ABSTRACT
BACKGROUND: Ziprasidone has been used to treat schizophrenia since 2000. It is unknown whether its modest QTc-prolonging effect increases cardiovascular event risk. PURPOSE: To describe the study design of the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). METHOD: The study was conducted between February 2002 and February 2006. One-year follow-up for the primary endpoint of nonsuicide death ended in April 2007. ZODIAC is an open-label, randomized, postmarketing study enrolling patients with schizophrenia in naturalistic practice in 18 countries. The primary outcome measure was the rate of nonsuicide mortality in the year after initial recommendation for therapy. Subjects were randomly assigned to either ziprasidone or olanzapine, after which follow-up was conducted by investigators aware of the assigned exposure. A physician-administered questionnaire collected baseline information on patients' demographics, medical and psychiatric history, and concomitant medication use. Data were self-reported by patients or reported by enrolling physicians. RESULTS: ZODIAC enrolled 18,240 patients with schizophrenia. Most (73.0%) were from the United States or Brazil. Patients' baseline mean age was 41.6 years, 55.1% were male, and 60.0% were white. At baseline, approximately 18% had hypertension, 14.8% had hyperlipidemia, 46.5% currently smoked, 28.9% had a body mass index >or= 30 kg/m(2), and 7.7% had diabetes. Mean time from schizophrenia diagnosis to study enrollment was 10.4 years and mean Clinical Global Impressions scale score was 5.2 (range: 1-8). Nearly one third of patients had ever attempted suicide. Seventy-one percent were using antipsychotics at baseline. Almost 80% were using concomitant medications, with 29.5% using antidepressants, 25.4% using anxiolytics, and 19.0% using mood stabilizers. Less than 3% were using antihypertensives or statins. CONCLUSIONS: ZODIAC is a uniquely designed study with an initial randomization to ziprasidone or olanzapine and follow-up largely consistent with usual practice (i.e., many characteristics of a nonexperimental study). Baseline data suggest this study population has a substantial prevalence of cardiovascular risk factors. Concomitant medications were used frequently, although hyperlipidemia and hypertension may be undertreated. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00174447.
Subject(s)
Antipsychotic Agents/adverse effects , Long QT Syndrome/chemically induced , Piperazines/adverse effects , Schizophrenia/drug therapy , Thiazoles/adverse effects , Adult , Antipsychotic Agents/therapeutic use , Body Mass Index , Dyslipidemias/diagnosis , Dyslipidemias/epidemiology , Female , Glycated Hemoglobin/analogs & derivatives , Glycated Hemoglobin/metabolism , Humans , Hypertension/diagnosis , Hypertension/epidemiology , Long QT Syndrome/diagnosis , Long QT Syndrome/epidemiology , Male , Observation , Piperazines/therapeutic use , Prevalence , Research Design , Schizophrenia/blood , Schizophrenia/epidemiology , Severity of Illness Index , Surveys and Questionnaires , Thiazoles/therapeutic use , Triglycerides/bloodABSTRACT
BACKGROUND: Moxifloxacin is an advanced-generation fluoroquinolone used primarily for the treatment of respiratory tract infections. OBJECTIVE: To further investigate moxifloxacin's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study. METHODS: A total of 18,409 outpatients with suspected bacterial episodes of acute sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia of mild to moderate severity were enrolled at 3377 community practice sites. Patients with sinusitis or pneumonia received once-daily oral moxifloxacin 400 mg for 10 days; those with bronchitis received 5 days' treatment. At follow-up, within 48 hours after the end of treatment, adverse event information was collected. An external safety committee assessed possible cardiac-related events. Efficacy was also evaluated at follow-up via the degree of resolution of clinical signs and symptoms. RESULTS: Of 18,374 safety-valid patients, 17.7% experienced adverse events and 14.3% experienced drug-related adverse events. The most common drug-related adverse events were nausea (5.3%), diarrhea (2.2%), and dizziness (2.0%). There was no clinical evidence of increased risk of cardiac arrhythmias with moxifloxacin treatment. Of 17,137 patients included in the efficacy analysis, 92.9% overall experienced clinical cure or improvement (92.8% with sinusitis, 92.9% with bronchitis, 94.1% with pneumonia). CONCLUSIONS: Once-daily oral moxifloxacin 400 mg was shown to be safe and effective in this trial for the treatment of respiratory tract infections of suspected bacterial origin in the clinical practice setting.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Aza Compounds/therapeutic use , Quinolines/therapeutic use , Respiratory Tract Infections/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/adverse effects , Aza Compounds/adverse effects , Child , Female , Fluoroquinolones , Humans , Male , Middle Aged , Moxifloxacin , Quinolines/adverse effectsABSTRACT
En julio de 1969 surgió en el Salvador una gran epidemia de disentería de shiga, que llegó al máximo en julio de 1970 y luego descendió rápidamente a niveles casi endémicos en 1973. Los casos registrados excedieron de 197,000, con unas 11,750 defunciones
