Generic drugs: benefit/risk ratio

2021 ◽  
Vol 13 (6) ◽  
pp. 98-104
Author(s):  
E. A. Ushkalova ◽  
S. K. Zyryanov ◽  
I. A. Gopienko
Keyword(s):  
Clinical Practice ◽  
Active Ingredient ◽  
Comparative Studies ◽  
Generic Drugs ◽  
Comparable Efficacy ◽  
Synthesis Methods ◽  
Therapeutic Equivalence ◽  
Efficacy And Safety ◽  
Attending Physician ◽  
The Impact

The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice. Results of pharmacoepidemiological studies, which have been widely carried out recently, speak of insufficient understanding of the impact of generics on remote outcomes of chronic diseases, including mortality. The longterm economic prospects of generic drug administration continue to remain unclear. Among the primary differences between generics and brandname drugs are the differences in active ingredient synthesis methods and the composition of adjuvants and additives. Comparative studies on the therapeutic equivalence of generics with their originals or between themselves are rarely conducted. They are often affected by methodological flaws, which cannot ensure their comparable efficacy and safety. In this regard, automatic replacement of drugs containing the same active ingredient should be avoided without the participation of the attending physician.

scholarly journals The strategy of obesity management: the results of All-Russian observational program “Primavera”

2016 ◽  
Vol 13 (1) ◽  
pp. 36-44 ◽  
Author(s):  
Ivan I. Dedov ◽  
Galina A. Mel'nichenko ◽  
Tat'yana I. Romantsova
Keyword(s):  
Clinical Practice ◽  
Microcrystalline Cellulose ◽  
Research Centre ◽  
Efficacy And Safety ◽  
Active Monitoring ◽  
Alimentary Obesity ◽  
Prevalence Of Obesity ◽  
Analysis Of Results ◽  
Average Body Mass ◽  
Attending Physician

Introduction. The prevalence of obesity and associated comorbidities is comparable to the scale of the epidemic. Along with the change in lifestyle, pharmacotherapy is necessary to lead obesity patients to a healthier state.Aim. The evaluation of efficacy and safety of Reduxin® (sibutramine + microcrystalline cellulose) application among patients with alimentary obesity and comorbidities in routine clinical practice. Analysis of results of Primavera program.Materials and methods. The observation program Primavera was conducted since November 2012 to July 2015 under the auspices ofEndocrinology Research Centre and the Russian Association of Endocrinologists. The program "Primavera" was attended by 3095 doctors of various specialties and 98.774 patients being treated in 1272 hospitals in 142 Russian cities. The average age of the patients was 39.4 ± 10.4 years, the ratio of male / female – 17.7%/82,3%, the average body mass – 99.1±14.28 kg, the average BMI – 35.7±4.41 kg/m2, the average waist circumstance – 105.7±13.7 cm. The Duration of Reduxine® treatment was determined by the attending physician and ranged from 3 months to 1 year.Results. The duration of therapy was 3 months for 3% of patients, 6 months for 59.3% of patients, 12 months for 37.7% of patients. The BMI reducing dynamics during 3, 6, 12 months was 3.4±1.53 kg/m2 (average 9.5±4.28 kg), 5.4±2.22 kg/m2 (15.0±6.22 kg), 7.2±3.07 kg/m2 (20.0±8.62 kg) respectively. The average waist circumference reduction for 3, 6 and 12 months was 6.3±4.31 sm, 10.6±6.30 sm, 16.0±8.94 sm, respectively. It was shown that the weight loss during prolonged (more than six months) Reduxine therapy under the supervision of a physician was associated with decreased levels of systolic and diastolic blood pressure and had no affect on heart rate. Adverse events were reported for 4.1% of patients, according to doctors, the cause-effect relationship with the use of Reduxine can be estimated as probable or definite for 1.9% of patients, possible – for 1.7%.Conclusions. Observation programs allow to implement the principles of active monitoring of the efficacy and safety of the drug in the current clinical practice and to develop a skill of reasonable prescribing. In Primavera program it was shown that the use of Reduxine® (sibutramine+ microcrystalline cellulose) leads to loss of body weight and doesn’t lead to serious adverse effects.

