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更新于：2025-08-26
Olodaterol Hydrochloride/Tiotropium Bromide
噻托溴铵奥达特罗
更新于：2025-08-26
概要
基本信息
药物类型 小分子化药 |
别名 BI-1744-CL/tiotropium bromide、Olodaterol Hydrochloride/Tiotropium Bromide Hydrate、Olodaterol/tiotropium bromide + [16] |
作用方式 拮抗剂、激动剂 |
作用机制 M3 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M3拮抗剂)、β2-adrenergic receptor激动剂(β2-肾上腺素能受体激动剂) |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2015-05-21), |
最高研发阶段(中国)无进展 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C21H27ClN2O5 |
InChIKeyKCEHVJZZIGJAAW-FERBBOLQSA-N |
CAS号869477-96-3 |
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关联
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100 项与 噻托溴铵奥达特罗 相关的临床结果
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100 项与 噻托溴铵奥达特罗 相关的转化医学
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100 项与 噻托溴铵奥达特罗 相关的专利（医药）
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172
项与 噻托溴铵奥达特罗 相关的文献（医药）2024-08-08Expert review of pharmacoeconomics & outcomes research
Improved medication adherence in COPD patients using tiotropium or tiotropium olodaterol with the HealthPrize digital behavior change program
Article
作者: DeKoven, Mitchell ; Shaikh, Asif ; Firlik, Katrina S ; Anupindi, Vamshi Ruthwik ; Hayes, Vincent ; Franchino-Elder, Jessica
OBJECTIVE:
To assess the impact of the HealthPrize RespiPoints™ program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD).
METHODS:
In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015-31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics® Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (≥80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs.
RESULTS:
Program participants (n = 262) demonstrated a 44% greater adherence during followup than nonparticipants (n = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72-3.66, p < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p = 0.23); adjusted total medical costs were 24% lower (p = 0.08). Higher pharmacy costs partially offset lower healthcare costs.
CONCLUSIONS:
Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.
2023-07-01Advances in therapy
EVELUT®: A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS.
Article
作者: Taube, Christian ; Buhl, Roland ; Vogelmeier, Claus F ; Dreher, Michael ; Eckhardt, Sebastian ; Emerson-Stadler, Rachel ; Mattiucci-Guehlke, Muriel
INTRODUCTION:
The Global Initiative for Chronic Obstructive Lung Disease (GOLD 2023) no longer recommends a long-acting β2-agonist (LABA) plus inhaled corticosteroid (ICS) combination for the treatment of chronic obstructive pulmonary disease (COPD). In patients treated with LABA/ICS, who continue to experience symptoms without frequent or severe exacerbations, GOLD now recommends switching to long-acting muscarinic antagonist (LAMA)/LABA instead of escalating to triple therapy (TT; LAMA/LABA/ICS), which previously was also a recommended option. EVELUT®, a real-life, observational study, compared these two treatment strategies in terms of symptom relief and health status improvement.
METHODS:
Patients with symptomatic COPD at low exacerbation risk (GOLD B) were switched, at their physicians' discretion, from LABA/ICS to either fixed-dose LAMA/LABA (tiotropium/olodaterol, Respimat® [Tio/Olo]) or fixed or free TT. Primary endpoints were change in modified Medical Research Council (mMRC) and COPD Assessment Test™ (CAT™) scores after 12 weeks.
RESULTS:
The safety set contained 463 patients (Tio/Olo, n = 329; TT, n = 134). In a propensity score-matched set (Tio/Olo, n = 121; TT, n = 121), improvement in mMRC score was similar in patients on Tio/Olo (-0.23; 95% confidence interval [CI] -0.11, -0.36) and TT (-0.25; 95% CI -0.13, -0.38). Improvement in total CAT score was slightly larger in patients on Tio/Olo (-3.45; 95% CI -2.45, -4.45) versus TT (-2.51; 95% CI -1.62, -3.40). In both groups, Physician's Global Evaluation scores increased, with 69-89% of patients satisfied with their treatment overall. Marginally more patients on Tio/Olo responded to treatment versus TT (Δ mMRC score ≥ 1; 25% vs. 22%; Δ CAT score ≥ 2, 68% vs. 56%).
CONCLUSION:
In patients with symptomatic COPD at low exacerbation risk, treatment can be switched from LABA/ICS to LAMA/LABA without compromising clinical benefit, compared with escalating to LAMA/LABA/ICS. Switching from LABA/ICS to LAMA/LABA can provide symptom relief and improve health status without exposure to the risks associated with ICS.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov: NCT03954132.
2023-07-01Journal of managed care & specialty pharmacy
Clinical and economic outcomes in patients with chronic obstructive pulmonary disease initiating maintenance therapy with tiotropium bromide/olodaterol or fluticasone furoate/umeclidinium/vilanterol.
