1.Efficacy and Tolerability of Anticholinergics in Korean Children with Overactive Bladder: A Multicenter Retrospective Study.
Se Jin PARK ; Ki Soo PAI ; Jun Mo KIM ; Kwanjin PARK ; Kun Suk KIM ; Sang Hoon SONG ; Sungchan PARK ; Sun Ouck KIM ; Dong Soo RYU ; Minki BAEK ; Sang Don LEE ; Jung Won LEE ; Young Jae IM ; Sang Won HAN ; Jae Min CHUNG ; Min Hyun CHO ; Tae Sun HA ; Won Yeol CHO ; Hong Jin SUH
Journal of Korean Medical Science 2014;29(11):1550-1554
We investigated the efficacy and tolerability of various anticholinergics in Korean children with non-neurogenic overactive bladder (OAB). A total of 326 children (males:females= 157:169) aged under 18 yr (mean age 7.3+/-2.6 yr) who were diagnosed with OAB from 2008 to 2011 were retrospectively reviewed. The mean duration of OAB symptoms before anticholinergic treatment was 16.9+/-19.0 months. The mean duration of medication was 5.6+/-7.3 months. Urgency urinary incontinence episodes per week decreased from 1.9+/-3.1 to 0.4+/-1.5 times (P<0.001). The median voiding frequency during daytime was decreased from 9.2+/-5.4 to 6.3+/-4.2 times (P<0.001). According to 3-day voiding diaries, the maximum and average bladder capacity were increased from 145.5+/-66.9 to 196.8+/-80.3 mL and from 80.8+/-39.6 to 121.8+/-56.5 mL, respectively (P<0.001). On uroflowmetry, maximum flow rate was increased from 17.6+/-8.4 to 20.5+/-8.2 mL/sec (P<0.001). Adverse effects were reported in 14 (4.3%) children and six children (1.8%) discontinued medication due to adverse effects. Our results indicate that anticholinergics are effective to improve OAB symptoms and tolerability was acceptable without severe complications in children.
Child
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Child, Preschool
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Cholinergic Antagonists/adverse effects/*therapeutic use
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Constipation/etiology
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Dizziness/etiology
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Female
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Humans
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Male
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Retrospective Studies
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Treatment Outcome
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Urinary Bladder, Overactive/*drug therapy
2.Evaluation of the efficacy and safety of tiotropium bromide (5 µg) inhaled via Respimat in Chinese patients with chronic obstructive pulmonary disease.
Yan TANG ; Dan MASSEY ; Nan-shan ZHONG
Chinese Medical Journal 2013;126(19):3603-3607
BACKGROUNDA pharmacokinetic study in an Asian population showed that tiotropium 5 µg via Respimat leads to the same plasma levels compared to 18 µg via HandiHaler. The objective of the trial was to compare the efficacy and safety of longterm treatment (1 year) with tiotropium bromide (5 µg) via Respimat® with placebo in patients with chronic obstructive pulmonary disease (COPD).
METHODSA total of 3991 patients were randomized in this double-blind, placebo controlled, parallel group study, while in China 338 patients (309 males, 29 females) received either tiotropium bromide (n = 167) or placebo (n = 171). Tiotropium bromide solution or matching placebo was delivered via Respimat® at a dosage of 5 µg (2×2.5 µg/puff) once daily for 48 weeks. Co-primary endpoints were trough forced expiratory volume in one second (FEV1) and the time to first exacerbation.
RESULTSStatistically significant improvements in trough FEV1 and trough forced vital capacity (FVC) in the tiotropium group were achieved at weeks 4, 24, and 48 compared with those in the placebo group. A statistically significant difference (P = 0.0027) in favour of tiotropium was also observed for the time to first exacerbation. The total numbers of exacerbations during treatment were 90 and 128 in the tiotropium and placebo groups, respectively, with a rate ratio of 0.69 (P = 0.0164). The difference between the treatment groups in the adjusted mean changes from baseline of St. George Respiratory Questionnaire (SGRQ) total score was -3.9 (95% CI: -7.5, -0.2) and was of statistical significance (P = 0.0367). The incidences of serious adverse events (SAEs) in the tiotropium and placebo groups were 16.2% and 17.0%, respectively. Seven deaths occurred whilst patients were on treatment, four in the tiotropium group and three in the placebo group, all of which were assessed as non-related study drugs by the investigators.
CONCLUSIONSTiotropium significantly improved lung function and quality of life, delayed the time to first exacerbation, reduced the number of exacerbations. Overall, tiotropium was well tolerated.
Administration, Inhalation ; Aged ; Bronchodilator Agents ; adverse effects ; therapeutic use ; Cholinergic Antagonists ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Forced Expiratory Volume ; Humans ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; physiopathology ; Scopolamine Derivatives ; adverse effects ; therapeutic use ; Tiotropium Bromide