Pooled Safety Analysis Of Adjudicated Serious Adverse Events With The Fixed-Dose Combination Of Tiotropium + Olodaterol

Pneumologie ◽  
2016 ◽  
Vol 70 (S 01) ◽  
Author(s):  
T Köhnlein ◽  
R Buhl ◽  
K Tetzlaff ◽  
L Korducki ◽  
C Vogelmeier ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Analysis ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Serious Adverse Events ◽  
Dose Combination

scholarly journals The Study of the Fixed Dose Combination of Lisinopril with Prolonged Indopamide (FIXLINDA) with Daily Blood Pressure Monitoring and Diuresis in Hypertensive Patients

2019 ◽  
Vol 15 (4) ◽  
pp. 510-517 ◽  
Author(s):  
M. P. Savenkov ◽  
S. N. Ivanov ◽  
M. P. Mikhaylusova ◽  
M. V. Borschevskaya ◽  
A. M. Savenkova ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Ace Inhibitor ◽  
Blood Pressure Monitoring ◽  
Home Monitoring ◽  
Target Blood Pressure ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Serious Adverse Events ◽  
Dose Combination

Аim. To study the efficacy, tolerability and safety of using a fixed dose combination of an ACE inhibitor lisinopril with a prolonged-action diuretic indapamide in patients with degree 1-2 hypertension.Material and methods. Patients (n = 32) with uncontrolled 1-2 degrees hypertension, moderate or high cardiovascular risk, without severe comorbid diseases, who were prescribed a fixed dose combination of lisinopril (5, 10 or 20 mg) and indapamide (1.5 mg) were included in the observational study. All patients had home monitoring of blood pressure and diuresis, as well as assessment of subjective tolerance of treatment and registration of adverse events within 3 months of observation. Assessment of changes in circadian fluctuations in blood pressure and diuresis, the frequency of achieving the target blood pressure at the outpatient stage, as well as the subjective tolerance of treatment and adverse events during a three-month follow-up.Results. Target blood pressure was achieved in 44.5% of patients taking the fixed dose combination of lisinopril 5 mg + prolonged-acting indapamide1.5 mg; 76.9% – in patients taking the combination of lisinopril 10 mg + indapamide 1.5 mg; 78,6% – in patients taking the combination of lisinopril 20 mg + indapamide 1.5 mg. The achieved antihypertensive effect was characterized by daily circadian stability, accompanied by an improvement in the initially impaired day and night diuretic profile (increase in the share of daytime diuresis by 29.6% and 22.3% with a decrease in the share of nighttime diuresis by 35% and 49% when using a combination with lisinopril 5 and 10 mg, respectively). The treatment was well tolerated by patients and did not cause the development of serious adverse events. Reported adverse events (non-intense dry cough, headache, general weakness) were transient and did not require correction or withdrawal of treatment.Conclusion. The fixed dose combination of the ACE inhibitor lisinopril (5, 10 or 20 mg) and the long-acting thiazide-like diuretic indapamide (1.5 mg) had good antihypertensive efficacy with improved circadian blood pressure and diuresis profiles, acceptable tolerance and safety of treatment, as well as a simple choice of doses of the drug components.

scholarly journals Adding a Second Bronchodilator in COPD: A Meta-Analysis on the Risk of Specific Cardiovascular Serious Adverse Events of Tiotropium/Olodaterol Fixed-Dose Combination

2020 ◽  
Vol 17 (2) ◽  
pp. 215-223
Author(s):  
Paola Rogliani ◽  
Beatrice Ludovica Ritondo ◽  
Bartolomeo Zerillo ◽  
Mario Cazzola ◽  
Maria Gabriella Matera ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Serious Adverse Events ◽  
Dose Combination

scholarly journals Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2

2020 ◽  
Vol 37 (4) ◽  
pp. 1620-1631 ◽  
Author(s):  
Sanjay Asrani ◽  
Jason Bacharach ◽  
Edward Holland ◽  
Hayley McKee ◽  
Huan Sheng ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Open Angle Glaucoma ◽  
Safety Analysis ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Open Angle ◽  
Phase 3 ◽  
Dose Combination

scholarly journals Determinants of virological outcome and adverse events in African children treated with paediatric nevirapine fixed-dose-combination tablets

AIDS ◽  
2017 ◽  
Vol 31 (7) ◽  
pp. 905-915 ◽  
Author(s):  
Andrzej Bienczak ◽  
Paolo Denti ◽  
Adrian Cook ◽  
Lubbe Wiesner ◽  
Veronica Mulenga ◽  
...  
Keyword(s):  
Adverse Events ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
African Children ◽  
Virological Outcome ◽  
Dose Combination

Ocular adverse events in drug sensitive TB patients on daily fixed dose combination anti-TB drugs: A record review study from Kerala, India

