Assessment of safety and efficacy of generic and branded metformin
Journal name: World Journal of Pharmaceutical Research
Original article title: Assessment of safety and efficacy of generic and branded metformin
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Ainan Fathima, Mahendra Kumar Betur Jayappa, Mohammed Sadath Shariff, Fulchan Ali
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Assessment of safety and efficacy of generic and branded metformin
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20241-30737
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Type II Diabetes Mellitus (T2DM) is a chronic condition characterized by elevated blood sugar levels and is often managed with oral hypoglycemic agents, with Metformin being among the most commonly prescribed. This study aimed to evaluate the safety and efficacy of branded versus generic forms of Metformin. The research focused on assessing adverse drug reactions (ADRs) as well as changes in Random Blood Sugar (RBS) and Glycosylated Hemoglobin (HbA1c) levels over three months among participants using either formulation.
Safety and Adverse Drug Reactions
The study gathered data on various adverse drug reactions experienced by participants taking either branded or generic Metformin. The most frequently reported ADR was diarrhea (56.7%), followed by acidity (43.3%) and joint pain (40%). Importantly, the analysis found no statistically significant differences in the incidence of these ADRs between the two groups, indicating that both branded and generic Metformin share equivalent safety profiles. This suggests that healthcare providers can consider either formulation for their patients without significant concerns regarding adverse effects.
Efficacy Comparison
Efficacy was evaluated by comparing changes in RBS and HbA1c levels among users of both Metformin versions over three months. While both formulations were effective in lowering blood glucose levels, branded Metformin demonstrated a marginally superior effect on RBS, with a mean difference of 63.53 mg/dl compared to 49.73 mg/dl in the generic group, which was statistically significant (p=0.003). Conversely, changes in HbA1c levels showed no significant difference between the two groups, with the branded formulation exhibiting a mean difference of 0.766 compared to 0.4 for the generic Metformin (p=0.21). This highlights that while branded Metformin may reduce immediate blood sugar levels more effectively, both formulations perform similarly in long-term glycemic control.
Patient Awareness and Economic Impact
The study also examined the need for patient awareness regarding the equivalence of branded and generic medications. It emphasized that although both types of Metformin are pharmacologically the same, misunderstandings and skepticism about generic formulations often persist among patients and physicians. The research advocated for greater dissemination of information to patients, particularly in the context of increasing healthcare costs. Understanding that generic drugs can provide the same therapeutic benefits at a lower price could enhance adherence to treatment and alleviate the economic burdens of diabetes management.
Conclusion
In conclusion, the study demonstrated that both branded and generic Metformin are comparable regarding safety and overall efficacy, with only slight variances in blood glucose control. Given the cost-effectiveness of generics and the similarity in therapeutic outcomes, it is vital for healthcare practitioners to promote awareness around the use of generic medications. This will not only aid in reducing treatment costs for patients managing T2DM but will also encourage adherence to prescribed therapies without compromising clinical outcomes.
FAQ section (important questions/answers):
What is the primary focus of the study conducted on Metformin?
The study aimed to assess the safety and efficacy of both branded and generic Metformin among patients diagnosed with Type II Diabetes Mellitus.
What were the most common adverse drug reactions reported by participants?
The most reported adverse drug reactions were diarrhea (56.7%), followed by acidity and sour stomach (43.3%), pain or numbness in joints (40%), and dizziness (23.3%).
How did branded and generic Metformin compare in efficacy regarding RBS levels?
Branded Metformin showed a mean difference of 63.53 in RBS levels, while generic Metformin had a mean difference of 49.733, indicating branded Metformin improved RBS levels more significantly.
Were there any significant differences in HbA1c levels between the groups?
There was no statistically significant difference in HbA1c levels between branded and generic Metformin users, with branded showing a mean difference of 0.766 and generic showing 0.4.
What demographic information was collected from study participants?
The study collected demographic data on participants' gender, age, duration of diabetes diagnosis, and comorbidities to provide a comprehensive profile of the patients involved.
What conclusions were drawn regarding the safety of branded and generic Metformin?
