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J Opioid Manag ; 6(3): 193-202, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20642248


BACKGROUND: This multicenter, parallel-group, 35-day study in adults with osteoarthritis (OA) pain evaluated the analgesic efficacy and safety of buprenorphine transdermal system (BTDS) designed for 7-day wear. METHODS: Patients with OA pain inadequately controlled with nonsteroidal antiinflammatory drugs or patients who had taken opioids for OA pain within the past year entered a 7-day run-in period during which they took ibuprofen only. Patients with pain > or = on a 0-10 scale had their ibuprofen discontinued and were randomized into a 28-day double-blinded period to receive either BTDS at 1 of 3 dose levels (5, 10, or 20 microg/b) or placebo. Doses were titrated to effectiveness over a period of 21 days and maintained for 7 days. No rescue medication was allowed during the study. The primary efficacy measure was the proportion of patients who achieved treatment success, defined as a patient satisfaction score of good, very good, or excellent (on day 28 or at early discontinuation) for those who did not discontinue due to ineffective treatment. RESULTS: More BTDS-treated patients experienced treatment success than placebo TDS-treated patients (44 percent and 32 percent; odds ratio = 1.66, p = 0.036). Fewer patients taking BTDS titrated to the highest dose compared with placebo (p < 0.05). There were two serious adverse events (both in the placebo group) and no deaths. The most common (> or =5 percent) adverse events reported in BTDS-treated patients were nausea, headache, dizziness, somnolence, application site pruritus, and vomiting. CONCLUSION: Compared with placebo, BTDS treatment was effective in treating patients with moderate to severe pain due to OA of the knee or hip. BTDS was well-tolerated.

Buprenorfina/administração & dosagem , Osteoartrite/tratamento farmacológico , Administração Cutânea , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Buprenorfina/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
Curr Med Res Opin ; 24(12): 3531-42, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19032135


OBJECTIVE: To compare the efficacy and safety of ciprofloxacin otic solution 0.2% to polymyxin B-neomycin-hydrocortisone (PNH) otic solution in the treatment of acute diffuse otitis externa in children, adolescents, and adults. METHODS: This was a randomized, parallel-group, evaluator-blind, active-controlled, multicenter, noninferiority study. The primary efficacy endpoint was clinical cure of otitis symptoms at the test-of-cure (TOC) visit. Clinical cure at the end-of-treatment (EOT) visit and percentages of patients with clinical improvement and resolution and/or improvement of otalgia at EOT and TOC visits were secondary efficacy endpoints. RESULTS: A total of 630 patients were randomized to ciprofloxacin twice daily (n = 318) or PNH 3 times daily (n = 312) for 7 days. Ciprofloxacin was shown to be noninferior to PNH. The percentage of patients with clinical cure at the TOC visit was 86.6% with ciprofloxacin and 81.1% with PNH; the treatment difference was 5.6% in favor of ciprofloxacin (95% CI: -0.9 to 12.1). At the EOT visit, clinical cure was achieved in 70.0% and 60.5% of patients, respectively, with a treatment difference in favor of ciprofloxacin (9.5%, 95 CI: 1.2 to 17.9). In all secondary efficacy variables, ciprofloxacin and PNH showed similar results, including pain duration and resolution. The clinical cure rate for patients with baseline cultures showing P. aeruginosa was 87.5% in the ciprofloxacin group and 78.6% in the PNH group, a treatment difference of 8.9% in favor of ciprofloxacin (95% CI: 0.6 to 17.3); for patients with baseline cultures showing S. aureus, the clinical cure rate was 72.7% for the ciprofloxacin group and 75.9% for the PNH group (treatment difference of 3.1% in favor of PNH, 95% CI: -21.1% to 27.4%). Most adverse events were mild and unrelated to study medication in both treatment groups. A limitation of this study is the assessment of signs and symptoms at baseline and after treatment, which does not provide data to evaluate the interim response. CONCLUSIONS: Ciprofloxacin otic solution 0.2% was found to be noninferior to PNH. This efficacy, good tolerability, and ease of administration make ciprofloxacin otic solution 0.2% without a topical steroid an attractive option for the treatment of acute otitis externa.

Antibacterianos/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Ciprofloxacino/administração & dosagem , Hidrocortisona/administração & dosagem , Neomicina/administração & dosagem , Polimixina B/administração & dosagem , Doença Aguda , Administração Tópica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Criança , Pré-Escolar , Ciprofloxacino/efeitos adversos , Combinação de Medicamentos , Feminino , Humanos , Hidrocortisona/efeitos adversos , Masculino , Pessoa de Meia-Idade , Neomicina/efeitos adversos , Otite Externa , Soluções Farmacêuticas/administração & dosagem , Soluções Farmacêuticas/efeitos adversos , Polimixina B/efeitos adversos , Espanha , Estados Unidos
J Urol ; 179(3): 1060-5, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-18206950


