Currently licensed initial proton pump inhibitor (PPI) treatment regimens of 4-8 weeks are failing to achieve complete remission in patients with severe gastro-oesophageal reflux disease (GERD), according to results presented today at the United European Gastroenterology Week (UEGW) in Berlin.
In response, experts recommended that severe patients should initially be treated for 12 weeks with a PPI before stepping down to maintenance treatment.
The study used a new classification tool to assess not only damage to the oesophagus (oesophagitis) but also the complete range of patients’ symptoms. In the past, doctors have concentrated on acid-related symptoms such as heartburn and reflux, but questionnaires have revealed that about half of all GERD patients in fact suffer a wide range of other symptoms, especially sleep disturbance.
The new classification was developed with support of Altana, who market the PPI Protium (pantoprazole), and combines ReQuest, a comprehensive symptom questionnaire, and the standard LA classification of oesophagitis on endoscopy.
ReQuest is now being tested to investigate whether it can be used in everyday practice to predict treatment needs and assess the response to treatment in individual patients with GERD. The ‘Real Life’ trial will include 2000 GERD patients at 196 outpatient centres in 22 countries, and will use ReQuest as well as the GERDyzer, a short patient quality of life questionnaire that was also developed with the support of Altana.
Speaking at a press conference held during UEGW, Professor Gerald Holtman, Royal Adelaide Hospital, Australia, commented: “Clinical trials [of PPIs in GERD] have focussed on healing of oesophagitis, probably because this is easy to address. As a result it has become more difficult to demonstrate that any one PPI is superior to another.”
This stalemate may be coming to an end, as a second study reported at UEGW found that Protium was better than AZ’s Nexium in improving sleep quality in patients with GERD. This study used ReQuest and GERDyzer to assess patients’ symptoms, and in future there are likely to be more clinical trials that use these instruments to tease out differences between PPIs that could really matter to patients and prescribers.