LIVIVO - Search results -

Search results

Result 1 - 10 of total 40

Search options

Article ; Online: Management of stable coronary artery disease and atrial fibrillation with anti-thrombotic therapy: A systematic review and meta-analysis.

Malladi, Srikanth / Hamid, Kewan / Pendyala, Nitin Chandra / Veerapaneni, Vijaysai / Deliwala, Smit / Dubre, Donald / Elian, Samir A / Singh, Adiraj

Medicine

2022 Volume 100, Issue 48, Page(s) e27498

Abstract: Introduction: Long term management of patients with stable coronary artery disease of >1 year after myocardial infarction (MI) or percutaneous coronary intervention and atrial fibrillation is unclear. Current guidelines recommend using oral anti- ... ...

Abstract	Introduction: Long term management of patients with stable coronary artery disease of >1 year after myocardial infarction (MI) or percutaneous coronary intervention and atrial fibrillation is unclear. Current guidelines recommend using oral anti-coagulation (OAC) alone although the recommendation is weak and there is low quality evidence. Two new randomized control trials (RCTs) were published recently. We conducted an updated meta-analysis to evaluate the effect of these studies on patient outcomes. Objective: To conduct a systematic review and meta-analysis of published RCTs and observational studies to compare OAC alone versus OAC plus single anti-platelet therapy. Methods: Electronic searches were conducted using appropriate terms from 3 databases. Relevant studies included. Data extracted and analysis were performed using STATA. Measurements: Summary statistics were pooled and measured for primary and secondary outcomes of both treatment arms. Main results: Eight studies involving 10,120 patients were included for the analysis. Five thousand two hundred thirty-seven patients were on combination therapy while 4883 were on OAC alone. There was no statistically significant difference in the primary outcome of major adverse cardiac events (hazard ratio [HR] 1.067; 95% confidence interval [CI] 0.912-1.249; P value .417). There was no statistically significant difference even in the measured secondary outcomes namely all cause mortality (HR 1.048; 95% CI 0.830-1.323; P value .695), cardiovascular mortality (HR 0.863; 95% CI 0.593-1.254; P value .439). However, we found statistically significant difference between the 2 groups in the incidence of MI with higher incidence in mono therapy group (HR 1.229; 95% CI 1.011-1.495; P value .039) and higher incidence of major bleeding in the combination therapy group in the subgroup analysis (HR 0.649; 95% CI 0.464-0.907; P value .011). Conclusion: We found no reduction of major adverse cardiac event between combination therapy and mono therapy. Although mono therapy showed increased risk of major bleeding overall, subgroup analysis of the RCTs showed increased risk of major bleeding in the combination therapy group. MI was higher in the mono therapy group compared to the combination therapy group, however this outcome was not reproducible in the subgroup analysis of the RCTs.
MeSH term(s)	Anticoagulants/therapeutic use ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy ; Coronary Artery Disease/drug therapy ; Hemorrhage ; Humans ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Platelet Aggregation Inhibitors/therapeutic use ; Thrombosis/prevention & control
Chemical Substances	Anticoagulants ; Platelet Aggregation Inhibitors
Language	English
Publishing date	2022-01-20
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000027498
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Ua VI Zs.171: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.

Borin, Marie T / Lo, Arthur / Barnes, Chris N / Pendyala, Srikanth / Bourdet, David L

International journal of chronic obstructive pulmonary disease

2019 Volume 14, Page(s) 2305–2318

Abstract: Purpose: Revefenacin, a long-acting muscarinic antagonist for nebulization, has been shown to improve lung function in patients with chronic obstructive pulmonary disease. Here we report pharmacokinetic (PK) and safety results from two multicenter, open- ...