The study concluded that both branded and generic Metformin have comparable safety profiles, with no significant differences in the reported adverse drug reactions.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Assessment of safety and efficacy of generic and branded metformin”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
Drugs refer to chemical substances that induce physiological changes in the body. The document discusses both generic and branded drugs, particularly metformin, highlighting their therapeutic effects on diabetes management. The focus on the type and formulation of drugs has implications for patient treatment regimens and compliance.
2) Medicine:
Medicines encompass a range of substances used to diagnose, treat, or prevent diseases. The paper discusses both branded and generic medicines, specifically focusing on metformin, which is essential for treating Type II Diabetes. Understanding the differences between these medicines is key to patient adherence and health outcomes.
3) Study (Studying):
The study represents the investigation documented in the journal focusing on the safety and efficacy of metformin formulations. It utilizes a comparative analysis of branded and generic drugs, emphasizing methodologies, findings, and implications for diabetes management within the Indian healthcare context.
4) Quality:
The quality of medications, specifically regarding their therapeutic equivalence and safety, is a critical focus in the study. Evaluating the quality between branded and generic formulations is essential for informing patients and healthcare providers about safe choices in medication management.
5) India:
India is the nation where the study was conducted, highlighting the relevance of drug accessibility and affordability within its healthcare system. The rising incidence of diabetes in India necessitates effective management plans involving both branded and generic medicines, influencing societal health and economic burden.
6) Table:
Table refers to the structured format used to present data and results in the study. Various tables illustrate demographic details, adverse drug reactions, and blood sugar levels, providing clear visual representations of comparative analysis between branded and generic metformin users.
7) Aushadhi (Ausadhi, Aushadhin, Ausadhin):
Aushadhi refers to a government initiative in India aimed at providing affordable medicines, including generics. The Jan Aushadhi scheme helps mitigate financial barriers in healthcare, enhancing accessibility to quality medications for economic sections, thus playing a vital role in diabetes treatment across diverse populations.
8) Disease:
Disease denotes a pathological condition affecting the body, impacting overall health. The research addresses Type II Diabetes Mellitus as a chronic disease, analyzing treatment outcomes with metformin. Understanding disease management is essential for evaluating treatment efficacy, patient quality of life, and healthcare resource allocation.
9) Life:
Life in this context pertains to the quality of life of patients undergoing treatment for diabetes. The study aims to assess how different metformin formulations influence daily living and health outcomes, which is vital for understanding treatment effectiveness and patient satisfaction.
10) Mysore:
Mysore is the geographical location where the study was conducted, specifically at healthcare facilities such as the CSI Holdsworth Hospital and Jan Aushadhi Kendra. The locale is central to understanding regional healthcare issues, drug accessibility, and treatment efficacy for diabetes patients in that area.
11) Indian:
Indian refers to the demographic context of the study, highlighting the cultural and economic factors affecting diabetes treatment in India. Patient preferences for branded versus generic medicines are significantly influenced by specific regional attitudes, awareness, and accessibility challenges present within the Indian healthcare system.
12) Pain:
Pain, often a symptom related to various health conditions, is one potential adverse drug reaction noted in the study. The research highlights the side effects experienced by patients using metformin, emphasizing the importance of monitoring and managing any pain associated with medication use in diabetes treatment.
13) Perception:
Perception identifies how patients view and understand generic versus branded medications. Addressing common biases and assumptions about quality and efficacy is crucial for convincing patients to consider generic options, which may enhance medication adherence and reduce overall treatment costs.
14) Sour:
Sour in this context refers to one of the adverse drug reactions reported by participants; specifically, it pertains to gastrointestinal issues experienced by metformin users. Addressing these side effects is significant for patient management and improving the overall experience in diabetes treatment.
15) Performance:
Performance refers to the measure of how effectively branded and generic metformin formulations reduce blood sugar levels and manage diabetes. Evaluating the performance of these drugs is essential for determining both patient outcomes and overall healthcare practices in medication management.
16) Science (Scientific):
Sciences encompass the systematic study and understanding of natural phenomena. The study integrates principles of clinical pharmacy and pharmacology to address the effectiveness and safety of metformin, reflecting the multifaceted nature of healthcare science.
17) Kendra (Kemdra):
Kendra translates to 'center' in Hindi and refers specifically to the Jan Aushadhi Kendra initiative, providing affordable generic medications. This initiative is critical for improving access to required medications for patients with diabetes, promoting equity in healthcare within Indian society.
