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Being commonly used skin care products, comedogenic potential of moisturizers should be assessed. : The aim of the study was to evaluate the comedogenic potential of a moisturizer Venusia Max Lotion (paraben-, alcohol-, mineral oil-, animal origin-(PAMA) free) when applied topically to the skin compared to the controls. : Double-blind, single-center, comparative study conducted at private institute in Mumbai, India: Approximately 0.025 gm of the test product and 0.025 ml of positive control (coconut oil) and negative control (glycerin) were applied and occluded under a patch on the upper back of healthy female participants. Patch application and removal were made 12 consecutive times on alternate days for each participant. On the last day, approximately 2 hours after patch removal, a follicular biopsy was taken for all participants on all product application zones. : Data analyzed with descriptive statistics using the SPSS software version 10.0.: Data from a total of 19 participants was analyzed. The mean age was 35.32 years. The mean comedone grade for Venusia Max Lotion (PAMA free) was significantly lower compared to the positive control (Coconut Oil) (1.00 vs. 2.11, respectively; P=.001). The mean comedone grade was 0.79 for negative control (Glycerine) which is nearly similar to that of the test product. The moisturizer product Venusia Max Lotion (PAMA free) is non-comedogenic as compared to positive control. Thus, it can be considered for moisturizing purposes without the fear of comedogenicity.

Fondaparinux is a low molecular weight heparin anticoagulant used to manage the full spectrum of acute coronary syndrome (ACS) patients and has proved its efficacy and safety in multiple clinical trials. However, there are limited data available showing whether the same results could be reproduced in real-world practice on an Indian population. Our objective was to determine the effectiveness and tolerability of fondaparinux in the management of symptomatic ACS in real-world clinical practice.The EMR data of hospitalized ACS patients (n = 611), from January 2015 to January 2020, representing UA or NSTEMI or STEMI and were prescribed fondaparinux (2.5 mg once daily) to manage ACS were analyzed. The effectiveness was analyzed as recurrence of ACS and tolerability as total incidence of major bleeding during hospitalization, at 30 days and 180 days. Appropriate statistical analysis was used with a statistically significance of p value 0.05.The incidence of recurrent ACS was not seen during hospitalization and in the first 30 days, while in only 0.65% (n = 4) patients, ACS reoccurred within 180 days. In a mean duration of 172.75 ± 3.20 days, UA was reported in 0.49% (n = 3) patients, NSTEMI in 0.16% (n = 1) of patients, and STEMI was not documented. None of the major bleeding events occurred during the entire study period, whereas minor bleeding events were reported during hospitalization 0.98% (n = 6) and at 30 days 0.16% (n = 1). The bleeding events were statistically insignificant (p value 0.05). No incidences of stent thrombosis were reported during the entire study period.In the real world, fondaparinux was found to be effective and tolerable when used to manage symptomatic ACS patients regardless of revascularization procedure with no incidence of stent thrombosis, and minimal recurrent ACS and insignificant increase in bleeding events.

Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis.To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting.Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p0.05) between the two groups.The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p0.05).The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.

Introduction The renoprotective effects of dihydropyridine calcium channel blockers (CCBs) have been established as non-inferior to other classes of antihypertensive drugs. Studying their effect on renal outcome parameters, specifically for amlodipine as monotherapy, in real-world settings can further help in expanding its usage among Indian patients. This study was performed to assess the effects of amlodipine and other dihydropyridine CCBs (cilnidipine, benidipine and azelnidipine) on renal parameters and effectiveness in blood pressure reduction in Indian patients. Methods The retrospective data of adult patients (> 18 years) with essential hypertensive who were prescribed amlodipine (n = 92), cilnidipine (n = 91), benidipine (n = 70) or azelnidipine (n = 71) as monotherapy were analyzed. The renal outcomes, serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), microalbumin, urine albumin-to-creatinine ratio (UACR), sodium and potassium levels, and mean changes in BP were analyzed from baseline to 12 months. Appropriate statistical methods were used to determine the significance (p value 0.05). No significant changes were observed in BUN, sodium or potassium levels. Overall, for all CCBs, the mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were reduced from baseline to the end of the study (p = 0.002). At the end of the study, the average dose of amlodipine was 7.25 mg, and the average reduction in SBP and DBP per mg dose was 1.54 and 0.57 mmHg. The corresponding numbers for the other CCBs were as follows: cilnidipine, 14.28 mg, 0.26 and 0.01; benidipine, 5.71 mg, 0.41 and 0.11; azelnidipine, 15.88 mg, 0.13 and 0.06. Conclusion Amlodipine and other CCBs demonstrated good efficacy and similar effects on renal parameters from baseline to end of study. Amlodipine also showed higher potency by demonstrating greater BP reduction at a lower dose. Thus, amlodipine can remain a preferred choice among CCBs, even with the advent of the newer CCBs. Supplementary Information The online version contains supplementary material available at 10.1007/s40119-021-00224-8.

