Reviews for Primary Care - Fall 2007 - (Page 25) Chronic Constipation and Functional Bowel Disorders were no notable effects on vital signs, physical findings, or pregnancy outcome. There were some primate model data presented at DDW 2007 regarding lubiprostone and pregnancy.67 In this study, pregnant rhesus monkeys were given various supratherapeutic doses (4.2 to 12.5 times greater than a recommended clinical dose for the primates) of lubiprostone or placebo. On gestational days 150 or 151, the pregnancy was terminated by Cesarean delivery, and the fetuses were examined. No abnormalities were seen in clinical signs, food consumption, or serum progesterone concentrations in any group. Based on this limited study in primates, it appears that even though lubiprostone has a pregnancy category C rating, it may be safe in pregnant humans. This makes intuitive sense due to the fact that lubiprostone is not absorbed nor does it appear to stimulate uterine muscle contractions. Question: Could you please review the therapeutic options for the aging population? Panel: Jack DiPalma’s group recently published some long-term data on PEG 3350 (17 g/d) use in an elderly population suffering from chronic constipation.68 At the end of the 12-month treatment period, 50% of all evaluable patients reported that their constipation symptoms were “completely relieved.” This efficacy also was displayed in the elderly subset of patients, with 84% to 94% (dependent on month of treatment) rated as being treated “successfully.” This study further indicates that PEG 3350 is safe for long-term use in elderly patients. Panel: There are also data emerging for lubiprostone in the elderly population. A recent report by Ueno and colleagues demonstrated increased stool frequency in patients aged 65 years and older suffering from chronic constipation who received either lubiprostone 24 g twice daily or placebo.69,70 The study suggests that elderly as well as nonelderly patients do better on lubiprostone than those receiving placebo. In fact, lubiprostone actually might be more effective in elderly patients compared to younger patients for improving the overall symptoms of chronic constipation. Lubiprostone was very well tolerated in this study, with elderly patients reporting fewer treatment-related adverse events with lubiprostone than their nonelderly counterparts. Panel: One of the concerns in treating the elderly population suffering from chronic constipation with long-term traditional therapies is that some can cause electrolyte imbalances. There has been one study looking at electrolytes and long-term laxative therapy in the elderly population.71 The results from this study indicate that lubiprostone 24 g twice daily does not appear to affect serum electrolyte levels in elderly patients, or in the overall study population of this pooled analysis. Question: When is it time to consider surgery in chronic constipation? Panel: According to the colorectal surgery literature, you should consider surgery under these circumstances72: • Evidence of severe slow-transit constipation that proves to be refractory to laxative therapy • Evidence of clinically significant rectal prolapse, rectal ulcer(s), enterocele, or intussusception by history, examination, or defecography • Complications of chronic constipation including refractory anal fissure disease; persistent leakage, bleeding, or thrombosis related to hemorrhoids; recurrent volvulus; or solitary rectal ulcer syndrome with complications Exclusion of pelvic floor dysfunction is mandatory if contemplating colectomy. Panel: Long-term outcomes and potential complications should always be considerations when deciding whether colorectal surgery for severe constipation is necessary. Although there are some outcome data in this population, data are still quite sparse. One retrospective study examined 69 patients who underwent total colectomy with ileorectal anastomosis for severe constipation between 1983 and 1998.73 The investigators found that many patients had complications resulting from surgery, including small bowel obstruction (20%), persistent constipation (9%), diarrhea (7%), hernia (4%), pelvic abscess (1.5%), incontinence (1.5%), and rectal pain (1.5%). Postsurgery mental health scores also were shown to be lower in areas of vitality and social functioning. Interestingly, 25 of the 35 (77%) respondents to the postsurgical survey stated that they felt the surgery was beneficial. Question: Biofeedback clinical trials show 70% to 90% response in patients with pelvic floor dysfunction and associated constipation symptoms. Do real-world data exist showing what happens in routine clinical practice with biofeedback? How accessible is it, and most pragmatically, do insurance companies pay for it? Panel: Biofeedback does work. Based on clinical experience in the Mayo Clinic, which is a real-world, all-patient experience, approximately 70% of patients with pelvic floor dysfunction get substantially better with biofeedback once they have been properly worked up.74 Unfortunately, 30% of the patients will not get better, and they are a very, very difficult group to manage. Unfortunately, good quality biofeedback centers are not widely available. Practically, this is a real-world problem. It may take some time to locate a referral center for this type of training, but in the long run it will be beneficial as they will be appropriately trained and managed. VOL. 1 NO. 1 2007 REVIEWS FOR PRIMARY CARE 25
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