AIM： To evaluate the efficacy and safety of tegaserod, 6 mg twice daily （b.i.d.）, in men and women with chronic constipation （CC） from China. METHODS： This was a multicenter, double-blind, placebo-controlled stu...AIM： To evaluate the efficacy and safety of tegaserod, 6 mg twice daily （b.i.d.）, in men and women with chronic constipation （CC） from China. METHODS： This was a multicenter, double-blind, placebo-controlled study. Following a 2-wk treatmentfree baseline period, patients were randomized to receive either tegaserod （6 mg b.i.d.） or placebo （b.i.d.） for 4 wk. An analysis of covariance with repeated measures was used to determine the overall effect of treatment for the primary efficacy variable; the change from baseline in the number of complete spontaneous bowel movements （CSBMs） during the 4-wk treatment period. Secondary efficacy endpoints included other measures of response in terms of CSBMs, and patients＇ daily and weekly assessment of bowel habits. Safety was also assessed, based on the incidence and severity of adverse events （AEs）. RESULTS： A total of 607 patients were randomized to receive either tegaserod （n = 304） or placebo （n = 303）. Tegaserod treatment resulted in a rapid and significant increase from baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with placebo （1.39 vs 0.91, P = 0.0002）. A statistically significant difference in favor of tegaserod was also observed for a mean increase ≥ 1 CSBM/wk over wk 1-4 （47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018） and for the absolute number of≥ 3 CSBMs/wk over wk 1-4 （25.0% vs 14.5%, tegaserod vs placebo, respectively, P = 0.0021）. Improvements in other symptoms of CC were also seen in the tegaserod group, including improved stool form and reduced straining. In addition, more patients in the tegaserod group reported satisfactory relief from their constipation symptoms. The frequency and severity of AEs was comparable between tegaserod and placebo groups, with the exception of a greater incidence of diarrhea in patients receiving tegaserod （3.6%） compared with placebo （1.7%）. CONCLUSION： Tecjaserod treatment improved multiple symptoms of CC and was associated with a favorable safety profile.展开更多
AIM:To study the crystals form of tegaserod maleate. METHOD:The DSC,TGA and X -ray powder diffraction were used in this observation. RESULT and CONCLUSION: Twe crystals of tegaserod maleate,S-form and W-form,were obta...AIM:To study the crystals form of tegaserod maleate. METHOD:The DSC,TGA and X -ray powder diffraction were used in this observation. RESULT and CONCLUSION: Twe crystals of tegaserod maleate,S-form and W-form,were obtained and it was confirmed that the S-crystal form is a monohydrate crystal. Preliminary pharmacokinetic test shows that the S-crystal form bioavailability is 46% in mice and the W-crystal form is only 19%.展开更多
文摘AIM： To evaluate the efficacy and safety of tegaserod, 6 mg twice daily （b.i.d.）, in men and women with chronic constipation （CC） from China. METHODS： This was a multicenter, double-blind, placebo-controlled study. Following a 2-wk treatmentfree baseline period, patients were randomized to receive either tegaserod （6 mg b.i.d.） or placebo （b.i.d.） for 4 wk. An analysis of covariance with repeated measures was used to determine the overall effect of treatment for the primary efficacy variable; the change from baseline in the number of complete spontaneous bowel movements （CSBMs） during the 4-wk treatment period. Secondary efficacy endpoints included other measures of response in terms of CSBMs, and patients＇ daily and weekly assessment of bowel habits. Safety was also assessed, based on the incidence and severity of adverse events （AEs）. RESULTS： A total of 607 patients were randomized to receive either tegaserod （n = 304） or placebo （n = 303）. Tegaserod treatment resulted in a rapid and significant increase from baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with placebo （1.39 vs 0.91, P = 0.0002）. A statistically significant difference in favor of tegaserod was also observed for a mean increase ≥ 1 CSBM/wk over wk 1-4 （47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018） and for the absolute number of≥ 3 CSBMs/wk over wk 1-4 （25.0% vs 14.5%, tegaserod vs placebo, respectively, P = 0.0021）. Improvements in other symptoms of CC were also seen in the tegaserod group, including improved stool form and reduced straining. In addition, more patients in the tegaserod group reported satisfactory relief from their constipation symptoms. The frequency and severity of AEs was comparable between tegaserod and placebo groups, with the exception of a greater incidence of diarrhea in patients receiving tegaserod （3.6%） compared with placebo （1.7%）. CONCLUSION： Tecjaserod treatment improved multiple symptoms of CC and was associated with a favorable safety profile.
文摘AIM:To study the crystals form of tegaserod maleate. METHOD:The DSC,TGA and X -ray powder diffraction were used in this observation. RESULT and CONCLUSION: Twe crystals of tegaserod maleate,S-form and W-form,were obtained and it was confirmed that the S-crystal form is a monohydrate crystal. Preliminary pharmacokinetic test shows that the S-crystal form bioavailability is 46% in mice and the W-crystal form is only 19%.
