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Treatment-related Adverse Events (treatment-related + adverse_event)

Distribution by Scientific Domains

Medical Sciences	93%

Distribution within Medical Sciences

Dermatology	27%
Transplantation	13%

Selected Abstracts

Adefovir dipivoxil for wait-listed and post,liver transplantation patients with lamivudine-resistant hepatitis B: Final long-term results

LIVER TRANSPLANTATION, Issue 3 2007
Eugene Schiff
Wait-listed (n = 226) or post,liver transplantation (n = 241) chronic hepatitis B (CHB) patients with lamivudine-resistant hepatitis B virus (HBV) were treated with adefovir dipivoxil for a median of 39 and 99 weeks, respectively. Among wait-listed patients, serum HBV DNA levels became undetectable (<1,000 copies/mL) in 59% and 65% at weeks 48 and 96, respectively. After 48 weeks, alanine aminotransferase (ALT), albumin, bilirubin, and prothrombin time normalized in 77%, 76%, 60%, and 84% of wait-listed patients, respectively. Among posttransplantation patients, serum HBV DNA levels became undetectable in 40% and 65% at weeks 48 and 96, respectively. After 48 weeks, ALT, albumin, bilirubin, and prothrombin time normalized in 51%, 81%, 76%, and 56% of posttransplantation patients, respectively. Among wait-listed patients who underwent on-study liver transplantation, protection from graft reinfection over a median of 35 weeks was similar among patients who did (n = 34) or did not (n = 23) receive hepatitis B immunoglobulin (HBIg). Hepatitis B surface antigen was detected on the first measurement only in 6% and 9% of patients who did or did not receive HBIg, respectively. Serum HBV DNA was detected on consecutive visits in 6% and 0% of patients who did or did not receive HBIg, respectively. Treatment-related adverse events led to discontinuation of adefovir dipivoxil in 4% of patients. Cumulative probabilities of resistance were 0%, 2%, and 2% at weeks 48, 96, and 144, respectively. In conclusion, adefovir dipivoxil is effective and safe in wait-listed or posttransplantation CHB patients with lamivudine-resistant HBV and prevents graft reinfection with or without HBIg. Liver Transpl 13:349-360, 2007. © 2007 AASLD. [source]

Safety and efficacy of oral fexofenadine in children with seasonal allergic rhinitis , a pooled analysis of three studies

PEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 3 2004
Eli O. Meltzer
Allergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6,11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6,11 years. [source]

Ibudilast in healthy volunteers: safety, tolerability and pharmacokinetics with single and multiple doses

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 6 2008
Paul Rolan
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Ibudilast is an oral drug approved in Asia for asthma. , Tolerability of 10-mg regimens has been described previously. , Published pharmacokinetics (PK) are limited: single or 7-day repeat oral administration of 10 mg in healthy male Asian volunteers. WHAT THIS STUDY ADDS , Safety/tolerability and PK of a single 30-mg dose and a 30-mg twice daily (b.i.d.) 2-week regimen in male and female healthy volunteers. , Higher-dose regimens are relevant for testing in new neurological indications. , LC-MS/MS analytics for quantification of plasma and urine levels of ibudilast parent and its primary metabolite (6,7-dihydrodiol-ibudilast). AIMS To investigate the safety, tolerability and pharmacokinetics (PK) of ibudilast after a single-dose and a multiple-dose regimen. METHODS Healthy adult male (n = 9) and female (n = 9) volunteers were evaluated over a 17-day stay in a Phase 1 unit. Subjects were randomized 1 : 3 to either oral placebo or ibudilast at 30-mg single administration followed by 14 days of 30 mg b.i.d. Complete safety analyses were performed and, for PK, plasma and urine samples were analysed for ibudilast and its major metabolite. RESULTS Ibudilast was generally well tolerated. No serious adverse events occurred. Treatment-related adverse events included hyperhidrosis, headache and nausea. Two subjects discontinued after a few days at 30 mg b.i.d. because of vomiting. Although samples sizes were too small to rule out a sex difference, PK were similar in men and women. The mean half-life for ibudilast was 19 h and median Tmax was 4,6 h. Mean (SD) steady-state plasma Cmax and AUC0,24 were 60 (25) ng ml,1 and 1004 (303) ng h ml,1, respectively. Plasma levels of 6,7- dihydrodiol-ibudilast were approximately 30% of the parent. CONCLUSIONS Ibudilast is generally well tolerated in healthy adults when given as a single oral dose of 30 mg followed by 30 mg b.i.d. (60 mg day,1) for 14 days. Plasma PK reached steady state within 2 days of starting the b.i.d. regimen. Exposure to ibudilast was achieved of a magnitude comparable to that associated with efficacy in rat chronic pain models. [source]

