In treatment of uninvestigated dyspepsia: Are the PPIs preferable to H2Ras when patients have heartburn-dominant symptoms?

Proton pump inhibitors – rather than histamine H2 receptor antagonists – may be the better first-line therapy in the treatment of uninvestigated dyspepsia patients with moderate to severe or frequent heartburn symptoms, according to results of a recent study.

However, not all experts agree with the study findings. Based on this study, the four-week data indicate that omeprazole, a PPI, is significantly superior to ranitide, an H2RA, said the study’s lead author. Results showed that by four weeks, symptom relief was reported by 55 percent of patients receiving proton pump inhibitor (PPI) compared with 27 percent of those receiving an H2RA. Furthermore, 36 percent of PPI patients were completely heartburn-free compared with only 13 percent of H2RA patients.

Despite findings, controversy exists as to whether PPIs should be used in the primary care setting for heartburn-predominant uninvestigated dyspepsia (UD).

In his view, patients with heartburn predominant UD should first be treated with H2Ras, according to a clinical professor of medicine at the University of Oklahoma Health Sciences Center College of Medicine, Oklahoma City.

First H2Ras are less expensive, and second – and most important – PPIs may be addictive and hard to discontinue in many patients.

The research is part of the Canadian Adult Dyspepsia. Empirical Therapy (CADET) Program – Four Canadian Studies of Uninvestigated Dyspepsia in Primary Care Practice. Study findings were presented at the 2002 Digestive Diseases Week meeting.

The new study was designed to help guide the management of heartburn and UD in the primary care community, in patients who do not require prior endoscopy, noted an assistant professor in the Division of Gastroenterology at McMaster University, Hamilton, Ontario. His team also compared symptom relapse rated in a randomized study of 390 heartburn-dominant patients with UD (age range, 18, to 81; 51 percent male) during a six-month period. Patients had experienced heartburn for at least three months, with symptoms on three of the seven days before therapy.

Patients were divided into two groups. Group 1 consisted of 169 patients treated with omeprazole 20mg daily for four to eight weeks, with a step-up to omeprazole 40mg daily for another eight to 12 weeks as needed if symptoms persisted or recurred on therapy (O-strategy). The remaining 194 patients began therapy with ranitidine, 150mg twice daily for four to eight weeks, with step down to omeprazole 20mg daily for another eight to 12 weeks as needed if symptoms persisted or recurred on therapy (R-strategy). Results showed the 308 experienced heartburn relief after acute therapy, 159 in the O-strategy group and 149 in the R-strategy group. Based on daily patient dairy data, heartburn relapse occurred in 79 percent of O-strategy patients in 76 percent of the R-strategy arm. Patients were considered to have relapsed if they experienced moderate to severe heartburn on tow days within a seven-day period; 10 percent (5 percent in each arm) completed the study without relapse. Gastrointestinal medical experts conclusions cannot be drawn about the superiority of one class of medicines over another based on this research. The number of days to relapse and the number of days to the first occurrence of moderate to severe heartburn did not differ between treatment strategies.

These results do not support the suggestion that initial treatment with PPI is addictive or any more difficult to discontinue than initial H2RA Therapy. They added that both omeprazole and ranitidine have excellent safety profiles. There is no indication that the greater acid suppression produced by omerazole and other PPIs is in any way detrimental.

Other PPIs include esomeprazole, pantoprazole, lansoprazole and rabeprazole. Overall, 50 percent of patients with heartburn-dominant patients remain symptom-free while off therapy for at least six months. Additionally, the majority of heartburn UD patients seen it primary practices have recurrent symptoms shortly after discontinuing therapy and need long-term treatment.