Appropriateness of proton pump inhibitors treatment in clinical practice: Prospective evaluation in outpatients and perspective assessment of drug optimisation.

BACKGROUND: High rates of inappropriate proton pump inhibitor (PPI) prescriptions have been reported in retrospective database analyses. Assessing the appropriateness of long-term PPIs in outpatients, with a proactive approach at drug optimisation may enhance treatment adequacy. AIMS: To describe the characteristics of outpatients who are on long-term PPIs, to assess the magnitude of inappropriate PPI prescriptions, and to evaluate the rate of drug optimisation following specialist recommendations. METHODS: Appropriateness of long-term (>8weeks) PPI prescription was prospectively assessed in 249 consecutive patients referred to a Gastroenterology outpatient clinic. We recorded reason for prescription, dose, modality, duration of therapy, and attempts at PPI optimisation. RESULTS: PPIs were inappropriately prescribed in 96/249 patients (38.6%). Gastro-oesophageal reflux disease (50/143, 35.0%) and prophylaxis of anti-platelet/non-steroidal anti-inflammatory drugs (5/49, 10.2%) were the most common PPI indications and those with the lowest rate of inappropriateness, while the highest rates were observed for treatment of dyspepsia (10/12, 83.3%) and anti-coagulant therapy (21/21, 100%). PPI treatment was optimised in 112 patients (45.0%). CONCLUSIONS: PPIs are inappropriately used in about 40% of outpatients, reflecting scant attention to guidelines. A proactive approach may improve therapeutic adequacy in approximately half of patients. Educational efforts to guide PPI prescription should be further pursued.

The appropriate use of proton-pump inhibitors.

The introduction of proton-pump inhibitors (PPIs) into clinical practice since about thirty years has greatly improved our therapeutic approach to acid-related diseases for their well recognized efficacy and safety. Accordingly, the role of surgery has been enormously reduced in this field. The main indications for PPI use are universally acknowledged by many scientific societies and are the following: treatment of gastroesophageal reflux disease in its various forms and complications, eradication of H. pylori infection in combination with two or more antibiotics, therapy of H. pylori-negative peptic ulcers, healing and prevention of NSAID-associated gastric ulcers, co-therapy with endoscopic procedures to control upper digestive bleeding and medical treatment of Zollinger-Ellison Syndrome. Despite the above well-defined indications, however, the use of PPIs continues to grow every year in both Western and Eastern countries and this phenomenon poses serious queries about the appropriate prescription of these drugs worldwide. In fact, the endless expansion of PPI market has created important problems for many regulatory authorities for two relevant features: the progressive and irreversible increase of the costs of therapy with this class of drugs and the greater potential harms for the patients. So, there is the need for a reappraisal of PPI correct indications for both general practitioners and various specialists in order to re-establish a correct use of these effective drugs in daily clinical practice, according to the best evidence-based guidelines.

Management strategy for patients with gastroesophageal reflux disease: a comparison between empirical treatment with esomeprazole and endoscopy-oriented treatment.

OBJECTIVES: Whether patients with typical gastroesophageal reflux disease (GERD) symptoms and without alarm features should be treated empirically or undergo endoscopy first is a debated issue. In this study, our aim was to assess the efficacy, and to compare the direct costs and impact on health-related quality of life (HRQL), of two treatment strategies (empirical vs endoscopy-oriented treatment) in a large population of patients with GERD. METHODS: In total, 612 patients were randomized to either empirical treatment with esomeprazole 40 mg once daily (od) (group 1, N = 309) or endoscopy and treatment according to endoscopic findings (group 2, N = 303, esomeprazole 40 mg od in patients with reflux esophagitis and esomeprazole 20 mg od in patients without esophagitis) for 4 wk, followed by esomeprazole 20 mg od maintenance treatment in both groups. Direct costs and HRQL were analyzed in both treatment arms. RESULTS: At the end of the acute treatment phase (week 4), 267 patients in group 1 (86.4%) and 265 patients in group 2 (87.5%) were considered responders to treatment (intention-to-treat analysis, P= 0.878). Empirical treatment proved to be cost-effective by saving 38.72 euros per treated patient. At the end of the maintenance phase (week 24), a similar proportion of patients responded to treatment in the two groups (71.8%vs 68.3%, P= 0.389). HRQL improved from baseline to week 24 in both groups (difference between study groups not significant). CONCLUSIONS: In patients with GERD, empirical treatment with esomeprazole proved to be cost-effective compared with endoscopy-oriented treatment, and did not negatively affect patient HRQL. These results should be taken into account in the management of GERD patients in clinical practice.

Once-Daily Bedtime Dose of Roxatidine and Ranitidine in Acute Duodenal Ulcer: A Combined Assessment of Acid Inhibitory Activity and Healing Rate.

This study was carried out in order to compare the antisecretory effect of a single bedtime dose of roxatidine 150 mg and ranitidine 300 mg and to assess the relationship between the degree and the duration of acid suppression and the healing rates obtained in duodenal ulcer patients treated with the above regimens. Sixty-three patients with endoscopically proven ulcer underwent 24-h gastric pH-metry on day 0, day 1, and day 28 of treatment with both roxatidine and ranitidine. Ulcer healing was checked endoscopically after 4 weeks of therapy. RESULTS: Eight patients did not complete the study, leaving 55 patients eligible for final analysis, 28 in the roxatidine group and 27 in the ranitidine group. Duodenal ulcers were healed in 24--28 (85%) patients of the former and in 22--27 (81%) patients of the latter group (p minus sign NS). Gastric pH was significantly higher (p < 0.001) than basal values on days 1 and 28 with both H2-antagonists. The 24-h pH levels did not differ between day 1 and day 28 with both roxatidine and ranitidine. There was also do difference between the two active treatments. The pattern of gastric acidity significantly differed (p < 0.01) between responder (n = 46) and nonresponder (n = 9) patients to both H2-blockers, and this difference was mainly sustained by nocturnal pH. CONCLUSIONS: A bedtime close of roxatidine 150 mg and ranitidine 300 mg was able to heal more than 80% of duodenal ulcers within 4 weeks of treatment. The lack of tolerance to H2-blockers in duodenal ulcer patients contributes to this good result. The antisecretory effect of H2-antagonists is reduced in nonresponder patients with respect to responder patients and this is mainly due to an impaired control of nocturnal acidity.