scholarly journals Correlation of reference and generic fluconazole-based drugs

2020 ◽  
pp. 98-104
Author(s):  
A. S. Dukhanin
Keyword(s):  
Generic Drugs ◽  
Medical Community ◽  
Quantitative Composition ◽  
Therapeutic Equivalence ◽  
Efficacy And Safety ◽  
Federal Law ◽  
Reference Drug ◽  
State Register ◽  
The Law ◽  
Preclinical And Clinical Studies

The article describes the basic rules for the selection of a systemic antifungal drug from the fluconazole-based preparations available on the Russian pharmaceutical market. Questions of interchangeability of generic and original drugs, research of equivalence (pharmaceutical, pharmacokinetic), possible methodological difficulties of its estimation are discussed. Data on comparative analysis of original and generic fluconazole drugs are presented. The algorithm of rational choice of a drug on an example of fluconazole is formulated, property of a drug to suppress selectively activity of fungi of genus Candida, not showing hepatotoxic drugs, and also questions of correlation between reference and generic drugs on the basis of fluconazole is considered. The Federal Law “On Amendments to the Federal Law “On Circulation of Medicines“ No. 429-FZ (adopted on December 22, 2014 and entered into force on July 1, 2015) regarding the establishment of the procedure for determining the interchangeability of drugs, states: “Information on the interchangeability of drugs shall be included in the State Register of Medicines from January 1, 2018“. The law discloses the notion of interchangeable drugs, which “means a drug with proven therapeutic equivalence or bioequivalence regarding reference drugs, having equivalent qualitative formula and quantitative composition of active substances, formula and method of administration“. However, some definitions used so far in the law have been changed. Thus, instead of the term “original medicine“ the term “reference drug“ is used from July 1, 2015, which is defined as a medicine first registered in the Russian Federation, the quality, efficacy and safety of which has been proved based on the results of preclinical and clinical studies, and which is used to assess the bioequivalence or therapeutic equivalence, quality, efficacy and safety of generic or bioanalogue medicine. However, this article still uses the terms “original“ and “generic“ drugs, which are familiar to our medical community.

P5712Research Network in Africa (RNA): quality assessment of antihypertensive generic drugs in 10 African countries

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Macquart De Terline ◽  
P Zabsonre ◽  
D Balde ◽  
S Ikama ◽  
R N Guetta ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Active Ingredient ◽  
Antihypertensive Drugs ◽  
Generic Drugs ◽  
Poor Quality ◽  
Sub Saharan Africa ◽  
African Countries ◽  
Sub Saharan ◽  
The Impact ◽  
Percentage Ratio

Abstract Introduction Hypertension results in more deaths than any other risk factor and has been on the rise in Sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. Purpose We performed a quality assessment of five commonly used antihypertensive generic drugs in ten Sub-Saharan African countries and studied the impact of price on quality. Methods Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. Results A total of 1185 samples were assessed, of which 70.0% were generic (n=830). Among the generic drugs, the percentage of poor quality drugs was 24.3% (n=202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2% to 111.3%; the majority (81.7%) of the poor quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. Conclusion In this study from ten Sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low and middle income countries. Figure 1. Percentage of poor quality in generic antihypertensive drugs according to the country of purchase. Acknowledgement/Funding Grant AAP-2014-042, ANSM (Agence Nationale Sécurité du Médicament

scholarly journals Efficacy and safety profile of xanthines in COPD: a network meta-analysis

2018 ◽  
Vol 27 (148) ◽  
pp. 180010 ◽  
Author(s):  
Mario Cazzola ◽  
Luigino Calzetta ◽  
Peter J. Barnes ◽  
Gerard J. Criner ◽  
Fernando J. Martinez ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Meta Analysis ◽  
Forced Expiratory Volume ◽  
Therapeutic Window ◽  
Comparable Efficacy ◽  
Chronic Obstructive ◽  
Efficacy And Safety ◽  
Quantitative Synthesis ◽  
The Impact

Theophylline can still have a role in the management of stable chronic obstructive pulmonary disease (COPD), but its use remains controversial, mainly due to its narrow therapeutic window. Doxofylline, another xanthine, is an effective bronchodilator and displays a better safety profile than theophylline. Therefore, we performed a quantitative synthesis to compare the efficacy and safety profile of different xanthines in COPD.The primary end-point of this meta-analysis was the impact of xanthines on lung function. In addition, we assessed the risk of adverse events by normalising data on safety as a function of person-weeks. Data obtained from 998 COPD patients were selected from 14 studies and meta-analysed using a network approach.The combined surface under the cumulative ranking curve (SUCRA) analysis of efficacy (change from baseline in forced expiratory volume in 1 s) and safety (risk of adverse events) showed that doxofylline was superior to aminophylline (comparable efficacy and significantly better safety), bamiphylline (significantly better efficacy and comparable safety), and theophylline (comparable efficacy and significantly better safety).Considering the overall efficacy/safety profile of the investigated agents, the results of this quantitative synthesis suggest that doxofylline seems to be the best xanthine for the treatment of COPD.

scholarly journals Original drugs and their generics: a problem of choice

2009 ◽  
Vol 15 (2) ◽  
pp. 209-213
Author(s):  
S. Y. Martsevich ◽  
S. Tolpygina
Keyword(s):  
Comparative Studies ◽  
Generic Drugs ◽  
Therapeutic Equivalence ◽  
Generic Medicines ◽  
Enalapril Maleate

The main distinctions of original and generic drugs are described, and the registration criteria of generics are given. The article considers the main causes of bioequivalence and therapeutic equivalence mismatch of original and generic medicines presenting several examples based on the results of clinical comparative studies, including Enalapril Maleate (comparison of original Renitec and generic Enam). The main approaches of planning the therapeutic equivalence comparative studies are offered.

Translating Principles of Speech Science to Clinical Practice: Current and Future Trends in Craniofacial Disorders

2008 ◽  
Vol 18 (1) ◽  
pp. 31-40 ◽  
Author(s):  
David J. Zajac
Keyword(s):  
Clinical Practice ◽  
Speech Intelligibility ◽  
Current Practice ◽  
Computer Assisted ◽  
Behavioral Management ◽  
Single Word ◽  
Future Directions ◽  
Speech Science ◽  
The Impact ◽  
Opinion Article

Abstract The purpose of this opinion article is to review the impact of the principles and technology of speech science on clinical practice in the area of craniofacial disorders. Current practice relative to (a) speech aerodynamic assessment, (b) computer-assisted single-word speech intelligibility testing, and (c) behavioral management of hypernasal resonance are reviewed. Future directions and/or refinement of each area are also identified. It is suggested that both challenging and rewarding times are in store for clinical researchers in craniofacial disorders.

Endovenous procedures in varicose veins

Phlebologie ◽  
2008 ◽  
Vol 37 (05) ◽  
pp. 229-236
Author(s):  
N. Cayne ◽  
G. Jacobowitz ◽  
P. Lamparello ◽  
T. Maldonado ◽  
C. Rockman ◽  
...  
Keyword(s):  
Varicose Veins ◽  
Treatment Options ◽  
Postoperative Recovery ◽  
Comparable Efficacy ◽  
Intense Pulse Light ◽  
Efficacy And Safety ◽  
Endovenous Laser Ablation ◽  
The Past ◽  
Early Evidence ◽  
Endovenous Treatment

SummaryOver the past ten years endoveous treatment options for varicose veins have evovled considerably, offering clinicians a multitude of options to meet the needs of their patients. The endothermal ablation procedures have moved to the forefront as the choice modality for treating truncal reflux. Both radiofrequency ablation and endovenous laser ablation are widely accepted and interchangeable, showing comparable efficacy and safety. Although numerous endovenous laser wavelengths exist, the data indicates that the differences do not affect the efficacy or postoperative recovery of the procedure. The endovenous laser innovation that has shown early evidence of improved patient outcome is the jacket-tip fiber. The versatility of sclerotherapy makes it a critical component in the endovenous treatment of varicosities. Although not approved by the Food and Drug Administration (USA), the use of a foamed sclerosing agent is the fastest growing segment of sclerotherapy and an important treatment modality in the future of varicose vein treatment. Cutaneous lasers and intense pulse light devices contribute a crucial element, enabling clinicians to treat minute veins that may be impossible to treat with other therapies.

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