Viswanathan Mohan,1 Abdul Zargar,2 Manoj Chawla,3 Ameya Joshi,4 Usha Ayyagari,5 Bipin Sethi,6 Kumar Gaurav,7 Usha Rani H Patted,7 Seema Vikas Bhagat,7 Amey Ishwara Mane7 1Department of Diabetes, Madras Diabetes Research Foundation & Dr Mohan’s Diabetes Specialities Centre, Chennai, Tamil Nadu, India; 2Department of Diabetes and Endocrine Care, Centre for Diabetes and Endocrine Care, Srinagar, Jammu and Kashmir, India; 3Department of Diabetes, Lina Diabetes Care Mumbai Diabetes Research Centre, Mumbai, India; 4Department of Endocrinology, Bhaktivedanta Hospital and Research Institute, Thane, India; 5Department of Endocrinology, Apollo Sugar Clinics, Apollo Speciality Hospital OMR, Chennai, Tamil Nadu, India; 6Department of Endocrinology, Care Hospitals, Hyderabad, Telangana, India; 7Department of Medical Affairs, Dr Reddy’s Laboratories Ltd, Hyderabad, Telangana, IndiaCorrespondence: Kumar GauravDepartment of Medical Affairs, Dr Reddy’s Laboratories Ltd, 7-1, 27, Ameerpet Road, Leelanagar, Ameerpet, Hyderabad, Telangana, 500016, IndiaTel +91 9971053456Email kumargaurav2@drreddys.comBackground: Early use of combination therapy in diabetes patients may lead to sustained glycemic control and thereby reduce the progression of diabetic complications. Given the limitation of the traditional stepwise intensification strategy, early combination therapy can be an effective approach. Therefore, this study aims to assess the real-world efficacy of a combination of metformin and vildagliptin in comparison to metformin alone in type 2 diabetes mellitus (T2DM) patients in India.Methods: This was an observational, retrospective, non-interventional study based on electronic medical records (EMRs) of 2740 T2DM patients, retrieved from 2010 onwards from 22 diabetes centres across India. Adult drug naïve patients with a 5-year history of T2DM treated with either metformin or a combination of metformin and vildagliptin for at least 3 months were considered for this study. Efficacy assessment was done to evaluate the post-treatment HbA1c levels and patients requiring additional oral antidiabetic drugs (OADs) at the time of follow-up visit. Patients were also analyzed for the occurrence of adverse events.Results: Out of the total, 2452 patients were in metformin only arm, and 288 patients were in metformin plus vildagliptin treatment arm. A more significant reduction in HbA1c level was observed in metformin plus vildagliptin arm than metformin only arm (median: − 0.5% vs 0%, respectively; p< 0.001). Patients requiring additional OAD at follow-up were significantly lesser in the metformin plus vildagliptin arm than the metformin only arm (15.6% vs 35.2%, respectively; p< 0.001). The adverse events were comparable across the two arms, and commonly reported adverse events were giddiness, fatigue and gastric discomfort.Conclusion: The findings of this EMR-based real-world study emphasizes the need for early initiation of combination therapy (metformin plus vildagliptin) over metformin monotherapy for achieving better glycemic control.Keywords: metformin, vildagliptin, type-2 diabetes, electronic medical records, real-world study

