Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


The Clinical and Economic Burden of Corticosteroid Adverse Events (AEs): A Systematic Literature Review.

Sarnes2,  Evelyn F., Watson1,  Maria E.

GlaxoSmithKline, Research Triangle Park, NC
Xcenda, Palm Harbor, FL

Background:

Systemic corticosteroids are an important and commonly used therapy; however, their use must be balanced against a set of side effects. This study evaluated the clinical and economic burden of systemic corticosteroid AEs in a wide variety of patient populations. A secondary objective was to consider the clinical and economic impact of reducing daily corticosteroid doses.

Methods:

A systematic review of 2007–2009 studies retrieved by a predefined search strategy in Medline, EMBASE, and Cochrane Library, as well as AHRQ, NICE, and NHS HEED (free text) was performed to supplement an existing literature review. Relevant articles (observational and intervention studies) evaluated incidence/relative risk of AEs following corticosteroid use or the relationship between dose/duration and AEs. Case studies, studies in infants, and studies with inhaled corticosteroids were excluded. Titles/abstracts of retrieved articles were screened for eligibility. A secondary search, based on citations from other systematic reviews and including pre-2007 articles, was conducted to obtain data on psychiatric conditions, infections, and peptic ulcers. Information about dose-response relationships was combined with cost data from the literature to estimate the cost implications of a dose reduction for two corticosteroid AEs.

Results:

A total of 323 articles were evaluated from the primary search; 27 were included. Excluded articles did not focus on corticosteroid AEs (n=70), were case studies (n=50), evaluated corticosteroid efficacy (n=38), or evaluated therapy to alleviate corticosteroid AEs (n=13). The secondary search added 20 studies. Overall, 25 were retrospective in design, 13 were conducted in the US and 21 in Europe. The AEs for which the literature contained the greatest number of reports were psychiatric events (18 reports), infections (15), gastrointestinal (GI) conditions (14), and fracture (11). Common AEs (>30% incidence) with a greater number of reports were sleep disturbances, lipodystrophy, adrenal suppression, and hypertension. The incidence of fracture varied by location: wrist fracture, Colles' fracture, and lower limb fracture were generally low (incidence 3–5%). Vertebral fractures were more common (range, 21–30%). Severe GI AEs were less frequent (ulcers, 1–5%; bleeding, 3–5%). Despite wide variability in study design, population, daily dose, conditions treated, and treatment duration, most AEs (fracture, myocardial infarction (MI), weight gain, infections, glaucoma, and psychiatric events) demonstrated a dose-response pattern with increasing daily dose. Studies of fractures and MIs demonstrated the clearest dose-response relationship. As such, reducing daily dose requirements may reduce AE clinical and economic burden. For example, dose reduction from 7.5–15 mg/day to <7.5 mg/day may avoid 96 fractures per 10,000 elderly patients at $18,358 per fracture and a reduction from >10 mg/day to <=10 mg/day avoid 19 MIs per 10,000 patients at $26,472 per MI (US $ 2009).

Conclusions:

The clinical and economic burden of corticosteroid AEs is substantial; lowering the daily dose requirements may lower the incidence of many AEs.

To cite this abstract, please use the following information:
Sarnes, Evelyn F., Watson, Maria E.; The Clinical and Economic Burden of Corticosteroid Adverse Events (AEs): A Systematic Literature Review. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1566
DOI: 10.1002/art.29332

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