scholarly journals Fluralaner 5.46% (W/W) Flavored Chewable Tablet (Bravecto® 1-Month) Is Effective for Treatment of Canine Generalized Demodicosis

2021 ◽  
Author(s):  
Nadja Rohdich ◽  
Leon Meyer ◽  
Frank Guerino
Keyword(s):  
Body Weight ◽  
Arithmetic Mean ◽  
Primary Efficacy ◽  
Chewable Tablet ◽  
Clinical Assessments ◽  
Demodex Canis ◽  
Chewable Tablets ◽  
Monthly Administration ◽  
Pre Treatment ◽  
To Receive

Abstract Background: Orally administered fluralaner (13.64% w/w) is effective for treating canine generalized demodicosis. A study was initiated to assess the efficacy of a novel 5.46% w/w fluralaner chewable tablet formulation for monthly administration in the treatment of this disease.Methods: Client-owned dogs diagnosed with generalized demodicosis were acclimatized to laboratory conditions and randomized to receive either orally administered fluralaner (Bravecto® 1-Month) (10.0 to 14.4 mg/kg body weight) (n = 8) or topical imidacloprid-moxidectin (Advocate® for dogs, Elanco) applied per label on Days 0, 28 and 56 (n = 8), or more frequently for ongoing severe demodicosis. On Days -2, 28, 56 and 84, deep skin scrapings were taken from 5 sites on each dog for mite identification and counting, and semi-quantitative clinical assessments of generalized demodicosis were recorded. Primary efficacy was based upon arithmetic mean mite count reductions relative to pre-treatment.Results: By Day 28, mean pre-treatment mite counts, >600 in both groups, were significantly reduced by 99.7% and 89.5% (both P < 0.001) in the fluralaner and imidacloprid-moxidectin groups, respectively. Parasitological cure (100% reduction in mite counts on Days 56 and 84) was achieved in all fluralaner-treated dogs (100%) and in 2 imidacloprid-moxidectin treated dogs (25%). In the imidacloprid-moxidectin group, the reduction in mean mite counts was 89.5% (Day 28), 94.4% (Day 56) and 97.5% (Day 84). All study dogs were free of crusts on Days 56 and 84. Scales resolved by Day 84 in all fluralaner-treated dogs and in 3 imidacloprid-moxidectin treated dogs. All fluralaner-treated dogs and 5 imidacloprid-moxidectin treated dogs had > 90% hair re-growth on Day 84.Conclusion Three consecutive monthly oral administrations of fluralaner (5.46% w/w) flavored chewable tablets (minimum dose rate 10 mg/kg body weight) eliminated Demodex canis mites from dogs diagnosed with generalized demodicosis.

scholarly journals Treatment of canine sarcoptic mange with afoxolaner (NexGard®) and afoxolaner plus milbemycin oxime (NexGard Spectra®) chewable tablets: efficacy under field conditions in Portugal and Germany

Parasite ◽  
2018 ◽  
Vol 25 ◽  
pp. 63 ◽  
Author(s):  
Verena Hampel ◽  
Martin Knaus ◽  
Jürgen Schäfer ◽  
Frederic Beugnet ◽  
Steffen Rehbein
Keyword(s):  
Field Study ◽  
Treatment Initiation ◽  
Geometric Mean ◽  
Clinical Signs ◽  
Sarcoptic Mange ◽  
Field Conditions ◽  
Chewable Tablets ◽  
Baseline Values ◽  
Pre Treatment ◽  
To Receive

The efficacy of NexGard® and NexGard Spectra® against sarcoptic mange in dogs was evaluated in a clinical field study. Skin scrapings from dogs presenting signs suggestive of sarcoptic mange were examined to confirm infestation. A total of 106 dogs were screened at eight sites in Portugal and Germany. In all, 80 dogs that had demonstrated ≥5 live Sarcoptes mites in five skin scrapings were enrolled, scored for specific clinical signs (pruritus; papules and crusts; alopecia), and allocated at random to receive either NexGard® or NexGard Spectra® twice, one month apart per label instructions. To determine efficacy, live Sarcoptes mites in five skin scrapings per dog were counted, and clinical signs were scored one month and two months after first treatment and compared to pre-treatment (baseline) values. Based on compliance, 65 dogs were determined to be evaluable cases at the end of the study. The efficacy, in terms of reduction of geometric mean live Sarcoptes mite counts, was 98.9% and 99.7% for NexGard®-treated (n = 38) and 99.6% and 100% for NexGard Spectra®-treated dogs (n = 27) at one month and two months after treatment initiation (p < 0.001, both treatments). Both treatments resulted in a significant improvement in pruritus, papules and crusts, and alopecia one month and two months after treatment initiation (p = 0.0001, both treatments). In conclusion, this field study confirms that both NexGard® and NexGard Spectra® administered twice one month apart provide an effective and safe treatment against sarcoptic mange in dogs.

