Adherence with regulatory resolutions on prevention of NSAIDs-related gastrointestinal injury in Italy
- 234 Downloads
Background The rate of gastrointestinal (GI) complications with non-steroidal antiinflammatory drugs (NSAIDs) or low-dose aspirin (LD-ASA) varies according to risk factors. For at risk patients, the Italian regulatory resolution enforce prophylaxis with proton pump inhibitors (PPIs) or misoprostol. Objective This study evaluated the consistency with such resolution in patients receiving NSAIDs or LD-ASA and assessed whether patients continued to receive GI protection with PPIs for an adequate time following NSAID discontinuation. Setting An observational retrospective study was conducted using data from Health District of Pisa. Methods The analysis was performed on patients receiving prescription of NSAIDs or LD-ASA, with or without concomitant PPIs or misoprostol, accordingly with the presence of risk factors (2008–2010). Prescription data were retrieved from the database of reimbursement claims for dispensed drugs, while history of past GI diseases was obtained from primary or secondary discharge diagnosis. Main outcome measure The consistency rates of PPI and misoprostol prescriptions with Italian regulatory rules in patients receiving chronic NSAIDs or LD-ASA. Results 6869 patients, receiving NSAIDs or LD-ASA during the observation period, were eligible for the analysis. For NSAIDs or LD-ASA, gastroprotection rates in patients without risk factors were: 8 and 6 % in 2008; 10 and 8 % in 2009; 9 and 6 % in 2010; while the proportions of patients with one or more risk factors not receiving gastroprotection were: 12 and 17 % in 2008; 25 and 22 % in 2009; 15 and 17 % in 2010. In patients discontinuing chronic NSAIDs, 62 % were maintained on protection with PPIs, but only 28 % continued the PPI treatment for an adequate time (60 ± 7 days). Conclusions The present analysis, although restricted to prescription patterns in a single health district, suggests scarce levels of consistency with Italian regulatory resolution on the prophylaxis of GI adverse events associated with chronic NSAIDs or LDASA.
KeywordsGastrointestinal injury Italy Misoprostol Prescription data Proton pump inhibitors
This research did not receive specific funding.
Conflicts of interest
No conflicts of interest to declare.
- 6.Lanas A, Garcia Rodriguez LA, Arroyo MT, et al. Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2-inhibitors, traditional non-aspirin, non-steroidal anti-inflammatory drugs, aspirin and combinations. Gut. 2006;55(12):1731–8.CrossRefPubMedPubMedCentralGoogle Scholar
- 15.Graham DY, Agrawal NM, Campbell DR, NSAID-Associated Gastric Ulcer Prevention Study Group, et al. Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active- and placebo-controlled study of misoprostol versus lansoprazole. Arch Intern Med. 2002;162(2):169–75.CrossRefPubMedGoogle Scholar
- 18.AIFA. Determinazione AIFA, 11 febbraio 2008—www.agenziafarmaco.gov.it. 2008. Last accessed 01 Sept 2015.
- 26.World Health Organization. International classification of disease: injuries and causes of death. Ninth Revision (ICD-9). Geneva: World Health Organization; 1987.Google Scholar
- 27.AIFA. Determinazione AIFA, 22 settembre 2009—www.agenziafarmaco.gov.it. 2009. Last accessed 01 Sept 2015.
- 33.OsMed working group. The use of drugs in Italy. National Report 2010. Rome: Il Pensiero Scientifico Editore. www.agenziafarmaco.gov.it/it/content/osmed-report. Last accessed 01 Sept 2015.