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178
SYMPTOM IMPROVEMENT AT ONE WEEK TO PREDICT OUTCOME AT FOUR WEEKS WITH ESOMEPRAZOLE (E) IN UNINVESTIGATED DYSPEPSIA (UD) PATIENTS: THE CONFIRMATORY ACID SUPPRESSION TEST (CAST) STUDY
D Armstrong1, SJO Veldhuyzen van Zanten2, AN Barkun3, L Tanser4, A Popat4, B Chakraborty4, K Nevin4, and the CAST Study Advisory Board
1McMaster University, Ontario; 2Dalhousie University, Nova Scotia; 3McGill University, Quebec; 4AstraZeneca Canada Inc, Ontario
BACKGROUND: Early identification of UD in primary care practice (PCP) is hampered by the lack of a validated, non-invasive test.
AIMS: To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a 1-week acid suppression test for diagnosing UD using E 40 mg bid or E 40 mg od by reference to symptom improvement after 3 further weeks of E 40 mg od.
METHODS: 1121 subjects (555M:566F); with UD symptoms (heartburn [HB] and heartburn-non-dominant [HND]) (³1 month) were recruited from PCP and randomized (double-blind) to receive E 40 mg od (N=556) or E 40 mg bid (N=565) for 1 week; all then received E 40 mg od for 3 weeks. Symptom improvement (1 and 4 wks) was defined as a reduction of ³2 points on the Global Overall Symptoms (GOS) score (7-point Likert scale).
RESULTS: There were no significant differences between the E 40 mg od and E 40 mg bid (Table). Both treatments were safe and well tolerated.
CONCLUSIONS: The 1-week esomeprazole acid suppression test is highly predictive of a good outcome at 4 weeks, however lack of response at 1 week merits completion of a 4-week trial of acid suppression.
TABLE: Estimate of symptom response, sensitivity and specificity.
Sponsored by AstraZeneca Canada Inc, Mississauga, Ontario.