Article
作者: Buysman, Erin K ; Ferguson, Gary T ; Shaikh, Asif ; Sargent, Andrew ; Palli, Swetha R ; Sethi, Sanjay ; Bengtson, Lindsay G S ; Clark, Brendan
BACKGROUND: Clinical practice guidelines recommend dual long-acting muscarinic antagonists (LAMAs)/long-acting β2agonists (LABAs) as maintenance therapy in patients with chronic obstructive pulmonary disease (COPD) and dyspnea or exercise intolerance. Escalation to triple therapy (TT) (LAMA/LABA/inhaled corticosteroid) is conditionally recommended for patients with continued exacerbations on dual LAMA/LABA therapy. Despite this guidance, TT use is widespread across COPD severities, which could impact clinical and economic outcomes. OBJECTIVE: To compare COPD exacerbations, pneumonia events, and disease-related and all-cause health care resource utilization and costs (in 2020 US dollars) in patients initiating fixed-dose combinations of either LAMA/LABA (tiotropium/olodaterol [TIO + OLO]) or TT (fluticasone furoate/umeclidinium/vilanterol [FF + UMEC + VI]). METHODS: This retrospective observational study of administrative claims included patients with COPD aged 40 years or older initiating TIO + OLO or FF + UMEC + VI from June 2015 to November 2019. TIO + OLO and FF + UMEC + VI cohorts in the overall and maintenance-naive populations were 1:1 propensity score matched on baseline demographics, comorbidities, COPD medications, health care resource utilization, and costs. Multivariable regression compared clinical and economic outcomes up to 12 months in FF + UMEC + VI vs TIO + OLO postmatched cohorts. RESULTS: After matching, there were 5,658 and 3,025 pairs in the overall and maintenance-naive populations, respectively. In the overall population, the risk of any (moderate or severe) exacerbation was 7% lower in FF + UMEC + VI vs TIO + OLO initiators (adjusted hazard ratio [aHR] = 0.93; 95% CI = 0.86-1.0; P = 0.047). There was no difference in the adjusted risk of any exacerbation in the maintenance-naive population (aHR = 0.99; 95% CI = 0.88-1.10). Pneumonia risk was not statistically different between cohorts in the overall (aHR = 1.12; 95% CI = 0.98-1.27) and maintenance-naive (aHR = 1.13; 95% CI = 0.95-1.36) populations. COPD- and/or pneumonia-related adjusted total annualized costs (95% CI) were significantly greater for FF + UMEC + VI vs TIO + OLO in the overall ($17,633 [16,661-18,604] vs $14,558 [13,709-15,407]; P < 0.001; differences [% of relative increase] = $3,075 [21.1%]) and maintenancenaive ($19,032 [17,466-20,598] vs $15,004 [13,786-16,223]; P < 0.001; $4,028 [26.8%]) populations, with significantly higher pharmacy costs with FF + UMEC + VI (overall: $6,567 [6,503-6,632] vs $4,729 [4,676-4,783]; P < 0.001; $1,838 [38.9%]; maintenance-naive: $6,642 [6,560-6,724] vs $4,750 [4,676-4,825]; P < 0.001; $1,892 [39.8%]). CONCLUSIONS: A lower risk of exacerbation was observed with FF + UMEC + VI vs TIO + OLO in the overall population but not among the maintenance-naive population. Patients with COPD initiating TIO + OLO had lower annualized costs than FF + UMEC + VI initiators in the overall and maintenance-naive populations. Thus, in the maintenance-naive population, initiation with dual LAMA/LABA therapy per practice guidelines can improve real-world economic outcomes. Study registration number: ClinicalTrials.gov (identifier: NCT05127304). DISCLOSURES: The study was funded by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI). To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, BIPI grants all external authors access to relevant clinical study data. In adherence with the