regimens of Dietressa (in a daily dose of 6 tablets with a six- or three-time intake). The goals were achieved by 49% [53%] of patients in the first treatment regimen (statistically significant compared to placebo therapy: p=0.04) [р=0.018]), 48% (51%) in the second (p=0.004 [р=0.0004]) and 48% [52%] of patients in the combined Dietressa group (p=0.0007 [р0.0001]). The average absolute weight loss was -4.44.2 [-4.84.2] kg in the Dietressa-1 group (p=0.0001 [р0.0001]) and -4.44.4 [-4.74.4] kg in the Dietressa-2 group (p0.0001) [р0.0001]). Against the background of the conducted therapy mental component was improved on week 4 (p0.0001) and 24 (p=0.006) as well as parameter of physical health on week 4 (p=0,003) and 12 (p=0,006). Waist circumference significantly decreased every 4 weeks in patients receiving Dietressa (p0.0001 for three comparisons between weeks). A 6-month course of Dietressa therapy demonstrated a favorable safety profile. The frequency of adverse events had no significant differences between Dietressa and Placebo groups.
Conclusion. The monotherapy with Dietressa is safe, and it leads to at least 5 percent reduction in body weight during 24 weeks of therapy in patients with Class 1 obesity. |
| format |
article |
| author |
Tatiana Y. Demidova Elena I. Krasil’nikova Sergey V. Vorob’ev Tatiana V. Morugova Tatiana V. Adasheva |
| author_facet |
Tatiana Y. Demidova Elena I. Krasil’nikova Sergey V. Vorob’ev Tatiana V. Morugova Tatiana V. Adasheva |
| author_sort |
Tatiana Y. Demidova |
| title |
The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| title_short |
The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| title_full |
The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| title_fullStr |
The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| title_full_unstemmed |
The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| title_sort |
use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial |
| publisher |
"Consilium Medicum" Publishing house |
| publishDate |
2021 |
| url |
https://doaj.org/article/dcf0ff956e4d49f68ae5f3edce4a3cd0 |
| work_keys_str_mv |
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1718405205164294144 |