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2024 ◽  
Vol 84 ◽  
Author(s):  
E. Madrigal-Bujaidar ◽  
P. Gómez-González ◽  
S. Camacho-Cantera ◽  
J. A. Morales-González ◽  
E. Madrigal-Santillán ◽  
...  

Abstract The present research was made to determine the micronuclei and cytotoxic capacity of the antidepressant venlafaxine in an in vivo acute and subchronic assays in mouse. In the first study, we administered once 5, 50, and 250 mg/kg of the drug, and included a negative and a daunorubicin treated group. Observations were daily made during four days. The subchronic assay lasted 5 weeks with daily administration of venlafaxine (1, 5, and 10 mg/kg) plus a negative and an imipramine administered groups. Observations were made each week. In the first assay results showed no micronucleated polychromatic erythrocytes (MNPE) increase, except with the high dose at 72 h. The strongest cytotoxic effect was found with 250 mg/kg at 72 h (a 51% cytotoxic effect in comparison with the mean control level). In the subchronic assay no MNPE increase was found; however, with the highest dose a significant increase of micronucleated normochromatic erythrocytes was observed in the last three weeks (a mean of 51% respect to the mean control value). A cytotoxic effect with the two high doses in the last two weeks was observed (a polychromatic erythrocyte mean decrease of 52% respect to the mean control value). Results suggest caution with venlafaxine.


Author(s):  
M. Voinot ◽  
F. Arroyo ◽  
J. Á. Hernández ◽  
A. Paz-Silva ◽  
R. Sánchez-Andrade ◽  
...  

2021 ◽  
pp. 089875642110542
Author(s):  
Jerzy Gawor ◽  
Katarzyna Jodkowska ◽  
Emilia Klim ◽  
Michał Jank ◽  
Celine S. Nicolas

Giving dental chews to dogs is part of the passive homecare that helps prevent the formation of plaque and tartar. The objectives of these studies were to assess the effectiveness of a vegetable-based dental chew (VF) to maintain oral health, and to compare it to 2 different reference chews (RC) with a proven effectiveness. The first study was conducted on 45 small dogs (<10 kg) and the second on 60 larger dogs (15-30 kg) who were randomly assigned to 3 different groups. During 30 days, one group received no chew (control) while the second and third group received either one RC (RC1 or RC2) or one VF per day. All dogs had their teeth scaled on Day 0. On Day 30, scores were given for plaque and calculus. Gingival parameters were also assessed. Statistical analysis (analysis of variance and Tukey tests ± Bonferroni's adjustment) were performed to compare groups with α set at .05 for significance. The 3 types of chews were found to be efficacious to reduce plaque and calculus formation and the gingival bleeding compared to control ( P < .05). There was no significant difference between RCs and VF in both trials except for the gingival bleeding parameters which showed a greater improvement with VF. Therefore, daily administration of the VF is effective to reduce plaque and calculus formation and gingival bleeding and has a better efficacy on gingival bleeding than the other reference products tested. It can therefore be used with confidence at home for preventative dental care.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052449
Author(s):  
Anette-Gabriele Ziegler ◽  
Stefanie Arnolds ◽  
Annika Kölln ◽  
Peter Achenbach ◽  
Reinhard Berner ◽  
...  

IntroductionThe Global Platform for the Prevention of Autoimmune Diabetes-SINT1A Study is designed as a randomised, placebo-controlled, double-blind, multicentre, multinational, primary prevention study aiming to assess whether daily administration of Bifidobacterium infantis from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.Methods and analysisInfants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype. Infants are randomised 1:1 to daily administration of B. infantis EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies. Secondary outcomes are (1) Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate in first year of life during supplementation and (5) Safety. Exploratory outcomes include allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin.Ethics and disseminationThe study was approved by the local ethical committees of the Technical University Munich, Medical Faculty, the Technische Universität Dresden, the Medizinische Hochschule Hannover, the Medical University of Warsaw, EC Research UZ Leuven and the Swedish ethical review authority. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the study.Trial registration numberNCT04769037.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Hamid Reza Farpour ◽  
Najme Rajabi ◽  
Bahareh Ebrahimi

Purpose. The high prevalence of knee osteoarthritis (KOA) is a major cause of disability among elders. NSAIDs are recommended to reduce KOA patients’ symptoms, but their adverse side effects limit their consumption. In this study, we evaluated the effectiveness of Harpagophytum procumbens compared to a routine NSAID (meloxicam) on pain reduction and functional improvement of KOA patients. Patients and Methods. Sixty patients aged 40–60 years, with painful knee osteoarthritis (grades 1-2 of Kellgren–Lawrence scale) for at least one month, were randomized into two groups with different routine medication periods. Group A consisted of daily administration of two Harpagophytum procumbens (Teltonal) tablets (2 ∗ 480 mg) for one month, and group B consisted of daily administration of meloxicam (15 mg) for ten days. The visual analogue scale (VAS), Western Ontario McMaster University Osteoarthritis Index (WOMAC), Oxford Knee Scale (OKS), and patient satisfaction were evaluated at the baseline and after 2, 4, and 8 weeks. Results. There were no statistically significant differences between demographic characteristics, pain intensity, and function scores before the treatment. VAS, OKS, and WOMAC scores improved in both groups p < 0.001 over time, but no significant superiority was shown; after 8 weeks: VAS (Teltonal (4.80 ± 1.80) vs. meloxicam (5.06 ± 1.43)), OKS (34.06 ± 4.38, 34.00 ± 7.87, Teltonal vs. meloxicam, respectively), and WOMAC scores (25.73 ± 10.11 Teltonal vs. 26.20 ± 13.94, meloxicam). Conclusion. Teltonal is an effective and safe treatment in patients with mild KOA in the short term. However, no significant superiority was shown in using Teltonal or meloxicam, in people who cannot take NSAIDs, it can be a good alternative, although difference in medication periods should be considered.


