RESUMEN
In this post-hoc analysis of data from patients with overactive bladder (OAB) in VIBRANT patients receiving solifenacin showed statistically significantly greater improvement versus placebo in most outcome measures regardless of OAB symptom duration (less than five years and five years or longer).
Asunto(s)
Antagonistas Muscarínicos/uso terapéutico , Satisfacción del Paciente , Calidad de Vida , Quinuclidinas/uso terapéutico , Tetrahidroisoquinolinas/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Adulto , Femenino , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Autoinforme , Succinato de Solifenacina , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/enfermería , Vejiga Urinaria Hiperactiva/psicologíaRESUMEN
OBJECTIVE: To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir in reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in Immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes. PATIENTS AND METHODS: From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 6 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-blind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and Instructed to take 2 caplets once daily without regard to meals for 60 days. Daily genital and anal or rectal swabs were self-collected during the 60-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay. RESULTS: One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 60 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (P < .001), a 58% reduction in subclinical shedding (P < .001), and a 64% reduction in clinical shedding (P = .01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo. CONCLUSION: This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy that significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.