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document
Efficacy and safety of mizolastine 10 mg in a placebo-controlled comparison with loratadine in chronic idiopathic urticaria : results of the MILOR Study . BACKGROUND Mizolastine is a novel histamine H1-antagonist registered in Europe for the management of allergic rhinitis and urticaria . OBJECTIVES To compare the clinical efficacy and safety of mizolastine with loratadine and placebo in patients with chronic idiopathic urticaria ( CIU ) . METHODS A multicentre , double-blind , parallel group study was designed in which 247 patients with CIU were randomised after a 1-week placebo run-in period to 10 mg daily mizolastine ( n = 88 ) , 10 mg daily loratadine ( n = 79 ) , or placebo ( n = 80 ) for a 4-week treatment period . RESULTS Mizolastine and loratadine both relieved symptoms of CIU . After 2 weeks ' treatment , the severity of pruritus ( visual analogue score ( VAS ) assessed by patients ) decreased significantly in both the mizolastine and loratadine groups compared with placebo ( mizolastine : -36.7 mm , P = 0.0001 ; loratadine : -29.8 , P = 0.0071 ; placebo : -16.3 ) ; this improvement with both active treatments was maintained throughout the treatment period , the difference being significant only for the mizolastine group ( P = 0.0090 ) . Both active treatments were also associated with reduced weekly episodes of urticaria compared with placebo , which was significant after 2 weeks ' treatment ( mizolastine : 7.9 episodes , P = 0.0061 ; loratadine : 8.3 , P = 0.0221 ; placebo : 13.3 ) . Angioedema was improved to a clinically significant extent with mizolastine , and loratadine compared with placebo in those patients who had this symptom before treatment . Overall tolerability of both treatments was similar to placebo , and there were no clinically relevant effects on cardiac repolarisation with either mizolastine or loratadine . CONCLUSION Mizolastine ( 10 mg daily ) is confirmed as an effective and well tolerated agent , comparable to loratadine and superior to placebo , for the management of CIU . Mizolastine acted as rapidly as loratadine in improving urticarial symptoms from the first day of treatment .
468
Intervention_Pharmacological
mizolastine
469
Intervention_Control
placebo-controlled
470
Intervention_Pharmacological
loratadine
471
Intervention_Pharmacological
Mizolastine
472
Intervention_Pharmacological
mizolastine with loratadine
473
Intervention_Control
placebo
474
Intervention_Control
placebo
475
Intervention_Pharmacological
mizolastine
476
Intervention_Pharmacological
loratadine
477
Intervention_Control
placebo
478
Intervention_Pharmacological
Mizolastine
479
Intervention_Pharmacological
loratadine
480
Intervention_Pharmacological
mizolastine and loratadine
481
Intervention_Control
placebo
482
Intervention_Pharmacological
mizolastine
483
Intervention_Pharmacological
loratadine
484
Intervention_Control
placebo
485
Intervention_Control
placebo
486
Intervention_Pharmacological
mizolastine
487
Intervention_Pharmacological
loratadine
488
Intervention_Control
placebo
489
Intervention_Pharmacological
mizolastine
490
Intervention_Pharmacological
loratadine
491
Intervention_Control
placebo
492
Intervention_Control
placebo
493
Intervention_Pharmacological
mizolastine or loratadine
494
Intervention_Pharmacological
Mizolastine
495
Intervention_Control
placebo
496
Intervention_Pharmacological
Mizolastine
497
Intervention_Pharmacological
loratadine
498
Outcome_Other
Efficacy and safety
499
Outcome_Physical
relieved symptoms of CIU
500
Outcome_Physical
severity of pruritus ( visual analogue score ( VAS ) assessed by patients )
501
Outcome_Physical
episodes of urticaria
502
Outcome_Physical
Angioedema
503
Outcome_Other
Overall tolerability
504
Outcome_Physical
effects on cardiac repolarisation
505
Outcome_Other
effective and well tolerated
506
Outcome_Physical
urticarial symptoms
507
Participant_Condition
chronic idiopathic urticaria
508
Participant_Condition
chronic idiopathic urticaria ( CIU )
509
Participant_Sample-size
247
510
Participant_Condition
CIU