Abstract P5-14-16: Pharmacokinetics/pharmacodynamics of Sandoz biosimilar pegfilgrastim compared to both US- and EU-reference pegfilgrastim: A meta-analysis of three clinical studies in healthy subjects

Author(s):  
Roumen Nakov ◽  
Jessie Wang ◽  
Anne Bellon ◽  
Sreekanth Gattu ◽  
Ramin Arani
2021 ◽  
Author(s):  
Junying Bai ◽  
Yan Li ◽  
Wenhui Zhang ◽  
Mingcong Fan ◽  
Haifeng Qian ◽  
...  

Cereal fiber supplementation significantly affected fecal SCFA concentrations in randomized clinical studies. A more significant impact appeared in overweight and obese subjects with BMI >29 kg m−2 than in individuals with BMI ≤29 kg m−2.


Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  

AbstractObjectivesNumerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA1c, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).MethodsSystematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA1c. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design.ResultsOne study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CVI=1.4% (1.2–2.1) and CVG=5.7% (4.7–10.6), whereas estimates for HbA1c, CVI=1.2% (0.3–2.5), CVG=5.4% (3.3–7.3), and glucose, CVI=5.0% (4.1–12.0), CVG=8.1% (2.7–10.8) did not differ from previously published global estimates.ConclusionsThe critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA1c.


2021 ◽  
pp. 174248
Author(s):  
Kiarash Saleki ◽  
Shakila Yaribash ◽  
Mohammad Banazadeh ◽  
Ehsan Hajihosseinlou ◽  
Mahdi Gouravani ◽  
...  

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 351
Author(s):  
Massimiliano Creta ◽  
Giuseppe Celentano ◽  
Luigi Napolitano ◽  
Roberto La Rocca ◽  
Marco Capece ◽  
...  

Bladder cancer (BCa) is an endocrine-related tumour and the activation of androgen signalling pathways may promote bladder tumorigenesis. We summarized the available preclinical and clinical evidence on the implications of the manipulation of androgen signalling pathways on the outcomes of BCa therapies. A systematic review was performed in December 2020. We included papers that met the following criteria: original preclinical and clinical research; evaluating the impact of androgen signalling modulation on the outcomes of BCa therapies. Six preclinical and eight clinical studies were identified. The preclinical evidence demonstrates that the modulation of androgen receptor-related pathways has the potential to interfere with the activity of the Bacillus Calmette Guerin, doxorubicin, cisplatin, gemcitabine, and radiotherapy. The relative risk of BCa recurrence after transurethral resection of the bladder tumour (TURBT) is significantly lower in patients undergoing therapy with 5 alpha reductase inhibitors (5-ARIs) or androgen deprivation therapy (ADT) (Relative risk: 0.50, 95% CI: 0.30–0.82; p = 0.006). Subgroup analysis in patients receiving 5-ARIs revealed a relative risk of BCa recurrence of 0.46 (95% CI: 0.22–0.95; p = 0.040). A significant negative association between the ratio of T1 BCa patients in treated/control groups and the relative risk of BCa recurrence was observed. Therapy with 5-ARIs may represent a potential strategy aimed at reducing BCa recurrence rate, mainly in patients with low stage disease. Further studies are needed to confirm these preliminary data.


Materials ◽  
2021 ◽  
Vol 14 (5) ◽  
pp. 1147
Author(s):  
Alessio Danilo Inchingolo ◽  
Angelo Michele Inchingolo ◽  
Ioana Roxana Bordea ◽  
Edit Xhajanka ◽  
Donato Mario Romeo ◽  
...  

Many different osteotomy procedures has been proposed in the literature for dental implant site preparation. The osseodensification is a drilling technique that has been proposed to improve the local bone quality and implant stability in poor density alveolar ridges. This technique determines an expansion of the implant site by increasing the density of the adjacent bone. The aim of the present investigation was to evaluate the effectiveness of the osseodensification technique for implant site preparation through a literature review and meta-analysis. The database electronic research was performed on PubMed (Medline) database for the screening of the scientific papers. A total of 16 articles have been identified suitable for the review and qualitative analysis—11 clinical studies (eight on animals, three on human subjects), four literature reviews, and one case report. The meta-analysis was performed to compare the bone-to-implant contact % (BIC), bone area fraction occupied % (BAFO), and insertion torque of clockwise and counter-clockwise osseodensification procedure in animal studies. The included articles reported a significant increase in the insertion torque of the implants positioned through the osseodensification protocol compared to the conventional drilling technique. Advantages of this new technique are important above all when the patient has a strong missing and/or low quantity of bone tissue. The data collected until the drafting of this paper detect an improvement when the osseodensification has been adopted if compared to the conventional technique. A significant difference in BIC and insertion torque between the clockwise and counter-clockwise osseodensification procedure was reported, with no difference in BAFO measurements between the two approaches. The effectiveness of the present study demonstrated that the osseodensification drilling protocol is a useful technique to obtain increased implant insertion torque and bone to implant contact (BIC) in vivo. Further randomized clinical studies are required to confirm these pieces of evidence in human studies.


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