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Selover D, Dana T, Smith C, et al. Drug Class Review: Nasal Corticosteroids: Final Report Update 1 [Internet]. Portland (OR): Oregon Health & Science University; 2008 Jun.

Cover of Drug Class Review: Nasal Corticosteroids

Drug Class Review: Nasal Corticosteroids: Final Report Update 1 [Internet].

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Appendix E. Adverse effects in head-to-head trials

Study
Sample size
Trial duration
Age
% female
Rhinitis type
Treatments (total daily dose in mcg)Withdrawals due to adverse eventsHeadacheThroat sorenessEpistaxisNasarritation
Al-Mohaimeid
1993
N=120
3 wks
30 years
27.5%
PAR
BUD 400 μg vs. BEC 4005.2% vs. 1.7%; NSNRNRNRNR
Bende 2002
N=438
4 wks
31.0 years
57.7%
PAR
MOM 200 vs.
BUD 256/128
1.9% vs. 4.7% vs. 0.9%; NS9% vs. 11% vs. 11%; NSNR6% vs. 9% vs. 6%; NSNR
Berger 2003
3 wks
N=295
31.6 yrs
62%
SAR
TRI AQ 220 vs. FLUT 200None6.8% vs. 4.1%, NSPharyngitis:
0.7% vs.
2.7%; NS
2.7% vs. 4.8%, NSNR
Bronsky 1987
N=151
4 wks
29 yrs
52%
SAR
FLUN 200/300 vs. BEC 168/336NR10% vs. 10% vs. 12% vs. 10%, NS8% vs. 5% vs. 5% vs. 0%, NS8% vs. 8% vs. 7% vs. 8%, NSStinging/burning: 30% vs. 33% vs. 10% vs. 10%; P<0.05
Bunnag 1984
N=45
4 wks
28.5 years
66.7%
PAR
FLUN 200 vs. BEC 4002.2% vs. 0; NS2.2% vs. 2.2%; NSNRNRBurning sensation: 20% vs. 2.2%; P= 0.0081
Nasal irritation: 2.2% vs. 0; NS
Conley 1994
N=100
1 day
40.0 years
61%
PAR
FLUN 50 vs. BEC 84None0 vs. 2%; NSNRNRNR
Day 1998
N=273
6 wks
30.8 years
54.9%
PAR
BUD 256 vs
FLUT 200
1.8% vs. 1.8%; NS9% vs. 10%; NSNRBloody nasal discharge: 18% vs. 7%; NSNR
Drouin 1996
N=427
12 wks
31.7 years
45.4%
PAR
MOM 200 vs. BEC 4005.6% vs. 4.1%; NS10% vs. 7%; NSPharyngitis: 4% vs. 6%; p-value NR19% vs. 23%; NSNasal irritation: 3% vs. 3%; NS
Nasal Burning: 3% vs. 3%; NS
Graft 1996
N=347
8 wks
34.7 yrs
47.3%
SAR
MOM 200 vs. BEC 3360.8% vs. 4.3%; NS36% vs. 22%; P=0.02Pharyngitis: 6% vs. 10%; NSNRNR
Greenbaum
1988
N=122
4 wks
NR
NR
SAR
New vs. old
FLUN 200
2.4% vs.
4.1%; NS
<12% overall; NS between groups (data NR)Throat irritation: 2% vs. 0; NSNRSevere nasal burning/stinging: 0 vs. 13%; P<0.001
Gross 2002
N=352
3 wks
38.8 yrs
66.5%
SAR
TRI AQ 220 vs. FLUT 2001.2% vs. 0; NS11% vs. 11.7%; NSPharyngitis: 2.3% vs. 6.7%; NSNRNR
Haye 1993
N=242
≤ 1 year
37.6 years
56.6%
PAR
FLUT 200 vs. BEC 200NR8% vs. 4%; NSNR14% vs. 5%; P=0.0285NR
Hebert 1996
N=477
4 wks
32 yrs
8.5%
SAR
