Preventing steroid harms in people with polymyalgia rheumatica in UK primary care

Study type
Protocol
Date of Approval
Study reference ID
22_002246
Lay Summary

Polymyalgia rheumatica (PMR) is an illness affecting older adults. It causes pain and stiffness around the shoulders and hips and can affect people’s ability to do everyday activities. The main treatment is steroid tablets (prednisolone), which need to be taken for two years but sometimes longer.

Prednisolone can cause side-effects including increasing the chances of people breaking bones and bleeding from the gut. People with PMR have told researchers that understanding more about the side-effects of steroids and how to prevent them is important. Some medicines given to treat pain in PMR also increase the chances of bone and gut problems. There are other medicines that can be given to reduce the chances of these side-effects happening (called “preventative medicines”), but previous research has shown that low numbers of people receive these.

Using information from people’s anonymous medical records we will find out:
- whether preventative medicines are being given to people who should be offered them
- which medicines are given for pain in PMR and who receives these.

This is the first part of a larger project. The second stage of the project will look at the effect of preventative medicines and pain medicines on the chances of having fractures / gut side effects.
We will discuss the findings with our study patient group to ensure we produce information that is helpful to people with PMR and healthcare staff that care for them.

Technical Summary

Background
Polymyalgia rheumatica (PMR) causes pain, stiffness, and disability in older adults. It typically responds rapidly to glucocorticoids (GCs) and the dose of GCs is tapered over an average period of 2-3 years.

Two risks associated with GCs are an increased rate of fractures and serious gastrointestinal (GI) adverse events. Pharmacological strategies to reduce the risk of complications exist, but studies have shown that prescribing of prophylactic medication is low. In addition, patients with PMR often report residual pain, despite glucocorticoid treatment. Analgesia used to manage pain in PMR can contribute to risks of fractures and GI adverse events. We do not know what factors affect prescribing of prophylactic medication or analgesia, nor the implications of this on incidence of fracture or GI adverse effects.

This study will use UK primary care data to describe how medicines other than GCs are used in the management of people with PMR. Findings will be used to inform a subsequent application for data to examine the impact of these medicines on adverse outcomes.

Methods
A retrospective cohort of people with PMR will be formed in CPRD Aurum. Participants will be defined as prevalent, incident, or non-users of the relevant prophylactic medications/analgesia. Prescribing will be analysed by age-group, sex, ethnicity, geographic region, deprivation and appropriateness compared to clinical guidelines.

Outcomes
This study will describe patterns of prescribing of bone- and gastro-protective medication and analgesia for people with PMR across England.
Subsequent planned work will assess the impact of prescribing of bone- and gastro-protective medications and analgesia on risks of fractures and gastrointestinal complications and model the effect of prescribing bone- and gastro-prophylaxis and analgesia on rates of fragility factures and GI adverse events.
Findings will be used to inform care pathways, prescribing guidance and improve shared decision-making.

Health Outcomes to be Measured

Bone-prophylaxis prescriptions (calcium and vitamin D, bisphosphonates); gastro-prophylaxis prescriptions (proton pump inhibitors (PPIs) and H2-receptor antagonists); analgesic prescriptions (opioids amitriptyline, gabapentinoids, and non-steroidal anti-inflammatory drugs (NSAIDs))

Collaborators

Helen Twohig - Chief Investigator - Keele University
Helen Twohig - Corresponding Applicant - Keele University
David Jenkinson - Collaborator - Keele University
Ian Scott - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Samantha Hider - Collaborator - Keele University
Sara Muller - Collaborator - Keele University

Linkages

Patient Level Index of Multiple Deprivation