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In Chronically Constipated Patients, History of GERD and Non-Ulcer Dyspepsia Is Common and Does Not Alter the Response to Tegaserod (T)

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Lembo, A., M.D.; Bottoli, I., M.D.; Dunger-Baldauf, C., Ph.D.; Shetzline, M., M.D.

American Journal of Gastroenterology: September 2005 - Volume 100 - Issue - p S46–S47
Supplement Abstracts Submitted for the 70th Annual Scientific Meeting of the American College of Gastroenterology: ESOPHAGUS
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Beth Israel Deaconess Medical Center, Boston, MA and Novartis Pharma Corp, East Hanover, NJ.

Purpose: Patients (Pts) with GI dysmotility disorders have significant overlap of lower/upper GI (UGI) Sx (Locke GR et al 2005). Research confirms overlap of dysmotility Sx in a subgroup of CC pts (Bonapace ES et al 2000). We evaluated response to T in these CC pts who may represent a more generalized and severe Sx subgroup.

Methods: Data from 2 randomized, placebo-controlled CC trials were used. UGI conditions were noted e.g. GERD, dyspepsia. For analysis, pts were assessed on T (6 mg bid; n = 867), or placebo (P) (n = 863). Response was defined as a mean increase from baseline of ≥ 1 complete spontaneous bowel movement (CSBM) with a treatment duration of at least 7 days. Response at wks 1–4 (primary trial endpoint) and wks 1–12 were analyzed. Proportion of pts with response (wks 1–4 and wks 1–12) was compared between Tx groups (logistic regression) including Tx, center, study, gender, UGI condition as factor, Tx subgroup interaction and CSBM at baseline as covariate. Odds ratio (OR) of 6 mg bid vs P in the subgroups were estimated and tested for equality.

Results: 23% of pts had overlapping conditions: GERD 18%, dyspepsia 8%, and both 3%. Tx differences within subgroups with/without a specific UGI condition were statistically significant for response to T 6 mg bid vs P except for the small group with both GERD and dyspepsia. P rates tended to be slightly lower in the UGI condition subgroups, most pronounced for pts with dyspepsia vs non-dyspepsia (not significant). OR tended to be higher in the UGI condition subgroups vs those without.

Conclusions: In these CC pts, a history of other GI disorders (NUD and GERD) was common (23%) and did not alter the response to T in pts with CC.

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