Abstract	Purpose: Revefenacin, a long-acting muscarinic antagonist for nebulization, has been shown to improve lung function in patients with chronic obstructive pulmonary disease. Here we report pharmacokinetic (PK) and safety results from two multicenter, open-label, single-dose trials evaluating revefenacin in subjects with severe renal impairment (NCT02578082) and moderate hepatic impairment (NCT02581592). Subjects and methods: The renal impairment trial enrolled subjects with normal renal function and severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m Results: In the renal impairment study, the maximum observed plasma revefenacin concentration (C Conclusion: Systemic exposure to revefenacin increased modestly in subjects with severe renal impairment but was similar between subjects with moderate hepatic impairment and normal hepatic function. The increase in plasma exposure to THRX-195518 in subjects with severe renal or moderate hepatic impairment is unlikely to be of clinical consequence given its low antimuscarinic potency, low systemic levels after inhaled revefenacin administration, and favorable safety profile.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Benzamides/adverse effects ; Benzamides/pharmacokinetics ; Carbamates/adverse effects ; Carbamates/pharmacokinetics ; Female ; Hepatic Insufficiency/metabolism ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Muscarinic Antagonists/adverse effects ; Muscarinic Antagonists/pharmacokinetics ; Renal Insufficiency/metabolism ; Severity of Illness Index ; Young Adult
Chemical Substances	Benzamides ; Carbamates ; Muscarinic Antagonists ; revefenacin (G2AE2VE07O)
Language	English
Publishing date	2019-10-08
Publishing country	New Zealand
Document type	Journal Article
ISSN	1178-2005
ISSN (online)	1178-2005
DOI	10.2147/COPD.S203709
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Revefenacin, a Long-Acting Muscarinic Antagonist, Does Not Prolong QT Interval in Healthy Subjects: Results of a Placebo- and Positive-Controlled Thorough QT Study.

Borin, Marie T / Barnes, Chris N / Darpo, Borje / Pendyala, Srikanth / Xue, Hongqi / Bourdet, David L

Clinical pharmacology in drug development

2019 Volume 9, Issue 1, Page(s) 130–139

Abstract: Revefenacin is a novel once-daily, lung-selective, long-acting muscarinic antagonist developed as a nebulized inhalation solution for the maintenance treatment of chronic obstructive pulmonary disease. In a randomized, 4-way crossover study, healthy ... ...

Abstract	Revefenacin is a novel once-daily, lung-selective, long-acting muscarinic antagonist developed as a nebulized inhalation solution for the maintenance treatment of chronic obstructive pulmonary disease. In a randomized, 4-way crossover study, healthy subjects received a single inhaled dose of revefenacin 175 µg (therapeutic dose), revefenacin 700 µg (supratherapeutic dose), and placebo via standard jet nebulizer, and a single oral dose of moxifloxacin 400 mg (open-label) in separate treatment periods. Electrocardiograms were recorded, and pharmacokinetic samples were collected serially after dosing. The primary end point was the placebo-corrected change from baseline QT interval corrected for heart rate using Fridericia's formula, analyzed at each postdose time. Concentration-QTc modeling was also performed. Following administration of revefenacin 175 and 700 µg, placebo-corrected change from baseline QTcF (ΔΔQTcF) values were close to 0 at all times, with the largest mean ΔΔQTcF of 1.0 millisecond (95% confidence interval [CI], -1.2 to 3.1 milliseconds) 8 hours postdose and 1.0 millisecond (95%CI, -1.1 to 3.1 milliseconds) 1 hour postdose after inhalation of revefenacin 175 and 700 µg, respectively. Revefenacin did not have a clinically meaningful effect on heart rate (within ±5 beats per minute of placebo), or PR and QRS intervals (within ±3 and ±1 milliseconds of placebo, respectively). Using concentration-QTc modeling, an effect of revefenacin > 10 milliseconds can be excluded within the observed plasma concentration range of up to ≈3 ng/mL. Both doses of revefenacin were well tolerated. These results demonstrate that revefenacin does not prolong the QT interval.
MeSH term(s)	Adolescent ; Adult ; Benzamides/blood ; Benzamides/pharmacokinetics ; Benzamides/pharmacology ; Carbamates/blood ; Carbamates/pharmacokinetics ; Carbamates/pharmacology ; Cross-Over Studies ; Double-Blind Method ; Electrocardiography/drug effects ; Female ; Healthy Volunteers ; Heart Rate/drug effects ; Humans ; Long QT Syndrome ; Male ; Middle Aged ; Muscarinic Antagonists/blood ; Muscarinic Antagonists/pharmacokinetics ; Muscarinic Antagonists/pharmacology ; Young Adult
Chemical Substances	Benzamides ; Carbamates ; Muscarinic Antagonists ; revefenacin (G2AE2VE07O)
Language	English
Publishing date	2019-08-29
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.732
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

