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      Delayed release pancrelipase for the treatment of pancreatic exocrine insufficiency associated with cystic fibrosis

      Therapeutics and Clinical Risk Management

      Dove Medical Press

      pancrelipase, cystic fibrosis, malabsorption, pancreatic enzymes

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          Abstract

          Pancreatic enzyme replacement therapy (PERT) is the only treatment for malabsorption in cystic fibrosis (CF) caused by pancreatic insufficiency (PI). PI occurs in approximately 85% of patients with CF. PERT overcomes some, but not all the signs and symptoms of malabsorption. Clinical parameters such as growth, abdominal pain, diarrhea and gassiness, commonly used to adjust PERT dosing, are shown not to be good indicators of their effectiveness. The FDA does not provide oversight of preparations of pancreatic enzymes consistent with the oversight it provides for all other drugs. The FDA intends to rectify this situation. Measures of the effectiveness of PERT are limited to the coefficient of fat absorption, a difficult and unpleasant exercise for patients.

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          Most cited references 37

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          Helping patients follow prescribed treatment: clinical applications.

          Low adherence to prescribed medical regimens is a ubiquitous problem. Typical adherence rates are about 50% for medications and are much lower for lifestyle prescriptions and other more behaviorally demanding regimens. In addition, many patients with medical problems do not seek care or drop out of care prematurely. Although accurate measures of low adherence are lacking for many regimens, simple measures, such as directly asking patients and watching for appointment nonattendance and treatment nonresponse, will detect most problems. For short-term regimens (< or =2 weeks), adherence to medications is readily achieved by giving clear instructions. On the other hand, improving adherence to long-term regimens requires combinations of information about the regimen, counseling about the importance of adherence and how to organize medication taking, reminders about appointments and adherence, rewards and recognition for the patient's efforts to follow the regimen, and enlisting social support from family and friends. Successful interventions for long-term regimens are all labor-intensive but ultimately can be cost-effective.
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            Abdominal pain and irritable bowel syndrome in adolescents: a community-based study.

            This study was undertaken to determine (1) the prevalence of gastrointestinal symptoms including abdominal pain in a community-based population of adolescents, (2) whether a subgroup of these subjects have symptoms resembling Irritable bowel syndrome (IBS), and (3) whether anxiety and depression are more commonly found in adolescents with IBS-type symptoms compared with unaffected adolescents. We collected data by administration of a gastrointestinal symptoms questionnaire, State-Trait Anxiety Inventory, and Children's Depression Inventory to middle school and high school students. A total of 507 subjects participated (mean age of middle school students 12.6 years; mean age of high school students 15.6 years). Abdominal pain was noted by 75% of all students. The pain occurred weekly in 13% to 17% of the subjects and was severe enough to affect activities in approximately 21%. Irritable bowel syndrome-type symptoms were noted by 17% of high school students and 8% of middle school students (p <0.01) who reported abdominal pain (n = 381), representing 14% and 6% of all high school and middle school students (p <0.005), respectively. Anxiety and depression scores were significantly higher for students with IBS-type symptoms compared with those without symptoms. Eight percent of all students had seen a physician for abdominal pain in the previous year. These visits were correlated with abdominal pain severity, frequency, duration, and disruption of normal activities but not with anxiety, depression, gender, family structure, or ethnicity. Recurrent abdominal pain and symptoms of IBS are commonly noted in a community-based adolescent population and frequently result in use of health care resources. Health care providers who work with this age group need to be able to recognize the symptom complex associated with IBS, as well as the possible relationship to anxiety and depression.
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              Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features.

              Constipation is a common heterogeneous condition, possibly encompassing different clinical subtypes. Little is known about the comparative epidemiology of constipation subtypes. This study was conducted to estimate the prevalence of constipation subtypes and determine whether subtypes differ by sociodemographic factors. Between June and September 1997, a telephone interview was conducted with individuals about their bowel habits in the preceding 3 months. Survey data on 15 constipation-related symptoms were used to identify individuals who met prespecified symptom criteria for the following mutually exclusive subgroups: functional constipation, irritable bowel syndrome (IBS), outlet obstruction or delay (outlet), both IBS and outlet (IBS-outlet), and frequent laxative users (i.e., at least every other day). A total of 10,018 eligible individuals in the United States 18 yr of age or older completed the interview. Test-retest reliability of reporting symptoms was assessed in a separate national survey. The Spearman's correlation coefficient for reporting symptoms ranged from 0.54 to 0.83; all but three symptoms had correlations above 0.68. The overall prevalence of constipation was 14.7%. By subtype, prevalence was 4.6% for functional, 2.1% for IBS, 4.6% for outlet, and 3.4% for IBS-outlet. An additional 1.8% of respondents reported laxative use at least every other day. Outlet was the most common subtype among women, whereas functional constipation was the most common subtype among men. The gender ratio varied by subtype, with elevated ratios for outlet (F/M = 1.65) and IBS-outlet (F/M = 2.27) subtypes. The age pattern differed among each of the four subtypes. Prevalence of functional subtype decreased with increasing age. In contrast, outlet subtype did not seem to vary by age, and IBS (both men and women) and IBS-outlet (women only) subtypes increased to age 35 yr and declined thereafter. Prevalence of functional constipation increased with increasing education. Outlet type was more common in nonwhites compared to whites. Finally, 45% of individuals with constipation reported having the condition for 5 yr or more. Constipation is a heterogeneous condition. Differences in epidemiological profile by age, sex ratio, and relation to other sociodemographical factors support the distinction of two and possibly more symptom-based subtypes.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                October 2008
                October 2008
                : 4
                : 5
                : 1079-1084
                Affiliations
                Department of Pediatrics, University at Buffalo, Buffalo, NY, USA
                Author notes
                Correspondence: Susan S Baker, Professor of Pediatrics, Digestive Diseases and Nutrition Center, Women and Children’s Hospital, 219 Bryant Street, Buffalo, NY 14222, USA, Tel +1 716 878 7793, Fax +1 711 888 3842, Email bakers@ 123456upa.chob.edu
                Article
                tcrm-4-1079
                2621407
                19209287
                © 2008 Dove Medical Press Limited. All rights reserved
                Categories
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                Medicine

                pancrelipase, pancreatic enzymes, malabsorption, cystic fibrosis

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