scholarly journals Effectiveness and Impact on Adherence of a New Fixed-Dose Combination of Ivabradine and Metoprolol in a Wide Range of Stable Angina Patients in Real-Life Practice

2019 ◽  
Vol 8 (2) ◽  
pp. 317-328
Author(s):  
Dimitar Divchev ◽  
◽  
Georg Stöckl
Keyword(s):  
Stable Angina ◽  
Real Life ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Wide Range ◽  
Dose Combination

scholarly journals Importance of patents and data exclusivity in fixed-dose combination medicinal products

2019 ◽  
Vol 65 (2) ◽  
pp. 33-38
Author(s):  
Marija Mitkovska ◽  
Katerina Anchevska Netkovska ◽  
Aleksandra Grozdanova ◽  
Ana Poceva Panovska ◽  
Ema Kikovska Stojanovska
Keyword(s):  
Data Protection ◽  
Developed Countries ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Medicinal Products ◽  
Active Compounds ◽  
Intellectual Property Rights Protection ◽  
Data Exclusivity ◽  
Wide Range ◽  
Dose Combination

The efficacy of an active compound can be advantageously improved when combined with other active compounds. Medicinal products for a particular indication(s) that contain combination of two or more active compounds in a fixed dose ratio is so called fixed-dose combination medicinal products or FDCs. FDCs are beneficial for patients’ adherence to the treatment because of the simplified drug regimen. They are used in the treatment of a wide range of medical conditions especially in the treatment of chronic illnesses including AIDS, type 2 diabetes, and many cardiovascular diseases. FDCs as other medicines are subject to variety of intellectual property rights protection (IPRs), including patents and data protection. Different jurisdictions worldwide have different standards when determining the eligibility of FDCs for patent and/or data protection. They can vary from 1) cases with lower standards for assessing the inventive step, where FDCs are given additional combination patent rights, 2) cases where FDCs is given status of new chemical entities thus allowing supplementary protection certificates and 3) cases where additional data protection for FDCs of already known active compounds is allowed. In this study, we have assessed the national standards among different jurisdictions of developing and developed countries. A comparison of their approaches in respect to their benefits and deficiencies related to the originators, patient accessibility and public health policies has been made. Key words: Fixed-dose combination medicinal products, patents, data exclusivity

scholarly journals Patient Reported Outcome (PRO) in Patients Receiving High and Moderate Emetogenic Chemotherapy (Ctx) - Results of a German Prospective Non-Interventional Study with Netupitant/Palonosetron Fixed Dose Combination (NEPA)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4844-4844 ◽  
Author(s):  
Meinolf Karthaus ◽  
P Klare ◽  
N Gazawi ◽  
MO Zahn ◽  
B Reimann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Fixed Dose Combination ◽  
Moderate Intensity ◽  
Fixed Dose ◽  
Interventional Study ◽  
Patient Reported ◽  
Dose Combination ◽  
Good For

Abstract Introduction:NEPA is a fixed dose combination of the NK1-receptor antagonist (RA) netupitant and 5-HT3-RA palonosetron approved for prevention of chemotherapy-induced nausea and vomiting (CINV) in pts receiving highly emetogenic (HEC) on cisplatin-basis or moderately emetogenic Ctx (MEC). NEPA demonstrated safety and efficacy in platinum, anthracycline and cyclophosphamid based Ctx, These drugs are frequently used in regimens for hematology pts. A German non-interventional study investigated NEPA's efficacy and impact on quality of life in adult cancer pts by patient-related outcomes (PRO) and physicians' personal assessment under real life conditions. Primary objective was the evaluation of quality of life (QoL) in adults receiving NEPA for CINV prevention. Secondary endpoints were efficacy and safety of NEPA. Methods: Open label, non-interventional, prospective, national, multicenter study that evaluates CINV prevention and patients' QoL receiving NEPA in pts with either HEC or MEC on up to 2 consecutive Ctx days for at least consecutive 3 cycles. QoL was evaluated by the validated FLIE questionnaires at the end of each Ctx cycle. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hrs and on 4 additional d after Ctx. Safety, additional medication and physicians' overall satisfaction was reported via eCRF. Results: Between June 2015 and Sept 2017 a total of 2429 pts were enrolled with 1997 pts being eligible for the 2nd interim analysis. 1901 pts were included in the efficacy analysis in the 1st, 1808 pts in the 2nd and 1734 pts in the 3rd cycle. Median age was 58 (range of 28-89). A total of 630 evaluable pts received MEC (53% carboplatin based) and 1185 pts received HEC (88% anthracycline/ cyclophosphamide based), PRO with complete response (CR=no nausea, no vomiting, no rescue medication) was analyzed based on patient diaries. Diaries for PRO in MEC-pts (n=401) reported CR in 94% in cycle 1, 85% in cycle 2 and 86% in cycle 3. Efficacy, assessed by physicians (n=630 pts) on a 4-point scale, was rated very good/good for 91%, 93%, and 94% in cycle 1, 2 and 3, respectively. PRO of 896 pts with HEC reported 81% CR in cycle 1, 82% in cycle 2 and 83% in cycle 3. Efficacy, assessed by physicians (1185 HEC pts), was rated very good/good for 88%, 89%, and 90% in cycle 1, 2 and 3, respectively. A high percentage of patients receiving HEC or MEC did not suffer from any emesis (93%, 93% and 94% in cycle 1-3, respectively). Over 85%of pts reported no impact on daily QoL due to vomiting in all 3 cycles with HEC or MEC.The most common treatment emergent adverse events were constipation and insomnia of mild-moderate intensity. Conclusions: NEPA prevented CINV highly effective in the acute and delayed phase of HEC and MEC with no impact on daily life due to vomiting in >85% of pts. Physicians evaluation was concordant to PRO.Safety profile was good. Disclosures Karthaus: Riemser: Consultancy. Schilling:Riemser: Honoraria.

A New Fixed-Dose Combination for Added Blood Pressure Control: Telmisartan Plus Hydrochlorothiazide

2002 ◽  
Vol 30 (4) ◽  
pp. 366-379 ◽  
Author(s):  
Y Lacourcière
Keyword(s):  
Blood Pressure ◽  
Cost Effective ◽  
Pressure Control ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Angiotensin Ii Receptor Blocker ◽  
Angiotensin Ii Receptor ◽  
Wide Range ◽  
Dosing Regimens ◽  
Dose Combination

Population surveys on hypertension management reveal worrying deficiencies in the awareness and treatment of high blood pressure. Many patients with hypertension will require two or more drugs with complementary mechanisms of action (which generally have additive effects, producing greater blood pressure reductions than either agent alone) to attain the blood pressure goals specified in internationally accepted guidelines. Nevertheless, physicians are often reluctant to prescribe multiple anti-hypertensive drugs due to concerns over side-effects, inconvenient dosing regimens and costs. Fixed-dose formulations combining two agents from different classes in a single tablet should help to allay these concerns. A fixed-dose combination containing telmisartan (an angiotensin II receptor blocker) and hydrochlorothiazide (a thiazide diuretic) has recently been developed. Telmisartan/hydrochlorothiazide provides additional anti-hypertensive efficacy compared with the respective monotherapies in a wide range of patients, including black patients, requires once-daily dosing, is cost-effective, well tolerated and is associated with less potassium depletion than hydrochlorothiazide administered alone.

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