ABSTRACT
Title
Use of Proton Pump Inhibitors (PPIs) in clinical practice: a population-based study in the years 2004-2009
Authors
C. Sirianni1, R. Ferrara1, M.S. Gagliostro1, A. Cannata1, C. Pagliaro2, I. Lombardi2, S. Moretti2, M. Tari2, A. Capuano3, F. Rossi3, A.P. Caputi1, V. Arcoraci1.
1Department of Clinical and Experimental Medicine and Pharmacology, Pharmacology Unit, University of Messina, Italy; 2”Caserta-1” Local Health Unit, 3Pharmacovigilance and Pharmacoepidemiology Centre of Campania Region, Dept. of Experimental Medicine, Pharmacology Section, Second University of Napoli, Italy.
1Department of Clinical and Experimental Medicine and Pharmacology, Pharmacology Unit, University of Messina, Italy; 2”Caserta-1” Local Health Unit, 3Pharmacovigilance and Pharmacoepidemiology Centre of Campania Region, Dept. of Experimental Medicine, Pharmacology Section, Second University of Napoli, Italy.
Abstract
Proton Pump Inhibitors (PPIs) are among the most prescribed drugs, in Italy, and an increasingly use was observed in the last years, particularly due to newer compounds. On this basis, the Italian National Health System introduced an health-policy intervention (as reported in “Nota 1”) which restricted the refundability of PPIs only to patients affected by Gastrointestinal ulcer and Gastroesophageal reflux disease (GERD), indications for which scientific evidence have been provided. Moreover, PPIs are refunded also in prevention of bleeding risk from drugs in specific conditions (Nota 48). Nevertheless, several studies reported a wide use of PPIs also for unlicensed indications.
Aims: to assess the prescription pattern of PPIs in general practice; to characterize the PPI users, to analyse PPIs appropriate use in treatment of acid-related diseases and prevention of bleeding risk in patients treated with NSAIDs or ASA, as described in Notes.
Methods:
Data were extracted from the Arianna database that currently contains information about a population of almost 150,000 individuals living in the area of Caserta and registered in 118 general practitioners’ (GPs) lists. Patients aged over 14 who received at least one PPIs prescription during 2004-2009 were identified. The use of PPIs was calculated as one-year prevalence and incidence; PPIs consumption was evaluated as DDD 1000/inh day. Appropriate use has been defined as prescriptions dispensed within 60 days after licensed indications. Sub-analyses by gender, age and indication of use have been performed.
Results: PPIs prevalence of use and incidence of new treatments linearly increased during the observation period up to 13.7/100 inhabitants and 6.9/100 inhabitants in 2009, respectively . The number of PPIs-treated patients was higher in female (55.6% in 2009) and increased with age. Lansoprazole was the most used molecule in 2009, followed by pantoprazole and omeprazole. Esomeprazole and rabeprazole use linearly increased until 2008, and significantly decreased in the last year. Lansoprazole new users increased from 2005 to 2007, while pantoprazole and omeprazole were the first choice molecules in the last two years. GERD is the main indication of PPIs use, affecting about 40-45% of patients. The percentage of patients treated because different kind of ulcer decreased from 21% in 2004 to 9% in 2009. Over 55% of PPI users in 2004 and more than 65% in 2009 were assuming NSAIDs or ASA at antiplatelet dose. Concerning indications of use, 50,7% of total PPIs prescritions were inappropriate. In particular, about 25% of PPIs prescriptions were made out of licensed indications and in absence of risk factors. In several patients, PPIs were co-prescribed with antiplatelet drugs other than ASA, or Coxibs. In 3.3% of prescriptions, PPIs were associated with corticosteroid or other anticoagulant drugs alone and, in 5,6%, with NSAIDs in absence of additional risk factors.
Conclusions: According to costs appropriateness, first-generation and cheaper PPIs (omeprazole, pantoprazole, lansoprazole) are the most used drugs and incidence of use of these molecules increased after patent lost and the consequent prices fall. However, a large proportion of patients were treated for other non specific indications of PPIs. Inappropriate treatments represented more than 50% of total PPIs prescripitions during the study period. Indeed they were not filled as first therapeutic approach in patients with acid-related diseases or to prevent the bleeding risk in patients treated with NSAIDs or ASA .
PPIs should be administered when there is a clear indication and they should be discontinued when possible. These results suggest that target interventions are needed to improve GPs prescription behaviours about PPIs use.
Aims: to assess the prescription pattern of PPIs in general practice; to characterize the PPI users, to analyse PPIs appropriate use in treatment of acid-related diseases and prevention of bleeding risk in patients treated with NSAIDs or ASA, as described in Notes.
Methods:
Data were extracted from the Arianna database that currently contains information about a population of almost 150,000 individuals living in the area of Caserta and registered in 118 general practitioners’ (GPs) lists. Patients aged over 14 who received at least one PPIs prescription during 2004-2009 were identified. The use of PPIs was calculated as one-year prevalence and incidence; PPIs consumption was evaluated as DDD 1000/inh day. Appropriate use has been defined as prescriptions dispensed within 60 days after licensed indications. Sub-analyses by gender, age and indication of use have been performed.
Results: PPIs prevalence of use and incidence of new treatments linearly increased during the observation period up to 13.7/100 inhabitants and 6.9/100 inhabitants in 2009, respectively . The number of PPIs-treated patients was higher in female (55.6% in 2009) and increased with age. Lansoprazole was the most used molecule in 2009, followed by pantoprazole and omeprazole. Esomeprazole and rabeprazole use linearly increased until 2008, and significantly decreased in the last year. Lansoprazole new users increased from 2005 to 2007, while pantoprazole and omeprazole were the first choice molecules in the last two years. GERD is the main indication of PPIs use, affecting about 40-45% of patients. The percentage of patients treated because different kind of ulcer decreased from 21% in 2004 to 9% in 2009. Over 55% of PPI users in 2004 and more than 65% in 2009 were assuming NSAIDs or ASA at antiplatelet dose. Concerning indications of use, 50,7% of total PPIs prescritions were inappropriate. In particular, about 25% of PPIs prescriptions were made out of licensed indications and in absence of risk factors. In several patients, PPIs were co-prescribed with antiplatelet drugs other than ASA, or Coxibs. In 3.3% of prescriptions, PPIs were associated with corticosteroid or other anticoagulant drugs alone and, in 5,6%, with NSAIDs in absence of additional risk factors.
Conclusions: According to costs appropriateness, first-generation and cheaper PPIs (omeprazole, pantoprazole, lansoprazole) are the most used drugs and incidence of use of these molecules increased after patent lost and the consequent prices fall. However, a large proportion of patients were treated for other non specific indications of PPIs. Inappropriate treatments represented more than 50% of total PPIs prescripitions during the study period. Indeed they were not filled as first therapeutic approach in patients with acid-related diseases or to prevent the bleeding risk in patients treated with NSAIDs or ASA .
PPIs should be administered when there is a clear indication and they should be discontinued when possible. These results suggest that target interventions are needed to improve GPs prescription behaviours about PPIs use.