Real-world data expose high-dose NSAID patterns and lack of guideline compliance :- Medznat
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Italian study raises concerns over NSAID overuse and non-compliance with guidelines

Overuse of NSAIDs Overuse of NSAIDs
Overuse of NSAIDs Overuse of NSAIDs

What's new?

Despite guideline restrictions, NSAID prescribing continues to rise, highlighting a gap between regulation and clinical practice.

A new real-world analysis has uncovered significant trends in the prescription of non-steroidal anti-inflammatory drugs (NSAIDs) in Italy, raising concerns about compliance with the Italian Medicines Agency (Agenzia italiana del farmaco, AIFA) Note 66 guidelines. The study led by Valentina Perrone et al. evaluated NSAID utilization patterns between 2019 and 2022 and revealed increasing prescription rates, a shift in the most commonly used molecules, and potential inappropriate use beyond approved medical indications.

Researchers analyzed data collected from administrative health databases covering approximately 9.1 million Italian citizens. All individuals receiving at least one NSAID prescription between 2019 and 2022 were included. The study assessed patient demographics, frequency of NSAID prescriptions over time, most prescribed NSAID molecules, and drug consumption measured in defined daily doses (DDD) per 1,000 inhabitants per day.

Key findings

NSAID use increased steadily from 2019 to 2022.

  • Proportion of patients receiving NSAIDs rose from 1.9% to 3.0%.
  • Drug consumption escalated from 15.5 DDD to 16.8 DDD per 1,000 inhabitants/day, particularly among those aged 65–74 years (36.2 → 39.3 DDD).

The top prescribed NSAIDs are depicted in Table 1:

Notably, while most NSAIDs were administered at low-to-medium doses, ibuprofen (600 mg) was used at high dosage in 80% of prescriptions, raising safety considerations.

Patient Characteristics & Prescribing Patterns

  • A total of 2,811,910 NSAID-treated patients met Note 66 criteria.
  • The average patient age was 59.7 years, younger than populations typically associated with Note 66 indications (e.g., chronic rheumatic disorders, cancer-related pain).
  • Only 0.1–1.0% of prescriptions were related to rheumatic diseases, and 11.9% were issued in oncological settings, suggesting widespread off-label or non-note-related prescribing.

Researchers concluded that NSAIDs may be over-prescribed or used outside AIFA Note 66-approved clinical indications, especially given the younger-than-expected patient demographic and limited association with chronic rheumatologic or oncologic conditions. The findings emphasize the requisition for:

  • Better adherence to prescribing guidelines
  • Risk–benefit assessment prior to NSAID usage
  • Greater awareness among clinicians regarding safe dosing practices

As NSAIDs are linked with potential gastrointestinal, renal, and cardiovascular adverse effects—particularly at higher doses and prolonged use—experts emphasize optimizing pain management strategies in Italy to ascertain safety and cost-effectiveness.

Source:

Advances in Therapy

Article:

An Up-to-Date Description of the Use of Non-steroidal Anti-inflammatory Drugs (NSAIDs) in Italy: Evidence from Real Clinical Practice

Authors:

Valentina Perrone et al.

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