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Iron deficiency (ID) with or without anemia is frequently observed in patients with heart failure (HF). Uncorrected ID is associated with higher hospitalization and mortality in patients with acute HF (AHF) and chronic HF (CHF). Hence, in addition to chronic renal insufficiency, anemia, and diabetes, ID appears as a novel comorbidity and a treatment target of CHF. Intravenous (IV) ferric carboxymaltose (FCM) reduces the hospitalization risk due to HF worsening and improves functional capacity and quality of life (QOL) in HF patients. The current consensus document provides criteria, an expert opinion on the diagnosis of ID in HF, patient profiles for IV FCM, and correct administration and monitoring of such patients

This study aimed to compare the clinical and biochemical profiles as well as the complications in males and females with type 2 diabetes (T2DM) presenting to a private tertiary diabetes care centre in India. This is a retrospective study, conducted between 1 January 2017 and 31 December 2019, and included 72,980 individuals with T2DM, aged ≥ 18 years (age and sex-matched—males—36,490; females—36,490). Anthropometric measurements, blood pressure, fasting plasma glucose (FPG), post-prandial plasma glucose (PPPG), glycated haemoglobin (HbA1c), lipids, urea, and creatinine were measured. Retinopathy was screened using retinal photography, neuropathy using biothesiometry, nephropathy measuring urinary albumin excretion, peripheral vascular disease (PVD) using Doppler, and coronary artery disease (CAD) based on the history of myocardial infarction and/or drug treatment for CAD and/or electrocardiographic changes. Obesity (73.6% vs. 59.0%) rates were significantly higher in females compared to males. FPG, PPPG, and HbA1c were higher among younger age groups among both sexes, with males having higher values compared to females. However, after the age of 44 years, control of diabetes was worse among females. In addition, only 18.8% of the females achieved glycemic control (HbA1c < 7%) compared to 19.9% in males (p < 0.001). Males had higher prevalence of neuropathy (42.9% vs. 36.9%), retinopathy (36.0% vs. 26.3%), and nephropathy (25.0% vs. 23.3%) compared to females. Males had 1.8- and 1.6-times higher risk of developing CAD and retinopathy compared to females. Hypothyroidism (12.5% vs. 3.5%) and cancers (1.3% vs. 0.6%) were significantly higher in females compared to males. In this large sample of T2DM seen at a chain of private tertiary diabetes centres, females had higher prevalence of metabolic risk factors and poorer diabetes control compared to males, emphasizing the need for better control of diabetes in females. However, males had higher prevalence of neuropathy, retinopathy, nephropathy, and CAD compared to females.