PURPOSE: Phosphodiesterase type 5 inhibitors are the first choice therapy in the treatment of erectile dysfunction. Many men in their reproductive years are now using phosphodiesterase type 5 inhibitors. The purpose of this study was to determine the effects of 6 months of treatment with 20 mg vardenafil, compared with 100 mg sildenafil and placebo, on semen characteristics and reproductive hormones in men with and without erectile dysfunction. MATERIALS AND METHODS: This was a randomized, double-blind, placebo controlled, parallel group, multicenter study. A total of 200 men with or without erectile dysfunction, able to produce semen samples without erectile dysfunction therapy, 25 to 64 years old, were randomized to daily treatment with vardenafil, sildenafil or placebo for 6 months. The primary variable was the percentage of vardenafil treated individuals with a 50% or greater decrease in mean sperm concentration from baseline to 6-month last observation carried forward, compared with placebo treated individuals. RESULTS: The between group difference (vardenafil minus placebo) in the percentage of patients with 50% or greater decrease in sperm concentration (baseline to 6 months last observation carried forward) was 0.07% (95% CI, -8.53% to 8.39%). Vardenafil also had no clinically significant effects on any other semen parameters, or on levels of reproductive hormones, when compared with placebo. Similar data were observed with sildenafil. CONCLUSIONS: This study demonstrated that vardenafil had no adverse effects on sperm concentration, compared with sildenafil and placebo, when administered daily at the maximum recommended dose for 6 months. Specifically, use of vardenafil for 6 months does not impair sperm concentration, total sperm count per ejaculate, or sperm morphology and motility. Levels of reproductive hormones were also unaffected.

Disfunção Erétil/tratamento farmacológico , Hormônios Gonadais/metabolismo , Imidazóis/farmacologia , Inibidores de Fosfodiesterase/farmacologia , Piperazinas/farmacologia , Sêmen/efeitos dos fármacos , Adulto , Método Duplo-Cego , Disfunção Erétil/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Purinas/farmacologia , Citrato de Sildenafila , Contagem de Espermatozoides , Sulfonas/farmacologia , Triazinas/farmacologia , Dicloridrato de Vardenafila
Vaccine ; 24(7): 914-20, 2006 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-16213066


BACKGROUND: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. GOAL: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. STUDY DESIGN: Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year. RESULTS: The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82%) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9% versus 17.2% versus 13.1% versus 16.4%, respectively). CONCLUSION: This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.

Herpes Genital/terapia , Vacinas contra o Vírus do Herpes Simples/uso terapêutico , Adolescente , Adulto , Linfócitos T CD8-Positivos/imunologia , Feminino , Vacinas contra o Vírus do Herpes Simples/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Fatores de Tempo , Replicação Viral , Eliminação de Partículas Virais
Chest ; 128(4): 2230-7, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16236879


BACKGROUND: Community-acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. The inability or failure of many subjects to adhere to standard antibiotic regimens, which may last up to 10 days, results in suboptimal antibiotic treatment. Treatment with a single-dose antibiotic regimen may improve compliance with prescribed therapy. A novel microsphere formulation of azithromycin provides a single-dose regimen while maintaining tolerability. STUDY OBJECTIVE: To compare the efficacy and safety of a single 2.0-g dose of azithromycin microspheres to that of an extended-release formulation of clarithromycin (1.0 g/d for 7 days) for the treatment of adults with mild-to-moderate CAP. DESIGN: A phase III, multinational, multicenter, randomized, double-blind, double-dummy study, comparing single-dose azithromycin microspheres to extended-release clarithromycin, both administered orally. METHODS: Subjects with mild-to-moderate CAP (Fine class I and II) were included. The primary end point was clinical response at the test-of-cure (TOC) visit (days 14 to 21) in the clinical per protocol (CPP) population. The bacteriologic response at the TOC visit was assessed in subjects with a baseline pathogen. RESULTS: A total of 501 subjects were randomized, and 499 were treated. Clinical cure rates at the TOC visit in the CPP population were 92.6% (187 of 202 subjects) for azithromycin microspheres and 94.7% (198 of 209 subjects) for extended-release clarithromycin. Overall pathogen eradication rates were 91.8% (123 of 134 subjects) for azithromycin microspheres and 90.5% (153 of 169 subjects) for extended-release clarithromycin. Both agents were well tolerated. The incidence of treatment-related adverse events was 26.3% with azithromycin microspheres and 24.6% with extended-release clarithromycin. Most adverse events were mild to moderate in severity. CONCLUSION: A single 2.0-g dose of azithromycin microspheres was as effective and well tolerated as a 7-day course of extended-release clarithromycin in the treatment of adults with mild-to-moderate CAP.

Azitromicina/uso terapêutico , Claritromicina/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Pneumonia/tratamento farmacológico , Adulto , Idoso , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Azitromicina/administração & dosagem , Claritromicina/administração & dosagem , Infecções Comunitárias Adquiridas/microbiologia , Preparações de Ação Retardada , Método Duplo-Cego , Feminino , Humanos , Masculino , Microesferas , Pessoa de Meia-Idade