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

2017 ◽  
Vol 1 (3) ◽  
pp. 117-127
Author(s):  
Yasaman Mansouri ◽  
Yasmin Amir ◽  
Michelle Min ◽  
Raveena Khanna ◽  
Ruiqi Huang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Subcutaneous Administration ◽  
Open Label ◽  
Post Dose ◽  
Subcutaneous Injections ◽  
Pain Scores ◽  
Observational Cohort ◽  
Vas Scores ◽  
Pre Treatment ◽  
To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

scholarly journals Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study

2020 ◽  
Vol 8 (1) ◽  
pp. e000773
Author(s):  
Carol H Wysham ◽  
Julio Rosenstock ◽  
Marion L Vetter ◽  
Hui Wang ◽  
Elise Hardy ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Phase Iii ◽  
Open Label ◽  
Open Label Study ◽  
Registration Number ◽  
Efficacy Measures ◽  
Design And Methods ◽  
To Receive

IntroductionInvestigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.Research design and methodsIn this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.ResultsIn total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28–52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of –1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of –1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.ConclusionsSwitching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.Trial registration numberNCT01652716.

scholarly journals Effect of liraglutide 3.0 mg on eating behavior in patients with obesity

2021 ◽  
pp. 156-164
Author(s):  
O. V. Logvinova ◽  
E. A. Troshina
Keyword(s):  
Body Weight ◽  
Eating Behavior ◽  
Lifestyle Modification ◽  
Disease Recurrence ◽  
Metabolic Parameters ◽  
Anthropometric Parameters ◽  
Lower Glucose ◽  
Initial Severity ◽  
To Receive

Introduction. One of the objectives of weight loss in obesity is to prevent metabolic disorders associated with it. An important component in the maintenance of the achieved results is a change of eating behavior.Goal: to study the effect of liraglutide 3.0 mg on the dynamics of metabolic parameters and eating behavior in patients with obesity. Materials and methods. The study enrolled 42 obese patients in whom anthropometric parameters, metabolic parameters, and eating behavior were assessed with Dutch Eating Behavior Questionnaire (DEBQ). Patients were divided into 2 groups, one of which received liraglutide 3.0 mg with lifestyle modification for 3 months. The other group was recommended to receive only lifestyle modification. The participants were re-examined after 3 months.Results and discussion. in the liraglutide group in addition to a significant decrease in body weight, BMI and waist circumference, there was a statistical trend toward lower glucose, insulin and HOMA-IR levels. When comparing the dynamics of parameters between the groups, Д body weight, BMI and glucose in the liraglutide group were significantly superior. In reassessment of eating behavior after 3 months of treatment, no statistically significant differences were found with the initial severity of restrictive, emotional, and/or external types in both groups and, despite a more pronounced decrease in body weight in the liraglutide group, between them.Conclusions: Three months of isolated lifestyle modification and/or its combination with liraglutide 3.0 mg is not sufficient to make a lasting change in eating behavior. However, considering that obesity is a chronic and relapsing disease, the need for eating behavior correction remains relevant to prevent disease recurrence. This substantiates the need for more long-term intervention in obesity, including drug therapy.

scholarly journals Oxytocin Administration Alleviates Acute but Not Chronic Leptin Resistance of Diet-Induced Obese Mice

2018 ◽  
Vol 20 (1) ◽  
pp. 88 ◽  
Author(s):  
Mehdi Labyb ◽  
Chloé Chrétien ◽  
Aurélie Caillon ◽  
Françoise Rohner-Jeanrenaud ◽  
Jordi Altirriba
Keyword(s):  
Body Weight ◽  
Weight Gain ◽  
Food Intake ◽  
Body Weight Gain ◽  
Leptin Resistance ◽  
Obese Mice ◽  
Short Term ◽  
Continuous Administration ◽  
Pre Treatment ◽  
Treatment Of Obesity

Whereas leptin administration only has a negligible effect on the treatment of obesity, it has been demonstrated that its action can be improved by co-administration of leptin and one of its sensitizers. Considering that oxytocin treatment decreases body weight in obese animals and humans, we investigated the effects of oxytocin and leptin cotreatment. First, lean and diet-induced obese (DIO) mice were treated with oxytocin for 2 weeks and we measured the acute leptin response. Second, DIO mice were treated for 2 weeks with saline, oxytocin (50 μg/day), leptin (20 or 40 µg/day) or oxytocin plus leptin. Oxytocin pre-treatment restored a normal acute leptin response, decreasing food intake and body weight gain. Chronic continuous administration of oxytocin or leptin at 40 µg/day decreased body weight in the presence (leptin) or in the absence (oxytocin) of cumulative differences in food intake. Saline or leptin treatment at 20 µg/day had no impact on body weight. Oxytocin and leptin cotreatments had no additional effects compared with single treatments. These results point to the fact that chronic oxytocin treatment improves the acute, but not the chronic leptin response, suggesting that this treatment could be used to improve the short-term satiety effect of leptin.

