Adverse events from head-to-head and active control trials in adults (Original Report)a

Author
Year
Adverse eventsTotal withdrawalsWithdrawals from AEs
Head-to-head trials
Ciprandi 199729

L: loratadine 10 mg qd
C: cetirizine 10 mg qd
No significant AEs reportedTotal: 00
Hampel 200331

F: fexofenadine 180mg qd
C: cetirizine 10mg qd
Total AEs: 16.7%
AEs per group:
F: 16.9%
C: 16.6%
F: less overall drowsiness
P=0.0110, NS effect on motivation
Total: 3.2%
F: 2.8%
C: 3.6%
1.2% AEs
3 efficacy
Safety evaluated in AE population
Howarth 199932

F1: fexofenadine 120 mg qd
F2: fexofenadine 180 mg qd
C: cetirizine 10 mg qd
P: placebo
Treatment-related AEs:
F1: 23%
F2: 23%
C: 25%
P: 25 %
Total: 14%
Similar among groups (numbers per group NR)
F: 2%
C: <1%
P: 2%
Prenner 200033

L: loratadine 10 mg qd
F: fexofenadine 120 mg qd
F 22.1% vs. L 18.2% had ≥1 AE.
Considered treatment related in F 8.3% L 5.3%
NRNR
Van Cauwenberge 200036

L: loratadine 10 mg qd
F: fexofenadine 120 mg qd
P: placebo
16.4% of total
F: 16.8%
L: 17.5%
P: 14.7%
Total: 10%
F: 9%
L: 12%
P: 11%
F: 1%
L: 2%
P: 3%
Guerra 199474

L: loratadine 10mg
C: cetirizine 10mg
P: placebo
20.7% Total NSD.
L: 15.8%
C: 27.5%
P: 15.8%
C: 1C: 2.5% stomach pain
Active control trials
Frolund 199072

L: loratadine 10 mg qd
C: clemastine 1 mg bid
P: placebo
32.9% Total
L: 15% (P<0.05)
C: 58.8%, sedation significant
P: 49% placebo
Total: 13.5%
L: 9.4%
C: 5.8%
P: 25.4%
L: 0%
C: 1.9%: 1 AE/2 efficacy
P: 0%
Breneman 199687

C: cetirizine 10mg qd
H: hydroxyzine 25 mg tid
P: placebo
C: 18%
H: 30%
P: 6%
H vs. P. P=0.001
Total: 4.8%
C: 1.7%
H: 6.3%
P: 6.1%
Somnolence:
C: 1.7%
H: 6.3%
P: 6.1%
Berger 200327

D: desloratadine 5 mg
A1: azelastine nasal
A2: azelastine nasal + loratadine
P: placebo
Most common per treatment:
Bitter taste
A1: 11% vs. A2: 4%
D: Headache 3%, pharyngitis 4%
P: headache 7%
Somnolence:
A1: 2%; A2: 1%; D: 1%; P: 1%
A1: 2%
D: 1%
P: 1%
A1: 2% (moderate chest pain, lightheadedness)
D: 1% (headache and nausea)
P: 1% (rash)
Dockhorn 198756

L: loratadine 10 mg
C: clemastine 2 mg
P: placebo
More AEs (considered probably or possibly treatment-related) in C
C: 37%
L: 21%
P: 20% (p≤0.01)
More sedation in C:
C: 22%
L: 6% (p≤0.01)
NRNR
a

Only fair- and good-quality studies are presented in the table. Poor-quality studies are listed in Appendix F.

Abbreviations: bid, twice daily; mg, milligrams; NSD, no significant difference; NR, not reported; qd, once daily; tid, 3 times daily.

From: Appendix E, Reporting of adverse events

Cover of Drug Class Review: Newer Antihistamines
Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet].
Carson S, Lee N, Thakurta S.
Portland (OR): Oregon Health & Science University; 2010 May.
Copyright © 2010 by Oregon Health & Science University, Portland, Oregon 97239. All rights reserved.

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