Proton Pump Inhibitors in Germany: Status Quo of a Growing Market.

Introduction: The volume of prescriptions for proton pump inhibitors (PPIs) remains high, although the literature increasingly points to excessive prescribing in relation to guideline recommendations. No very recent data is available on the specific situation in Germany, particularly on the proportion of PPI consumption from over-the-counter (OTC) sales and self-selection, following PPI down-scheduling. The aim of this study was to determine the actual amount of prescribed and OTC PPIs in Germany. Methods: For this retrospective study, several IQVIA databases were used, representing all prescriptions billed to statutory and private health insurers in Germany, as well as OTC sales. Analyses were performed for the period November 2020 to October 2021 or partially November 2018 to October 2021 and were descriptive in nature. Mainly, data were collected from IQVIATM PharmaScope National® as well as IQVIA TM DPM® databases. Results: A total of 2.87 billion PPI tablets were shown to have been sold between November 2020 and October 2021, with most drugs prescribed in the largest packages and strengths. In addition, the OTC PPI market increased by an average of 14% per year over a 3-year period. Conclusions: The results of this study suggest the substantial size of the PPI market in Germany is based on prescriptions, a consistent increase in OTC PPI purchases and a recent increase in prescriptions.

Prescribing Patterns of Proton Pump Inhibitors in Germany: A Retrospective Study Including 472 146 Patients.

The aims of this study were to analyze proton pump inhibitor (PPI) users in Germany, defining and classifying them in terms of treatment appropriateness, and to analyze the PPI prescription practices of healthcare providers. The updated DGVS (Deutsche Gesellschaft für Gastroenterologie, Verdauungs-und Stoffwechselkrankheiten) gastroesophageal reflux disease (GERD) treatment guideline (published March 2023) for mild heartburn symptoms recommends carrying out a probatory treatment of mild symptoms via other medication such as antacids, alginates, and H2 blockers before escalating to PPI treatments, if the patient profile allows. This retrospective cross-sectional study was based on data from the IQVIA™ Disease Analyzer database (DA) and included adult patients (18 years or older) in 1006 general and 39 gastroenterological practices in Germany who received at least 1 PPI prescription or alginate between September 2019 and September 2021 (hereinafter referred to as the index period). Analyses included indications associated with PPI prescription, co-diagnoses, co-therapies of PPI patients, duration of PPI therapy, dosages of PPI prescriptions, and proportions of practices prescribing PPIs and alginates. A total of 472 146 patients taking PPIs and 9101 patients taking alginates were available for analysis. Very few patients (4.5%) of the total cohort were treated in complete adherence to treatment guidelines. Conditions such as gastritis and duodenitis (47.2%) and reflux diseases (38.4%) were more frequently associated with PPI prescriptions. The average PPI treatment period lasted 141 days, and 36.6% of patients were treated for >6 months. High doses were prescribed relatively often (ie, 42.8% of esomeprazole prescriptions were 40 mg, 59.1% of lansoprazole prescriptions 30 mg, 28.6% of omeprazole prescriptions 40 mg). With each practice prescribing PPIs to at least 10% of their patients; 72% of general practitioners (GPs) and 8% of GENTS (Gastroenterologists) prescribed alginates. This study highlights that discrepancies exist between clinical guidelines and real-life prescribing practices of PPIs in Germany. Particular attention should be given to the incidence of patients being prescribed high-dose or long-duration PPI with mild indications. These findings are particularly apt considering the publication (March 2023) of new guidelines on the "management of gastroesophageal reflux disease and eosinophilic esophagitis," by the DGVS.

Recombinant Mannheimia haemolytica serotype 1 outer membrane protein PlpE enhances commercial M. haemolytica vaccine-induced resistance against serotype 6 challenge.

Mannheimia haemolytica outer membrane protein PlpE, a major immunogenic outer membrane lipoprotein has identical sequences in serotypes 1 (S1) and S6. Recombinant outer membrane lipoprotein PlpE (rPLpE) from M. haemolytica S1 was added to commercial M. haemolytica S1 vaccines to determine if it would enhance vaccine-induced immunity against heterotypic M. haemolytica S6 challenge. Serum antibody responses to M. haemolytica whole cells, leukotoxin and rPlpE were measured. Experiment 1 consisted of four vaccine groups: controls, 100 microg rPlpE, M. haemolytica Bacterin-Toxoid (One Shot) and M. haemolytica Bacterin-Toxoid + 100 microg rPlpE. Vaccines were given on day 0. On day 21, calves were challenged transthoracically with M. haemolytica S6. Lung lesion scores and percentage lesion reduction were 6.3 +/- 2.0 for controls, 3.6 +/- 2.4 for rPlpE vaccinates (42.9% reduction), 3.4 +/- 1.5 for One Shot-vaccinates (46.0% reduction), and 2.4 +/- 1.4 for One Shot/rPlpE vaccinates (61.9% reduction). Experiment 2 consisted of four vaccine groups: controls, 100 microg rPlpE, M. haemolytica toxoid (Presponse), and M. haemolytica toxoid+100 microg rPlpE. On day 28, calves were challenged transthoracically with M. haemolytica S6. Lung lesion scores and percentage lesion reduction were 8.1 +/- 2.2 for controls, 4.4 +/- 4.7 for the rPlpE vaccinates (45.7% reduction), 4.8 +/- 2.2 for Presponse-vaccinates (40.7% reduction), and 2.0 +/- 1.2 for Presponse/rPlpE vaccinates (75.3% reduction). These results indicate that addition of rPlpE from M. haemolytica S1 can enhance commercial M. haemolytica vaccine-induced resistance against experimental challenge with M. haemolytica S6.