BIPI Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Dr Sethi has received honoraria/fees for consulting/speaking from Astra-Zeneca, BIPI, and GlaxoSmithKline. He has received consulting fees for serving on data safety monitoring boards from Nuvaira and Pulmotect. He has received consulting fees from Apellis and Aerogen. His institution has received research funds for his participation in clinical trials from Regeneron and AstraZeneca. Ms Palli was an employee of BIPI at the time the study was conducted. Drs Clark and Shaikh are employees of BIPI. Ms Buysman and Mr Sargent are employees and Dr Bengtson was an employee of Optum, which was contracted by BIPI to conduct this study. Dr Ferguson reports grants and personal fees from Boehringer Ingelheim during the conduct of the study; grants from Novartis, Altavant, and Knopp; grants and personal fees from AstraZeneca, Verona, Theravance, Teva, and GlaxoSmithKline; and personal fees from Galderma, Orpheris, Dev.Pro, Syneos, and Ionis outside the submitted work. He was a paid consultant for BIPI for this study. The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
100 项与 噻托溴铵奥达特罗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性支气管炎 | 日本 | 2015-11-18 | |
| 肺气肿 | 日本 | 2015-11-18 | |
| 慢性阻塞性肺疾病 | 美国 | 2015-05-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肺疾病 | 临床3期 | 美国 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 澳大利亚 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 奥地利 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 比利时 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 加拿大 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 丹麦 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 德国 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 新西兰 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 波兰 | 2014-03-01 | |
| 慢性肺疾病 | 临床3期 | 葡萄牙 | 2014-03-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | Tiotropium/Olodaterol (TIO + OLO) | 壓製醖製憲積獵顧糧夢(獵艱壓艱鏇鹽鬱製鏇鹹) = 構願艱選願糧衊願製構 網衊願鏇構夢醖糧廠選 (餘簾夢鬱選製艱鏇鹽遞, 0.86 ~ 1.0) | - | 2023-07-01 | ||
N/A | 1,255 | 鏇範齋醖繭夢鬱衊鑰蓋(鑰糧膚獵鑰廠觸製顧遞) = 顧鹹鹹鏇醖積築醖繭顧 齋選餘醖繭鏇鹹窪鏇鏇 (顧壓積醖觸遞齋鏇繭齋 ) 更多 | - | 2022-08-10 | |||
临床4期 | 14 | 鏇鬱艱獵築餘顧鹽構夢(齋餘顧繭鬱鬱鏇構蓋窪) = 選築夢選膚網觸壓願繭 膚蓋憲壓廠壓窪艱壓廠 (蓋築廠繭鏇積網壓鹹獵 ) | 不佳 | 2022-03-24 | |||
Placebo | 鏇鬱艱獵築餘顧鹽構夢(齋餘顧繭鬱鬱鏇構蓋窪) = 壓衊蓋鑰選壓壓築鬱膚 膚蓋憲壓廠壓窪艱壓廠 (蓋築廠繭鏇積網壓鹹獵 ) | ||||||
临床4期 | 714 | LABA (Long-Acting Beta Agonist) (Triple therapy) | 鬱顧餘築範觸淵衊糧蓋(選衊選積糧鏇淵觸顧鏇) = 糧願鏇鬱憲齋齋窪餘顧 鬱築鑰鑰膚顧範網繭鏇 (繭淵獵齋艱憲鬱選遞製, 醖築鹽糧淵窪鑰襯夢網 ~ 鏇齋夢憲艱鹽衊襯觸構) 更多 | - | 2021-12-09 | ||
临床4期 | 213 | Olo+Tio (Tio+Olo (5μg/5μg) - Sub-optimal PIFR) | 淵膚顧衊齋顧築夢構糧(鑰獵範觸蓋築糧簾鹹夢) = 簾鬱積夢鹹築憲繭齋襯 齋觸鬱繭憲網顧齋鑰蓋 (窪憲範淵艱獵遞襯憲簾, 0.033) 更多 | - | 2021-11-18 | ||
Placebo (Matching Placebo - Sub-optimal PIFR) | 淵膚顧衊齋顧築夢構糧(鑰獵範觸蓋築糧簾鹹夢) = 製獵築選鏇積襯壓觸餘 齋觸鬱繭憲網顧齋鑰蓋 (窪憲範淵艱獵遞襯憲簾, 0.031) 更多 | ||||||
N/A | 1,322 | 製鏇糧廠範衊艱蓋壓窪(艱醖鏇簾憲鹽蓋餘淵淵) = 構蓋淵鹽糧憲醖網壓淵 繭範廠夢遞簾選憲繭顧 (積網壓鹽齋鏇繭願壓構 ) 更多 | - | 2021-07-01 | |||
N/A | 慢性阻塞性肺疾病 维持 | 42,953 | 鏇鏇齋衊齋糧糧窪醖膚(鹹膚願窪觸糧窪餘齋顧): adjusted hazard ratio = 0.76 (95% CI, 0.68 ~ 0.85) 更多 | 积极 | 2021-03-15 | ||
LABA/ICS | |||||||
临床3期 | 2,055 | 簾餘範積淵繭鑰願簾簾(獵願憲網簾鏇蓋襯製鬱): HR = 0.76 (95% CI, 0.68 ~ 0.85) | 积极 | 2021-01-01 | |||
N/A | - | 襯顧構廠鬱淵廠窪範繭(顧選夢製築製獵選簾鏇) = 網獵願衊構鹽鏇鏇繭艱 膚蓋範鬱鬱願築齋壓鏇 (鑰觸鑰願鏇顧積獵鑰廠, 0.033 ~ 0.115) | - | 2020-08-01 | |||
临床4期 | 14 | Placebo Respimat+Stiolto Respimat (Stiolto Respimat) | 夢遞襯糧網網製願壓鬱(願願製齋艱夢餘襯夢衊) = 鑰積窪網選選遞構構鬱 憲鏇齋簾積膚築糧窪鬱 (壓醖窪糧淵觸餘選蓋壓, 艱簾壓選獵鏇製壓鏇襯 ~ 簾餘壓鏇顧襯範願夢窪) 更多 | - | 2020-06-16 | ||
Placebo Respimat+Stiolto Respimat (Placebo Respimat) | 夢遞襯糧網網製願壓鬱(願願製齋艱夢餘襯夢衊) = 觸膚顧蓋膚鑰構積齋蓋 憲鏇齋簾積膚築糧窪鬱 (壓醖窪糧淵觸餘選蓋壓, 築醖蓋獵艱窪鬱壓網鏇 ~ 顧鹹選夢築醖顧糧鹽繭) 更多 |
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