Abstract
G A A b st ra ct s research. Oral domperidone has been reported in some cases to prolong the QT interval and predispose to ventricular arrhythmias (Reddymasu et al. Am J Gastro 2007;102:20362045). The aims: 1) To establish an indications and clinical profile of patients receiving domperidone through the limited access protocol 2) to investigate possible side effects of domperidone 3) to analyze ECG reports and the duration of QT intervals. Methods: Study involved a retrospective chart review of 163 patients referred to a single physician at the tertiary GI Motility Center. Patients demographics, GI diagnosis, cardiovascular complain and ECG tracings were obtained. Prolonged QTc were verified if they were longer than 470 ms in females and longer than 450 ms in male patients. Results: Overall 23 out of 163 (13%) patients (15 F; mean age 47, range 18-73) presenting with chief complaints of nausea and vomiting were enrolled in FDA approved protocol and received doses of domperidone ranging from 10 to 30mg QID for at least 6 up to 12 months. 8 (36%) patients were Hispanic, 12 (52%) Caucasian, and 3(12%) African American. A total 16 (60%) of these patients (9F) were diagnosed with GP, 4 females met the criteria for Cyclic Vomiting Syndrome and 3 patients had symptoms of unexplained nausea. 6 (27%) ECG reports showed non-significant sinus arrhythmias, and one male patient had an irregular rhythm. Women had mean heart rates of 82 (range 52-112) and men's average HR was 86 (range 55-105) bpm. Overall the mean value of QTc for all domperidone patients was 427 ms (ranges 383 507 ms). Further analysis of ECGs for females showed, mean QTc duration of 425 (394-507) ms and in males it was 429 (383-469) ms. Two patients (9%), one of each gender, had QTc prolongation above the normal respected value. No patients complained about palpitation or cardiac/ chest pain. Two patients noticed breast discomfort. No other potential adverse events including extra-pyramidal side effects were reported during this investigation. Conclusions:1) Domperidone is legally available in USA under the FDAIND approved protocol and can be prescribed for patients with symptoms of nausea and vomiting related to gastroparesis and other motility disorders 2) No clinically relevant cardiac complaints and ECG changes including QTc prolongations were discovered during this observation 3) Domperidone can be regarded as a safe prokinetic and antiemetic agent.
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