Prescribing of Medication to Prevent Glucocorticoid Harms in Patients With Polymyalgia Rheumatica: A Cross-Sectional Study and Two Emulated Target Trials in the Clinical Practice Research Datalink Aurum.

OBJECTIVE

Polymyalgia rheumatica (PMR) is a common indication for long-term glucocorticoid (GC) treatment. Bone-protective and gastroprotective medications are recommended for those at high risk of adverse events from GCs, but no trials have evaluated their effectiveness in PMR. We describe bone-protective and gastroprotective medicine prescribing in people with PMR and evaluate its impact on adverse GC outcomes using a target trial approach.

METHODS

A sample of >40,000 individuals aged ≥50 years with a coded PMR diagnosis from January 2010 to March 2022 who were prescribed GCs within 21 days of the first PMR diagnosis code was constructed in the Clinical Practice Research Datalink Aurum. Prescriptions were defined as prevalent (pre-PMR diagnosis), incident (at diagnosis), or late (post diagnosis, still GC-treated), reported stratified by age, sex, and deprivation. A target trial approach assessed the effects of (1) bisphosphonates on fragility fractures and (2) proton-pump inhibitors/H2 receptor antagonists (PPIs/H2RAs) on gastrointestinal (GI) ulceration/bleeding. Treatment effect, adjusted for confounders, was modeled using targeted maximum likelihood estimation.

RESULTS

67.2% participants were coprescribed bisphosphonates and 78.6% were coprescribed PPIs/H2RAs. Male patients and those in more deprived areas were less likely to receive bisphosphonates. 1.40% (95% confidence interval [CI] 1.10%-1.70%) of those prescribed bisphosphonates for 12 months versus 2.32% (95% CI 2.12%-2.52%) of those not prescribed bisphosphonates for 12 months experienced a fracture (risk difference 0.92% points [95% CI 0.56%-1.27%], number needed to treat 109). Prescribing gastroprotective medications was not associated with serious GI events.

CONCLUSION

Rates of prescribing to mitigate GC harms are higher than previously reported. Bisphosphonates are associated with approximately one less fragility fracture per year for every 100 people treated. Gastro-prophylaxis is not associated with reduced risk of GI ulceration/bleeding, suggesting potential to reduce prescribing for this indication.