Order via subito

Details ▾
- Full text online
- Order with fees

Article ; Online: Data on the safety and tolerability of revefenacin, in patients with moderate to very severe chronic obstructive pulmonary disease.

Donohue, James / Kerwin, Edward / Sethi, Sanjay / Haumann, Brett / Pendyala, Srikanth / Dean, Lorna / Barnes, Chris N / Moran, Edmund J / Crater, Glenn

Data in brief

2019 Volume 26, Page(s) 104277

Abstract: This article contains information on the experimental design and methods on how the safety and tolerability data concerning patients with moderate to very severe chronic obstructive pulmonary disease (COPD) were obtained. This is in addition to our ... ...

Abstract	This article contains information on the experimental design and methods on how the safety and tolerability data concerning patients with moderate to very severe chronic obstructive pulmonary disease (COPD) were obtained. This is in addition to our original research article. [1] We have also provided information on the clinical laboratory tests that were conducted. Further interpretation and discussion of the data are demonstrated in the article "Revefenacin, a Once-daily, Lung-selective, Long-acting Muscarinic Antagonist for Nebulized Therapy: Safety and Tolerability Results of a 52-week Phase 3 Trial in Moderate to Very Severe Chronic Obstructive Pulmonary Disease." [1].
Language	English
Publishing date	2019-08-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2786545-9
ISSN	2352-3409 ; 2352-3409
ISSN (online)	2352-3409
ISSN	2352-3409
DOI	10.1016/j.dib.2019.104277
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article: Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate.

Mahler, Donald A / Ohar, Jill A / Barnes, Chris N / Moran, Edmund J / Pendyala, Srikanth / Crater, Glenn D

Chronic obstructive pulmonary diseases (Miami, Fla.)

2019 Volume 6, Issue 4

Abstract: Background: Patients with chronic obstructive pulmonary disease (COPD) and suboptimal peak inspiratory flow rate (sPIFR) may not benefit optimally from dry powder inhalers (DPI) because of inadequate inspiratory flow. Nebulized bronchodilators may ... ...

Abstract	Background: Patients with chronic obstructive pulmonary disease (COPD) and suboptimal peak inspiratory flow rate (sPIFR) may not benefit optimally from dry powder inhalers (DPI) because of inadequate inspiratory flow. Nebulized bronchodilators may provide a better alternative. We compared bronchodilation with the long-acting muscarinic antagonist (LAMA) revefenacin for nebulization versus the DPI LAMA tiotropium, in patients with COPD and sPIFR (< 60 L/min against the resistance of Diskus®). Methods: This was a randomized, double-blind, double-dummy, 28-day Phase 3b study in patients with COPD enrolled based on sPIFR. The primary endpoint was trough forced expiratory volume in 1 second (FEV Results: We enrolled 206 patients with mean (standard deviation) age, 65 (8) years; percent predicted FEV Conclusions: Revefenacin did not produce significant improvements in FEV1 versus tiotropium in the ITT population, but increased trough FEV
Language	English
Publishing date	2019-10-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2771715-X
ISSN	2372-952X
ISSN	2372-952X
DOI	10.15326/jcopdf.6.4.2019.0137
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article: Improvements in Lung Function with Nebulized Revefenacin in the Treatment of Patients with Moderate to Very Severe COPD: Results from Two Replicate Phase III Clinical Trials.

