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Your Yourlocation: Home > Comparative study on the efficacy of tiotropium bromide(136310-93-5) and other drugs

The first 24-week, randomized, double-blind, double-dummy, parallel-controlled trial compared the clinical efficacy and safety of UMEC /VI 62.5 /25mg with 125/25 mg, VI 25mg and tiotropium bromide(136310-93-5) 18mg. The study randomized 846 patients. The FEV1 trough at the end of the scheduled treatment (169 days) was the end point of efficacy. The clinical efficacy of both doses of UMEC /VI was significantly better than that of VI (88-90 mL, p <0.001) and tiotropium (88-90 mL, p <0.001), which was statistically significant.

The 24-week, randomized, double-blind, double-dummy, parallel-controlled trial compared the clinical efficacy and safety of UMEC /VI 62.5 /25mg with 125/25 mg, UMEC 125mg and tiotropium bromide(136310-93-5) 18mg. The study randomized 872 patients. The FEV1 trough at the end of the treatment (169 days) was pre-defined as the end point of efficacy. There was a statistically significant improvement in the clinical efficacy of both doses of UMEC /VI compared to VI (88-90 mL, p <0.001) and tiotropium (88-90 mL, p <0.001). The clinical efficacy of UMEC /VI 125/25 mg was significantly better than that of tiotropium (p = 0.003) in the first comparative trial, which was statistically significant (74 ml). In the second efficacy comparison trial, UMEC /VI showed a numerical difference (37 ml) in comparison to UMEC 125 mg (p = 0.003), but this difference was not statistically significant. The difference in the FEV1 trough values for UMEC /VI 62.5 /25 mg respectively compared with tiotropium bromide and UMEC 125 mg was 60 m (p = 0.018) and 22 ml (p = 0.377, respectively).

In these four studies, the most common adverse events in the treatment group included placebo, headache, nasopharyngitis, upper respiratory tract infection, cough, sore throat and back pain. In addition, the incidence of cardiovascular adverse events in the treatment groups was similar (5-9% in the placebo group, 7-11% in the VI group, 10% in the UMEC 62.5 mg group, 7-9% in the UMEC 125 mg group, 62.5 /25 mg in the UMEC /VI Group 6-11%, UMEC /VI 125/25 mg group 6-7%, tiotropium group 4-8%). The incidence of serious adverse events in the treatment arms was similar (3-6% in the placebo group, 5-7% in the group VI, 6% in the UMEC 62.5 mg group, 5-7% in the UMEC 125 mg group, 10%, 2-7% of the UMEC /VI 125/25 mg group, and 4-6% of the tiotropium bromide(136310-93-5) group.

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