Risk for Side Effects With Repeat Oral Corticosteroids

Ingrid Hein

November 26, 2019

"If you don't absolutely need to give a patient corticosteroids, don't," said Patrick Sullivan, PhD, from the Regis University School of Pharmacy in Denver.

In a new study, Sullivan and his colleagues showed that the risk for adverse events was 1.5 times higher for young people who received one to three prescriptions for systemic corticosteroids in a year than for those who received no prescriptions. And the rate was three times higher for those who received four or more prescriptions.

"When patients come in, not even in an urgent state — no asthma or bronchitis — they're given steroids," Sullivan told Medscape Medical News. "Sure, it helps them get over whatever problem they have faster, but the hospitals don't think about gravity of associated risks. We hope our study and others like it will change that."

Each year, about 43% of patients 1 to 18 years of age in the United States receive at least one prescription for systemic corticosteroids, according to one study.

The problem can be linked to the fact that, in the United States, childhood asthma is poorly controlled. "People with asthma have difficulty taking their medication properly," Sullivan explained.

Previous studies have shown that inhaler technique in asthma patients, especially children, is poor, as reported by Medscape Medical News.

"There's a disconnect along the path between physician, parent, and patient," said Sullivan, which often leads to hospitalization and the initiation of steroids.

In a previous study of adults that Sullivan was involved in, the researchers found that for each year of exposure to systemic corticosteroids, the odds increased for osteoporosis, hypertension, obesity, type 2 diabetes, gastrointestinal ulcers and bleeds, fractures, suppression of the hypothalamic–pituitary–adrenal (HPA) axis, and cataracts.

And each year of exposure to one to three prescriptions resulted in 1.07 times the odds of having a new adverse event in the current year.

That study prompted Sullivan and his colleagues to look at the effect of systemic corticosteroids in children. The results were presented in a poster at the American College of Allergy, Asthma & Immunology (ACAAI) 2019 Annual Scientific Meeting in Houston.

"When we saw the results for adults, we realized that kids receive steroids even more frequently, so we wanted to know if we would see the same problem," he explained.

Adverse Effects Cumulative

The team identified 23,898 patients, 2 to 18 years of age, with Healthcare Effectiveness Data and Information Set (HEDIS)-defined persistent asthma in the MarketScan claims database from 2000 to 2017. Patient records included data at least 12 months before and at least 24 months after the first prescription for systemic corticosteroids.

Patients with a diagnosis of COPD, chronic bronchitis, emphysema, cystic fibrosis, or autoimmune disorders were excluded from the analysis.

Patients with asthma were matched, using the k-nearest neighbor matching propensity score method, on a one-to-one basis, with a control group of patients who had not received systemic corticosteroids.

The researchers calculated the odds of the following adverse events: gastrointestinal, infectious, metabolic, bone, psychological, HPA-axis suppression, eye complications, and other.

They found that the risk for an adverse event was 2.9 times higher in patients who had received at least four annual prescriptions for systemic corticosteroids than in those who received no prescriptions, and was 1.6 times higher in patients who had received one to three annual prescriptions.

"This was a naturalistic trial. We were not randomizing," Sullivan pointed out. "We used an existing dataset; we looked at real usage patterns."

There were adverse events in a lot of different categories. "There was a gastrointestinal effect. An ulcer can develop. It messes with the mucosal lining of the digestive tract with serious bleeds," he explained.

"These drugs suppress the immune system. That's good, but it also reduces the patient's ability to fight infection. We had kids who got tuberculosis, herpes, sepsis, flu — things you can otherwise fight off."

Need for Education

"We need people to follow the guidelines and take their medications properly," Sullivan said. If nurse educators or pharmacy educators were enlisted to show people how to use their inhalers, it "could reduce exacerbations and all the horrible side effects of needing steroids."

Another problem is that when kids with asthma feel better, they stop using their inhalers, which are preventive therapy, and end up with exacerbations. "That's an education issue too; it doesn't matter how good you feel, you have to keep taking it to keep the asthma exacerbations away," he said.

It's important to understand that oral corticosteroids can induce adverse effects and they should be used for as short a period as possible, said Michael Blaiss, MD, executive medical director at the ACAAI.

"Maybe understanding these side effects will help patients understand that it's important to stay on track with preventive inhaled corticosteroids, which have minimal potential side effects," he said. "The patient, parent, and caregivers all need to understand that preventive treatments are effective."

But sometimes systemic corticosteroids can't be avoided. "I also want to make sure that patients realize that there are times when their asthma flares up and we don't have a choice but to use oral corticosteroids to get that under control," Blaiss added.

Currently, he said, there are no data to guide how long systemic corticosteroids should be given. "Do some get more than they need? We don't know. We don't have the data to know exactly how much each patient needs to control their asthma flare ups," he said.

American College of Allergy, Asthma & Immunology (ACAAI) 2019 Annual Scientific Meeting. Poster P231.

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