Ayyavoo Charmila,1 Suma Natarajan,2 Thevoor Venkatesan Chitra,3 Nivedita Pawar,4 Sucheta Kinjawadekar,5 Yogini Firke,6 Umaiyal Murugesan,7 Poonam Yadav,8 Neelam Ohri,9 Vidhu Modgil,10 Ajinkya Rodge,11 Onkar C Swami11 1Obstetrics and Gynecology, Aditi Hospital, Tiruchirappalli, Tamil Nadu, India; 2Obstetrics and Gynecology, Ganga Medical Centre & Hospitals, Coimbatore, Tamil Nadu, India; 3Obstetrics and Gynecology, PSG Hospitals, Coimbatore, Tamil Nadu, India; 4Obstetrics and Gynecology, Nivedita Maternity Home, Nashik, Maharashtra, India; 5Obstetrics and Gynecology, Kamalesh Mother and Child Hospital, New Mumbai, Maharashtra, India; 6Obstetrics and Gynecology, Dhanvantari Hospital, Mumbai, Maharashtra, India; 7Obstetrics and Gynecology, Sri Kumaran A Speciality Hospital, Chennai, Tamil Nadu, India; 8Obstetrics and Gynecology, SDMH Hospital, Jaipur, Rajasthan, India; 9Obstetrics and Gynecology, New Life Hospital, Varanasi, Uttar Pradesh, India; 10Obstetrics and Gynecology, Suman Hospital, Ludhiana, Punjab, India; 11Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, IndiaCorrespondence: Onkar C Swami, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, 411 057, India, Tel +91-93724 23101, Email onkar.swami@emcure.co.inBackground: Parenteral iron preparations, like ferric carboxymaltose (FCM), are commonly used to manage moderate-to-severe iron deficiency anemia (IDA). Real-world data on efficacy and safety of FCM is limited in India.Methods: A retrospective, observational and real-world study was conducted to assess the efficacy and safety of FCM in adolescents and adults with IDA across 269 centers in India. Data was retrieved from medical records of patients who received FCM for management of IDA. Physicians’ clinical assessment of efficacy and safety of FCM was also assessed. Data were analyzed for hematological parameters at baseline and at 4 ± 1 week for study population, and for severity of anemia.Results: In 1800 patients with IDA, intravenous FCM resulted in a significant increase in hemoglobin (Hb) of 2.76 g/dL, serum ferritin of 35.85 μg/L, red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (P < 0.001 for all) at 4 ± 1 week as compared to baseline. In subjects with severe IDA, an increase in Hb was of 3.31 g/dL, serum ferritin increased of 35.84 μg/L, RBC count, hematocrit and MCH improved significantly (P < 0.001 for all). In subjects with moderate IDA, Hb (increase of 2.63 g/dL), serum ferritin (increase of 35.92 μg/L), RBC count, hematocrit, MCV, and MCH improved significantly (P < 0.001 for all). In subjects with mild IDA, only the mean Hb values at 4 weeks were significantly higher (P < 0.001; increased by 1.89 g/dL). Physicians rated efficacy of FCM as very good to good in 97.5% of patients. Similarly, safety of FCM was rated very good to good in 97.2% subjects.Conclusion: FCM efficiently, safely and quickly corrects moderate-to-severe anemia in Indian patients in a short span of 4 weeks. Physicians’ positive clinical impression of efficacy and safety supports clinical usage of FCM in real-world scenario.Keywords: ferric carboxymaltose, iron deficiency anemia, pregnancy, efficacy, safety, India

Iron deficiency (ID) is clinically significant comorbidity usually reported with acute and chronic heart failure (HF) and associated with prognostic outcomes, independent of anemia. The exact cause of ID and anemia and their association with HF is not entirely clear. Current evidence highlights neuro-hormonal and proinflammatory cytokine activation and renal dysfunction favoring the development of anemia and ID. Intravenous iron therapy (IV Iron) enhances exercise capacity, HF-associated symptoms and health-related quality of life. Oral iron therapy might be less effective compared to IV Iron in HF patients. At the same time, large, well-designed cardiovascular outcome studies are warranted to establish the long-term efficacy and safety of IV Iron in patients with HF with coexisting ID. In India, the high prevalence of anemia increases the burden of ID in patients with HF. HF being a complex multifactorial disease, it is essential to understand the association of ID with HF which can be easily corrected to improve the patient outcomes. At the same time, there is a need to generate more robust clinical evidence on IV Iron therapy for in Indian patients of HF.

To study the frequency of iron deficiency anemia (IDA) in individuals with type 2 diabetes mellitus (T2DM) seen at tertiary diabetes care centres across India.This is a retrospective study (January 1, 2017-December 31, 2019), which included 1137 individuals with T2DM, aged ≥18 years, for whom data on glycemic, lipid and haematological parameters were available. Anthropometric measurements were done using standardized techniques. Biochemical investigations included fasting plasma glucose[FPG], post prandial plasma glucose, HbA1c, lipids and serum ferritin and iron wherever feasible.Of the 1137 individuals included for the study, 117 (10.3%) were categorized as no 'iron deficiency' (ID) group [normal hemoglobin: male ≥13 g/dl, female ≥12 g/dl and normal serum ferritin ≥70 μg/L], 123 (10.8%) as ID group [normal hemoglobin and low serum ferritin70 μg/L)], 447 (39.3%) as IDA group [low haemoglobin: male13 g/dl, female12 g/dl and low serum ferritin] and 450 (39.6%) as 'anemia of chronic disease' (ACD) group [low hemoglobin and normal serum ferritin]. The percentage of women having ID (57.7%) and IDA (65.3%) was significantly higher than their male counterparts. ID was most prevalent (61.7%) in the individuals with duration of diabetes5 years whereas ACD was most prevalent (50.5%) in individuals with long standing diabetes (10 years). Independent risk factors for IDA were female gender (OR 3.3,95% CI:1.75-6.23, p 0.001), duration of diabetes (OR 1.05, 95% CI 1.01-1.11, p = 0.028) and FPG (OR 1.01, 95% CI 0.99-1.00, p = 0.018).There is a need of identifying and monitoring iron status and anemia in patients with T2DM.

Patients with diabetic retinopathy (DR) are more likely to have subclinical cardiovascular disease. Objective of this study was to assess the prevalence and association of DR grades along with comorbidities in patients with established cardiovascular disease (CVD); association of DR grades beyond ocular morbidity, i.e., long-term outcomes among established CVD; influence of DR grades on prognosis in patients undergoing coronary revascularization. This was a single center, retrospective, data analysis of T2DM patients with established CVD. Goodness of fit was analyzed using Pearson’s chi-square test. DR was observed in 64% (n = 2560) of patients (non-proliferative diabetic retinopathy [NPDR] 37%; proliferative diabetic retinopathy [PDR] 27%). DR and CVD were strongly associated; highest association was observed for congestive heart failure (CHF) (n = 1325), followed by myocardial infarction (MI) (n = 795), unstable angina (UA) (n = 275), and cardiomyopathy (n = 165) (p

Morning blood pressure surge (MBPS) is a part of diurnal blood pressure (BP) variability. It has been correlated with increased cardiovascular (CV) risk. An increase in BP after waking is a physiological phenomenon; however, a marked and rapid MBPS is associated with increased CV risk. There is mounting evidence suggesting significant associations between MBPS and cardiac, cerebral, renal, and vascular damage. The difference between BP readings 2 h after rising and the average of all readings during sleep can be the most reliable approach for assessing the MBPS. There is no consensus over the definition, pathophysiological mechanisms, and treatment strategy of MBPS. There is a need for better understanding of this phenomenon. This Chapter discusses up-to-date data on MBPS with special emphasis on its definition, etiology, clinical outcomes, diagnostic evaluation, and treatment strategy. Home BP monitoring can be a useful tool in the assessment of MBPS. Control of morning hypertension can be considered as a cornerstone in 24-h BP control. Specific treatment for controlling morning hypertension includes the selection of a specific class of antihypertensive drugs, such as inhibitors of sympathetic activity or the renin angiotensin system and appropriate timing of dosing. Exaggerated MBPS can be treated with long-acting drugs, with the bedtime administration. Control of the MBPS would lead to effective CV protection in patients with hypertension.

Background: Tenecteplase, a third generation tissue plasminogen activator has important place in the thrombolytic therapy in acute ischemic stroke. The objective of present study was to understand the knowledge, attitude and practice (KAP) towards the usage of tenecteplase in daily clinical practice.Methods: This was a prospective questionnaire based knowledge, attitude and practice survey with involvement of practising neurologists across the country. A specially designed validated questionnaire containing 18 questions was shared with neurologists and their anonymous inputs were captured and analysed in qualitative manner.Results: Total Sixty-eight neurologists completed this questionnaire. The 73 percent of neurologist preferred tenecteplase in stroke patients arriving within 4.5 hours of onset of stroke symptoms. Almost 70% of neurologists preferred tenecteplase in patients

Proteinuria is a marker and predictor of cardiovascular morbidity and mortality. Blockade of angiotensin receptor might result in reduction in proteinuria. Olmesartan, an Angiotensin Receptor Blocker (ARB) which is approved for the treatment of hypertension is believed to produce antiproteinuric effects through different mechanisms. The objective of this review is to assess the cause, duration and degree of proteinuria and understand the current place of olmesartan in management of proteinuria associated with Cardiovascular Disease(CVD) and hypertension. We performed a comprehensive search of MEDLINE, PubMed and Google Scholar databases for articles related to Olmesartan and proteinuria (till June 2017). Angiotensin-II induces transforming growth factor-β upregulation and increase transcapillary pressure. AT-I receptor blocked by olmesartan result in reduction in proteinuria. Olmesartan significantly reduces Blood Pressure (BP) and delays the onset of Chronic Kidney Disease (CKD), it also delayed the risk of onset of microalbuminuria. Olmesartan have nephroprotective, antioxidant, antifibrotic activities and proteinuria reducing effects which can be beneficial in patients with hypertension. Olmesartanis believed to produce antiproteinuric effects through different mechanisms. It is indicated for treatment of hypertension to reduce the risk of fatal and non fatal CV events which may or may not be associated with proteinuria.

Type 2 Diabetes Mellitus (T2DM) is a chronic disease which requires treatment to prevent further complications. The Diabetes Epidemiology: Collaborative analysis of Diagnostic criteria in Europe (DECODE) study and diabetic intervention study demonstrated that high Postprandial Glucose (PPG) increased the mortality and cardiovascular complications. Voglibose, an ɑ-glucosidase inhibitor, controls PPG level and have cardiovascular benefits. Objective of this article was to review postprandial hyperglycaemia and clinical evidences of voglibose in management of PPG in T2DM patients, its role in prediabetic condition and cardiovascular benefits. Extensive search work was conducted on Google, Google scholar and PubMed from January, 1990 to May, 2017. Studies relevant to pharmacology, efficacy and safety of voglibose were included in the article. Voglibose significantly reduces the PPG level in T2DM patients compared to other antidiabetic drugs. Superior control on PPG contributes to cardioprotective action. Beyond PPG regulation, voglibose has an effective role on prediabetic condition. Weak absorption of voglibose through intestine make it a drug of choice in elderly patients or in hepatic impairment and mild to moderate renal function impairments when other anti-diabetic agents are contraindicated. Clinical studies on voglibose, highlighted its role to control PPG level in T2DM patients and its cardiovascular benefits.

Antibiotics are one of the greatest discoveries of medical science and have saved millions of lives since their discovery. Antimicrobial resistance is usually of acquired type and is mostly due to mutations in microbes and selection pressure from antibiotic use. Lack of adherence to drug therapies, suboptimal dosing and duration of treatment, ineffective infection control and lack of research on new antibiotics are some of the important factors responsible for development of antimicrobial resistance. Presently antimicrobial resistance is a global problem because of spread of resistant strains across the countries and continents. Economic implications of antimicrobial resistance are huge and enormous money is being spent for treatment various diseases which have become resistant to effective and cheaper older drugs. Here, we describe the epidemiology of antibiotic resistance, its major causes and consequences, and identify critical area which requires urgent action.

Teneligliptin is a recently developed oral dipeptidyl peptidase 4 inhibitor indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. Teneligliptin has been recently available in Japan (Teneria(®)), Argentina (Teneglucon(®)), and India (Tenepure; Teneza) at relatively affordable price. This is a positive step toward the management of T2DM in developing countries, where the cost of medicine is out-of-pocket expenditure and is a limiting factor for health care. This review evaluates the efficacy and safety of teneligliptin in the management of T2DM. Teneligliptin has been systematically evaluated in T2DM as monotherapy with diet and exercise and in combination with metformin, glimepiride, pioglitazone, and insulin in short-term (12 weeks) and long-term (52 weeks) studies. These studies have reported a reduction in HbA1c of 0.8%-0.9% within 12 weeks of therapy. Two 52-week studies reported sustained improvement in glycemic control with teneligliptin. Teneligliptin has been found to be well tolerated, and the safety profile is similar to other dipeptidyl peptidase 4 inhibitors. Hypoglycemia and constipation are the main adverse events. Teneligliptin can be administered safely to patients with mild, moderate, or severe renal impairment or end-stage renal disease without dose adjustment. Similarly, it can be used in patients with mild-to-moderate hepatic impairment. Teneligliptin is effective and well tolerated and may have an important role in the management of T2DM.

Background: Extracorporeal shock wave lithotripsy (ESWL) is an effective non-invasive method for managing urinary tract calculi. Present study was undertaken to evaluate factors that may influence ESWL clinical outcomes in Indian patients with urinary tract calculi.Methods: This prospective study was conducted at Department of Urology, Medical Trust Hospital Cochin, India in the period from September 2006 to March 2009. Sixty patients with upper urinary tract lithiasis having stone size between 5 to 25 mm were included and patients with ˃2 calculi, distal ureteric obstruction (not relieved), renal anomalies were excluded. All patients were treated with DIREX medical system lithotripter. Clinical outcome of ESWL was assessed by factors like site, size, density and skin-to-stone distance. After statistical analysis, p-value ≤0.05 was taken as the level of significance.Results: The overall success of ESWL was 82%. The final success of ESWL for sites like ureter, pelvis, mid or upper and lower calyx were 94.1%, 84%, 85.7% and 58% respectively (p = 0.095). The rate of fragmentation of stone after one session of ESWL for stone size ≤10 mm, 11 mm - 20 mm and ≥21 mm was 76.5%, 68.4% and 16.7% respectively (p=0.009). For stone density 751-1000 HU, 22.2% patients required ≥2 sessions to achieve stone free status (p

Background: One of the conservative management of ureteric caculi is by medical expulsive therapy by targeting common causes of obstruction such as edema, ureteral spasm and infection which will favour expulsion of calculi. The objective of this study was to assess comparative efficacy and safety of medical expulsive therapy of ureteric calculi.Methods: This was a randomized, prospective, open label, comparative study. Subjects satisfying inclusion and exclusion criteria were randomized into 4 groups tamsulosin, nifedipine, progesterone and control. Medical expulsion of calculi of 6mm to 15 mm size was carried out in 120 patients. Patients were followed up on OPD basis every third day. Calculi expulsion until day 28 as confirmed by abdominal ultrasonography was taken as the end point.Results: Expulsion rate in tamsulosin group was 90%, whereas nifedipine, progesterone group were 83.33% and 70% respectively which was significant compared to control group which was 36.6% (p < 0.005). Expulsion time was also reported to be significantly less in these groups as compared to control group. Therapy related adverse effects were minor and were seen in only 6 patients.Conclusions: Medical expulsive therapy of ureteric calculi of size 6 to 15mm with Tamsulosin, nifedipine and progesterone were safe and efficacious and could be implemented for initial management in selected patients.

The prevalence of type 2 diabetes mellitus and its resultant morbidity and mortality is rapidly increasing. An important factor in reducing the microvascular complications of diabetes is strict glycemic control. Most patients require additional insulin therapy in spite of regularly taking oral anti-diabetic drugs. Though classically used later in the natural course of the disease, newer treatment guidelines suggest early initiation of insulin analogues. The discovery of insulin has been hailed as one of the most dramatic events in the history of diabetes, improving the life-span of most diabetics. Replacement insulin therapy should mimic physiological insulin release patterns. Modern insulin and its analogues have been developed to serve as an ideal replacement therapy. There are various insulin preparations available in the market and each of them has their own advantages and disadvantages. The modern insulin’s have been developed to overcome certain side effects of the older preparations. A range of insulin products are under development that aim to increase absorption prolong action and provide alternative delivery methods. Greater patient adherence is important since most patients are reticent about insulin therapy. This review describes the role of insulin in the management of type 2 diabetes mellitus.

Antimicrobial resistance (AMR) is a global problem. AMR has posed new challenges in treatment of infectious diseases. Antimicrobials are losing efficacy due to development of resistant pathogens. It has lead to re-emergence of certain infectious diseases. Treatment of such diseases has undergone changes with use of alternative antimicrobials and drug combinations. Pathogens are likely to develop resistance to alternative antimicrobials also and risk of infections with nonexistent treatment is real. Salmonella showed widespread resistant to ampicillin which resulted in use of alternative antimicrobials like fluroquinolones and cephalosporins in the treatment of enteric fever in last two decades. Unfortunately there are growing reports of resistance to these antimicrobials. Interestingly there are numerous reports of ampicillin regaining activity against Salmonella. Speculatively lack of exposure of Salmonella to ampicillin for long time resulted in the loss of plasmid mediated resistance in the pathogen. There may have been emergence of de novo ampicillin susceptible strains. This is assuring in the era where problem of AMR is compounded by the scarcity of new antimicrobial development.

Globally, antimicrobial resistance is alarming concern especially in commonly reported disease entities like respiratory tract infection, enteric fever and infections associated with gram-negative bacilli (GNB). Rational use of antimicrobial drugs reported significant decrease in bacterial burden and may also reduce the risk of disease progression. However, at times in particular indication, certain patient and pathogen factor limits the selection and use of specific antibiotic therapy while in some case, due to presence of additional risk factor, aggressive therapy is required to achieve clinical reemission and prevent complications. Delay in start of suitable antibiotic therapy is another imperative factor for treatment failure and rise of drug resistance. With rapidly increasing antibiotic resistance and decline in new antibiotic drug development, the toughest challenge remains to maintain and preserve the efficacy of currently available antibiotics. Therefore, the best rational approach to fight these infections is to ‘hit early and hit hard’ and kills drug-susceptible bacteria before they become resistant. The preferred approach is to deploy two antibiotics that produce a stronger effect in combination than if either drug were used alone. Various society guidelines in particular indications also justify and recommend the use of combination of antimicrobial therapy. Combination therapies have distinct advantage over monotherapy in terms of broad coverage, synergistic effect and prevention of emergence of drug resistance.

The global burden of antimicrobial resistance is rising and is associated with increased morbidity and mortality in clinical and community setting. Spread of antibiotic resistance to different environmental niches and development of superbugs have further complicated the effective control strategies. International, national and local approaches have been advised for control and prevention of antimicrobial resistance. Rational use of antimicrobials, regulation on over-the-counter availability of antibiotics, improving hand hygiene and improving infection prevention and control are the major recommended approaches. Thorough understanding of resistance mechanism and innovation in new drugs and vaccines is the need. A multidisciplinary, collaborative, regulatory approach is demanded for combating antimicrobial resistance.

Antimicrobial resistance (AMR) is a global problem. AMR has posed new challenges in treatment of infectious diseases. Antimicrobials are losing efficacy due to development of resistant pathogens. It has lead to re-emergence of certain infectious diseases. Treatment of such diseases has undergone changes with use of alternative antimicrobials and drug combinations. Pathogens are likely to develop resistance to alternative antimicrobials also and risk of infections with nonexistent treatment is real. Salmonella showed widespread resistant to ampicillin which resulted in use of alternative antimicrobials like fluroquinolones and cephalosporins in the treatment of enteric fever in last two decades. Unfortunately there are growing reports of resistance to these antimicrobials. Interestingly there are numerous reports of ampicillin regaining activity against Salmonella. Speculatively lack of exposure of Salmonella to ampicillin for long time resulted in the loss of plasmid mediated resistance in the pathogen. There may have been emergence of de novo ampicillin susceptible strains. This is assuring in the era where problem of AMR is compounded by the scarcity of new antimicrobial development.

Introduction: Clomiphene citrate (CC) has an important place in therapy for management of ovulatory dysfunction. The objective of the present survey was to understand the knowledge, attitude, and practice (KAP) of Indian gynecologists toward the use of CC. Materials and Methods: A prospective, cross-sectional, observational, questionnaire-based KAP survey conducted among Indian gynecologists. Out of 22 multiple-choice questions (MCQs), 9 questions were related to efficacy, 5 to safety, and 8 to perception about CC usage in routine clinical practice. Data were summarized by percentages in frequency tables and graphs. Results: Seven hundred seventy-one gynecologists in total across India participated in this survey. The majority of the participants preferred CC in treatment of ovulatory dysfunction associated with polycystic ovary syndrome (PCOS). The ovulation rate was reported to vary 21-60% and the pregnancy rate was noticed to be 11-30% by the majority of the participants. CC was reported to have very good to excellent efficacy and tolerability. Resistance to CC was encountered sometimes. Commonly encountered adverse effects included abdominal/pelvic discomfort or pain, ovarian enlargement, and nausea and vomiting. Frequent complications included multiple gestation, ovarian hyperstimulation syndrome (OHSS), and spontaneous abortion. Quite a few doctors reported congenital malformations with CC therapy. A majority of participants preferred CC in a dose of 50-100 mg/day for 5 days starting on the second or third day of the cycle. Most participants advised natural conception to patients receiving CC therapy. Metformin and gonadotropins were the preferred drugs coadministered with CC treatment. Conclusion: The present KAP survey highlighted CC as a commonly used agent for ovulatory dysfunction, with very good to excellent efficacy and tolerability.

Sir, We have read with interest the article ‘Ondansetron induced fatal ventricular tachycardia’ by Chandrakala et al., published in the Indian Journal of Pharmacology, August 2008. We would like you to give us the opportunity to discuss some of our observations on the same. Ondansetron is a racemic compound having one chiral centre. Racemic Ondansetron is a 50:50 mixture of two enantiomers, R-Ondansetron and S-Ondansetron. In one animal study (in dogs), effects of R-Ondansetron, S-Ondansetron and racemic Ondansetron on cardiac arrhythmias (cardiotoxicity) were evaluated. QTc interval was most prolonged among animals receiving S-Ondansetron and racemic Ondansetron and was shortest among animals receiving R-Ondansetron. Based on these results it was reported that R-Ondansetron has less cardiotoxicity than S-Ondansetron or racemic Ondansetron.[1] Bodhankar et al. in 2006 studied the effect of racemic Ondansetron, R-Ondansetron and S-Ondansetron on QTc interval in electrocardiograms of rats. The Ondansetron and its enantiomers were administered IV in a dose of 3 mg/Kg and changes in QT and RR interval and heart rate were calculated. The results of this study showed that racemic Ondansetron and S-Ondansetron significantly prolonged QTc interval, while R-Ondansetron did not prolong QTc interval as compared to the vehicle treated group. They concluded that R-Ondansetron is safer on the heart. Authors reported that S-Ondansetron might have higher inhibitory effects on Bezold-Jarisch reflex and this might be the reason for QTc prolongation with S-Ondansetron and racemic Ondansetron.[2] A multicentric, randomized, double-blind, parallel group, comparative study on efficacy and safety of R-Ondansetron 4 mg versus racemic Ondansetron 8 mg in 240 Indian patients with nausea and vomiting concluded that R-Ondansetron 4 mg BID was equally effective compared to racemic Ondansetron 8 mg BID with a slightly better safety profile compared to racemic Ondansetron.[3] This suggests that the S-Ondansetron component can be omitted without loss of efficacy. Efficacy and safety of R-Ondansetron solution was also studied in 410 pediatric patients confirming R-Ondansetron solution is safe and effective in pediatric patients with nausea and vomiting.[4] From the above discussion it is clear that R-Ondansetron 4 mg alone is sufficient for its anti-emetic potential and is preferable without its counterpart – the S-isomer which can prolong the QTc. So switching from racemic Ondansetron to R-Ondansetron is a rational therapeutic approach. R-Ondansetron has been approved by the DCGI on 15th April 2005 and is available as tablets (2 mg/4 mg), solution (1 mg/5 ml) and injection (1 mg/ml).

Introduction Neuropathic pain is intense in nature and difficult to manage. Thus, the primary goal is maximum relief from pain. The aim of this study was to assess the efficacy and safety of a fixed-dose combination of sustained-release pregabalin and methylcobalamin in reducing neuropathic pain in Indian patients, in the real-life situation. Methods This was a multicenter, prospective, open-labeled, single-arm, observational, 14-day study. Patients received fixed dose combination of 75 or 150 mg sustained-release pregabalin combined with 1500 mcg immediate release methylcobalamin, depending on the clinical requirement. Data was collected for pain reduction and other positive and negative symptoms associated with neuropathy, including hyperesthesia, paresthesia, numbness/tingling, burning sensation, muscle weakness, sleep disturbances, and impairment of movement. Pain intensity was measured on a ten-point visual analog scale (VAS) (0 represented “no pain,” and 10 represented “worst pain ever”). The safety of the drug was also evaluated throughout the study duration. Data was analyzed using appropriate statistical methods. Results The overall reduction in mean VAS score over 14 days was 72.3%. The reduction in mean VAS score was significant as early as the first week. Both positive and negative symptoms of peripheral neuropathy were significantly improved in >50% patients within the 2 weeks. Giddiness (4.7%), followed by sedation (3.6%), dizziness (2.9%), drowsiness (2.3%), and nausea (2.3%) were the most commonly observed adverse effects. The overall efficacy and tolerability was rated as good to excellent by >95% of the investigators and patients. Conclusion Fixed dose combination of sustained-release pregabalin and methylcobalamin significantly reduced neuropathic pain, with significant improvement in both the positive and negative symptoms associated with neuropathy, in Indian patients and was well tolerated., Video abstract