11799
document
Long-term use of Viozan ( sibenadet HCl ) in patients with chronic obstructive pulmonary disease : results of a 1-year study . Viozan ( sibenadet HCl , AR-C68397AA ) is a novel dual D2 dopamine receptor , beta2-adrenoceptor agonist that has been investigated for efficacy in alleviating the symptoms of chronic obstructive pulmonary disease ( COPD ) . The slowly progressive nature of this disease means that patients will require ongoing therapeutic management for many years , or even decades . With such long-term treatment , the safety profile of new agents will be of paramount importance . As part of the large-scale assessment of sibenadet , a 12-month safety study has been conducted . Following completion of a 2-week baseline period , 435 adults with stable , symptomatic , smoking-related COPD were randomized to receive either 500 microg sibenadet or placebo delivered via pressurized metered dose inhaler ( pMDI ) , three times daily for 52 weeks . Sibenadet therapy was generally well tolerated , with the only notable differences seen in the incidence of tremor and taste of treatment ( 16.9 % vs. 4.1 % and 14.5 % vs. 4.1 % in the sibenadet and placebo groups respectively ) . There were a total of 79 patients with serious adverse events ( SAEs ) , 43 ( 14.8 % ) in the sibenadet pMDI group and 36 ( 24.8 % ) in the placebo group . No clinically significant abnormal laboratory values or overall differences between treatment groups were noted . Similarly , there were no clinically significant differences between the two treatment groups for cardiac variables , or in vital signs . The secondary variables showed no notable differences with respect to lung function , exacerbations or health-related quality of life . Due to the effective beta2-agonist properties , patients in the sibenadet group did , however , report reduced rescue medication usage at all timepoints . While the results of this study show that , overall , sibenadet therapy was well tolerated , the lack of sustained benefit reported in large-scale clinical efficacy studies means that sibenadet development will not be continued .
11800
Intervention_Pharmacological
Viozan ( sibenadet HCl )
11801
Intervention_Pharmacological
Viozan
11802
Intervention_Pharmacological
sibenadet HCl
11803
Intervention_Pharmacological
AR-C68397AA
11804
Intervention_Pharmacological
sibenadet
11805
Intervention_Pharmacological
500 microg sibenadet
11806
Intervention_Control
placebo
11807
Intervention_Pharmacological
Sibenadet
11808
Intervention_Control
placebo
11809
Intervention_Control
placebo
11810
Outcome_Other
well tolerated
11811
Outcome_Physical
notable differences
11812
Outcome_Physical
incidence of tremor and taste of treatment
11813
Outcome_Adverse-effects
serious adverse events
11814
Outcome_Physical
clinically significant abnormal laboratory values
11815
Outcome_Physical
overall differences
11816
Outcome_Physical
no clinically significant differences
11817
Outcome_Physical
cardiac variables , or in vital signs
11818
Outcome_Physical
no notable differences
11819
Outcome_Physical
lung function
11820
Outcome_Physical
exacerbations or health-related quality of life
11821
Outcome_Other
reduced rescue medication usage at all timepoints
11822
Outcome_Other
well tolerated
11823
Outcome_Other
lack of sustained benefit
11824
Outcome_Other
large-scale clinical efficacy studies
11825
Participant_Condition
chronic obstructive pulmonary disease
11826
Participant_Sample-size
435
11827
Participant_Age
adults
11828
Participant_Condition
stable , symptomatic , smoking-related COPD
11829
Participant_Sample-size
79
11830
Participant_Condition
serious adverse events
11831
Participant_Condition
SAEs
11832
Participant_Sample-size
43
11833
Participant_Condition
sibenadet pMDI
11834
Participant_Sample-size
36
11835
Participant_Condition
placebo