Ferguson, Gary T / Feldman, Gregory / Pudi, Krishna K / Barnes, Chris N / Moran, Edmund J / Haumann, Brett / Pendyala, Srikanth / Crater, Glenn

Chronic obstructive pulmonary diseases (Miami, Fla.)

2019 Volume 6, Issue 2, Page(s) 154–165

Abstract: Background: Revefenacin, a novel, lung-selective, long-acting muscarinic antagonist, has been developed for nebulized therapy for chronic obstructive pulmonary disease (COPD). We present the results of replicate Phase III efficacy and safety studies of ... ...

Abstract	Background: Revefenacin, a novel, lung-selective, long-acting muscarinic antagonist, has been developed for nebulized therapy for chronic obstructive pulmonary disease (COPD). We present the results of replicate Phase III efficacy and safety studies of revefenacin in patients with moderate to very severe COPD. Methods: In 2 double-blind, parallel-group studies, (Study 0126 and Study 0127), patients ≥ 40 years old were randomized to revefenacin 88 μg, revefenacin 175 μg or placebo administered once daily by standard jet nebulizer for 12 weeks. The primary endpoint was 24-hour trough forced expiratory volume in 1 second (FEV Results: At day 85, revefenacin 88 µg and 175 µg improved trough FEV Conclusion: Revefenacin, administered once daily for 12 weeks to patients with moderate to very severe COPD, demonstrated clinically significant improvements in trough FEV
Language	English
Publishing date	2019-04-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2771715-X
ISSN	2372-952X
ISSN	2372-952X
DOI	10.15326/jcopdf.6.2.2018.0152
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD).

Donohue, James F / Kerwin, Edward / Sethi, Sanjay / Haumann, Brett / Pendyala, Srikanth / Dean, Lorna / Barnes, Chris N / Moran, Edmund J / Crater, Glenn

Respiratory research

2019 Volume 20, Issue 1, Page(s) 241

Abstract: Background: Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, ...

Abstract	Background: Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial. Methods: In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium. Results: Over the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV Conclusions: Significant sustained improvements from baseline in trough FEV Trial registration: NCT02518139 Registered 5 August 2015.
MeSH term(s)	Aged ; Benzamides/administration & dosage ; Bronchodilator Agents/administration & dosage ; Carbamates/administration & dosage ; Double-Blind Method ; Drug Administration Schedule ; Female ; Forced Expiratory Volume/drug effects ; Forced Expiratory Volume/physiology ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage ; Pulmonary Disease, Chronic Obstructive/diagnosis ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Pulmonary Disease, Chronic Obstructive/physiopathology ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	Benzamides ; Bronchodilator Agents ; Carbamates ; Muscarinic Antagonists ; revefenacin (G2AE2VE07O)
Language	English
Publishing date	2019-10-30
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2041675-1
ISSN	1465-993X ; 1465-9921
ISSN (online)	1465-993X
ISSN	1465-9921
DOI	10.1186/s12931-019-1187-7
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Redox regulation of Nox proteins.

Pendyala, Srikanth / Natarajan, Viswanathan

Respiratory physiology & neurobiology

2010 Volume 174, Issue 3, Page(s) 265–271

Abstract: The generation of reactive oxygen species (ROS) plays a major role in endothelial signaling and function. Of the several potential sources of ROS in the vasculature, the endothelial NADPH oxidase (Nox) family of proteins, Nox1, Nox2, Nox4 and Nox5, are ... ...

