Table 5.
Lubiprostone Trials
| Study | Efficacy Measures | Safety Measures |
|---|---|---|
| Johanson8 Randomized, placebo-controlled, dose-ranging study of lubiprostone (24 μg/d, 48 μg/d, or 72 μg/d vs daily placebo) in 127 constipated patients; Symptoms: <3 SBMs/wk and 6 months of at least one protocol-defined symptom (straining, hard stools, or sensation of incomplete evacuation) 25% of the time 3-wk treatment period TMS=8 (moderate quality) |
Data based on ITT population Average weekly number of SBMs: Significant increase during weeks 1 and 2 for 48 μg/d and 72 μg/d doses vs placebo. Percentage of patients with SBM within 24 hours: Significantly more patients in 48 μg/d and 72 μg/d groups vs placebo Stool consistency, bloating, and global assessment of constipation severity: statistically significant improvement in patients receiving lubiprostone versus placebo |
Most common AEs: nausea, headache, diarrhea, bloating Incidence of nausea was statistically significantly higher in patients receiving lubiprostone vs placebo. Discontinuations due to AEs: nausea (which increased in a dose-dependent fashion) resulted in four treatment discontinuations, equally distributed among the treatment groups Undisclosed number of patients in the placebo group (none in the lubiprostone group) withdrew due to lack of efficacy |
| Johanson9 Multicenter, randomized, placebo-controlled trial of lubiprostone 24 μg bid vs placebo bid in 242 constipated patients; mean age, 48.6 y; sex: 10% M/90% F; Symptoms: <3 SBMs/wk and 6 months of at least one Rome II criterion for functional constipation 2-wk drug-free baseline 4-wk treatment period 2-wk drug-free follow-up period TMS=13 (high quality) |
Data based on ITT population SBM frequency: lubiprostone > placebo at all weeks, P<.002 Time to first SBM/lubiprostone (57%) vs placebo (37%) within 24 hours of first dose, P=.0024 Improvement in straining and stool consistency: lubiprostone > placebo at all weeks, P<.001 Global assessment of treatment effectiveness: lubiprostone > placebo during the entire 4-wk treatment period, P<.0001 at all weeks |
Most common AEs: nausea, diarrhea, headache Discontinuations due to AEs: Lubiprostone = 9 patients Placebo: not reported |
| Johanson10,13 Multicenter, double-blind, randomized, placebo-controlled trial of lubiprostone (24 μg bid) vs placebo bid in 237 constipated patients; mean age, 45.8 y; sex: 12% M/88% F; Symptoms: <3 SBMs/wk and 6 months of at least one Rome II criterion for functional constipation 2-wk drug-free baseline 4-wk treatment period 2-wk drug-free follow-up period TMS=13 (high quality) |
Data based on ITT population SBM frequency: lubiprostone > placebo at all weeks, P<.002 Time to first SBM/lubiprostone (61%) vs placebo (31%) within 24 hours of first dose, P<.0001 Improvement in straining and stool consistency: lubiprostone > placebo at all weeks, P<.001 |
Most common AEs: nausea, diarrhea, headache Discontinuations due to AEs: Lubiprostone = 15 patients Placebo: not reported |
AEs = adverse events; SBM = spontaneous bowel movement; ITT = intention to treat; TMS = total methodology score.