Introduction Constipation is a common condition affecting millions globally. Lubiprostone has demonstrated safety and efficacy in treating adults with chronic idiopathic constipation. Through an analysis of the subgroups of two Phase 3 studies, the efficacy of lubiprostone based on factors such as age, gender, and race was reviewed.
Aims and Methods Combined data from two Phase 3 well-controlled studies were used to analyse the following subpopulations: non-elderly (< 65 years) and elderly (≥65 years); male and female; and white and non-white. The efficacy endpoints for spontaneous bowel movement (SBM) frequency, stool consistency, and straining were compared between placebo and lubiprostone (24 mcg BID) groups within each subpopulation.
Results Among non-elderly patients, lubiprostone produced a greater increase (p≤0.001) in SBM frequency each week over placebo. Statistically significant increases were observed in the elderly (p = 0.0188 to p = 0.0268) at each week except Week 2 (p = 0.0806). Statistically significant improvements were noted in females (p≤0.001) at all weeks and in males at all weeks (p = 0.0115 to p = 0.0500) except Week 3 (p = 0.0758). For non-whites (p = 0.0003 to p = 0.0021) and whites (p≤0.001), statistically significant increases in SBM frequencies were reported at all weeks. Table 1 shows the weekly change in SBM frequency for each group. Stool consistency was improved with lubiprostone in the non-elderly (p = 0.0172 to p = 0.0441) and the elderly (p≤0.001) at all weeks. Straining was also improved with lubiprostone treatment at all weeks in non-elderly patients (p≤0.001), with similar improvement trends observed in the elderly. Stool consistency and straining were statistically significantly improved with lubiprostone at all weeks (p≤0.001) in females. A similar trend was observed for males but did not achieve statistical significance at all weeks. Lubiprostone improved stool consistency at all weeks in whites (p≤0.001) and non-whites (p≤0.0001 to p = 0.0006). Straining was improved at all weeks for whites (p≤0.001) and non-whites (p≤0.0001 to p = 0.0144).
Conclusion Treatment with lubiprostone resulted in increased SBM frequencies and improvement in related symptoms in patients with chronic idiopathic constipation regardless of age, gender, or race.
Disclosure of Interest None Declared.