Abstract	The generation of reactive oxygen species (ROS) plays a major role in endothelial signaling and function. Of the several potential sources of ROS in the vasculature, the endothelial NADPH oxidase (Nox) family of proteins, Nox1, Nox2, Nox4 and Nox5, are major contributors of ROS. Excess generation of ROS contributes to the development and progression of vascular disease. While hyperoxia stimulates ROS production through Nox proteins, hypoxia appears to involve mitochondrial electron transport in the generation of superoxide. ROS generated from Nox proteins and mitochondria are important for oxygen sensing mechanisms. Physiological concentrations of ROS function as signaling molecule in the endothelium; however, excess ROS production leads to pathological disorders like inflammation, atherosclerosis, and lung injury. Regulation of Nox proteins is unclear; however, antioxidants, MAP Kinases, STATs, and Nrf2 regulate Nox under normal physiological and pathological conditions. Studies related to redox regulation of Nox should provide a better understanding of ROS and its role in the pathophysiology of vascular diseases.
MeSH term(s)	Animals ; Blood Vessels/enzymology ; Gene Expression Regulation/physiology ; Humans ; NADPH Oxidases/metabolism ; Oxidation-Reduction ; Oxygen/metabolism ; Reactive Oxygen Species/metabolism ; Signal Transduction/physiology
Chemical Substances	Reactive Oxygen Species ; NADPH Oxidases (EC 1.6.3.-) ; Oxygen (S88TT14065)
Language	English
Publishing date	2010-09-29
Publishing country	Netherlands
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	2077867-3
ISSN	1878-1519 ; 1569-9048
ISSN (online)	1878-1519
ISSN	1569-9048
DOI	10.1016/j.resp.2010.09.016
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 519: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Cardiovascular safety of revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy of chronic obstructive pulmonary disease: Evaluation in phase 3 clinical trials.

Donohue, James F / Feldman, Gregory / Sethi, Sanjay / Barnes, Chris N / Pendyala, Srikanth / Bourdet, David / Crater, Glenn

Pulmonary pharmacology & therapeutics

2019 Volume 57, Page(s) 101808

Abstract: The cardiovascular safety of revefenacin, an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive lung disease (COPD), was evaluated in phase 3 trials in patients with moderate to very severe COPD. No clinically ... ...

Abstract	The cardiovascular safety of revefenacin, an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive lung disease (COPD), was evaluated in phase 3 trials in patients with moderate to very severe COPD. No clinically meaningful changes in 12-lead electrocardiogram recordings were observed with up to 52 weeks of once-daily revefenacin 88 or 175 μg. In a pooled analysis of Studies 0126 and 0127, the incidence of prolonged QT interval corrected for heart rate using the Fridericia correction formula (QTcF; >450 msec) for revefenacin 88 μg (n = 23, 5.6%) and revefenacin 175 μg (n = 23, 5.9%) was similar to that for placebo (n = 22, 5.3%). In Study 0128, the incidence of prolonged QTcF was similar in the revefenacin 175 μg (n = 25, 7.7%) and tiotropium (n = 26, 7.3%) groups and lower in the revefenacin 88 μg (n = 15, 4.2%) group. There were four major adverse cardiac events (MACEs) in Study 0126 (one, two, and one in the placebo, revefenacin 88 μg, and revefenacin 175 μg groups, respectively), no MACEs in Study 0127 and 26 MACEs in Study 0128 (9, 10 and 7 in the revefenacin 88 μg, revefenacin 175 μg and tiotropium groups, respectively). In Study 0128, only one MACE was considered possibly/probably related to revefenacin (atrial fibrillation in the revefenacin 175 μg group). Thus, revefenacin may provide beneficial nebulized therapy for patients with COPD without further elevating their risk of cardiovascular events.
MeSH term(s)	Administration, Inhalation ; Adult ; Aged ; Aged, 80 and over ; Benzamides/administration & dosage ; Benzamides/adverse effects ; Benzamides/therapeutic use ; Bronchodilator Agents/administration & dosage ; Bronchodilator Agents/adverse effects ; Bronchodilator Agents/therapeutic use ; Carbamates/administration & dosage ; Carbamates/adverse effects ; Carbamates/therapeutic use ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions ; Female ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage ; Nebulizers and Vaporizers ; Pulmonary Disease, Chronic Obstructive/complications ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Risk Assessment ; Tiotropium Bromide/administration & dosage
Chemical Substances	Benzamides ; Bronchodilator Agents ; Carbamates ; Muscarinic Antagonists ; revefenacin (G2AE2VE07O) ; Tiotropium Bromide (XX112XZP0J)
Language	English
Publishing date	2019-05-30
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1399707-5
ISSN	1522-9629 ; 1094-5539
ISSN (online)	1522-9629
ISSN	1094-5539
DOI	10.1016/j.pupt.2019.101808
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 2389: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease.

