摘要
Background: Tegaserod, a prokinetic 5-HT4 receptor agonist, has demonstrated efficacy and tolerability in irritable bowel syndrome (IBS) patients with constipation (IBS- C) in controlled clinical trials. Its use in primary care has not been investigated. Aim: To determine whether tegaserod is effective and well tolerated by primary care IBS- C patients. Methods: Patients received tegaserod 6 mg b.i.d. for 12 weeks and were assessed for response, abdominal pain/discomfort, bloating, stool consistency/frequency and straining at weeks 4 and 12. Previous successful treatment with the withdrawn drug, cisapride, was noted. A 9- month study extension was offered to patients completing 12 weeks of tegaserod treatment. Results: 212 patients entered the 12- week treatment period; 166 completed as planned. Response rates were 64.2% at week 4 and 70.3% at week 12. After 12weeks, abdominal pain/discomfort and bloating were reduced from baseline (p< 0.0001; mean change - 1.02 and - 0.91 points, respectively), stool frequency increased (0.78- 0.97 stools/day) and stool consistency improved (2.45- 3.42; lumpy stools became softer). Tegaserod was well tolerated; the most common adverse events were headache (13.2% ) and diarrhea (9.4% ). One hundred and twenty patients entered the 9- month extension study, 85 completed and tegaserod continued to be well tolerated. Conclusions: In ambulatory primary care IBS- C patients, tegaserod is an effective and well- tolerated long- term treatment.
Background: Tegaserod, a prokinetic 5-HT4 receptor agonist, has demonstrated efficacy and tolerability in irritable bowel syndrome (IBS) patients with constipation (IBS- C) in controlled clinical trials. Its use in primary care has not been investigated. Aim: To determine whether tegaserod is effective and well tolerated by primary care IBS- C patients. Methods: Patients received tegaserod 6 mg b.i.d. for 12 weeks and were assessed for response, abdominal pain/discomfort, bloating, stool consistency/frequency and straining at weeks 4 and 12. Previous successful treatment with the withdrawn drug, cisapride, was noted. A 9- month study extension was offered to patients completing 12 weeks of tegaserod treatment. Results: 212 patients entered the 12- week treatment period; 166 completed as planned. Response rates were 64.2% at week 4 and 70.3% at week 12. After 12weeks, abdominal pain/discomfort and bloating were reduced from baseline (p< 0.0001; mean change - 1.02 and - 0.91 points, respectively), stool frequency increased (0.78- 0.97 stools/day) and stool consistency improved (2.45- 3.42; lumpy stools became softer). Tegaserod was well tolerated; the most common adverse events were headache (13.2% ) and diarrhea (9.4% ). One hundred and twenty patients entered the 9- month extension study, 85 completed and tegaserod continued to be well tolerated. Conclusions: In ambulatory primary care IBS- C patients, tegaserod is an effective and well- tolerated long- term treatment.
