2016 Section 5 Green Book

Smith et al.

TABLE 2. Hypothalamic pituitary adrenal axis testing (n = 35)

TABLE 1. Baseline characteristics for cohort with CRS (n = 35)

Outcome

Characteristic

Morning serum cortisol level Mean ± SD (nmol/L)

Gender, n (%) Female

431.2 ± 146.88

13 (37)

Range (nmol/L)

128–808

Male

22 (63)

Normal (n) a

16

Age (years), mean (range)

49.5 (20–77)

Low (n) b

2

Asthma, n (%)

18 (62)

Nondiagnostic (n) c

17

Allergy, n (%)

13 (45)

250 mcg cosyntropin stimulation test Normal (n) d

ASA intolerance, n (%)

6 (21)

19

Smoker, n (%)

2 (7)

Abnormal (n) e

0

Nasal polyposis, n (%)

20 (69)

SNOT-22 score presentation, mean ± SD SNOT-22 score follow-up, mean ± SD Sinus CT score (Lund-Mackay), mean (range)

49.1 ± 21.9 20.5 ± 16.9 14.3 (4–24)

a Normal: greater than 500 nmol/L. b Low: less than 200 nmol/L, greater than 100 nmol/L. c Nondiagnostic: less than 500 nmol/L, greater than 200 nmol/L. d Normal: cortisol greater than 500 nmol/L at 60 minutes. e Abnormal: cortisol less than 500 nmol/L at 60 minutes. SD = standard deviation.

Duration of budesonide use (months), mean (range)

38.2 (15–96)

Concurrent medication use, n (%) Inhaled corticosteroids

in patients on prolonged topical steroids. Two patients had low serum AM cortisol levels, which in the general popula- tion would have prompted further testing but are not di- agnostic of exogenous suppression (less than 200 nmol/L, greater than 100 nmol/L). All 19 of these patients went on to receive normal 250 mcg cosyntropin stimulation tests. Eighteen patients in this cohort (62%) had a history of concurrent asthma and were taking inhaled corticosteroids. Hypothetically, the systemic effects of multiple corticos- teroids may be cumulative and potentially put this subset of patients at higher risk for HPA axis suppression. How- ever, none of these patients had evidence of suppression. None of the patients were concurrently prescribed oph- thalmic corticosteroids or intranasal corticosteroid sprays and as such the cumulative effectives of these medications of budesonide irrigations cannot be assessed. The importance of topical intranasal steroids in the man- agement of CRS is well established. 3,17,20,21 Although the safety profiles for intranasal steroid sprays are well known, the greatest drawback of these low-volume sprays is in- adequate delivery into the paranasal sinuses. 5,6,8,9 High- volume irrigation techniques have been shown to optimize delivery of medications into the sinuses and are believed to offer a better maintenance technique to control mucosal inflammation. 6,8–10 High-volume irrigation techniques are now recommended as the primary delivery mechanism for topical intranasal corticosteroid therapy in patients with CRS. 11,22 Unfortunately, they remain limited to off-label agents and lack robust safety profiles. 4 Prolonged topical steroids are associated with a risk of unintended systemic absorption, which can lead to a vari- ety of adverse effects such as increased intraocular pres- sure, glaucoma, osteoporosis, avascular necrosis of the hip, and HPA axis suppression. 23 However, HPA axis

18 (62)

Intranasal corticosteroid sprays

0 (0)

Ocular corticosteroid drops

0 (0)

Systemic corticosteroids

0 (0)

Oral contraceptive pills

1 (3)

ASA = acetylsalicylic acid; CRS = chronic rhinosinusitis; CT = computed tomog- raphy; SD = standard deviation; SNOT-22 = 22-item Sino-Nasal Outcome Test.

results less than 500 nmol/L and required cosyntropin stim- ulation testing. Serum AM cortisol results are detailed in Table 2. Of the 19 patients who required cosyntropin stim- ulation testing, none had abnormal test results (all cortisol levels greater than 500 nmol/L at 60 minutes). Discussion This study examined the effect of long-term (greater than 12 months) high-volume sinonasal budesonide irrigations on HPA axis function in patients with CRS. After a mean of 38.2 months (2.9 years) of twice daily use of 1 mg per irrigation (2 mg daily dose), there were no de- tected cases of HPA axis suppression on objective testing. The results from this study suggest that the long-term use of sinonasal budesonide irrigations (up to 2.9 years) may be a safe treatment option in patients with CRS after ESS. The mean serum AM cortisol level was 431.2 nmol/L, with a range of 128 to 808 nmol/L. Of the 35 patients enrolled into this study, 19 had serum AM cortisol levels that could not exclude exogenous HPA axis suppression (less than 500 nmol/L). Seventeen of these patients had serum levels within the normal range, which cannot exclude suppression

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