• T Y Demidova, E I Krasil'nikova, S V Vorob'ev, T V Morugova, and T V Adasheva.
• Pirogov Russian National Research Medical University.
• Terapevt Arkh. 2021 Aug 15; 93 (8): 904-915.

AimTo 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 MethodsA 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.ResultsA 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.ConclusionThe 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.

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