Risks of glucocorticoid therapy in PMR and GCA patients with co-existing type 2 diabetes

Study type
Protocol
Date of Approval
Study reference ID
18_043
Lay Summary

Polymyalgia rheumatica (PMR) is one of the commonest inflammatory rheumatic illnesses causing muscle pain, stiffness and joint swelling in people over 50 years old. It is closely linked to giant cell arteritis (GCA), an illness causing swelling and narrowing of blood vessels mainly in the temple area of the head; if not treated appropriately, it can lead to permanent blindness. These conditions are treated with medications called glucocorticoids (commonly known as steroids). Steroids can cause side effects including bone thinning and may worsen pre-existing illnesses (e.g. diabetes). Current guidelines recommend using alternative treatments if a high risk of developing side effects exists, but currently we are unable to accurately tell who should get these alternative treatments. This study will investigate the impact of steroid treatment on diabetes, a common disease in the typical age group of people that get PMR and GCA. We will use a large database to identify PMR or GCA patients with diabetes to measure the impact of steroid treatment on their illness after being diagnosed and treated with steroids. This will clarify if the impact is significant and whether alternative medications should be considered in patients who already have this condition.

Technical Summary

Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic illness affecting patients over 50 years old, causing severe muscle pain with joint pain and stiffness and impacts on work, daily life and activity. The life-time risk is 2.4% in women and 1.7% in men and is linked to giant cell arteritis (GCA), which if not treated appropriately can cause irreversible blindness. Both are treated with glucocorticoid medications which have the potential to cause adverse effects (e.g. osteoporosis) and exacerbate co-existing illnesses (e.g. diabetes). Current guidance suggests that glucocorticoid sparing agents be considered if a significant risk of developing adverse effects exists. However, exactly who should receive these alternatives is not specified. This study will investigate the impact of glucocorticoid treatment in incident PMR and GCA patients with co-existing diabetes (a common comorbidity in patients over 50 years old and potentially affected by glucocorticoid treatment). The Clinical Practice Research Datalink (CPRD) will be used to identify PMR/GCA patients with diabetes to quantify the impact of glucocorticoid treatment after being diagnosed and treated. This will clarify if the impact of glucocorticoid treatment on diabetes is significant and whether these patients should be considered high risk and appropriate for glucocorticoid sparing therapy.

Health Outcomes to be Measured

Change in HbA1C of 5 mmol/l (NICE, America Diabetes Association)Change in HbA1C of 5 mmol/l (NICE, America Diabetes Association)
Type 2 diabetes related complications: retinopathy, neuropathy, cerebrovascular accident, cardiovascular disease, cataracts, death

Collaborators

Toby Helliwell - Chief Investigator - Keele University
Toby Helliwell - Corresponding Applicant - Keele University
Alyshah Abdul Sultan - Collaborator - AstraZeneca Ltd - UK Headquarters
Christian Mallen - Collaborator - Keele University
Milica Bucknall - Collaborator - Keele University
Sara Muller - Collaborator - Keele University

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation