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Parmi Patel
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Maladkar, Manish

Game Changer in the Management of Diabetic Neuropathy: an Indian Perspective - Post-Marketing Surveillance of Epalrestat and Methylcobalamin

Abstract Views :178 | PDF Views:0

Authors

Manish Maladkar ¹, Srividya Sankar ¹, Parmi Patel ¹

Affiliations
1 Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, IN

Source

The Indian Practitioner, Vol 66, No 12 (2013), Pagination: 745-750

Abstract

Background: Diabetic Neuropathy is one amongst the most common long - term complication of diabetes. It is prevalent in more than 50% of people suffering from diabetes mellitus. Management of diabetic neuropathy is aimed at targeting the pathogenetic factors that leads to neuropathy. Epalrestat helps to prevent neuronal degeneration by reducing the accumulation of toxic sorbitol and decreasing the oxidative stress while methylcobalamin helps to recover neuronal injury.The purpose of this study was to evaluate safety and efficacy of fixed dose combination of Epalrestat+ Methylcobalamin in patients with diabetic neuropathy.

Method: A prospective, open-label, non-comparative study was conducted in different regions of India. A pool of 150 patients was involved in the study and the duration of study was 12 weeks. A fixed dose combination of Epalrestat 50 mg + Methylcobalamin 500 mcg three times a day was administered.

Results: At the end of the study, a significant difference was observed in various parameters from baseline. A significant reduction in neuropathic symptoms was observed at the end of the treatment (58% reduction at 4th week and 94% reduction at 12^th week). The mean pain intensity score reduced to 89.4% from baseline. A positive effect was also observed in muscle strength that increased to 36% in patients. As per investigator's assessment about efficacy and tolerability, 82.7% of patients reported excellent efficacy and 86.7% of patients reported excellent tolerability. The therapy was well tolerated with few adverse events (AEs).

Conclusion: The results of this study confirm that this combination of Epalrestat+ Methylcobalamin is well tolerated and it showed significant improvement in the symptoms of diabetic neuropathy at the end of treatment.

Keywords

Diabetes Neuropathy, Epalrestat, Methylcobalamin, Polyol Pathway, Aldose Reductase Inhibitor, Diabetes.

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Tamsulosin for the Treatment of Voiding Dysfunction in Women – A Review

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Authors

Manish Maladkar ¹, Chitra Tekchandani ¹, Nehali Save ¹

Affiliations
1 Aristo Pharmaceuticals Ltd, 23-A Shah Industrial Estate, Veera Desai Road, Andheri (West), Mumbai, IN

Source

The Indian Practitioner, Vol 71, No 10 (2018), Pagination: 34-38

Abstract

Lower urinary tract symptoms (LUTS) have high prevalence worldwide in the aging population including both, men and women and with the advancing age, the incidence of LUTS continues to increase. Interference of the symptoms with the daily activities has a negative impact on the quality of life of many individuals. Apart from watchful waiting and surgery, medical therapies have shown to provide significant control of LUTS. α1- adrenergic receptor blockers are used as first-line therapy for men to alleviate Benign Prostatic Hyperplasia (BPH) induced urinary symptoms. Similar underlying etiology of LUTS in men and women proposes the utility of α1-adrenergic receptor blockers for female lower urinary tract symptoms (FLUTS). Tamsulosin, the highly uroselective α1-adrenergic receptor blocker, has steadily borne positive results in symptomatic management of FLUTS. Improvement in quality of life has been a vital criteria in the assessment of the efficacy of Tamsulosin. All the reviewed studies substantiate the safety and tolerability of Tamsulosin. Numerous clinical trials of Tamsulosin in women suggest the suitability of Tamsulosin as an appropriate therapeutic option for management of female LUTS.

Keywords

Tamsulosin, Luts/ Fluts, α1-adrenergic Receptors, Bladder, Urethra.

Full Text

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COVID-19 Treatment:Current and Emerging Options

Abstract Views :205 | PDF Views:0

Authors

Manish Maladkar ¹, Chitra Tekchandani ¹, Akshata Karchodi ¹

Affiliations
1 Aristo Pharmaceuticals Private Limited, Mumbai, IN

Source

The Indian Practitioner, Vol 73, No 6 (2020), Pagination: 37-41

Abstract

Coronavirus disease 2019 (COVID-19) which is caused by the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) has posed a clinical threat to the global population. Its resemblance to SARS-CoV along with several other bat coronaviruses have been established through genome sequencing- related studies. The disease spreads by human-to-human transmission via droplets or direct contact and presents flu-like symptoms. It can have poor prognosis in high-risk individuals having co-morbid conditions. Though currently, no proven effective therapies for SARS-CoV-2 exist, many therapeutic agents are being repurposed to treat patients with COVID-19. The key aspect determining the prognosis of COVID-19 patients is the early accurate diagnosis followed by the management of acute respiratory failure and hemodynamic instability in moderate-severe cases. COVID-19 presents an unparalleled chal-lenge to identify potential therapeutic agents for prophylaxis and treatment. There is an explicit and urgent need to explore all the possible prophylactic and therapeutic strategies to curb the spread of SARS-CoV-2. A large number of clinical trials have been launched to investigate potential therapies for COVID-19 and to provide the clinicians ac-curate evidence regarding effective medical treatments for this infection. The current review closely examines the drugs that are being explored and also those drugs which have a potential for consideration. Though the therapeutic options have not undergone extensive pre-clinical and clinical testing, each has a known merit and identified mecha-nism against viral infection. The review is based on currently available information and as new evidence emerges, reappraisal of therapies is anticipated.

Keywords

COVID-19, Management, SARS-CoV-2, Potential Therapies, Evidence.

Full Text

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A Review of the Role of Silodosin as Medical Expulsive Therapy for Ureteral Stones

Abstract Views :230 | PDF Views:0

Authors

Manish Maladkar ¹, Srividya Sankar ¹, Sudhir Awate ¹

Affiliations
1 Aristo Pharmaceuticals Private Limited, Mumbai, IN

Source

The Indian Practitioner, Vol 73, No 9 (2020), Pagination: 25-32

Abstract

Urolithiasis is a chronic human condition that has immense public health importance and it poses a tremendous economic burden on our society. Medical expulsive therapy (MET) for the treatment of ureteral stones has emerged as a cost-effective approach. In the last few years, a number of drugs have been introduced and used successfully as MET for the expulsion of small, uncomplicated ureteral calculi. Using a selective α-adrenoceptor blocker for MET has emerged as an effective treatment approach and is widely used for ureteral stones. Silodosin, a selective α-blocker, has a higher selectivity for the α1A receptor as compared to other agents in the class. The objective of this review is to determine the efficacy and safety of Silodosin in MET as compared to placebo and Tamsulosin.

Keywords

Ureteral Stone Expulsion, Urolithiasis, alpha-1 adrenoceptor blocker, Silodosin, Tamsulosin.

Full Text

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COVID-19: Impact on Mental Health

Abstract Views :177 | PDF Views:1

Authors

Manish Maladkar ¹, Chitra Tekchandani ², Raveena Bajaj ³

Affiliations
1 President - Medical and Regulatory Affairs, Aristo Pharmaceuticals Private Limited, Mumbai-400053, IN
2 Dy. General Manager – Medical, Aristo Pharmaceuticals Private Limited, Mumbai, IN
3 Asst. Manager – Scientific, Aristo Pharmaceuticals Private Limited, Mumbai, IN

Source

The Indian Practitioner, Vol 74, No 2 (2021), Pagination: 17-22

Abstract

The outbreak of the novel coronavirus (COVID-19) which was first detected in Wuhan, China in December 2019 has created havoc worldwide. It progressed to the status of a pandemic in March 2020 with countries across the various continents adversely affected.

This coronavirus crisis has not only affected the health, safety & well-being but has also significant negative impact on the mental health. Moreover, stigma of the disease, uncertain prognoses, imposition of unfamiliar preventive measures, large and growing economic burden, and information incessant on media platforms are among some of the major stressors that has undoubtedly contributed to widespread emotional distress. Though this coronavirus crisis has affected the mental health of almost everyone in the world, there are certain groups of people who may be more vulnerable to mental health illness than the rest of the general public. In particular, people who contract the disease, those at heightened risk for it (including the healthcare workers, elderly, people with compromised immune function, and family members/close contacts of COVID-19 patients) and people with pre-existing medical, psychiatric illness are at increased risk for adverse mental health outcomes. This review focusses on impact of COVID-19 on mental health of various population and explores various strategies to tackle these health concerns.

Keywords

COVID-19, Mental Health, Neuropsychiatric Symptoms.

Full Text

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Essential Immunonutrients in COVID-19: An Evidence-Based Review

Abstract Views :213 | PDF Views:0

Authors

Manish Maladkar ¹, Ashok Yadav ², Nehali Save ³

Affiliations
1 President- Medical & Regulatory Affairs Aristo Pharmaceuticals Private Limited, Mumbai, IN
2 Assistant General Manager- Medical, Scientific Department, Aristo Pharmaceuticals Private Limited, IN
3 Sr. Scientific Executive- Scientific Department, Aristo Pharmaceuticals Private Limited, IN

Source

The Indian Practitioner, Vol 74, No 6 (2021), Pagination: 20-26

Abstract

A ‘well-fed’ immune system is extremely important to ensure it performs the function of protecting against the viral offense. Various nutrients and minerals play a vital role in maintaining the integrity and function of the immune system. Among the various nutrients and minerals, vitamin C, vitamin D, and zinc stand out for having immune-modulatory functions which are demonstrated in a substantial body of evidence. In the ongoing pandemic of COVID-19, nutrients that can optimize the immune system to prevent or lower the risk of severe disease progression are very essential. Medical literature shows that deficiency of one or more of these nutrients may affect the immunity status of an individual and may predispose a person to an adverse prognosis of COVID-19. Therefore, adequate intake of vitamin C, D, and zinc may present as a promising tool in prehabilitation with immunonutrition for COVID-19 prevention and management. This review provides a comprehensive overview of the role of vitamin C, D, and zinc as an immunomodulatory agent in COVID-19 management.

Keywords

Vitamin C, vitamin D, zinc, immunity, immunonutrition, COVID-19

Full Text

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The Journey of Vildagliptin: From Bench to Bedside

Abstract Views :119 | PDF Views:83

Authors

Manish Maladkar ¹, Srividya Sankar ², Mahesh Darshanwad ³

Affiliations
1 President – Medical & Regulatory Affairs, IN
2 Sr. General Manager – Scientific, Scientific Department, IN
3 Dy. Manager – Scientific, Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, IN

Source

The Indian Practitioner, Vol 75, No 4 (2022), Pagination: 28-36

Abstract

Vildagliptin, a DPP-4 inhibitor has been available for the management of type 2 diabetes mellitus for more than a decade. The extensive clinical data support from several vildagliptin clinical trials and real-world studies provided the clinicians with an effective treatment option for lowering blood glucose, which neither causes weight gain nor increased the risk of hypoglycemia and cardiovascular events. This article reviews the development journey of vildagliptin from the proof-of-concept of DPP-4 inhibition from its earlystages in the 1990s to the present, being an extensively studied, well-established DPP-4 inhibitor.The article highlights the clinical effectiveness, safety, and tolerability studies of vildagliptin, which proved vildagliptin as an effective and safe option in the armamentarium of type 2 diabetes mellitus management in this era of evidence-based medical practice. This vildagliptin journey, from proof-of-concept to a very well-established molecule gives a lesson that a novel concept takes time and requires focused efforts, persistence, and long-term perseverance for bringing it into clinical practice.

Keywords

Vildagliptin, gliptins, DPP-4 inhibitor, diabetes, glucose lowering therapy

Full Text

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Chawla M, Kim TH, Mirasol RC, Faruque P, Hours-zesiger P, Shete A. Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24- week real-life study from Asia. Curr Med Res Opin. 2018;34(9):1605-1611.

Matthews DR, Paldánius PM, Proot P, Chiang Y, Stumvoll M, Prato SD. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year , multicentre , randomised, doubleblind trial. Lancet. 2019;394(10208):1519-1529.

Matthews D, Del S, Viswanathan P, Mathieu C, Vencio S, Chan JCN. Insights from VERIFY: Early combination therapy provides better glycaemic durability than a stepwise approach in newly diagnosed Type 2 Diabetes. Diabetes Ther. 2020;11(11):2465-2476.

From Darkness to Light : Clinical Insights on Melatonin

Abstract Views :83 | PDF Views:0

Authors

Manish Maladkar ¹, Ashok Yadav ², Sonal Kamble ²

Affiliations
1 Medical & Regulatory Affairs, Aristo Pharmaceuticals Private Limited, 23-A Shah Industrial Estate, Andheri, Mumbai, IN
2 Scientific Department, Aristo Pharmaceuticals Private Limited, IN

Source

The Indian Practitioner, Vol 74, No 8 (2021), Pagination: 30-36

Abstract

Melatonin also known as ‘sleep hormone’ is synthesized and released from the pineal gland in response to the luminous information. Melatonin primarily contributes to the regulation of biological rhythms and induction of sleep. Apart from this, due to its inherent anti-oxidant property, it is known to impart protection to various tissues. In addition, it also exhibits multiplicity of physiological effects all over the body. At therapeutic level, Melatonin is used for the management of primary as well as secondary sleep disorders, jet lag, and synchronization of cardiac rhythms. Additionally, due to its pleiotropic benefits it is used in various disorders.

Keywords

Melatonin, Sleep Disorders, Pleiotropic Benefits, Therapeutic Benefits.

Full Text

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Role of Antihistamine and Leukotriene Receptor Antagonist in Allergic Rhinitis Management: Newer Perspectives

Abstract Views :129 | PDF Views:87

Authors

Manish Maladkar ¹, Shrikant Patil ², Sonal Kamble ³

Affiliations
1 President- Medical & Regulatory Affairs, IN
2 Deputy General Manager- Medical, Scientific Department, IN
3 Manager- Scientific Department, Aristo Pharmaceuticals Private Limited, Mumbai, India., IN

Source

The Indian Practitioner, Vol 75, No 6 (2022), Pagination: 28-34

Abstract

Allergic disorders are conditions induced by the immune system’s hypersensitivity to normally harmless chemicals known as allergens. The most common allergens include dust mites, pollution, grass pollens and food allergens such as milk, egg, soy, wheat, nut, or fish proteins. Allergic diseases include allergic rhinitis (AR), allergic asthma, urticaria, atopic dermatitis, contact allergies and food allergies. AR is the most common of all atopic diseases, afflicting 10%–30% of adults and up to 40% of children all over the world. The mechanisms underlying AR are highly complex and involve multiple immune cells, mediators and cytokines such as histamine and leukotrienes. It is characterized by nasal symptoms such as sneezing, nasal itching, rhinorrhea, and nasal congestion. It is also, associated with non-nasal symptoms such as watery eyes, redness in the eyes or inflammation. It has a significant effect on one’s health, as well as the quality of one’s sleep, work productivity and academic performance. The management of AR includes allergen avoidance, pharmacotherapy, and immunotherapy. Complete avoidance of allergens that trigger AR symptoms is not possible. Current pharmacologic options include antihistamines (oral and intranasal), Leukotriene Receptor Antagonists (LTRAs), Intranasal Corticosteroids (INCS), decongestants and oral and intranasal anticholinergics. Amongst other antihistamines, Bilastine has emerged as a new, non-sedating and well-tolerated antihistamine while Montelukast is an effective add-on LTRA option to an antihistamine with well-established literature in the management of moderate-severe AR. Immunotherapy is a treatment option for patients who have not responded to medication.

Keywords

Allergic rhinitis, antihistamines, LTRAs, montelukast, bilastine

Full Text

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Hypertension : Burden, Awareness, and Control

Abstract Views :69 | PDF Views:0

Authors

Manish Maladkar ¹

Affiliations
1 President-Medical & Regulatory Affairs, Dept. of Scientific, Aristo Pharmaceuticals Private Limited, IN

Source

The Indian Practitioner, Vol 76, No 5 (2023), Pagination: 6-10

Abstract

Hypertension is a highly prevalent modifiable cause of cardiovascular disease, stroke, and death. However, awareness, treatment, and control of high BP are very low, significantly increasing the risk of CVD and premature mortality and morbidity. Accuracy in BP measurement is critical, as even an error of 5-mmHg in measurement can lead to incorrect classification of hypertension in 84 million individuals worldwide. As the consequences of inaccurate BP measurement are grave, all the leading hypertension guidelines have placed a strong emphasis on accurate BP measurement. Achieving BP target goals is absolutely essential for significantly reducing composite cardiovascular outcomes in hypertensive patients.

Keywords

Cardiovascular Disease, Hypertension, Control, Blood Pressure, Target Goals, Measurement.

Full Text

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Impact of Climate Changes on Allergic Diseases

Abstract Views :56 | PDF Views:0

Authors

Manish Maladkar ¹

Affiliations
1 President-Medical & Regulatory Affairs, Dept. of Scientific, Aristo Pharmaceuticals Private Limited, India., IN

Source

The Indian Practitioner, Vol 76, No 6 (2023), Pagination: 06-09

Abstract

Climate change is a serious global health concern. Longer allergy seasons and worsening air quality are the results of rising temperatures brought on by climate change. Extreme weather events increased exposure to pollen and other allergens, all contributing to worsening allergy and asthma symptoms with a rising prevalence of allergic disorders. Allergic disorders are conditions induced by the immune system’s hypersensitivity to normally harmless chemicals known as allergens. Allergic diseases include Allergic Rhinitis (AR), allergic asthma, urticaria, atopic dermatitis, contact allergies, and food allergies. The prevalence of allergic illnesses is rising globally, which is quite concerning. AR is the most common of all atopic diseases, afflicting 10%–30% of adults and up to 40% of children all over the world. The increased prevalence of allergic airway disease worldwide can be partially attributed to those global environmental changes. Climate change and air pollution pose adverse impacts on respiratory allergies. The chronic and recurring nature of AR, which results in poor quality of life and work/school loss despite the fact that it is not a life-threatening condition, poses a serious healthcare challenge.

Keywords

Allergic Rhinitis, Asthma, Climate change, Air pollution.

Conflict of Interest:Aristo Pharmaceuticals Private Limited, India

Full Text

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Dapagliflozin and Neuro-Nutrition: A Pragmatic Approach to Manage Diabetic Peripheral Neuropathy

Abstract Views :55 | PDF Views:0

Authors

Manish Maladkar ¹, Shrikant Patil ², Ashok Yadav ³

Affiliations
1 President-Medical & Regulatory Affairs, Dept. of Scientific, Aristo Pharmaceuticals Private Limited, Mumbai, IN
2 Deputy General Manager-Medical, Dept. of Scientific, Aristo Pharmaceuticals Private Limited, IN
3 Assistant General Manager-Medical, Dept. of Scientific, Aristo Pharmaceuticals Private Limited, IN

Source

The Indian Practitioner, Vol 76, No 2 (2023), Pagination: 28-30

Abstract

Diabetic peripheral neuropathy (DPN) is the most prevalent microvascular complication of diabetes mellitus. DPN results from a complex interaction of factors including hyperglycemia, glucotoxicity, increased intracellular glucose concentration-induced mitochondrial dysfunction, oxidative stress, etc. A multifaceted approach is warranted for the clinical treatment of DPN. Combination therapy of an antidiabetic agent along with neuro-nutrition aimed at addressing the pathogenic features of neuropathy can be a potential treatment option for effective management of DPN.

Keywords

Type 2 Diabetes (T2DM), Diabetic Peripheral Neuropathy (DPN), Dapagliflozin, Neuro-Nutrition, B-Group Vitamins, Neuroprotection.

Full Text

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