Donohue, James F / Kerwin, Edward / Sethi, Sanjay / Haumann, Brett / Pendyala, Srikanth / Dean, Lorna / Barnes, Chris N / Moran, Edmund J / Crater, Glenn

Respiratory medicine

2019 Volume 153, Page(s) 38–43

Abstract: Background: Prior replicate 12-week phase 3 trials demonstrated that once-daily doses of revefenacin inhalation solution at 88 μg and 175 μg produced significant bronchodilation over 24 h post dose in patients with moderate to very severe chronic ... ...

Abstract	Background: Prior replicate 12-week phase 3 trials demonstrated that once-daily doses of revefenacin inhalation solution at 88 μg and 175 μg produced significant bronchodilation over 24 h post dose in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The objective was to characterize the safety profile of revefenacin 88 μg and 175 μg over 52 weeks of treatment. Methods: In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 88 μg or 175 μg in a double-blind manner, or open-label active control tiotropium. Results: Treatment-emergent adverse events (AEs) were comparable across all treatment groups (n [%] patients; revefenacin 88 μg, 272 [74.7%]; 175 μg, 242 [72.2%]; tiotropium, 275 [77.2%]). Numerically fewer COPD exacerbations (n [%] patients) were observed with revefenacin 175 μg (73 [21.8%]) than with 88 μg (107 [29.4%]) or tiotropium (100 [28.1%]). Serious AEs were comparable with revefenacin 88 μg (58 [15.9%] and tiotropium (58 [16.3%]), but were lower with revefenacin 175 μg (43 [12.8%]), and mortality was low. In patients using revefenacin 88 μg or tiotropium with a concurrent long-acting β-agonist (LABA) product, the incidence of AEs was slightly higher than without concurrent LABA. LABA did not affect the incidence of AEs for patients who received revefenacin 175 μg. Conclusions: Revefenacin was generally well tolerated over 52 weeks of treatment, and had a safety profile that supports its use as a long-term once-daily bronchodilator for the nebulized treatment of COPD.
MeSH term(s)	Administration, Inhalation ; Adrenergic beta-2 Receptor Agonists/therapeutic use ; Aged ; Benzamides/administration & dosage ; Benzamides/adverse effects ; Benzamides/therapeutic use ; Bronchodilator Agents/therapeutic use ; Carbamates/administration & dosage ; Carbamates/adverse effects ; Carbamates/therapeutic use ; Case-Control Studies ; Cholinergic Antagonists/therapeutic use ; Disease Progression ; Drug Therapy, Combination ; Drug Tolerance ; Female ; Forced Expiratory Volume/drug effects ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage ; Muscarinic Antagonists/adverse effects ; Muscarinic Antagonists/therapeutic use ; Nebulizers and Vaporizers/standards ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Pulmonary Disease, Chronic Obstructive/physiopathology ; Safety ; Severity of Illness Index ; Tiotropium Bromide/therapeutic use ; Vital Capacity/drug effects
Chemical Substances	Adrenergic beta-2 Receptor Agonists ; Benzamides ; Bronchodilator Agents ; Carbamates ; Cholinergic Antagonists ; Muscarinic Antagonists ; revefenacin (G2AE2VE07O) ; Tiotropium Bromide (XX112XZP0J)
Language	English
Publishing date	2019-05-23
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1003348-8
ISSN	1532-3064 ; 0954-6111
ISSN (online)	1532-3064
ISSN	0954-6111
DOI	10.1016/j.rmed.2019.05.010
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Ui III Zs.19: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

To top

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

Full text online

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito