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BACKGROUND - A phase II open-label study was conducted in hemodialysis patients evaluating the short-term safety, tolerability, and iron absorption with ferric citrate when used as a phosphate binder.
METHODS - Enrollment occurred in two periods. Period 1 recruited patients taking 6-15 pills/day of binder with phosphorus of ≥2.5 mg/dl. Period 2 recruited patients taking ≥12 pills/day of binder with phosphorus of ≥3.5 mg/dl. Participants with ferritin ≥1,000 µg/l or transferrin iron saturation (TSAT) ≥50% at screening were excluded. Subjects discontinued their previous binders and started 4.5 g/day of ferric citrate (period 1) or 6 g/day (period 2) and were titrated for 4 weeks to maintain a phosphorus of 3.5-5.5 mg/dl. Chemistries and complete blood count were obtained weekly and a gastrointestinal questionnaire was administered at drug initiation and final visit. Iron therapy was permitted if the ferritin was <500 µg/l and TSAT <30%.
RESULTS - Fifty-five subjects were enrolled. Four serious adverse events were reported; none were related to the study drug. Findings from the gastrointestinal questionnaire included stool discoloration (69%), constipation (15%), and bloating (7%). Mean iron parameters at the beginning of the study were ferritin 554 ± 296 µg/l, iron 68 ± 21 µg/dl, and iron saturation 30 ± 7.8%. At the end of study, mean ferritin was 609 ± 340 µg/l (p = 0.02), iron 75 ± 27 µg/dl (p = 0.04), and TSAT was 35 ± 13% (p = 0.001). Mean phosphorus and calcium levels were unchanged from baseline at the end of study.
CONCLUSION - Ferric citrate was well tolerated by patients after 4 weeks with no significant clinical or biochemical adverse events related to exposure.
Copyright © 2012 S. Karger AG, Basel.
PURPOSE - Questionnaires to quantify pediatric bladder/bowel dysfunction have recently been developed as research instruments. We evaluated our use of a bladder/bowel dysfunction questionnaire in a busy clinical setting.
MATERIALS AND METHODS - We distributed a validated bladder/bowel dysfunction questionnaire to all new pediatric urology outpatients older than age 4 years from May 1 to July 31, 2010. We instructed families to complete the questionnaire without assistance. Physicians were blinded to responses during the study period. We compared total scores between groups of patients with bladder/bowel dysfunction related and bladder/bowel dysfunction unrelated primary diagnoses. We also compared individual item scores pertaining to urinary incontinence, dysuria, nocturnal enuresis and constipation in patients with those specific primary ICD-9 diagnosis codes to those of other bladder/bowel dysfunction related diagnoses.
RESULTS - Of 358 questionnaires reviewed 91 (25%) could not be adequately scored. Of the remaining 267 patients 134 had bladder/bowel dysfunction related diagnoses and 133 had bladder/bowel dysfunction unrelated diagnoses. The patients with bladder/bowel dysfunction related diagnoses had a higher score on the validated questionnaire (p <0.001). Patients with primary ICD-9 diagnoses for urinary incontinence (p = 0.0026, p = 0.0164), dysuria (p = 0.008) and nocturnal enuresis (p <0.0001) had higher scores on corresponding items of the questionnaire than those with other bladder/bowel dysfunction related diagnoses. The ICD-9 diagnosis of constipation was not associated with higher scores for constipation related items.
CONCLUSIONS - A validated bladder/bowel dysfunction questionnaire is a useful tool in the pediatric urology clinical setting that correlates well with physician assessment. The questionnaire can help patients and their families better define their bladder/bowel symptoms before their visit. Some families will not be able to fill out the questionnaire appropriately.
Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
PURPOSE - Fecal incontinence and constipation in children with spina bifida are recognized to impact quality of life. Most disease specific quality of life instruments on fecal incontinence target adults and/or children without neuropathic bowel. We developed an instrument to evaluate bowel function and its impact on quality of life in children with spina bifida and their caregivers.
MATERIALS AND METHODS - A 51-item questionnaire termed the FIC QOL (Fecal Incontinence and Constipation Quality of Life) survey was developed from expert opinion, patient interviews, and modification of previously published adult and pediatric studies for nonneuropathic bowel dysfunction. The items are divided into 7 quality of life factor groupings, including bowel program, dietary management, symptoms, travel and socialization, family relationships, caregiver emotional impact and financial impact. The questionnaire was given to caregivers of children with and without spina bifida. Discriminant validity was evaluated by comparing the spina bifida and control groups. Test-retest reliability was evaluated by having 41 patients complete 2 surveys within 4 to 6 weeks.
RESULTS - Comparing questionnaires from 92 index patients and 52 controls showed a statistically significant difference for all 7 quality of life factor groupings. The FIC QOL instrument objectively demonstrated the negative impact of fecal incontinence and constipation on quality of life in these families. Comparing 82 questionnaires at 2 time points demonstrated the reliability of all FIC QOL questions.
CONCLUSIONS - The FIC QOL instrument provides a valid and reliable measure of the effect of fecal incontinence and constipation on the quality of life of caregivers and their children with spina bifida.
OBJECTIVES - Alosetron (Lotronex) is a new therapeutic agent for irritable bowel syndrome (IBS) in women with diarrhea-predominant IBS. This multicenter randomized, double-blind, placebo-controlled study assessed the safety and tolerability of alosetron during long-term (< or = 12 months) treatment.
METHODS - A total of 859 subjects (637 female and 222 male) with IBS were enrolled from 130 sites in the United States and were randomized 3:1 to receive 1 mg alosetron or placebo b.i.d. for 48 wk; of the subjects, 649 (76%) were randomized to the alosetron group and 212 (24%) to the placebo group. Of the original group, 850 subjects received at least one dose of alosetron (n = 640) or placebo (n = 210).
RESULTS - In all, 59% of the subjects completed the study. Safety data were similar in treatment groups and within age, sex, racial origin, and hormone use. Adverse events were reported by 83% (530/640) and 76% (159/210) of subjects in the alosetron and placebo groups, respectively, (p < 0.05) and were similar with the exception of constipation; 32% of subjects receiving alosetron reported constipation, compared to 5% in the placebo group (p < 0.001). Most reports (72%) of constipation were of mild or moderate severity, and 66% of subjects with constipation had single episode of 8 days median duration. Constipation occurred a median of 13 days after initiating treatment and resolved spontaneously, with laxative, or after a brief interruption of therapy. Of the subjects, 4% (11/210) in the alosetron and 5% (28/ 640) in the placebo group experienced serious adverse events. Two deaths occurred in subjects with pre-existing cardiovascular risk factors; neither death was attributed to the study drug.
CONCLUSIONS - Alosetron 1 mg b.i.d. for 12 months was well tolerated. Constipation is the most frequent adverse event, with a higher incidence of transient constipation in alosetron-treated patients, typically occurring in the first month of treatment.
An analysis is made of functional studies performed in 96 constipated patients to see how these studies influenced the choice of surgical treatment. All patients underwent anal manometry, and other investigations included colonic transit studies (56), anal sphincter electromyography (42) and defaecatory proctography (34). Additionally nine patients underwent full thickness rectal biopsy. The resting anal canal pressures of the patients studied were lower than controls, and fibre density studies on electromyography were abnormal in half the patients studied suggesting a degree of denervation of the sphincter muscles, which possibly related to chronic straining on the toilet. There was evidence of reduced rectal sensation as shown by an increase in the least perceived volume on balloon distension of the rectum, and in those with megarectum and/or megacolon an increase in maximum tolerated volume. The recto-anal inhibitory reflex was used to screen for adult Hirschsprung's disease, but in one patient the reflex was present despite absence of ganglia on full thickness rectal biopsy indicating the need for biopsy as the definitive diagnostic procedure. Delayed colonic transit using radio opaque markers was a necessary requirement before recommending colectomy, and delayed transit was demonstrated in 34% of the patients studied. Anismus on electromyography was found in 20% of the patients but there was poor correlation with failure of the anorectal angle to widen when bearing down on proctography. The investigations helped in the choice of treatment, but were difficult to interpret. They should be used in severe constipation when surgery is being contemplated.