2020 ◽  
Vol 67 (2) ◽  
pp. 216-221 ◽  
Author(s):  
Muraleedharan Sarojini Manu ◽  
Kedar Mehta ◽  
Mrinalini Das ◽  
Shibu Balakrishnan ◽  
Mrithyunjayan Sunil kumar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination ◽  
Review Study ◽  
Record Review

scholarly journals The novel bronchodilator navafenterol: a phase 2a, multi-centre, randomised, double-blind, placebo-controlled crossover trial in COPD

2021 ◽  
pp. 2100972
Author(s):  
Dave Singh ◽  
Jutta Beier ◽  
Carol Astbury ◽  
Maria G. Belvisi ◽  
Carla A. Da Silva ◽  
...  
Keyword(s):  
Adverse Events ◽  
Mean Difference ◽  
Beta Agonist ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Double Blind ◽  
Once Daily ◽  
Significant Difference ◽  
Dose Combination ◽  
Severe Copd

BackgroundNavafenterol (AZD8871) belongs to a new class of bronchodilator, the single-molecule muscarinic antagonist and beta agonist (MABA), being developed for the treatment of chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the efficacy, pharmacokinetics and safety of navafenterol versus placebo and an active comparator treatment for moderate-to-severe COPD.MethodsThis phase 2a, randomised, multicentre (Germany and UK), double-blind, double-dummy, three-way complete crossover study (ClinicalTrials.gov identifier: NCT03645434) compared 2 weeks’ treatment of once-daily navafenterol 600 µg via inhalation with placebo and a fixed-dose combination bronchodilator (umeclidinium/vilanterol [UMEC/VI]; 62.5 µg/25 µg) in participants with moderate-to-severe COPD. The primary outcome was change from baseline in trough FEV1 on day 15. Secondary endpoints included: change from baseline in peak FEV1; change from baseline in breathlessness, cough and sputum scale (BCSS); change from baseline in COPD assessment tool (CAT); adverse events; and pharmacokinetics.ResultsSeventy-three participants were randomised. After 14 days, trough FEV1 was significantly improved with navafenterol compared with placebo (least-squares [LS] mean difference 0.202 L; p<0.0001). There was no significant difference in FEV1 between navafenterol and UMEC/VI (LS mean difference −0.046 L; p=0.075). COPD symptoms (CAT and BCSS) showed significantly greater improvements with both active treatments versus placebo (all p<0.005). Novel objective monitoring (VitaloJAK) showed that cough was reduced with both active treatments compared with placebo. Safety profiles were similar across the treatment groups and no serious adverse events were reported in the navafenterol treatment period.ConclusionOnce-daily navafenterol was well tolerated, improved lung function and reduced COPD-related symptoms, similar to an established once-daily fixed-dose combination bronchodilator.

scholarly journals Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection

2020 ◽  
Vol 75 (9) ◽  
pp. 2661-2665
Author(s):  
Daniëlle W M Pijnenburg ◽  
Minou van Seyen ◽  
Evertine J Abbink ◽  
Angela Colbers ◽  
Joost P H Drenth ◽  
...  
Keyword(s):  
Drug Exposure ◽  
Swallowing Disorders ◽  
Similarity Criteria ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Pharmacokinetic Parameters ◽  
Serious Adverse Events ◽  
Combination Tablet ◽  
Significant Difference ◽  
Dose Combination

Abstract Background Finding a suitable treatment for HCV patients with swallowing disorders is still a major challenge. In practice, direct-acting antivirals are crushed without knowledge of adequate absorption. Crushing can alter drug exposure, possibly leading to treatment failure, development of resistance or toxicity. Currently, there is no information about crushing of the fixed-dose combination tablet of elbasvir/grazoprevir; therefore, crushing of this tablet is not recommended. Objectives To investigate the influence of crushing on the pharmacokinetics of the elbasvir/grazoprevir fixed-dose combination tablet. Methods We conducted an open-label, two-period, randomized, cross-over, Phase I, single-dose trial in 11 healthy adult volunteers. Subjects randomly received whole-tablet elbasvir/grazoprevir or crushed and suspended elbasvir/grazoprevir in a fasted state. Pharmacokinetic similarity criteria (90% CIs lie within 70%–143% acceptance range) were used for AUC0–∞ and AUC0–72. Results Mean plasma concentration–time curves of elbasvir and grazoprevir showed similar pharmacokinetic profiles. The primary pharmacokinetic parameters AUC0–∞ and AUC0–72 of elbasvir and grazoprevir after intake of a crushed tablet were on average 12%–16% higher compared with the whole tablet, but 90% CIs were all within the predefined boundaries of pharmacokinetic similarity. Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir. No serious adverse events were reported during the trial. Conclusions Pharmacokinetic similarity could be demonstrated for a crushed and suspended tablet compared with a whole tablet, without impacting drug safety or efficacy. Crushed and suspended administration of elbasvir/grazoprevir can be used in patients with swallowing disorders.

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