LOS ANGELES, May 23  Amitiza (lubiprostone) is safe and effective as a long-term therapy for chronic constipation in elderly patients, according to a team of researchers from Sucampo Pharmaceuticals, the drug's manufacturer.
"The results are very promising," said Dr. Ryuji Ueno, M.D., Ph.D., Ph.D., founder and executive chair of Sucampo. "Our trial was quite successful, and it hit all the endpoints." Dr. Ueno presented his study results during a poster session at the Digestive Diseases Week meeting here.
Action Points
- As chronic constipation is common in elderly patients, and some medications are contraindicated for this population, the safety and efficacy of Amitiza (lubiprostone) for long-term use in elderly patients seem to make it a reasonable choice of therapy.
The FDA approved Amitiza for chronic constipation on Jan. 31, making it the newest treatment available for a condition that afflicts more Americans than asthma, heart disease, diabetes, or migraines.
In previous studies, Amitiza was found safe and effective in adult patients in general. Dr. Ueno and his colleagues wanted to know what effects the drug would have specifically in older patients. So they analyzed data on 163 patients who were 65 or older who had participated in three earlier studies. The results suggested that Amitiza is at least as effective in the seniors as in the more general populations studied earlier.
These results are important because of the high rate of constipation among older patients suffer from constipation. Estimates of the prevalence among seniors in the general community range from 15% to 20%, and in nursing homes the prevalence may be as high as 50%.
"Treating this population is key because there are a lot of elderly patients, but some of the other compounds can't be used in them," Dr. Ueno said.
The three studies from which the data were drawn used similar designs. The subjects received oral Amitiza at 24 mcg twice daily with food and water for six to 12 months as needed. Doses were adjusted in response to reactions such as diarrhea. Evaluations were performed at baseline and after four months and six months, with follow-ups after one or two weeks after completion of the dose administration.
Assessments were based on constipation severity, abdominal bloating, and abdominal discomfort using a five-point scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
The researchers found improvements in all the outcome measures that were evaluated. For severity of constipation, the elderly patients started at a baseline of 2.76 and achieved an improvement between 0.92 and 1.71 points across the studies.
For abdominal bloating the baseline was 1.7 and the improvement ranged from 0.45 to 1.19 points. For abdominal discomfort, the baseline was 1.4 and improvement ranged from 0.49 to 0.89 points.
There were adverse reactions, however. In fact, 74.2% of the elderly patients reported some adverse events such as nausea, diarrhea, abdominal distension, abdominal pain, flatulence, vomiting, loose stools, headache, or dizziness.
Not only is Amitiza safe and effective for long-term use in the elderly, the researchers concluded, it is actually less likely to produce adverse reactions in this population than in the general populationâ€â€results they presented in a separate poster during the same session.