MOM 100/200 vs. BEC 4003% vs. 4% vs. 0; NS8% vs. 10% vs. 8%; NSPharyngitis: 3% vs. 2% vs. 4%, NS3% vs. 6% vs. 5%, NSNR
Laforce 1994
N=238
4 wks
24 yrs
29%
SAR
FLUT 200 BID or QD vs. BEC 3360 vs. 0 vs. 1.6%; NS4.7% vs. 3.6% vs. 4.9%, NS3.1% vs. 0 vs. 3.3%, NS0 vs. 1.8% vs. 4.9%; NSBurning: 1.6% vs. 1.8% vs. 6.5%; NS
Langrick 1984
N=60
7 wks
66.7 yrs
37.5%
SAR
FLUN 200 vs. BEC 400NoneDry throat: 2.9% vs. 0; NS
Tickling sensation in nose: 0 vs. 2.8%; NS
Lumry 2003
N=147
3 wks
37 yrs
51%
SAR
TRI AQ 220 vs. BEC 336NoneRespiratory system: 15% vs. 10%; skin and appendages: 1% vs. 9%; digestive system: 5% vs. 5%; nervous system: 4% vs. 0; all P=NS
Mandl 1997
N=550
3 mo
33.0 years
54.7%
PAR
MOM 200 vs. FLUT 2001% vs. 2%; NS6% vs. 9%; NSNR17% vs. 17%; NSNasal burning: 3% vs. 3%; NS
Nasal irritation: 2% vs. 3%; NS
McArthur 1994
N=77
3 wks
27 yrs
51%
SAR
BUD 200 vs. BEC 2004% vs. 0; NS2% vs. 0; NS2% vs. 0; NS0 vs. 2.6%; NSItchy nose: 0 vs. 2.6%; NS
Ratner 1992
N=136
2 wks
44 yrs
62%
SAR
FLUT 200 vs. BEC 336None0 vs. 1%; NS2% vs. 2%; NS3% vs. 2%; NSNasal burning: 5% vs. 2%; NS
Ratner 1996
N=218
6 wks
44 yrs
62%
SAR
New vs. old FLUN 200NR9% vs. 5%; NSNRNRIrritation/tenderness: 4% vs. 4%; NS
Sahay 1980
N=60
4 wks
37 yrs
48%
PAR
FLUN 200 vs. BEC 4003.3% vs. 10%; NS13.3% vs. 3.3%; NSNR0 vs. 10%; NSNasal irritation: 10% vs. 3.3%; NS
Nasal dryness: 6.7% vs. 10%; NS
Small 1997
N=233
3 wks
28 yrs
52%
SAR
TRI HFA 220 vs. FLUT 200NR5% vs. 9%; NSNR3% vs. 4%; NSNR
Stern 1997
N=635
4–6 wks
Age NR
51%
SAR
BUD 128/256 vs. FLUT 2000.5% vs. 0.5% vs. 1.7%; NSNRNRNRNR
Synnerstad
1996
N=25
12 mo
44.1 years
16%
NAR
BUD 256 vs. BEC 336NRNRNR0 vs. 25%8.3% vs. 16.6%; p-value
NR
Tai 2003
N=24
8 wks
40.9 years
62.5%
PAR
BUD 400 vs FLUT 200NoneNRNRNRNR
van As 1993
N=466
6 mo
36.3 years
51.3%
PAR
FLUT 200
BID/200 QD vs. BEC 168
5% vs. 3% vs. 9%; NS4% vs. 2% vs. 5%; NS14% vs. 15% vs. 9%; NSNasal irritation: 0 vs. 2% vs. 0 Nasal dryness: 3% vs. 2% vs. 0; NS
Nasal burning: 1% vs. 3% vs. 3%; NS
Welsh 1987
N=100
6 wks
28 yrs
33%
SAR
FLUN 200 vs. BEC 3366.7% vs. 0; NS0 vs. 16.7%; P=0.0522NRNosebleeds: 0 vs. 0Sore nose: 3.3% vs. 3.3%; NS
Zawisza 1992
N=43
4 wks
NR
NAR
FLUN 200 vs. BEC 3000% vs. 10%NRNRNR20% vs. 40%; p-value
NR

Prophylaxis trial;

Fisher’s exact test performed using StatsDirect (CamCode, U.K.)

Copyright © 2008, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK47240

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