Safety and efficacy of a sucrose-formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China

HAEMOPHILIA, Issue 4 2007
J. SHI
Summary., The use of plasma-derived products has contributed to a high rate of blood-borne infections among haemophilia patients in China. Recombinant factor VIII (rFVIII) products that are manufactured without human or bovine albumin and include dedicated viral inactivation steps, hold a significant safety advantage over plasma products. However, there is little information published on the use of rFVIII products in non-caucasian populations. This is the first reported evaluation of the efficacy and safety of a rFVIII product in Chinese haemophiliacs. An open-label, non-randomized, prospective, multicentre trial enroled previously treated Chinese patients with haemophilia A. All treatments were administered using a sucrose-formulated rFVIII-FS (Kogenate®). Forty-nine patients received totals of 291 infusions (mean, 5.94/patient) and 742 140 IU rFVIII-FS (mean, 2550.3 IU/infusion). Of the 60 acute bleeding episodes that were treated, 90% were successfully managed with only one (81.7%) infusion or two (8.3%) infusions. Physicians reported haemostasis control for acute bleeds to be ,Excellent' or ,Improved' with rFVIII-FS therapy. No FVIII inhibitors were detected in any patient. Only one treatment-related adverse event was reported, which was mild dizziness that resolved spontaneously. rFVIII-FS was efficacious, safe and well tolerated in the treatment of previously treated patients with haemophilia A in China. [source]

Safety of specific sublingual immunotherapy with SQ standardized grass allergen tablets in children

PEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 6 2007
Maria Dolores Ibañez
The aim of the study was to confirm the safety of an orodispersible grass allergen tablet 75,000 SQ-T (Grazax®, ALK-Abelló A/S, Hørsholm, Denmark) in children aged 5,12 yr. The study was randomized, double-blinded and placebo-controlled. Sixty children aged 5,12 yr suffering from grass pollen-induced rhinoconjunctivitis (with or without asthma) from five centres in two countries (three in Germany and two in Spain) participated in the study. They were randomized at the ratio of 3:1 as receiving either Grazax or placebo tablet given sublingually once daily for 28 days outside the grass pollen season. A total of 810 treatment-related adverse events were reported in the Grazax group. The majority of these were local reactions in the mouth or throat and were mostly mild (71%) to moderate (27%) in severity and resolved within days. Thirty-five (78%) subjects treated with Grazax and five (33%) treated with placebo reported at least one treatment-related adverse event. Oral pruritus, throat irritation, mouth oedema and ear pruritus appeared as the most frequently reported treatment-related adverse events. 62% (28 of 45) of the actively treated subjects reported oral pruritus, 36% (16 of 45) throat irritation, 31% (14 of 45) mouth oedema and 22% (10 of 45) ear pruritus. Two actively treated subjects withdrew from the study: one subject due to four adverse events (moderate eye pruritus, moderate pharyngolaryngeal pain, moderate non-cardiac chest pain and moderate dysphagia) and one subject due to a serious adverse event (asthmatic attack). The subjects recovered completely from the events. In conclusion, in the present study, Grazax was in general tolerated in a paediatric population and considered suitable for further clinical investigations in children. [source]

