RESUMEN

OBJECTIVE: The objective was to characterize the safety of duloxetine for treatment of stress urinary incontinence (SUI) in women, using an integrated database generated from four published placebo-controlled clinical trials. METHODS: The database included 1913 women randomized to duloxetine (N=958) or placebo (N=955), examining adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms, and laboratory analytes. AEs occurring initially or worsening during the double-blind treatment period were considered treatment-emergent (TEAE). Differences between duloxetine-treated and placebo-treated groups were compared statistically. RESULTS: Common TEAEs included: nausea (23.2%), dry mouth (13.4%), fatigue (12.7%), insomnia (12.6%), constipation (11.0%), headache (9.7%), dizziness (9.5%), somnolence (6.8%), and diarrhea (5.1%). Most TEAEs that emerged early were mild to moderate, rarely worsened, and resolved quickly. Overall AE discontinuation rates were 20.5% for duloxetine and 3.9% for placebo (P<.001). Most discontinuations (83%) occurred within the first month of treatment. SAEs were uncommon and did not differ between treatments. Statistically significant, but clinically unimportant mean increases in heart rate (2.4 bpm) and systolic and diastolic blood pressure (

Asunto(s)

Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Tiofenos/uso terapéutico , Incontinencia Urinaria de Esfuerzo/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Estreñimiento/inducido químicamente , Diarrea/inducido químicamente , Trastornos de Somnolencia Excesiva/inducido químicamente , Mareo/inducido químicamente , Método Doble Ciego , Clorhidrato de Duloxetina , Fatiga/inducido químicamente , Femenino , Cefalea/inducido químicamente , Humanos , Hígado/efectos de los fármacos , Hígado/enzimología , Persona de Mediana Edad , Náusea/inducido químicamente , Trastornos del Inicio y del Mantenimiento del Sueño/inducido químicamente , Tiofenos/efectos adversos , Xerostomía/inducido químicamente

RESUMEN

Primary care practitioners are in an ideal position to initiate treatment for patients with behavior, mood, and thought disturbances. It is believed that early identification and treatment of these symptomatic features of primary or secondary central nervous system disorders may significantly reduce morbidity and benefit the patient, his/her family, and involved caregivers, including the primary care physician. A broad list of central nervous system-active medications are utilized by family physicians to treat patients who exhibit symptoms of agitation, altered mood, and disordered thought. Some medications have demonstrated superiority over placebo or active medicines in reported clinical trials. This article is a brief overview of the safety and efficacy from reported studies of the use of medications frequently used to treat symptoms related to behavior, mood, and thought disturbances, with a specific focus on the clinical applicability of olanzapine.