Prospective Clinical Trial on the Efficacy of Amoxycillin Administered Twice or Four Times Daily in Children with Respiratory Tract Infections

1981 ◽  
Vol 9 (4) ◽  
pp. 274-276 ◽  
Author(s):  
F D Daschner ◽  
U Behre ◽  
A Dalhoff
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Respiratory Tract ◽  
Lower Respiratory Tract ◽  
Respiratory Tract Infections ◽  
Lower Respiratory Tract Infections ◽  
Duration Of Therapy ◽  
Daily Dose ◽  
Tract Infections ◽  
To Receive

Thirty-four children with upper or lower respiratory tract infections were randomly allocated to receive either a twice daily or four times daily dose of 50 mg amoxycillin/kg body-weight/day. Mean duration of therapy was identical in both groups. Peak and trough antibiotic concentrations were determined. Eradication of bacteria, clinical improvement and side-effects were comparable in both groups.

scholarly journals Comparison of Pharmacokinetics and Safety of Voriconazole Intravenous-to-Oral Switch in Immunocompromised Adolescents and Healthy Adults

2011 ◽  
Vol 55 (12) ◽  
pp. 5780-5789 ◽  
Author(s):  
Timothy A. Driscoll ◽  
Haydar Frangoul ◽  
Eneida R. Nemecek ◽  
Donald K. Murphey ◽  
Lolie C. Yu ◽  
...  
Keyword(s):  
Body Weight ◽  
Steady State ◽  
Oral Treatment ◽  
Area Under The Curve ◽  
Pharmacokinetic Data ◽  
Young Adolescents ◽  
Dosing Regimens ◽  
Oral Switch ◽  
To Receive ◽  
Higher Doses

ABSTRACTThe current voriconazole dosing recommendation in adolescents is based on limited efficacy and pharmacokinetic data. To confirm the appropriateness of dosing adolescents like adults, a pharmacokinetic study was conducted in 26 immunocompromised adolescents aged 12 to <17 years following intravenous (IV) voriconazole to oral switch regimens: 6 mg/kg IV every 12 h (q12h) on day 1 followed by 4 mg/kg IV q12h, then switched to 300 mg orally q12h. Area under the curve over a 12-hour dosing interval (AUC0–12) was calculated using a noncompartmental method and compared to the value for adults receiving the same dosing regimens. On average, the AUC0–12in adolescents after the first loading dose on day 1 and at steady state during IV treatment were 9.14 and 22.4 μg·h/ml, respectively (approximately 34% and 36% lower, respectively, than values for adults). At steady state during oral treatment, adolescents also had lower average exposure than adults (16.7 versus 34.0 μg·h/ml). Larger intersubject variability was observed in adolescents than in adults. There was a slight trend for some young adolescents with low body weight to have lower voriconazole exposure. It is likely that these young adolescents may metabolize voriconazole more similarly to children than to adults. Overall, with the same dosing regimens, voriconazole exposures in the majority of adolescents were comparable to those in adults. The young adolescents with low body weight during the transitioning period from childhood to adolescence (e.g., 12 to 14 years old) may need to receive higher doses to match the adult exposures. Safety of voriconazole in adolescents was consistent with the known safety profile of voriconazole.

scholarly journals Pharmacokinetics of Stavudine and Didanosine Coadministered with Nelfinavir in Human Immunodeficiency Virus-Exposed Neonates

2001 ◽  
Vol 45 (12) ◽  
pp. 3585-3590 ◽  
Author(s):  
Chokechai Rongkavilit ◽  
Pimolrat Thaithumyanon ◽  
Theshinee Chuenyam ◽  
Bharat D. Damle ◽  
Sompop Limpongsanurak ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Body Weight ◽  
Once Daily ◽  
Concentration Time ◽  
Pediatric Dose ◽  
Immunodeficiency Virus ◽  
To Receive

ABSTRACT We evaluated the pharmacokinetics of stavudine (d4T) and didanosine (ddI) in neonates. Eight neonates born to human immunodeficiency virus-infected mothers were enrolled to receive 1 mg of d4T per kg of body weight twice daily and 100 mg of ddI per m2 once daily in combination with nelfinavir for 4 weeks after birth. Pharmacokinetic evaluations were performed at 14 and 28 days of age. For d4T, on days 14 and 28, the median areas under the concentration-time curves from 0 to 12 h (AUC0–12s) were 1,866 and 1,603, ng · h/ml, respectively, and the median peak concentrations (C maxs) were 463 and 507 ng/ml, respectively. For ddI, on days 14 and 28, the median AUC0–10s were 1,573 and 1,562 h · ng/ml, respectively, and the median C maxs were 627 and 687 ng/ml, respectively. Systemic levels of exposure to d4T were comparable to those seen in children, suggesting that the pediatric dose of 1 mg/kg twice daily is appropriate for neonates at 2 to 4 weeks of age. Levels of exposure to ddI were modestly higher than those seen in children. Whether this observation warrants a reduction of the ddI dose in neonates is unclear.

Corticotropin- and lysine-vasopressin induced changes of plasma corticosteroids and testosterone in the adult male pig

1980 ◽  
Vol 95 (4) ◽  
pp. 518-522 ◽  
Author(s):  
W. Hahmeier ◽  
M. Fenske ◽  
L. Pitzel ◽  
W. Holtz ◽  
A. König
Keyword(s):  
Body Weight ◽  
Intravenous Injection ◽  
Intravenous Administration ◽  
The Other ◽  
Plasma Testosterone ◽  
Elevated Plasma ◽  
Other Hand ◽  
Lysine Vasopressin ◽  
Pre Treatment ◽  
Induced Changes

Abstract. Intravenous injection of 10.0 μg/kg body weight synthetic corticotropin (1-24 ACTH) into chronically cannulated boars resulted in significantly elevated plasma corticosteroid and testosterone levels between 20 and 140 min (corticosteroids) and 20–80 min (testosterone) after injection. Administration of lysine-vasopressin (LVP) at doses of 0.1, 0.2 and 0.4 IU/kg body weight elicited a significant increase of plasma corticosteroids between 20 and 40 min after injection; on the other hand, plasma testosterone concentrations tended to fall when compared to pre-treatment levels. From our results it can be concluded that exogenously applied ACTH can effectively stimulate the release of corticosteroids and testosterone. Intravenous administration of LVP results in significantly, although not maximally increased plasma corticosteroid concentrations; the release of endogenous ACTH induced by LVP injection, on the other hand, appeared to be too small to stimulate testosterone release significantly.

Evidence for rituximab (R) underdosing in subpopulations of elderly patients with DLBC: Results of the RICOVER-60 study of the DSHNHL.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8024-8024
Author(s):  
Michael Pfreundschuh ◽  
Carsten Mueller ◽  
Samira Zeynalova ◽  
Gerhard Held ◽  
Viola Poeschel ◽  
...  
Keyword(s):  
Body Weight ◽  
Elderly Patients ◽  
Half Life ◽  
Serum Levels ◽  
Lower Quartile ◽  
Elderly Male ◽  
Elimination Half ◽  
Outcome Improvement ◽  
The Difference ◽  
To Receive

8024 Background: Gender and weight independently influence R clearance and R serum elimination half life (Mueller et al., Blood 2012). To investigate whether the differences in R pharmacokinetics translate into different outcomes, we analyzed elderly patients (pts) with different R pharmacokinetics treated in the RICOVER-60 study. Methods: 1222 elderly pts. (61-80 y) were randomized to receive 6 or 8 cycles of CHOP-14 with or without R given on days 1, 15, 29, 43, 57, 71, 85, and 99. For this study, subgroup analyses were performed for pts with faster R clearance: elderly male (vs. female) pts and elderly weighty (upper quartile: >77kg) vs. slim (lower quartile: ≤60 kg) female pts. Results: Elderly females had a slower R clearance (8.21 ml/h vs. 12.68 ml/h; p=0.003) and a prolonged R half life compared to men (t1/2ß=30.7 vs. t1/2ß=24.7 d; p=0.003). Female pts had a higher 3-year PFS (68% vs. 61%; p=0.062) and OS (74% vs. 68% p=0.086). The differences in outcome were due to a greater outcome improvement by the addition of R in females: the difference in 3-year PFS between female and male pts was 5.1% (p=0.448) in pts. receiving CHOP-14 only and 7.7% (p=0.053) when R was added. In a multivariate analysis the relative risk for progression in male compared to female patients was not significantly elevated after CHOP-14 (1.1; p=0.348), but was significantly higher after R-CHOP-14 (1.6; p=0.004). With respect to weight, addition of R resulted in a significantly improved 3-year PFS (74% vs. 49%; p=0.006) in female pts with a body weight within the lower quartile (≤60 kg) who have an R serum half life of >38.1 days, while there was no improvement by the addition of R (72% vs. 71%; p=0.816) in female pts. with a body weight within the upper quartile (>77kg), who have a serum half life of <29.3 days. Conclusions: The reduced benefit of adding R to CHOP in elderly DLBCL pts. with a shorter rituximab serum half life (and hence lower serum levels) suggests that the respective subpopulations (males and weighty females) are underdosed when R is dosed based on body surface area at 375 mg/m2. Ongoing studies of the DSHNHL investigate whether higher R doses for pts with a shorter R serum half life can improve the outcome of the respective pts.

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