Publications by authors named "Tsvetalina I Tankova"

3 Publications

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Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial.

Lancet Diabetes Endocrinol 2021 09 21;9(9):563-574. Epub 2021 Jul 21.

Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.

Background: Semaglutide is an effective treatment for type 2 diabetes; however, 20-30% of patients given semaglutide 1·0 mg do not reach glycaemic treatment goals. We aimed to investigate the efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in adults with inadequately controlled type 2 diabetes on a stable dose of metformin with or without a sulfonylurea.

Methods: We did a 40-week, randomised, active-controlled, parallel-group, double-blind, phase 3B trial (SUSTAIN FORTE) at 125 outpatient clinics in ten countries. Participants (≥18 years) with inadequately controlled type 2 diabetes (HbA 8·0-10·0%) with metformin and with or without sulfonylurea were randomly assigned (1:1) by an interactive web-response system to 2·0 mg or 1·0 mg once-weekly semaglutide. Participants, site personnel, the clinical study group, and investigators were masked to the randomised treatment. Outcomes included change from baseline at week 40 in HbA (primary outcome) and bodyweight (secondary confirmatory outcome), evaluated through trial product estimand (no treatment discontinuation or without rescue medication) and treatment policy estimand (regardless of treatment discontinuation or rescue medication) strategies. This study is registered with ClinicalTrials.gov, NCT03989232; EudraCT, 2018-004529-96; and WHO, U1111-1224-5162.

Findings: Between June 19 and Nov 28, 2019, of 1515 adults assessed for eligibility, 961 participants (mean age 58·0 years [SD 10·0]; 398 [41%] women) were included. Participants were randomly assigned to once-weekly semaglutide 2·0 mg (n=480 [50%]) or 1·0 mg (n=481 [50%]); 462 (96%) patients in the semaglutide 2·0 mg group and 471 (98%) in the semaglutide 1·0 mg group completed the trial. Mean baseline HbA was 8·9% (SD 0·6; 73·3 mmol/mol [SD 6·9]) and BMI was 34·6 kg/m (SD 7·0). Mean change in HbA from baseline at week 40 was -2·2 percentage points with semaglutide 2·0 mg and -1·9 percentage points with semaglutide 1·0 mg (estimated treatment difference [ETD] -0·23 percentage points [95% CI -0·36 to -0·11]; p=0·0003; trial product estimand) and -2·1 percentage points with semaglutide 2·0 mg and -1·9 percentage points with semaglutide 1·0 mg (ETD -0·18 percentage points [-0·31 to -0·04]; p=0·0098; treatment policy estimand). Mean change in bodyweight from baseline at week 40 was -6·9 kg with semaglutide 2·0 mg and -6·0 kg with semaglutide 1·0 mg (ETD -0·93 kg [95% CI -1·68 to -0·18]; p=0·015; trial product estimand) and -6·4 kg with semaglutide 2·0 mg and -5·6 kg with semaglutide 1·0 mg (ETD -0·77 kg [-1·55 to 0·01]; p=0·054; treatment policy estimand). Gastrointestinal disorders were the most commonly reported adverse events (163 [34%] in the 2·0 mg group and 148 [31%] in the 1·0 mg group). Serious adverse events were similar between treatment groups, reported for 21 (4%) participants given semaglutide 2·0 mg and 25 (5%) participants given semaglutide 1·0 mg. Three deaths were reported during the trial (one in the semaglutide 1·0 mg group and two in the semaglutide 2·0 mg group).

Interpretation: Semaglutide 2·0 mg was superior to 1·0 mg in reducing HbA, with additional bodyweight loss and a similar safety profile. This higher dose provides a treatment intensification option for patients with type 2 diabetes treated with semaglutide in need of additional glycaemic control.

Funding: Novo Nordisk.
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http://dx.doi.org/10.1016/S2213-8587(21)00174-1DOI Listing
September 2021

Comparative Evaluation of the Diagnostic Value of Procalcitonin and hsCRP for the Presence of Mild-to-Moderate Diabetic Foot Infections.

