Lubiprostone Provides Long-Term Efficacy for Constipation in the Elderly

BOSTON — Approved earlier this year for the treatment of chronic idiopathic constipation in adults, lubiprostone has been shown to provide long-term relief for elderly patients, according to the findings of an industry-sponsored study.

Constipation is the most common gastrointestinal complaint among patients with advanced age. About 24%-37% of community-dwelling elderly people are affected; an estimated 60% use laxatives. The condition is even more common among nursing home residents. Left untreated, even mild constipation can eventually lead to serious complications such as fecal impaction, incontinence, and bowel perforations, Dr. Ryuji Ueno said at a meeting on neurogastroenterology and motility.

Dr. Ueno is the chief scientific officer at Sucampo Pharmaceuticals Inc., the manufacturer of lubiprostone that funded the investigation.

Dr. Ueno and colleagues analyzed data from three open-label clinical trials involving a total of 163 elderly patients (aged 65 years and older) and 715 nonelderly patients (aged 18–64 years) who had chronic constipation, defined as fewer than three spontaneous bowel movements per week, with a minimum history of 3 months of evacuation difficulties.

Patients were excluded if they had documented mechanical obstruction and/or organic disorders of the bowel, constipation secondary to a documented cause, or other clinically significant medical conditions.

Patients were treated with oral lubiprostone (24 mcg twice daily), a type-2 chloride channel activator that promotes gastrointestinal motility by increasing the production of chloride-rich intestinal fluid, without significantly affecting serum sodium or potassium. Patients were followed for up to 12 months, with efficacy and safety assessments every 4–6 weeks.

Lubiprostone produced sustained, statistically significant improvements from baseline in constipation severity, abdominal bloating, and discomfort across the year-long observation period for both the elderly and nonelderly groups. With use of a 5-point subjective severity scale (0 = absent to 4 = very severe), the mean improvement from baseline in constipation severity ranged from 0.92 to 1.71 points, for abdominal bloating mean improvement ranged from 0.45 to 1.19 points, and for abdominal discomfort the range was 0.49–0.89 points improved.

Elderly patients appeared to tolerate lubiprostone as well or better than their younger counterparts did. The elderly group reported fewer adverse events of any sort than did the nonelderly group (74% vs. 80%). No treatment-related serious side effects occurred in an elderly person and, with the exception of diarrhea (15% elderly vs. 12% nonelderly) and loose stools (6% vs. 3%), the incidence rates of commonly reported treatment-related adverse events were lower in the elderly than in the nonelderly. For example, nausea, the most common adverse event, was reported by 29% of the younger group but only 18% of the elderly.

BOSTON — Approved earlier this year for the treatment of chronic idiopathic constipation in adults, lubiprostone has been shown to provide long-term relief for elderly patients, according to the findings of an industry-sponsored study.

Constipation is the most common gastrointestinal complaint among patients with advanced age. About 24%-37% of community-dwelling elderly people are affected; an estimated 60% use laxatives. The condition is even more common among nursing home residents. Left untreated, even mild constipation can eventually lead to serious complications such as fecal impaction, incontinence, and bowel perforations, Dr. Ryuji Ueno said at a meeting on neurogastroenterology and motility.

Dr. Ueno is the chief scientific officer at Sucampo Pharmaceuticals Inc., the manufacturer of lubiprostone that funded the investigation.

Dr. Ueno and colleagues analyzed data from three open-label clinical trials involving a total of 163 elderly patients (aged 65 years and older) and 715 nonelderly patients (aged 18–64 years) who had chronic constipation, defined as fewer than three spontaneous bowel movements per week, with a minimum history of 3 months of evacuation difficulties.

Patients were excluded if they had documented mechanical obstruction and/or organic disorders of the bowel, constipation secondary to a documented cause, or other clinically significant medical conditions.

Patients were treated with oral lubiprostone (24 mcg twice daily), a type-2 chloride channel activator that promotes gastrointestinal motility by increasing the production of chloride-rich intestinal fluid, without significantly affecting serum sodium or potassium. Patients were followed for up to 12 months, with efficacy and safety assessments every 4–6 weeks.

Lubiprostone produced sustained, statistically significant improvements from baseline in constipation severity, abdominal bloating, and discomfort across the year-long observation period for both the elderly and nonelderly groups. With use of a 5-point subjective severity scale (0 = absent to 4 = very severe), the mean improvement from baseline in constipation severity ranged from 0.92 to 1.71 points, for abdominal bloating mean improvement ranged from 0.45 to 1.19 points, and for abdominal discomfort the range was 0.49–0.89 points improved.

Elderly patients appeared to tolerate lubiprostone as well or better than their younger counterparts did. The elderly group reported fewer adverse events of any sort than did the nonelderly group (74% vs. 80%). No treatment-related serious side effects occurred in an elderly person and, with the exception of diarrhea (15% elderly vs. 12% nonelderly) and loose stools (6% vs. 3%), the incidence rates of commonly reported treatment-related adverse events were lower in the elderly than in the nonelderly. For example, nausea, the most common adverse event, was reported by 29% of the younger group but only 18% of the elderly.

BOSTON — Approved earlier this year for the treatment of chronic idiopathic constipation in adults, lubiprostone has been shown to provide long-term relief for elderly patients, according to the findings of an industry-sponsored study.

Constipation is the most common gastrointestinal complaint among patients with advanced age. About 24%-37% of community-dwelling elderly people are affected; an estimated 60% use laxatives. The condition is even more common among nursing home residents. Left untreated, even mild constipation can eventually lead to serious complications such as fecal impaction, incontinence, and bowel perforations, Dr. Ryuji Ueno said at a meeting on neurogastroenterology and motility.

Dr. Ueno is the chief scientific officer at Sucampo Pharmaceuticals Inc., the manufacturer of lubiprostone that funded the investigation.

Dr. Ueno and colleagues analyzed data from three open-label clinical trials involving a total of 163 elderly patients (aged 65 years and older) and 715 nonelderly patients (aged 18–64 years) who had chronic constipation, defined as fewer than three spontaneous bowel movements per week, with a minimum history of 3 months of evacuation difficulties.

Patients were excluded if they had documented mechanical obstruction and/or organic disorders of the bowel, constipation secondary to a documented cause, or other clinically significant medical conditions.

Patients were treated with oral lubiprostone (24 mcg twice daily), a type-2 chloride channel activator that promotes gastrointestinal motility by increasing the production of chloride-rich intestinal fluid, without significantly affecting serum sodium or potassium. Patients were followed for up to 12 months, with efficacy and safety assessments every 4–6 weeks.

Lubiprostone produced sustained, statistically significant improvements from baseline in constipation severity, abdominal bloating, and discomfort across the year-long observation period for both the elderly and nonelderly groups. With use of a 5-point subjective severity scale (0 = absent to 4 = very severe), the mean improvement from baseline in constipation severity ranged from 0.92 to 1.71 points, for abdominal bloating mean improvement ranged from 0.45 to 1.19 points, and for abdominal discomfort the range was 0.49–0.89 points improved.

Elderly patients appeared to tolerate lubiprostone as well or better than their younger counterparts did. The elderly group reported fewer adverse events of any sort than did the nonelderly group (74% vs. 80%). No treatment-related serious side effects occurred in an elderly person and, with the exception of diarrhea (15% elderly vs. 12% nonelderly) and loose stools (6% vs. 3%), the incidence rates of commonly reported treatment-related adverse events were lower in the elderly than in the nonelderly. For example, nausea, the most common adverse event, was reported by 29% of the younger group but only 18% of the elderly.