Multiorgan Dysfunction Syndrome from Strongyloides stercoralis Hyperinfection in a Patient with Human T-Cell Lymphotropic Virus-1 Coinfection After Initiation of Ivermectin Treatment.

Strongyloides stercoralis is well known to cause hyperinfection syndrome during the period of immunosuppression; but dissemination, worsening hyperinfection, and development of multiorgan dysfunction syndrome after initiation of ivermectin has not been reported in the past. Herein, we describe the case of a 62-year-old man with chronic strongyloidiasis and human T-cell lymphotropic virus-1 coinfection, who developed significant clinical worsening after 24-48 hours of initiation of treatment with ivermectin (200 µg/kg daily). Oral albendazole (600 mg every 12 hours) was added to the regimen due to clinical deterioration. Notably, after a protracted clinical course with multiple complications, which included respiratory failure from gram-negative pneumonia and pulmonary alveolar hemorrhage, Klebsiella meningitis, Clostridium difficile colitis, and herpes labialis, the patient eventually recovered. Health-care providers should be aware that during the early days of antihelminthic treatment initiation, significant dissemination of S. stercoralis and worsening of the clinical scenario can occur.

Randomized, double-blind, placebo-controlled trial of the 5-HT1A receptor antagonist AZD7371 tartrate monohydrate (robalzotan tartrate monohydrate) in patients with irritable bowel syndrome.

OBJECTIVES: To investigate the efficacy and safety of the 5-hydroxytrypamine 1A (5-HT(1A)) receptor antagonist AZD7371 tartrate monohydrate (robalzotan tartrate monohydrate), termed AZD7371 here, in patients with irritable bowel syndrome (IBS). METHODS: Patients meeting the Rome II criteria for IBS (N = 402) were randomized to treatment with AZD7371 20 mg or 5 mg or matching placebo tablets twice daily for 12 wk. The patients completed daily and weekly diary assessments, reporting abdominal discomfort or pain and description of bowel movements. They also completed validated symptom and quality-of-life questionnaires. RESULTS: Neither AZD7371 regimen was significantly more effective than placebo in providing adequate relief from IBS symptoms in at least 2 out of 4 wk per month over the 12 wk of treatment. There was also no significant difference between the treatment groups and placebo in the change in score in the validated symptom and quality-of-life questionnaires. Overall, 22.1% of patients experienced adverse events (AEs) attributed to the study medication: 44 of 133 (33.1%) in the 20 mg AZD7371 group, 27 of 131 (20.6%) in the 5 mg AZD7371 group, and 17 of 134 (12.7%) in the placebo group. Also, 31 of 57 (54%) of AEs leading to discontinuation were central nervous system-related. Hallucinations or hallucination-like AEs were reported by eight patients taking AZD7371, and by none of the patients in the placebo group. After these events led to discontinuation in six patients, the study was prematurely terminated. CONCLUSIONS: In view of the AE profile and lack of efficacy in IBS, the clinical development of AZD7371 has been stopped.

Validation of the treatment satisfaction questionnaire for Crohn's disease (TSQ-C).

Treatment satisfaction is used to capture the full impact of disease on patients' lives. Currently, no instruments exist to evaluate satisfaction with pharmacologic therapy in patients with Crohn's disease (CD). The purpose of this study was to evaluate the psychometric properties of a treatment satisfaction questionnaire for CD (TSQ-C). The 36-item questionnaire was completed by CD patients who reported taking 5-aminosalicylic acid derivatives to treat their CD. Measures used in the validation study were the Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Work Activity Impairment Index (CWAII), and patient reports of clinical indicators (e.g., number of active flares and medications taken). Exploratory factor analysis was used to evaluate the items and subscale structure. Internal consistency reliability and concurrent and discriminant validity were assessed using Cronbach's alpha, Pearson correlation coefficients, and analysis of variance. A total of 813 CD patients participated, with the majority being Caucasian (95.9%), female (67.0%), and >34 years old (86.1%). Patient-rated severity of CD was mild (49.3%), moderate (41.7%), and severe (7.5%). The final TSQ-C consisted of 32 items, with six subscales (Symptoms, Satisfaction, Expectations, Physician Relationships, Bother, and Cost), with each subscale score ranging from 1 to 6. Cronbach's alpha values ranged from 0.63 (Cost) to 0.94 (Symptoms). Strong correlations were observed among the IBDQ, CWAII, and the Satisfaction and Symptoms subscales of the TSQ-C. TSQ-C subscales, particularly Symptoms and Satisfaction, significantly discriminated among levels of number of flares per year, patient-rated disease severity, and number of medication classes. The TSQ-C demonstrated excellent validity and reliability and appears to be a useful tool for evaluating satisfaction with pharmacologic therapy among patients with CD.