Original articleSafety and Tolerability of Tegaserod in Patients With Chronic Constipation: Pooled Data From Two Phase III Studies
Section snippets
Study Design and Patient Characteristics
Two phase III double-blind, randomized, placebo-controlled studies have been described extensively in the primary reports.30, 31 Both studies were performed in accordance with the Declaration of Helsinki and the US21 Code of Federal Regulations regarding patient consent and after institutional review board approval. Because the 2 studies were almost identical in design and inclusion criteria, pooling the data at the patient level was considered appropriate. The evaluations reported here were
Patient Demographics
A total of 3587 patients were screened for participation in the 2 phase III trials, and 2612 were randomized. Of the patients who received study medication, 881 received tegaserod 6 mg twice a day, 861 received tegaserod 2 mg twice a day, and 861 received placebo (Figure 2). The demographic characteristics of the patients were similar across the treatment groups (Table 1). Approximately 88% of patients were women, 91% were white, and the mean age was 47 years. All groups were comparable in
Discussion
This pooled analysis of safety and tolerability data from 2 randomized, placebo-controlled trials in patients with CC provided a large dataset (2603 patients), enabling a thorough investigation of the safety and tolerability of tegaserod. A high proportion of patients (83.2%) completed the studies, and this rate is consistent with that observed with tegaserod in IBS-C trials (ranging between 76%–93%).33, 35, 39
The overall incidences of AEs and SAEs were comparable for the placebo and both
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