Avoid High-Dose Steroids in Elderly With COPD and Diabetes

Marlene Busko

June 07, 2013

In a study of elderly Australians with chronic obstructive pulmonary disease (COPD) and newly diagnosed diabetes, those who received high-dose corticosteroids had an increased risk of being hospitalized for a diabetes-related complication within a year.

This is the first study to examine the effect of corticosteroid dose on longer-term diabetes complications in patients with both diabetes and COPD, lead author Gillian E. Caughey, PhD, from the University of South Australia, in Adelaide, told Medscape Medical News in an email.

The results indicate that, in this type of high-risk patient population, corticosteroid doses for COPD need to be closely watched, she and her colleagues advise in their paper, published online June 4 in Diabetes Care.

"Higher doses of corticosteroids in patients with diabetes and COPD should be limited to optimize the balance between the benefits and the risk of longer-term adverse effects," Dr. Caughey summarized.

"Regular revision and monitoring of corticosteroid dose to ensure the minimally effective dose is used, together with review of appropriate response to therapy and regular monitoring of blood glucose control, is particularly important" in these patients, she added.

A "Therapeutic Conflict": Better COPD, Worse Diabetes

About 10% of patients in Australia (and the United States) who have diabetes also have COPD, according to Dr. Caughey.

Treatment guidelines recommend the use of inhaled steroids in patients with moderate to severe COPD to reduce exacerbations, which are frequent, and the use of oral steroids for short-term treatment of exacerbations, but the latter are not recommended chronically due to their unfavorable risk/benefit profile.

But "the use of corticosteroids in patients with diabetes and COPD poses [a] therapeutic conflict, [since] corticosteroids are recommended as part of guideline therapies for COPD but are associated with hyperglycemia and an increased risk of diabetes complications," she noted.

Little evidence exists to guide treatment decisions in real-world, older patients with multiple comorbidities, she and her colleagues write. To investigate whether the risk of diabetes complications increases in a dose-dependent manner with rising doses of corticosteroids, the authors performed a retrospective cohort study using claims data from the Australian Department of Veterans' Affairs.

They identified 18,266 patients who had received an initial prescription for metformin or a sulfonylurea from 2001 to 2008. The current study cohort consisted of 1077 (5.9%) of these patients with diabetes who also had COPD, defined as receiving 2 prescriptions of tiotropium or ipratropium in the 6 months prior to their first prescription for either diabetes drug.

At baseline, the subjects had a median age of 80 years; 71% were male, and less than 5% were living in a residential care facility. They had a median of 6 to 7 comorbidities, and more than 92% had cardiovascular disease. Dr. Caughey said that they were unable to determine from the database the type of diabetes diagnosed, but the older age of the patients and the fact they were prescribed oral hypoglycemic agents indicate it would be type 2 diabetes for the most part.

The study outcome was the time to first hospitalization for mainly microvascular diabetic complications — hyperosmolarity, ketoacidosis, nephropathy, retinopathy, neuropathy, angiopathy, or arthropathy — starting at 12 months.

Dramatic Difference Between Highest Dose and Nonusers

In the 12 months after being diagnosed with diabetes, 67.2% of the patients had used corticosteroids.

Rates of hospitalization for a diabetic complication were similar among corticosteroid users and nonusers after 1 year (7.1% vs 6.3%, P = .37) and after 5 years (19.8% vs 16.2%, P = .18).

However, stratification by levels of corticosteroid use revealed a dramatic difference between patients who took the highest doses and patients who took no corticosteroids.

The median corticosteroid dose during 12 months was 0.34 of a defined daily dose/day. Patients were stratified into 3 levels of median daily corticosteroid dosage: more than 0 to less than 0.25; 0.25 or greater to less than 0.83; and 0.83 or greater.

Compared with patients who did not take any corticosteroids over 12 months, those who received 0.83 or greater of a defined daily dose/day had a 94% increased risk of being hospitalized for a diabetes-related complication.

"A dosage of 0.83 or greater defined daily dose/day over 12 months is comparable to receiving an inhaled maintenance dose of corticosteroids — for example, 400 µg of budesonide twice daily for a year plus treatment of acute exacerbations 6 times in a year with 50-mg oral prednisolone for 7 days," Dr. Caughey explained. "Or, [it is equal to treating] 9 COPD exacerbations with oral prednisolone 50 mg per day for 7 days."

There was no difference in hospitalization in patients who had received oral, inhaled, or both types of corticosteroids.

Need For Shared Decision Making in this Population

"Regular use of high-dose corticosteroids (0.83 or greater defined daily dose/day) should be avoided where possible for those individuals with comorbid diabetes," the researchers stress.

"Although we have shown that longer-term adverse effects on diabetes complications were evident only at higher doses of corticosteroids, use of corticosteroids (both inhaled and oral) in this patient population should be associated with close monitoring of blood glucose levels and a review of efficacy within 4 to 8 weeks of commencing inhaled therapy," they note.

The results also "highlight the importance of the need for shared decision making in this population, where treatment prioritization of the more symptomatic conditions, such as COPD, needs to be balanced with both the short-term and long-term harms associated with use of corticosteroids for patients with comorbid diabetes," they conclude.

The study was funded by a National Health and Medical Research Council/Australian Research Council Ageing Well Ageing Productively Program grant. The authors have reported no relevant financial relationships.

Diabetes Care. 2013. Abstract

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