18) Reason:
Reason highlights the motivations behind patients' choices between branded and generic medications. Understanding these reasons is crucial for improving policy measures, marketing strategies, and healthcare provider education to encourage cost-effective treatment options without sacrificing quality and efficacy.
19) Nanda (Namda):
Nanda is a name mentioned in the reference section of the study, linking back to previous research on perceptions of generic medicines. Citing authoritative sources strengthens the argument for generics, contributing to the ongoing conversation about public health and drug affordability.
20) Hand:
Hand generally relates to the practical aspect of healthcare delivery and patient management. The study emphasizes how healthcare practitioners should effectively communicate with patients about drug choices, ensuring informed decisions that balance efficacy, safety, and economic considerations in diabetes treatment.
21) Male:
Male refers to one demographic aspect of the study. With a notable percentage of male participants, analyzing gender differences in drug response and preferences is essential for understanding the broader implications for healthcare approaches within the diabetic patient population.
22) Pharmacological:
Pharmacological refers to the branch of medicine focused on the uses, effects, and mechanisms of drugs. The study is rooted in pharmacological assessment, comparing the therapeutic effects of metformin, ultimately guiding appropriate treatment strategies in managing Type II Diabetes Mellitus.
23) Pharmacology:
Pharmacology is the science of drugs and their effects on living organisms. The study incorporates pharmacological principles to interpret the safety and efficacy of metformin formulations, aiming to enhance the medical understanding of diabetes management through evidence-based research.
24) Measurement:
Measurement is critical in scientific studies, involving quantifying results to provide reliable data. Measurement of blood sugar levels and adverse drug reactions in the study is vital for comparing the efficacy of branded versus generic metformin for drawing valid conclusions about treatment outcomes.
25) Reliability:
Reliability pertains to the consistency and dependability of the study's findings. Ensuring the reliability of results through rigorous data collection and analysis informs healthcare practices and enhances trust in the research, ultimately guiding patient treatment decisions in diabetes management.
26) Discussion:
Discussion refers to the section of the study where results are interpreted and contextualized within existing literature. This segment helps to elucidate the implications of findings regarding the safety and efficacy of metformin, guiding future research and healthcare practices in diabetes.
27) Developing:
Developing relates to the process of pharmaceutical creation and testing. In the context of this study, it highlights the relevance of understanding drug development stages to ensure that both generic and branded formulations meet safety and efficacy standards necessary for patient care.
28) Substance:
Substance specifically refers to the active ingredients found in medications like metformin. Understanding the role of active substances in therapeutic effectiveness is crucial for assessing the safety, efficacy, and overall patient outcomes connected to diabetes management.
29) Karnataka:
Karnataka is the Indian state where the study was conducted, influencing regional healthcare practices and medication availability. The healthcare system in Karnataka, including initiatives like Jan Aushadhi, plays an essential role in improving access to necessary diabetes medications for local populations.
30) Knowledge:
Knowledge reflects the understanding and information that patients and healthcare providers possess regarding medications. Enhancing knowledge about the equivalence of generic and branded drugs is crucial for informed decision-making and improving adherence to diabetes treatment protocols.
31) Observing:
Observing relates to the systematic collection and analysis of data within the study. The act of observing patients' responses to branded versus generic metformin is pivotal in evaluating safety, efficacy, and patient preferences during the research timeframe.
32) Mahendra (Mahemdra, Maha-indra):
Mahendra is part of the names mentioned in the authorship of the study. Citing varied authors contributes to the credibility and scholarly discussion surrounding the issues presented, bolstering the research on the safety and efficacy of metformin formulations.
33) Toxicity:
Toxicity refers to the harmful effects drugs can produce. The study closely examines adverse drug reactions, highlighting the significance of monitoring for toxicity to ensure patient safety in the ongoing management of diabetes with metformin.
34) Teaching:
Teaching refers to the imparting of knowledge within the healthcare domain, particularly regarding medication use. The research underscores the need for better education for healthcare providers and patients about the implications of choosing between branded and generic medications.
35) Pradhan:
Pradhan refers to the governmental health initiative, the Pradhan Mantri Jan Aushadhi Yojana. This scheme plays a crucial role in providing affordable medication options, including generics, within the Indian healthcare landscape, particularly for managing chronic diseases like diabetes.
36) Company:
Company denotes the pharmaceutical organizations involved in producing branded and generic drugs. Understanding the differences in production, marketing, and pricing strategies of these companies is vital to addressing concerns about drug efficacy, safety, and public perception among healthcare consumers.
37) Mantri (Mamtri, Mantrin):
Mantri refers to a ministerial title within the Indian government and is linked with initiatives like Jan Aushadhi Yojana. Such government policies aim to enhance public access to essential medicines, directly impacting diabetes treatment options among the Indian population.
38) Family:
Family highlights the social dynamics surrounding health decision-making. Family influence often affects patient attitudes towards drug selection, healthcare practices, and adherence to prescribed therapy, especially in managing chronic conditions like diabetes, where patient support is essential for treatment success.
39) Nausea:
Nausea is an adverse effect associated with medications, including metformin. The study's documentation of nausea among patients emphasizes the need for monitoring and managing side effects to enhance patient comfort and compliance during diabetes treatment.
40) Joshi (Josi):
Joshi is referenced in connection with discussions on generic drugs in India. Mentioning authoritative figures strengthens the credibility of the arguments presented regarding the safety and affordability of generic versus branded medications within the study's findings.
41) Kumar:
Kumar is part of the authorship attribution in the study. Citing various authors contributes to demonstrating collaboration in research, thereby enhancing the credibility and reliability of findings regarding metformin's efficacy in diabetes management.
42) Annal:
Annal here likely refers to documentation or records of research findings over time. In the context of the study, annals can signify the importance of documenting research outcomes in clinical practice, enhancing continuous learning and healthcare delivery regarding diabetes management.
43) Sugar:
Sugar, particularly in blood glucose levels, is a central focus in diabetes management. Monitoring sugar levels is critical to evaluating treatment efficacy, especially concerning metformin. The study addresses the importance of effective management to prevent complications associated with abnormal sugar levels.
44) Trade:
Trade refers to the marketing and selling of pharmaceuticals, emphasizing how branded drugs are marketed versus generic medications. Understanding the trade dynamics is essential for analyzing patient perceptions and decisions regarding medication choices in diabetes treatment.
45) Doubt:
Doubt signifies skepticism concerning the efficacy and safety of generic medications compared to branded ones. Addressing these doubts is essential for healthcare providers to help patients make informed choices, ultimately improving access to affordable diabetes treatment options.
46) Money:
Money is a practical consideration involved in drug procurement. The cost disparity between branded and generic medicines plays a significant role in patient choices and adherence, impacting overall health outcomes, particularly in chronic disease management like diabetes.
47) Blood:
Blood, particularly in the context of sugar levels, is critical for assessing diabetes management. The study focuses on how different metformin formulations affect blood sugar control, which is essential for reducing the risk of diabetes-related complications among patients.
48) Pati (Patin):
Pati is mentioned as part of the authoritative references in the study. Citing studies conducted by reputable researchers like Pati lends credibility to the exploration of generic medication and further emphasizes the validity of the findings in the research.
49) Anni:
Anni could refer to a personal or familial narrative that ties into the patient's experience with medication. Although less formal, such references can draw attention to the human aspect of clinical studies, highlighting patients' real-life experiences with diabetes treatment.
50) Pur:
Poor references economically disadvantaged segments of the population. The study emphasizes the importance of affordable medication access for managing Type II Diabetes, underlining that improved access can significantly enhance health outcomes for the economically disadvantaged groups.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Assessment of safety and efficacy of generic and branded metformin’. Further sources in the context of Science might help you critically compare this page with similair documents:
Quality of life, Statistically Significant, Adverse drug reaction, Safety and efficacy, Type II Diabetes Mellitus, Economic burden, Quality of life (QoL), Functional status, Cost effectiveness, Glycosylated hemoglobin, Glycosylated hemoglobin (HbA1C), Adverse drug reactions (ADR), Random blood sugar, Mean Difference, Generic drug, Bioequivalence, Data collection form, Clinical Endpoint, Oral hypoglycemic, Interchangeability, Pharmaceutical Marketing, Therapeutic Equivalence, Jan Aushadhi Scheme, Branded drug, Jan Aushadhi, Humanistic outcomes, Patient medication non-adherence, ECHO model, Bio-equivalents.