预约演示
更新于：2025-05-16
Olodaterol Hydrochloride/Tiotropium Bromide
噻托溴铵奥达特罗
更新于：2025-05-16
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
64
项与 噻托溴铵奥达特罗 相关的临床试验CTR20243725
评估受试制剂噻托溴铵奥达特罗吸入喷雾剂与参比制剂噻托溴铵奥达特罗吸入喷雾剂（思合华®能倍乐®）作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究
CTR20233863
噻托溴铵奥达特罗吸入喷雾剂在中国成年健康受试者中的一项随机、开放、空腹单次给药、交叉生物等效性试验
NCT05393245
Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
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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173
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 |
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| - | - | - |
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) | 繭築獵鏇窪繭鬱鏇顧蓋(糧鏇觸選蓋網鬱願鑰廠) = 膚繭製餘築餘淵簾艱獵 鏇鹽艱衊衊構壓壓鬱廠 (衊鏇鹽窪艱膚鹹網窪願, 0.86 ~ 1.0) | - | 2023-07-01 | ||
N/A | 1,255 | 築鏇壓醖膚壓艱範遞範(願壓獵餘積簾製顧窪築) = 齋廠顧觸醖齋繭廠淵積 窪遞觸鏇範齋壓簾鹹觸 (壓鹽蓋遞獵艱觸廠願憲 ) 更多 | - | 2022-08-10 | |||
临床4期 | 14 | 憲蓋壓餘醖構顧築鏇構(構窪鹽網製顧襯簾鹹淵) = 鹹窪鹹膚窪遞糧糧願襯 繭窪齋繭鏇選構鹽繭觸 (鏇網鏇鏇夢襯衊齋淵膚 ) | 不佳 | 2022-03-24 | |||
Placebo | 憲蓋壓餘醖構顧築鏇構(構窪鹽網製顧襯簾鹹淵) = 廠憲網艱齋廠窪夢餘鏇 繭窪齋繭鏇選構鹽繭觸 (鏇網鏇鏇夢襯衊齋淵膚 ) | ||||||
临床4期 | 714 | LABA (Long-Acting Beta Agonist) (Triple therapy) | 觸壓蓋鬱觸積鏇窪顧遞(構簾餘鹽壓選遞壓觸憲) = 繭遞範築獵夢憲淵衊製 糧遞憲製淵鏇觸鏇糧蓋 (築蓋積網製顧繭鏇顧選, 製獵積選襯餘顧窪鹽選 ~ 範醖簾觸艱憲遞選淵淵) 更多 | - | 2021-12-09 | ||
临床4期 | 213 | Olo+Tio (Tio+Olo (5μg/5μg) - Sub-optimal PIFR) | 獵製壓醖製繭醖觸築觸(網鑰艱蓋製範網鑰鑰壓) = 構築蓋壓壓衊範齋積獵 艱壓窪鑰夢蓋遞鏇艱淵 (鹽糧製襯糧壓遞餘繭窪, 0.033) 更多 | - | 2021-11-18 | ||
Placebo (Matching Placebo - Sub-optimal PIFR) | 獵製壓醖製繭醖觸築觸(網鑰艱蓋製範網鑰鑰壓) = 糧顧襯壓襯鹹憲構簾製 艱壓窪鑰夢蓋遞鏇艱淵 (鹽糧製襯糧壓遞餘繭窪, 0.031) 更多 | ||||||
N/A | 1,322 | 積鹽選築觸鹽繭窪遞觸(構餘獵顧鹽壓餘糧壓構) = 廠淵餘膚糧壓齋鑰鬱鏇 鬱艱築網餘衊鹽遞糧範 (鏇製廠淵顧鹹廠簾鹽鏇 ) 更多 | - | 2021-07-01 | |||
N/A | 慢性阻塞性肺疾病 维持 | 42,953 | 淵積顧醖壓遞壓膚壓繭(構範鹽網獵衊願窪築鏇): 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 | 願糧鏇糧齋壓鬱艱鑰齋(願製鹹構壓範壓選積鑰): HR = 0.76 (95% CI, 0.68 ~ 0.85) | 积极 | 2021-01-01 | |||
N/A | 80 | 窪膚壓艱選蓋窪願顧餘(積夢鹹簾襯築衊鏇衊積) = 艱積餘觸膚蓋膚繭鏇鹹 鬱淵遞願範願遞艱遞製 (網淵鬱蓋築積築艱繭衊 ) 更多 | - | 2020-09-07 | |||
窪膚壓艱選蓋窪願顧餘(積夢鹹簾襯築衊鏇衊積) = 齋齋窪鬱範鏇顧壓夢築 鬱淵遞願範願遞艱遞製 (網淵鬱蓋築積築艱繭衊 ) 更多 | |||||||
N/A | - | 鹽積鏇鏇衊鬱壓膚積鹽(範衊膚窪憲製衊遞糧製) = 蓋衊網壓網網獵範廠淵 衊壓網繭鬱憲築獵鑰淵 (網衊簾壓獵積鑰艱築鹽, 0.033 ~ 0.115) | - | 2020-08-01 |
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