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Tegaserod (Zelnorm) Improved Esophageal Pain and Upper Gastrointestinal Symptoms in Patients With Functional Heartburn: Presented at DDW

By Bruce Sylvester

NEW ORLEANS, LA -- May 19, 2004 -- Tegaserod (Zelnorm) therapy significantly improved esophageal pain threshold to mechanical distention, and it improved upper gastrointestinal (GI) symptoms in patients with functional heartburn, particularly regurgitation, researchers reported here May 19^th in a late-breaking research presentation at the Digestive Diseases Week Annual Meeting.

"In this study patients with functional heartburn showed sensitivity to distension of a balloon in the esophagus, and the pain that they had from this distension improved significantly with the use of tegaserod at 6 mg twice a day," said lead researcher Philip Miner, MD, President and Medical Director of Clinical Research, Okalahoma Foundation for Digestive Research, and Clinical Professor of Medicine, University of Oklahoma School of Medicine, Okalahoma City, Oklahoma. "The clinical implication is that patients who have incomplete response to acid suppression will have additional response to this medication, which interferes with pain."

The investigators screened 70 patients to obtain 42 evaluable patients with functional heartburn. The subjects were screened using esophageal manometry, 24-hour constant pH monitoring, esophagogastroduodenoscopy, esophageal balloon distention, and Bernstein acid infusion.

The researchers randomized subjects to tegaserod 6 mg twice daily or placebo for 14 consecutive days, using a crossover design, separated by a 7- to 10-day washout period.

The subjects underwent esophageal acid infusion and balloon distention. After each treatment regimen patients completed a GI multi-symptom questionnaire, which queried for occurrence, frequency, severity and level of distress for each symptom. At the end of the study, subjects also rated overall treatment regimen preference.

The investigators analyzed the data from 15 men and 27 women aged 20-68 years. They found that tegaserod significantly increased balloon pressure required to induce pain (P =.02), balloon volume to induce pain (P =.05), mean wall tension of the balloon at the pain threshold (P =.001), and maximum wall tension at the pain threshold (P =.04).

They also found that tegaserod treatment did not alter pain threshold to acid infusion and that it significantly decreased occurrence of heartburn/acid reflux and regurgitation, and distress from regurgitation (P <.05).

Diarrhea rates were higher in patients given tegaserod than placebo, but no withdrawals were attributed to this adverse effect.

At the end of the trial, global treatment preference was 63.4% for tegaserod, 12.2% for placebo; 24.4% of patients had no treatment preference (tegaserod vs. placebo, P =.0002).

"Now we would like to proceed to find a better definition of mechanism of action of the pain and we would like to see in what part of the population with [functional heartburn] the pain response is more dependent on mechanical distention than on acid," Dr. Miner added.

The study was supported by Novartis.


[Presentation title: "Tegaserod significantly improves esophageal mechanical pain threshold, regurgitation and global preference vs placebo in patients with functional heartburn."]

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