Author(s):  
Wendy Ankrom ◽  
Deanne Jackson Rudd ◽  
Andrea Schaeffer ◽  
Deborah Panebianco ◽  
Evan J. Friedman ◽  
...  

MK-8507 is a novel HIV-1 non-nucleoside reverse transcriptase inhibitor in clinical development with potential for once-weekly oral administration for the treatment of HIV-1 infection. Two randomized, double-blind, placebo-controlled phase 1 studies in adults without HIV-1 evaluated the safety, tolerability, and pharmacokinetics of single and multiple doses of MK-8507; drug interaction with midazolam (a cytochrome P450 3A4 substrate) and food effect were also assessed. In Study 1, 16 participants received oral ascending single doses of MK-8507 (2–400 mg) or placebo in an alternating fashion. In Study 2, 24 participants received ascending single doses of MK-8507 (400–1200 mg) or placebo and multiple doses (once weekly for 3 weeks) of MK-8507 (100–400 mg) or placebo. MK-8507 pharmacokinetics were approximately dose proportional at 2–1200 mg. MK-8507 had a time to maximum concentration of 2–7 hours and a mean terminal half-life of ∼58–84 hours. MK-8507 doses ≥100 mg achieved a plasma concentration at 168 hours post-dose (7 days) associated with antiviral efficacy. A high-fat meal had no clinically meaningful effect on MK-8507 pharmacokinetics, and MK-8507 400 mg once weekly had no clinically meaningful effect on midazolam pharmacokinetics. Single and multiple doses of MK-8507 were generally well tolerated. No trends with dose and no clinically meaningful changes were observed in vital signs, electrocardiograms, and laboratory safety tests. The pharmacokinetics and safety data are supportive of once-weekly oral administration and support further clinical investigation of MK-8507 for the treatment of HIV-1 infection. Over the last 3 decades, substantial improvements have been made in oral HIV antiretroviral therapies (ART), which now offer people living with HIV (PLWH) the potential for a near-normal life expectancy (1, 2). To achieve this, individuals must maintain life-long viral suppression, which requires daily administration of efficacious medication (3). Issues surrounding tolerability, complicated regimens, and treatment fatigue from daily dosing can lead to poor adherence and suboptimal viral suppression (3–6). Regimens can become complex when there is the need to take multiple pills, requirement to take a medication fasted or with food, or the potential for interactions with other medications, including those required to treat HIV-related comorbidities (3, 78). New treatment options that are not only highly effective but also offer excellent tolerability, a high barrier to resistance, favorable drug interaction profiles, and the potential for less frequent dosing remain the focus of much clinical research (7, 9). While 1 pill once a day meets the needs of many PLWH, for others daily administration poses challenges, including treatment fatigue and daily reminders and/or stigma associated with ART (10, 11). While treatment regimens that can be taken less often than daily are attractive to many PLWH, the long-acting injectable combination of cabotegravir/rilpivirine is currently the only treatment option available without daily dosing; however, administration requires injection by a health care professional (12), potentially posing other challenges.


2021 ◽  
Vol 6 (3) ◽  
Author(s):  
Eleanor Best

PICO question In reducing surgical recovery time in rabbits (Oryctolagus cuniculus), should doses exceeding 0.2 mg/kg of oral meloxicam be given and is twice daily administration more effective than a single daily dose?   Clinical bottom line Category of research question Treatment The number and type of study designs reviewed Nine papers were critically reviewed, yet no studies were found to directly investigate the effects of twice daily dosing with meloxicam postoperatively in rabbits. There were five descriptive, non-comparative case series; two nonblinded parallel group randomised control trials; one blinded, placebo-controlled parallel group randomised trial and one prospective, randomised crossover trial Strength of evidence Weak Outcomes reported The current recommended oral dose of meloxicam in rabbits of 0.2–0.3 mg/kg once a day was consistently described as inadequate for postoperative analgesia following surgery (Delk et al., 2014). Instead, higher doses of 1–1.5 mg/kg were required to reach a similar peak plasma concentration as found to be clinically effective in other species, such as canines, and provide a better degree of analgesia in rabbits (Montoya et al., 2004; and Delk et al., 2014). Although no studies were found evaluating twice daily administration of meloxicam, the available evidence suggests a dose exceeding 0.2–0.3 mg/kg daily is required for adequate postoperative analgesia in rabbits. Whether this increased dose could be given twice daily should be investigated, providing scope for future research Conclusion Further studies are required to directly assess the benefits of twice daily oral meloxicam. However, it is possible that a dose exceeding 0.2–0.3 mg/kg is required and therefore higher doses should be considered in these studies   How to apply this evidence in practice The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources. Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.  


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