Introduction The effectiveness of telmisartan has been reported in Indian clinical trials; however, real-world data are limited. We aimed to provide real-world evidence regarding the effectiveness of telmisartan as monotherapy or in combination with other antihypertensive drugs (AHDs) in Indian patients with essential hypertension. Methods Electronic medical record data of adult patients diagnosed with essential hypertension (≥ 140/90 mmHg) and who were prescribed telmisartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified according to the number of AHD classes prescribed on initiating telmisartan. Change in systolic and diastolic blood pressure (SBP and DBP) after a month of treatment and the proportion of patients who achieved treatment goals according to the 2018 European Society of Cardiology/European Society of Hypertension guidelines were evaluated. Results A majority (90.6%) of the 1304 patients included in the study were on telmisartan monotherapy or telmisartan + 1 AHD. The mean (95% confidence interval [CI]) change in the telmisartan monotherapy group was SBP (−13.3 [−14.6, −12.0] mmHg) and DBP (−7.2 [−7.9, −6.5] mmHg), and the mean (95% CI) change in the telmisartan + 1 AHD group was SBP (−10.8 [−13.1, −8.5] mmHg) and DBP (−6.5 [−7.7, −5.3] mmHg) (P

The aim of this study was to provide real-world data on clinical characteristics, risk factors, and treatment patterns in Indian patients with epilepsy. Electronic medical record (EMR) data of patients diagnosed with epilepsy between January 2001 and December 2019, which included demographics, diagnosis, anti-epileptic drug usage, and underlying risk factors were evaluated. The majority of patients were between the age group of 18 and 55 years (n=3,186), with males accounting for 62% and the remaining 38% being females. Further, the most common comorbidity was hypertension (23.3%, n=1,470), followed by diabetes mellitus (10.8%, n=683) and depression (9.4%, n=597). The most prevalent form of epilepsy was focal epilepsy (n=5,141 81.4%), followed by generalized epilepsy (n=601). Focal epilepsy was most prevalent in males (62%, n=3,167) and most common in the age group of 18-55 years (50.3%, n=2588). Anti-epileptic drug (AED) usage data from 6,318 patients showed that the most commonly prescribed AED alone or in combination for both focal and generalized epilepsy was levetiracetam (41.8%, n= 2645). Data collected from this study are aligned but do not completely agree with the Guidelines for the Management of Epilepsy in India (GEMIND). This affirms treatment initiation with AED monotherapy; however, the treatment choices do not necessarily follow the recommended guidelines to select conventional AEDs, at low strengths, at initiation.

A multicentric cross-sectional observational survey was conducted to understand the patient, physician, nurse, caregiver, and diabetes counselor/educator-related factors that define the “glycemic happiness” of persons with type 2 diabetes mellitus (T2DM). Five sets of questionnaires based on a five-point Likert scale were used. A total of 167 persons with T2DM, 167 caregivers, and 34 each of physicians, nurses, and diabetes counselors/educators participated. For persons with T2DM, an adequate understanding of diabetes (mean score ± standard deviation: 4.2 ± 0.9), happiness and satisfaction with life (4.1 ± 0.8), flexibility (4.2 ± 0.8) and convenience (4.2 ± 0.7) of treatment, and confidence to handle hypo/hyperglycemic episodes (4.0 ± 0.9) were the factors positively associated with glycemic happiness. Caregivers’ factors included information from physicians on patient care (4.5 ± 0.6), constructive conversations with persons with T2DM (4.2 ± 0.8), helping them with regular glucose monitoring (4.2 ± 0.9), and caregivers’ life satisfaction (4.2 ± 0.8). Factors for physicians, nurses, and diabetes counselors/educators were belief in their ability to make a difference in the life of persons with T2DM (4.8 ± 0.4, 4.4 ± 0.5, and 4.5 ± 0.5), satisfaction from being able to help them (4.9 ± 0.3, 4.6 ± 0.5, and 4.6 ± 0.5), and professional satisfaction (4.9 ± 0.4, 4.4 ± 0.6, and 4.7 ± 0.4). Our survey identified the key factors pertaining to different stakeholders in diabetes care, which cumulatively define the glycemic happiness of persons with T2DM.

Objectives: Eczema is a papulosquamous disease characterized by itchy, dry, rough, flaky, inflamed, and irritated skin on arms, inner elbows, backs of the knees, or head. Numerous skin conditions can be managed with the help of moisturizers. Venusia® Max is a moisturizing cream meant for eczema with a unique combination of four butters – shea, cocoa, mango, and aloe that act as emollients along with glycerin, propylene glycol, emulsifying wax, and cyclomethicone. The study’s objective is to assess Venusia® Max cream’s moisturizing efficacy when used as an adjuvant to the main line of treatment for eczema. Material and Methods: This monocentric, real-world setting study evaluates the effectiveness of Venusia® Max as an adjuvant, along with prescribed treatment in patients with eczema, versus prescribed treatment only (without Venusia® Max) as well as baseline. One hundred and twenty subjects enrolled in the study were divided in two groups: 1. Receiving Venusia® Max cream as an adjuvant, along with prescribed treatment and 2. receiving prescribed treatment only. The subjects were assessed for eczema area and severity index (EASI) scores, skin hydration using moisture meter-SC, transepidermal water loss (TEWL) using VapoMeter, and subject self-assessment of itching, cutaneous dryness, and burning sensation. Results: In the group with Venusia® Max cream, significant reduction in the EASI score, burning sensation, itching, and TEWL along with significant increase in skin hydration was observed when compared to baseline. Conclusion: Thus, Venusia® Max cream offers a novel and effective topical treatment for the dry skin of eczema patients.

Various clinical trials have established anti-inflammatory and antipyretic properties of Nimesulide in a controlled setting, however, the fever management in real-world settings is quite different.To assess the effectiveness of Nimesulide in acute fever management in real-world clinical practice.A retrospective, multicenter study was conducted on electronic medical records (EMR) of 302 patients visiting out-patient departments at three centers between Jan 2016 and Jan 2020 and were prescribed Nimesulide for acute fever. The effectiveness of Nimesulide was analyzed as a change in fever from baseline to follow-up visit within 14 days and tolerability as the number of side effects captured post-Nimesulide ingestion.The provisional diagnosis at the baseline visit reported major complaints like fever, fever with abdominal pain, body-ache, cough and myalgia. The mean baseline body temperature was 103.2±1.5°F with a mean duration of 4.4±2.8 days significantly (p 0.0001) decreased to 99.7±1.8°F on the administration of Nimesulide. The liver and the renal profiles were found to be normal on records, and the side effects such as nausea and dyspepsia were reported only in 2% of patients.Nimesulide was found to be well-tolerated and effective as an antipyretic for acute fever management in adults during short-term use in real-world clinical practice.

Background: This is the first detailed Indian electronic medical record (EMR)-based real-world observational study to understand the clinical characteristics, associated comorbidities/risk factors and treatment(s) of CAD patients across India.Methods: EMR data of adult Indians (aged ≥ 18 years) diagnosed with CAD was retrospectively analyzed.Results: The majority of the participants had stable IHD (93%), were men (68.5% in ACS, 59.8% in stable IHD), most common age group was 40-64 years in ACS (56.6%) and stable IHD (51.4%). Both are common in metros (ACS 52%, 62% stable IHD). There is a high frequency of hypertension (38.2% in ACS, 59% in stable IHD) and diabetes mellitus (32.3% in ACS, 57.6% in stable IHD). Most common treatments are antiplatelet drugs and lipid-lowering drugs (96%).Conclusions: In India, stable IHD is the most prevalent form in vast majority of patients. The patients with CAD are mostly males, are mainly located in metros and majority fall between the age group of 40-64. The major comorbidities are hypertension and diabetes mellitus. Sociodemographic and clinical characteristics for CAD in India may not be similar to what is reported from the west. There is a significant difference in drug usage and adherence to guidelines in India for CAD.

Background: ‘Happiness’ is an essential component of type 2 diabetes (T2DM) management which potentially affects the treatment outcomes and psychosocial well-being of persons with T2DM. An observational survey was undertaken to understand and define “Glycemic Happiness” among persons with T2DM. Methods: A prospective, multicentric, cross sectional, observational survey involving 200 persons diagnosed with T2DM across 40 tertiary care centers in India. Interim analysis of 57 persons with T2DM is presented here. Survey (10 questions, Box 1) was based on a simple questionnaire developed by an expert panel and administered by designated personnel at study centers. Results: Responses correspond to either agree or strongly agree on a 5-point Lickert scale. To date, among 57 persons with T2DM, 53 (92.98%) and 52 (91.22%) agreed that a flexible and a convenient treatment regimen is linked to glycemic happiness respectively. Around 49 (85.96%) opined that glycemic happiness is affected by how happy and satisfied they are with their current life. A further 48 (84.22%) believed that glycemic happiness can be influenced by their understanding of T2DM. Conclusion: Apart from good glycemic control, a flexible and a convenient treatment regimen, level of diabetes education and their current satisfaction with life are important determinants of glycemic happiness in persons living with T2DM. Disclosure S. Kalra: Advisory Panel; Self; Dr Reddy’s Laboratories. A. K. Das: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Pharma, Sanofi. G. Priya: Advisory Panel; Self; Dr. Reddy’s Laboratories. N. K. Polavarapu: Employee; Self; Dr. Reddy’s Laboratories. K. Gaurav: Employee; Self; Dr. Reddy’s Laboratories. A. Mane: Employee; Self; Dr. Reddy’s Laboratories. C. S. Pinto: Employee; Self; Dr. Reddy’s Laboratories. Funding Dr. Reddy’s Laboratories, Ltd.

Background: Depression and anxiety are most disabling psychiatric conditions and add significantly to global health-related burden. Lifetime prevalence of major depression and anxiety disorders are very common and many times they can co-exist in the same time frame. The outcomes are poorer in such situations and compliance to medication is key to improve prognosis. A combination of tricyclic antidepressants and benzodiazepine is more practical in terms of compliance, and advantageous than that of a single class of drugs for the management of depression with co-morbid anxiety. This study will evaluate the safety and effectiveness of a fixed dose combination of amitriptyline and chlordiazepoxide as a part of post marketing surveillance.Methods: This is a prospective, single-arm, multi-centre, study which enrols patients who have been initiated with FDC of amitriptyline and chlordiazepoxide (Libotryp®: amitriptyline 12.5 mg and chlordiazepoxide 5 mg or libotryp-DS®: amitriptyline 25 mg and chlordiazepoxide 10 mg) tablets for the treatment of depression with co-morbid anxiety. A total of 375 patients will be enrolled and clinical assessments for safety will be done at follow up visits; assessments for effectiveness will be done using Hamilton Depression Rating Scale (HDRS or HAM-D) and Hamilton Anxiety Rating Scale (HARS or HAM-A).Conclusions: This study will provide more evidence on safety and usefulness of FDC of amitriptyline and chlordiazepoxide for the treatment of depression with co-morbid anxiety from Indian context.Trial registration: Trial registration number is CTRI/2021/03/031971.

Background: There is limited data highlighting the association of pruritus with Type 2 Diabetes Mellitus (T2DM). This was the first Electronic Medical Record (EMR) based real-world observational study on the demographics, clinical characteristics, associated risk factors and treatment(s) of pruritus in T2DM in India.Methods: EMR data of patients was retrospectively analysed with a baseline (V1) visit and two or more follow-up visits between June 2014-December 2019.Results: Majority of patients were 40-64 years old and mainly females (57%). Body mass index and co-morbidity data indicated a trend of obesity and hypertension. Observed HbA1c values were high (mean value of 9%). Majority of the patients were on hydroxyzine. Miconazole, fluconazole and corticosteroids were prescribed in 40% patients. Correlation between HbA1c levels with clinical pruritus was noted.Conclusions: Management of glycaemia along with timely dermatological intervention is needed for pruritus relief in T2DM, the use of antihistamines; in particular, hydroxyzine, should be further evaluated.

Background: Superficial (or cutaneous) mycoses are fungal infections that affect the superficial layers of the skin, hair, and nails. Luliconazole is an azole antifungal, used in the treatment of infections caused by fungus and yeast. The objective of the study is to assess the effectiveness and safety of new topical formulation of luliconazole (1% w/w luliconazole with 1% pramoxine added as excipient) in patients with cutaneous mycoses.Methods: Patients with cutaneous mycoses aged 18 years and older were included in the post-marketing open-label, monocentric, prospective study. Effectiveness was assessed on patients prescribed with new 1% w/w luliconazole cream. The primary endpoint was a change in itch severity as assessed on 10-point Visual analogue scale score. The secondary endpoints include the number of patients who achieved all-night relief from itching and the type of adverse events during the treatment. Clinical effectiveness for itching was assessed at different time points after baseline.Results: The mean itch severity scores at 2 min, 5 min, 10 min, 1 hour, 4 hour, and 8 hour time points were observed on 30 clinically diagnosed patients. A significant reduction of the mean±standard deviation score was observed from 6.82±0.72 at baseline to 3.37±1.68 after 8 hours. About 66.6% of patients achieved all-night relief from itching. There were no adverse events reported by any participant over the study duration.Conclusions: This new topical formulation of luliconazole (1% w/w) containing 1% pramoxine as excipient significantly reduced itch in cutaneous mycoses with no reported adverse events. Large randomised controlled studies are required to confirm our findings.

