scholarly journals PRS15 Cost-Utility Analysis of Fixed Dose Combination (FDC) of Indacaterol Acetate (IND) Glycopyrronium Bromide (GLY) and Mometasone Furoate (MF) As a Maintenance Treatment in Adult Asthma Patients not Adequately Controlled with a Maintenance Combination of a long-Acting beta2-Agonist and a High Dose of an Inhaled Corticosteroid who Experienced One or More Asthma Exacerbations in the Previous Year

2020 ◽  
Vol 23 ◽  
pp. S719
Author(s):  
P.P. Mangia ◽  
L. Pradelli ◽  
O. Gallo ◽  
D. Ritrovato ◽  
S. Gupta
Keyword(s):  
Cost Utility ◽  
Fixed Dose ◽  
High Dose ◽  
Utility Analysis ◽  
Glycopyrronium Bromide ◽  
Asthma Exacerbations ◽  
Asthma Patients ◽  
Dose Combination ◽  
Long Acting ◽  
Beta2 Agonist

scholarly journals Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Satoru Inoue ◽  
Soniya Vaidya ◽  
Hanns-Christian Tillmann ◽  
Yohei Sakita ◽  
Surendra Machineni ◽  
...  
Keyword(s):  
Geometric Mean ◽  
Mometasone Furoate ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
High Dose ◽  
Open Label ◽  
Post Dose ◽  
Glycopyrronium Bromide ◽  
Dose Combination ◽  
Medium Dose

Abstract Background A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler® device (IND/GLY/MF) is being developed for treatment of asthma. This study compared steady-state pharmacokinetics of IND, GLY and MF between Japanese and Caucasian male subjects after multiple inhalations of IND/GLY/MF o.d. Methods This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14. Results In total, 16 Japanese (median age 31 years [range 20–40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21–43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for Cmax for IND, GLY and MF at the high ICS dose on Day 14 were 1.31 [1.13, 1.51] 1.38 [1.13, 1.69] and 1.07 [0.969, 1.18], respectively. Geometric mean ratios (Japanese/Caucasian) [90% CI] for AUC0–24h on Day 14 for IND, GLY and MF at the high ICS dose were 1.17 [1.01, 1.35], 1.05 [0.920, 1.20] and 1.15 [1.05, 1.27] respectively. Similar trends were noted for all components for the medium ICS dose treatment. IND/GLY/MF was safe and well tolerated; no AEs suspected to be study drug-related were observed. Conclusion Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups. Trial registration Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.

scholarly journals Cost-effectiveness of the fixed-dose combination tiotropium/olodaterol versus tiotropium monotherapy or a fixed-dose combination of long-acting β2-agonist/inhaled corticosteroid for COPD in Finland, Sweden and the Netherlands: a model-based study

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e049675
Author(s):  
Martine Hoogendoorn ◽  
Isaac Corro Ramos ◽  
Stéphane Soulard ◽  
Jennifer Cook ◽  
Erkki Soini ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
The Netherlands ◽  
Cost Effective ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Inhaled Corticosteroid ◽  
Dose Combination ◽  
Long Acting ◽  
Β2 Agonist ◽  
Country Specific

ObjectivesChronic obstructive pulmonary disease (COPD) guidelines advocate treatment with combinations of long-acting bronchodilators for patients with COPD who have persistent symptoms or continue to have exacerbations while using a single bronchodilator. This study assessed the cost-utility of the fixed dose combination of the bronchodilators tiotropium and olodaterol versus two comparators, tiotropium monotherapy and long-acting β2 agonist/inhaled corticosteroid (LABA/ICS) combinations, in three European countries: Finland, Sweden and the Netherlands.MethodsA previously published COPD patient-level discrete event simulation model was updated with most recent evidence to estimate lifetime quality-adjusted life years (QALYs) and costs for COPD patients receiving either tiotropium/olodaterol, tiotropium monotherapy or LABA/ICS. Treatment efficacy covered impact on trough forced expiratory volume in 1 s (FEV1), total and severe exacerbations and pneumonias. The unit costs of medication, maintenance treatment, exacerbations and pneumonias were obtained for each country. The country-specific analyses adhered to the Finnish, Swedish and Dutch pharmacoeconomic guidelines, respectively.ResultsTreatment with tiotropium/olodaterol gained QALYs ranging from 0.09 (Finland and Sweden) to 0.11 (the Netherlands) versus tiotropium and 0.23 (Finland and Sweden) to 0.28 (the Netherlands) versus LABA/ICS. The Finnish payer’s incremental cost-effectiveness ratio (ICER) of tiotropium/olodaterol was €11 000/QALY versus tiotropium and dominant versus LABA/ICS. The Swedish ICERs were €6200/QALY and dominant, respectively (societal perspective). The Dutch ICERs were €14 400 and €9200, respectively (societal perspective). The probability that tiotropium/olodaterol was cost-effective compared with tiotropium at the country-specific (unofficial) threshold values for the maximum willingness to pay for a QALY was 84% for Finland, 98% for Sweden and 99% for the Netherlands. Compared with LABA/ICS, this probability was 100% for all three countries.ConclusionsBased on the simulations, tiotropium/olodaterol is a cost-effective treatment option versus tiotropium or LABA/ICS in all three countries. In both Finland and Sweden, tiotropium/olodaterol is more effective and cost saving (ie, dominant) in comparison with LABA/ICS.

scholarly journals An observational comparative study of different doses of azilsartan and with chlorthalidone combination in moderate hypertension

2019 ◽  
Vol 8 (2) ◽  
pp. 259
Author(s):  
Tamoghna Maiti ◽  
Sonai Mandal ◽  
Ratul Banerjee ◽  
Sourav Chakrabarty ◽  
Amrita Panda
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Antihypertensive Agents ◽  
Fixed Dose ◽  
High Dose ◽  
Hypertensive Patients ◽  
Medical College ◽  
Fda Approval ◽  
High Prevalence ◽  
Dose Combination

Background: High blood pressure (BP) is one of the significant non-communicable diseases that are of high prevalence in our country. Hypertension (HTN) is responsible cause of 57% of stroke and 24% of coronary heart disease deaths in India. Eight classes of medications are currently used in the treatment of hypertension. Azilsartan medoxomil is a newly added FDA approved drug to the ARB class of antihypertensive agents. azilsartan and chlorthalidone combination is also got the FDA approval. There is limited study in between these two groups regarding efficacy especially in rural Bengal.Methods: A prospective observational study was done in medicine OPD of Bankura Sammilani Medical College for twelve weeks with two groups that are azilsartan (80mg) and fixed dose combination of azilsartan (40mg) plus chlorthalidone (12.5mg) in the age group of 18 to 55years of moderate hypertensive patients. Change of heart rate was assessed as safety parameter.Results: It was found that both the group of drugs are very much effective in lowering blood pressure constantly in respect of both systolic and diastolic BP but azilsartan monotherapy in high dose reduce systolic blood pressure slightly high. Significant change of heart rate was not seen with both the groups.Conclusions: Both the group was effective as well as safe in hypertensive patients.

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