Autologous Cultured Fibroblast Injection for Facial Contour Deformities: A Prospective, Placebo-Controlled, Phase III Clinical Trial

DERMATOLOGIC SURGERY, Issue 3 2007
ROBERT A. WEISS MD
BACKGROUND Previous data indicate that injections of autologous fibroblasts increase collagen formation, accompanied by a concomitant increase in thickness and density of dermal collagen. OBJECTIVE The purpose of this study was to determine efficacy and side effects of autologous living fibroblast injections versus placebo in a randomized Phase III trial for the treatment of various facial contour defects. METHODS This was a double-blind, randomized comparison of injectable living autologous fibroblast cells and placebo for the treatment of facial contour defects (N=215). Live fibroblasts (20 million/mL) or placebo (the transport medium without living cells) were given as three doses administered at 1- to 2-week intervals. Efficacy evaluations were performed 1, 2, 4, 6, 9, and 12 months after the first injection. RESULTS Living fibroblasts produced statistically significantly greater improvements in dermal deformities and acne scars than did placebo. The difference between live fibroblast injections and placebo achieved statistical significance at 6 months (p<.0001). At 9- and 12-month follow-up, live fibroblast,treated patients continued to demonstrate benefit from treatment with response rates of 75.0 and 81.6%, respectively. No serious treatment-related adverse events were reported. CONCLUSIONS Our results indicate that autologous fibroblast injections can safely and effectively produce improvements in rhytids, acne scars, and other dermal defects continuing for at least 12 months after injection. [source]

Nonablative Acne Scar Reduction after a Series of Treatments with a Short-Pulsed 1,064-nm Neodymium:YAG Laser

DERMATOLOGIC SURGERY, Issue 8 2006
GRAEME M. LIPPER MD
BACKGROUND Effective treatment of facial acne scarring presents a major challenge. Nonablative lasers and radiofrequency devices work by thermally stimulating dermal collagen remodeling, thereby softening acne scars in a minimally invasive fashion. One such laser, a 1,064-nm short-pulsed Nd:YAG, uses rapidly scanned low-energy infrared pulses to heat the dermis selectively through the normal dermal microvasculature. OBJECTIVE In this pilot study, the safety and efficacy of a novel short-pulsed Nd:YAG laser were investigated for the treatment of moderate to severe facial acne scarring. MATERIALS AND METHODS Nine of 10 enrolled patients with moderate to severe facial acne scarring received eight sequential 1,064-nm Nd:YAG treatments (laser parameters 14 J/cm2, 0.3 milliseconds, 5-mm spot size, 7-Hz pulse rate, 2,000 pulses per side of face). Patients were graded for the presence and severity of three scar morphologies: superficial (rolling), medium-depth (boxcar), and deep (ice pick). Outcome measures included blinded evaluation of before and after photographs by three physician observers (scar severity score) and patient self-assessment. RESULTS Acne scarring improved in 100% of the nine patients completing the study. Scar severity scores improved by a mean of 29.36% (95% confidence interval, 16.93%,41.79%; p=.006); 89% of patients noted greater than 10% scar improvement. No treatment-related adverse events were seen. CONCLUSION Our findings support the use of a short-pulsed, low-fluence 1,064-nm Nd:YAG laser as a safe, effective treatment for facial acne scarring. Scar improvement was noted in all treated subjects with minimal discomfort and no downtime. This protocol appears to be most effective at reducing scar depth and softening scar contours. [source]

CLINICAL STUDY: Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial

ADDICTION BIOLOGY, Issue 2 2009
Paolo Mannelli
ABSTRACT Although current treatments for opioid detoxification are not always effective, medical detoxification remains a required step before long-term interventions. The use of opioid antagonist medications to improve detoxification has produced inconsistent results. Very low dose naltrexone (VLNTX) was recently found to reduce opioid tolerance and dependence in animal and clinical studies. We decided to evaluate safety and efficacy of VLNTX adjunct to methadone in reducing withdrawal during detoxification. In a multi-center, double-blind, randomized study at community treatment programs, where most detoxifications are performed, 174 opioid-dependent subjects received NTX 0.125 mg, 0.250 mg or placebo daily for 6 days, together with methadone in tapering doses. VLNTX-treated individuals reported attenuated withdrawal symptoms [F = 7.24 (2,170); P = 0.001] and reduced craving [F = 3.73 (2,107); P = 0.03]. Treatment effects were more pronounced at discharge and were not accompanied by a significantly higher retention rate. There were no group differences in use of adjuvant medications and no treatment-related adverse events. Further studies should explore the use of VLNTX, combined with full and partial opioid agonist medications, in detoxification and long-term treatment of opioid dependence. [source]

Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2009
H. Lottmann
Summary Background:, Primary nocturnal enuresis (PNE) is a distressing condition, particularly in severe cases (, 3 wet nights/week). A prevalent pathophysiological mechanism, especially in monosymptomatic PNE (PMNE), is commonly believed to be an insufficient increase in night-time release of antidiuretic hormone. Desmopressin, a synthetic analogue of antidiuretic hormone, has been shown to reduce the number of wet nights experienced by PMNE patients in several controlled trials. Aim: This study was performed to evaluate desmopressin treatment in the real-life clinical setting and was a large-scale, 6-month investigation of efficacy and safety in patients with severe PNE. Predictive factors for desmopressin response were also evaluated. A total of 744 children aged 5 years and above from four countries were involved in the study. Results: At baseline, patients had a median of 6 wet nights/week; at 6 months, 41% of patients had experienced , 50% reduction in the mean number of wet nights. Long-term desmopressin treatment was consistently well-tolerated across all ages, with 5% of patients experiencing any treatment-related adverse events. The strength of treatment response was associated with nocturnal diuresis (p < 0.0001) and age (p = 0.0167) in logistic regression analyses. Compliance and dosage were also associated with response and more patients experienced , 50% reduction in wet nights after 6 months' treatment than earlier in the study, suggesting the value of persistent treatment. Conclusion: This study shows that long-term desmopressin treatment in the clinical setting is effective and well-tolerated in PNE patients of 5 years and upwards. Early improvements in bedwetting of any appreciable magnitude may be rewarding, may facilitate compliance and enable good long-term response. [source]

Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: Results of a randomized, double-blind, vehicle-controlled study

JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 11 2006
Markus Dawid
Pimecrolimus; Elidel®; Vitiligo Summary Background: Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult to treat. In an earlier open label study in adult patients with vitiligo, pimecrolimus cream 1% was reported to have similar efficacy as clobetasol propionate 0.05%. We performed a double-blind, intrapatient comparison of pimecrolimus cream 1% with placebo cream. Patients and methods: Twenty adult Caucasians with symmetrical vitiligo (predominantly on extremities, none in the face) were treated b.i.d. for 6 months left/right with pimecrolimus/vehicle (N = 10) or vehicle/pimecrolimus (N = 10), respectively. Primary efficacy endpoint was the size of the target lesion at month 6 and secondary efficacy endpoint was re-pigmentation. Results: Treatment with pimecrolimus cream 1% or vehicle resulted in no significant change in mean target lesion size. Modest repigmentation (1,25%) was noted with pimecrolimus at month 2 in 12 of 17 patients (vehicle: 9 of 17 patients). Afterwards, the number of patients who experienced an improvement of pigmentation steadily decreased (3 of 14 patients with pimecrolimus and 2 of 14 with placebo at month 6).Treatment was well tolerated. There were no treatment-related adverse events, no induction of skin atrophy nor any other application site side effects. Conclusion: In this group of adult patients with symmetrical vitiligo, treatment of body lesions (except face) with pimecrolimus cream 1% could not be shown to be effective. Zusammenfassung Hintergrund: Vitiligo ist eine erworbene Pigmentstörung der Haut, die entstellend und schwer zu behandeln ist. In einer früheren offenen Studie an erwachsenen Patienten mit Vitiligo wurde mit Pimecrolimus-Creme 1% eine ähnliche Wirksamkeit beobachtet wie mit Clobetasol propionat 0.05%. Bei der vorliegenden Studie handelte es sich um einen doppelblinden, intraindividuellen Vergleich von Pimecrolimus-Creme 1% und Plazebo-Creme. Patienten und Methodik: Zwanzig erwachsene Patienten weißer Hautfarbe mit symmetrischer Vitiligo (vorwiegend an den Extremitäten) wurden zweimal täglich über 6 Monate im Halbseitenvergleich mit Pimecrolimus/Cremegrundlage (N = 10) oder Cremegrundlage/Pimecrolimus (N = 10) behandelt. Primärer Endpunkt war die Größe der behandelten Läsion, sekundärer Endpunkt der Prozentsatz an Repigmentierung. Ergebnisse: Die Behandlung mit Pimecrolimus-Creme 1% oder Vehikel ergab keine signifikante ,nderung der durchschnittlichen Größe der Läsion. Eine mäßige (1,25%) Repigmentierung wurde mit Pimecrolimus bei 12 von 17 (Grundlage:9 von 17) Patienten in Monat 2 beobachtet. Anschließend nahm die Anzahl der Patienten, die eine Repigmentierung aufwiesen, kontinuierlich ab (3 von 14 unter Pimecrolimus, 2 von 14 unter Grundlage im Monat 6). Die Behand-lung wurde gut vertragen. Es gab keine behandlungsbedingten Zwischenfälle und keine Induktion von Hautatrophie oder irgendwelche anderen Nebenwirkungen an der Applikationsstelle. Schlussfolgerung: In dieser Gruppe erwachsener Patienten mit symmetrischer Vitiligo konnte eine Wirksamkeit der Behandlung von Läsionen am Körper (nicht Gesicht) mit Pimecrolimus-Creme nicht gezeigt werden. [source]

Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis: a phase-2 multi-center study

JOURNAL OF CLINICAL PERIODONTOLOGY, Issue 2 2002
Thomas Van Dyke
Abstract Objective: P-113, a 12 amino acid histatin-based peptide, was evaluated in a mouthrinse formulation for safety and efficacy in a phase 2 multi-center clinical study. Method: 294 healthy subjects abstained from oral hygiene procedures and self-administered either 0.01% P-113, 0.03% P-113 or placebo mouthrinse formulations twice daily over a 4-week treatment period. During this time, the safety, anti-gingivitis, and anti-plaque effects of P-113 were evaluated. Results: There was a significant reduction in the change from baseline to Day 22 in bleeding on probing in the 0.01% P-113 treatment group of the intent to treat population (p=0.049). Non-significant trends in the reduction of the other parameters were observed in this population (p0.159). A sub-group of subjects which developed significant levels of disease within the four-week timeframe of the study was identified based on baseline gingival index scores 0.75. Significant findings were observed for bleeding on probing, gingival index and plaque index within this population (p<0.05). There were no treatment-related adverse events, and there were no adverse shifts in supragingival microflora during the study. Significant amounts of the peptide were retained in the oral cavity following rinsing. Conclusion: These data suggest that P-113 mouthrinse is safe and reduces the development of gingival bleeding, gingivitis and plaque in the human experimental gingivitis model. Zusammenfassung Ziel: In einer klinischen Phase-2 Multicenter-Studie wurde P-113, ein 12-Aminosäure-Histatin basierendes Peptid bezüglich Sicherheit und Effektivität in einer Mundspüllösung evaluiert. Methode:Für eine Behandlungszeitraum von 4 Monaten enthielten sich 294 Personen den Mundhygienemaßnahmen und spülten 2× täglich entweder mit 0.01% P-113, 0.03% P-113 oder mit einer Plazebolösung. Während dieser Zeit wurden die Sicherheit von P-113 sowie sein anti-Gingivitis- und sein anti-Plaqueeffekt evaluiert. Ergebnisse: In der 0.01% P-113-Behandlungsgruppe, der Population die behandelt werden sollte gab es eine signifikante Reduktion (p=0.049) der Veränderung zwischen Ausgangswert und Tag-22-Wert der Sondierungsblutung. In dieser Population wurden nichtsignifikante Trends in der Reduktion der anderen Parameter beobachtet (p0.159). Eine Untergruppe der Personen, welche während des vierwöchigen Zeitraumes ein signifikantes Erkrankungsniveau entwickelte, wurde auf der Grundlage eines Ausgangswertes für den Gingiva-Index von 0.75 identifiziert. Innerhalb dieser Population wurden signifikante Ergebnisse (p<0.05) für die Sondierungsblutung, den Gingiva-Index und den Plaque-Index beobachtet. Während dieser Studie gab es keine durch die Behandlung verursachten Nebenwirkungen und es gab keine unerwünschte Verschiebung der supragingivalen Mikroflora. Nach dem Spülen verblieb eine signifikante Menge des Peptids in der Mundhöhle. Schlussfolgerung: Diese Daten lassen annehmen, dass eine P-113-Mundspülössung sicher ist und die Entwicklung der Gingivablutung, Gingivitis und Plaque in einem humanen experimentellen Gingivitismodel hemmt. Résumé But: Le P-113, un peptide contenant de l'histatine a étéévalué dans un bain de bouche pour sa sécurité et son efficacité dans une étude multicentrique phase 2. Méthode. 294 sujets sains ont arrête toute hygiène buccale et se sont rincé avec soit 15 ml de P-113 0.01%, 15 ml de P-113 0.03% ou 15 ml d'une solution placebo 2× par jour durant une période de 4 semaines. Pendant ce temps, les effets anti-plaque et anti-gingivite, la sécurité ont étéévalués. Résultats: Il y avait une réduction significative entre l'examen de départ et le jour 22 dans le saignement au sondage dans le groupe P-113 0.01% (p=0.049). Aucune tendance significative dans la réduction des autres paramètres n'a été observée dans cette population (p0.159). Un sous-groupe de sujets qui développaient des niveaux significatifs de maladie durant ces 4 semaines a été identifié sur base de leur indice gingival initial 0.75. Des découvertes significatives ont été observées pour le saignement au sondage, l'indice gingival et l'indice de plaque dentaire dans cette population (p<0.05). Il n'y a eu aucun signe négatif dû au traitement ni aucune variation négative dans la flore sus-gingivale durant l'étude. Des quantités significatives du peptide ont été retenues dans la cavité buccale après rincage. Conclusion: Ces donnés suggèrent que le rincage au P-113 est sûr et réduit le dévelopement du saignement gingival, la gingivite et la plaque dentaire dans le modèle de la gingivite expérimentale humaine. [source]

Long-term treatment with botulinum toxin type A in cervical dystonia has low immunogenicity by mouse protection assay,

MOVEMENT DISORDERS, Issue 10 2008
Mitchell F. Brin MD
Abstract To evaluate the immunogenicity of botulinum toxin type A (BoNTA; BOTOX) in cervical dystonia (CD). Subjects diagnosed with CD for ,1 year and previously naïve to BoNTs were treated with BoNTA in a prospective, open-label, multicenter study. Serum samples were analyzed for BoNTA neutralizing antibodies using the Mouse Protection Assay (MPA). Clinical resistance was assessed with a test injection of 20 U BoNTA placed unilaterally into the frontalis (Frontalis Antibody Test; FTAT) or corrugator muscle (Unilateral Brow Injection; UBI). Efficacy was assessed and adverse events were recorded. Of 326 subjects enrolled, 251 (77%) completed the study. Subjects received a median of 9 BoNTA treatments (mean dose per session ranged from 148.4 to 213.0 U over a mean of 2.5 years [range: 3.2 months,4.2 years]). Only 4 of 326 subjects (1.2%) tested positive for antibodies in the MPA; three of these subjects stopped responding clinically to BoNTA (of whom one also showed clinical resistance in the FTAT) and one continued to respond. Consistent improvements in the signs/symptoms of CD were noted. The most frequent treatment-related adverse events were mild to moderate weakness, dysphagia, neck pain, and injection-site pain. The current formulation of BoNTA rarely causes neutralizing antibody formation in CD subjects treated ,4 years. © 2008 Movement Disorder Society [source]

Safety of specific sublingual immunotherapy with SQ standardized grass allergen tablets in children

Effect of Desonide Hydrogel 0.05% on the Hypothalamic-Pituitary-Adrenal Axis in Pediatric Subjects with Moderate to Severe Atopic Dermatitis

PEDIATRIC DERMATOLOGY, Issue 3 2007
Lawrence F. Eichenfield M.D.
A recent formulation advance has enabled the development of desonide 0.05% into a novel moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. This multicenter, open-label study evaluated the hypothalamic-pituitary-adrenal axis suppression potential, tolerability, and efficacy of this new Class VI topical steroid formulation in pediatric subjects with moderate-to-severe atopic dermatitis (mean body surface area = 51%). Forty children, aged 6 months to 6 years were enrolled and treated twice daily for 4 weeks. Desonide hydrogel 0.05% was well tolerated and no treatment-related adverse events were reported. No suppression of adrenal function was observed in subjects who completed the study without protocol violations related to cosyntropin administration or cortisol testing (n = 34). Of the subjects who completed the study with complications in cortisol testing (n = 3), there was one subject (1/37 = 3%) who had a low poststimulation cortisol level at week 4. Efficacy was demonstrated by marked improvement in overall disease state and in the signs and symptoms of atopic dermatitis. This study validates the systemic safety of a novel desonide hydrogel formulation in young pediatric patients and confirms the longstanding tolerability and efficacy profile of desonide. [source]

Valganciclovir Dosing According to Body Surface Area and Renal Function in Pediatric Solid Organ Transplant Recipients

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 3 2009
W. Vaudry
Oral valganciclovir is effective prophylaxis for cytomegalovirus (CMV) disease in adults receiving solid organ transplantation (SOT). However, data in pediatrics are limited. This study evaluated the pharmacokinetics and safety of valganciclovir oral solution or tablets in 63 pediatric SOT recipients at risk of CMV disease, including 17 recipients ,2 years old. Patients received up to 100 days' valganciclovir prophylaxis; dosage was calculated using the algorithm: dose (mg) = 7 × body surface area × creatinine clearance (Schwartz method; CrCLS). Ganciclovir pharmacokinetics were described using a population pharmacokinetic approach. Safety endpoints were measured up to week 26. Mean estimated ganciclovir exposures showed no clear relationship to either body size or renal function, indicating that the dosing algorithm adequately accounted for both these variables. Mean ganciclovir exposures, across age groups and organ recipient groups were: kidney 51.8 ± 11.9 ,g * h/mL; liver 61.7 ± 29.5 ,g * h/mL; heart 58.0 ± 21.8 ,g * h/mL. Treatment was well tolerated, with a safety profile similar to that in adults. Seven serious treatment-related adverse events (AEs) occurred in five patients. Two patients had CMV viremia during treatment but none experienced CMV disease. In conclusion, a valganciclovir-dosing algorithm that adjusted for body surface area and renal function provides ganciclovir exposures similar to those established as safe and effective in adults [source]