Int J Low Extrem Wounds 2021 Apr 28:15347346211011849. Epub 2021 Apr 28.

159238Medical University of Sofia, Sofia, Bulgaria.

The aim of this study is to compare the efficacy of procalcitonin (PCT) and high-sensitive C-reactive protein (hsCRP) as diagnostic biomarkers in patients with diabetes and mild-to-moderate diabetic foot infections. A total of 119 patients (102 with type 2 diabetes and 17 with type 1 diabetes), of mean age 60.29 ± 10.05 years, divided into 3 groups-diabetic foot ulcer (DFU) with active infection (IDFU group, n = 41), DFU without clinical signs of infection (non-IDFU group, n = 35), and a control group with diabetes without DFU (n = 43). Infection severity was graded according to the International Working Group on the Diabetic Foot guideline-non-IDFU group as Grade 1, IDFU group as Grade 2 (n = 22), and Grade 3 (n = 19). Serum hsCRP was assessed by the immunoturbidimetric method and PCT by the enzyme chemiluminescence immunoassay (ECLIA) method. Levels of white blood cells (WBC) were assessed using the Medonic hematology analyzer and erythrocyte sedimentation rate (ESR) by the Westergren method. Serum hsCRP, WBC count, and ESR were significantly higher in the IDFU group as compared to non-IDFU and control groups, whereas PCT levels did not differ between the groups. hsCRP presented with higher sensitivity (80%), specificity (79%), area under the curve (AUC) 0.856, in comparison to PCT (sensitivity 63%, specificity 62%, AUC 0.617) for the presence of IDFU, as well as in the Grade 3 subgroup (84% sensitivity and specificity, AUC 0.911). The combined model of both markers did not present with better accuracy than using hsCRP alone. In conclusion, hsCRP appears to be a better diagnostic biomarker than PCT in the diagnosis of moderate foot ulcer infection. Both markers fail to distinguish mild infection.
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http://dx.doi.org/10.1177/15347346211011849DOI Listing
April 2021

Vitamin D Status in a Bulgarian Population With Type 2 Diabetes and Diabetic Foot Ulcers.

Int J Low Extrem Wounds 2020 Oct 23:1534734620965820. Epub 2020 Oct 23.

Medical University of Sofia, Sofia, Bulgaria.

The aim of this study was to assess vitamin D status in patients with type 2 diabetes and diabetic foot ulcers (DFU). A total of 242 participants with type 2 diabetes, mean age 59.1 ± 10 years, mean body mass index 31.4 ± 6.3 kg/m, and estimated glomerular filtration rate ≥45 mL/min/1.73m, were divided into 2 groups: 73 with DFU (35 with and 38 without active infection) and 169 without DFU (106 with diabetic peripheral neuropathy, 63 without complications). Neuropathy was assessed by 10 g monofilament, Rydel-Seiffer 128 Hz tuning fork, and temperature discrimination. Serum 25(OH)D (25-hydroxy vitamin D) was assessed by ECLIA (electro-chemiluminescence immunoassay) method. Median 25(OH)D level was 12.6 ng/mL (IQR [interquartile range] 9.3-17.6 ng/mL) in the studied cohort. The DFU group presented with lower 25(OH)D level as compared with diabetic patients without foot ulcers (non-DFU group): 11.6 ng/mL (IQR 8.5-15.8 ng/mL) versus 13.5 ng/mL (IQR 9.6-18.6 ng/mL), = .001; the diabetic peripheral neuropathy subgroup demonstrated lower 25(OH)D level in comparison with participants without complications: 12.5 ng/mL (IQR 9-17.2 ng/mL) versus 15.9 ng/mL (IQR 10.4-20.8 ng/mL), = .031. This remained significantly different even after correction for age and duration of diabetes. There was no difference in 25(OH)D level between the subgroups according to the presence of active infection. In conclusion, vitamin D deficiency may play a role in the development of diabetes complications.
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October 2020
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