Prescribing omeprazole would conflict with desire to control prescribing costs

EDITOR—Hatlebakk et al suggest that omeprazole 20 mg once daily should be considered as a first choice when patients with heartburn are being treated in primary care.1 With the formation of primary care groups all general practitioners are coming under increasing pressure to control prescribing costs. If costs are exceeded in one budget, budgets in other clinical areas (such as staff, including practice nurses) may be threatened. I and my colleagues in the practice have worked hard over two years to control our prescribing costs. Omeprazole was the largest single gastrointestinal drug cost, accounting for 7% of our total drug budget and just over half of our gastrointestinal drug costs.

Hatlebakk et al make no mention of lifestyle advice—such as advice on smoking, diet, and weight reduction—as a method of controlling symptoms. Recent recommendations from our primary care group (through the primary care investment plan) suggest that we should target the use of proton pump inhibitors, and this will be linked to an element of payment that we receive under the prescribing incentive scheme. Increasingly we are using histamine receptor antagonists both as first line treatment of symptomatic reflux and as intermittent maintenance treatment. We are going to find considerable conflict in following Hatlebakk et al's recommendations.

Step up approach to management is best

EDITOR—Hatlebakk et al's study supports the empirical treatment of heartburn in a primary care setting.1 But the authors' conclusion that “omeprazole should be considered as a first choice when treating patients with heartburn in primary care” is unsupported by their findings that a proton pump inhibitor is more effective than cisapride in the empirical treatment of heartburn.

Because of the enormous cost of proton pump inhibitors to the NHS we favour the step up approach to managing patients with heartburn in primary care. Advice on lifestyle and use of antacids should be given initially, and H₂ antagonists and proton pump inhibitors should be given only for patients with unresolved symptoms.2

Study's results seem to be promotional rather than evidence based

EDITOR—Hatlebakk et al's study on heartburn in primary care shows clearly many of the problems of research sponsored by pharmaceutical companies.1

Firstly, health professionals in primary care are not asking the question being studied. We already know that omeprazole is more effective than cisapride, from evidence 2 and experience, and do not need a further expensive, multicentre trial by the makers of omeprazole to prove it.

Secondly, the authors' conclusion that “omeprazole should be considered as a first choice when treating patients with heartburn in primary care” seems to be promotional rather than a balance of all the available evidence. Even if this study had found omeprazole to be more effective than antacids, all H₂ antagonists, and all other proton pump inhibitors, recommended treatment of simple heartburn would probably still be to follow a step approach as recommended by the National Prescribing Centre.3 The authors' conclusion is not evidence based and puts across the wrong message at this important time for primary care.

Thirdly, the real agenda in primary care lies elsewhere. Our real dilemma in primary care is how to reduce prescribing of proton pump inhibitors rather than increase it. In Teesside, as I'm sure in other regions, omeprazole is already on the top of the prescribing bill and we are trying to use lower doses of the drug or to use treatment on an intermittent basis.4

If the huge amount of money used to fund studies such as this was instead used to reduce the cost of omeprazole it would be many times more beneficial to the NHS, primary care, and our patients.

Authors' reply

EDITOR—Williams, Saxena, and Alberti raise a relevant issue for all patients. The cost to patients and society is particularly important for a chronic disease such as gastro-oesophageal reflux disease. Cost effectiveness in terms of adequate symptom relief and avoiding expensive and scarce specialist care should also be considered.

Our study was designed and performed by primary care physicians and gastroenterologists working closely in networks. Gastro-oesophageal reflux disease is common in primary care and can usually be treated there. Prokinetic treatment with cisapride has been advocated as an alternative to acid suppression. Budget restrictions and time limits did not allow us to assess an H₂ receptor antagonist.

In Norway the recommended dose of cisapride 20 mg twice daily costs NOK 19.10 per day and that of omeprazole 20 mg every morning NOK 18.90 per day (NOK 1=80p). Ranitidine 150 mg twice daily costs NOK 10.30 and 300 mg twice daily NOK 18.80 per day. Marginal differences in cost highlight the fundamental question of effectiveness and cost effectiveness of each drug regimen. Other studies, including studies in primary care, have shown proton pump inhibitors to be superior to H₂ receptor antagonists.1 Prices for proton pump inhibitors are likely to decrease in the near future.

We were astonished by the severity of heartburn and other symptoms in our patients. Heartburn occurred on average 5.5 days per week and affected daily activities in 65% of patients. Symptom relapse occurred in 72% within six months. Few of these patients, however, had severe disease requiring specialist care. The focus should therefore be on adequate relief of symptoms in primary care.

Lifestyle advice was recommended, but, in our experience, lifestyle modifications are difficult to maintain. Patients with reflux symptoms have usually adjusted their diet and used antacids with only limited relief.

We have repeatedly observed undertreatment of gastro-oesophageal reflux disease in primary care. Doctors must listen to patients and understand the need for symptom control and how reflux symptoms affect overall health. Treatment should be individualised, allowing for intermittent and long term use of H₂receptor antagonists and proton pump inhibitors. We agree that a step up approach, starting with an H₂ receptor antagonist, is often reasonable, although a significant effect of H₂ receptor antagonists in long term treatment has been difficult to show. Our study shows that cisapride has no place in the treatment of heartburn in primary care.

Rapid relief of symptoms is important in this disease because treatment is usually used as an uncontrolled diagnostic test. Inadequate treatment will inevitably lead to higher referral rates for endoscopic examination.

Proton pump inhibitors must be used correctly, especially in patients with gastro-oesophageal reflux disease. A step up approach is often correct, but more effective acid suppression may be needed in a large proportion of patients.