Comparative efficacy and safety of once-daily versus twice-daily loratadine-pseudoephedrine combinations versus placebo in seasonal allergic rhinitis.
The objective of this study was to compare the efficacy and safety of Claritin-D 24 Hour (once daily) with that of Claritin-D 12 Hour (twice daily) and placebo in the treatment of patients with seasonal allergic rhinitis (SAR). In this double-blind, placebo-controlled, multicenter study, 469 patients with moderate-to-severe SAR symptoms were treated for 2 weeks with one of the following: Claritin-D 24 Hour (a combination tablet formulation of loratadine 10 mg in the coating and pseudoephedrine sulfate 240 mg in an extended-release core), Claritin-D 12 Hour (a combination tablet formulation of loratadine 5 mg in the tablet coating and 120 mg pseudoephedrine sulfate, 60 mg in the coating and 60 mg in the core), or placebo. Claritin-D 24 Hour and Claritin-D 12 Hour were consistently superior to placebo (P < 0.01) in reducing total, nasal, and nonnasal symptom scores. Patients in the Claritin-D 24 Hour and Claritin-D 12 Hour groups also had significantly greater (P </= 0.05) relief of rhinorrhea and nasal stuffiness as compared with placebo. Insomnia was reported significantly more often (P < 0.01) in Claritin-D 12 Hour (15%) patients compared with Claritin-D 24 Hour (4%) and placebo (2%) patients. Dry mouth was reported significantly more often (P < 0.05) in Claritin-D 24 Hour (13%) and Claritin-D 12 Hour (13%) groups compared with placebo (4%). Claritin-D 24 Hour has efficacy comparable to Claritin-D 12 Hour in relieving allergic rhinitis symptoms while producing significantly less insomnia.
Kaiser
H B
HB
Allergy & Asthma Specialists, PA, Minneapolis, MN 55402, USA.
Banov
C H
CH
Berkowitz
R R
RR
Bernstein
D I
DI
Bronsky
E A
EA
Georgitis
J W
JW
Mendelson
L M
LM
Rooklin
A R
AR
Sholler
L J
LJ
Stricker
W W
WW
Harrison
J E
JE
Danzig
M R
MR
Lorber
R R
RR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004809:Ephedrine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome; D014481:United States; D014662:Vasoconstrictor Agents / Q000008:administration & dosage* / Q000009:adverse effects
D018926:Anti-Allergic Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D013607:Tablets; D014662:Vasoconstrictor Agents; D017336:Loratadine; D004809:Ephedrine