Objectives To ensure that the marketed product is irritant-free, extensive premarket clinical testing of cosmetic products is necessary. Therefore, the present study evaluated the skin irritation reactions of the test product Venusia Max Cream-Paraben-free using a patch test. Material and methods This single group, blinded, controlled trial was conducted to compare our test product with negative saline and positive SLS control in healthy human subjects aged between 18 and 53 years (mean age of 30.93 years) having Fitzpatrick skin phototype classification III-V. During an initial phase, a patch dipped in test product, negative and positive control were applied under occlusion to the upper arm of participants and removed after 24 hours. Clinical evaluation of skin reactions (erythema, edema, dryness, and scaling wrinkling) in the area of the test product, negative and positive control after 24 hours of patch removal and then were scored based on the Draize scale. Results A total of 30 subjects were initiated and completed the study. Scoring for skin irritation (erythema/dryness/wrinkles/edema) of the subjects were evaluated based on Draize’s scale between test product, positive, and negative control. The combined mean score, i.e., of erythema/dryness/wrinkles, and edema was 0.00 in test product and negative control whereas 2.60 in the positive control. No adverse events or intolerances were reported due to the test product. Conclusion Venusia Max Cream-Paraben-free was dermatologically tested and found to be nonirritant.

Background. Foods rich in protein and dietary fibre could potentially improve lipid profile in overweight or obese diabetic patients with dyslipidemia and, thereby, mitigate their risk of cardiovascular disease (CVD). In this study, the effect of providing high-protein high-fibre (HPHF) nutritional supplement in addition to standard care of type 2 diabetes mellitus (T2DM) on lipid profile was evaluated. Methods. In this open-label, parallel-arm, prospective, randomized study, a total of 100 overweight/obese participants with T2DM were randomized to either an intervention group (25 g HPHF nutritional supplement given twice daily along with a standard care of T2DM) or a control group (standard care of T2DM) for 24 weeks. Change from baseline in lipid parameters such as total cholesterol (TChol), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG) was assessed between the intervention and control group at week 12 and week 24. Participant compliance was assessed using the dietary 24-hour recall. Statistical analysis was performed to assess the main effects on within- and between-group changes from baseline to end of 24 weeks. Results. Participants in the HPHF nutritional supplement group showed a statistically significant improvement in HDL-C levels by the end of 24 weeks ( p = 0.04 ) and a significant increase in protein and total dietary fibre intake ( p = 0.002 and p = 0.00 , respectively) compared to the control group. The TChol/HDL-C ratio was significantly lower ( p = 0.03 ) in the HPHF group from baseline to 24 weeks. Conclusion. Twice-daily consumption of a HPHF nutritional supplement significantly improved HDL-C levels. Inclusion of the HPHF supplement would be a useful effective aid for managing dyslipidemia in overweight/obese individuals with T2DM.

This study aimed to assess the efficacy of Saccharomyces boulardii, a yeast probiotic, in the management of acute diarrhoeal disorders in the paediatric population in outpatient settings. It was a multicentre retrospective analysis of medical records of children who were treated for acute diarrhoea by routine treatment (oral rehydration solution and zinc) with or without S. boulardii. Overall, 160 children presenting with acute diarrhoea at seven different outpatient paediatric settings were included in the study. Children were divided into two categories based on their treatment with S. boulardii (SB group) or without S. boulardii (Non-SB group). Baseline demographic, anthropometric and clinical variables were compared between the two groups. The median duration of diarrhoea post-treatment was significantly shorter in the S. boulardii group (3 days) than in the non-SB group (4 days). A significant reduction in the frequency of stools was observed post-treatment in the S. boulardii group (1.7 versus 2.5 in the non-SB group). There was a significant weight gain in the S. boulardii group post-treatment (300 g) in comparison with the non-SB group (mean loss of 400 g). This study established the positive role of S. boulardii in the management of acute diarrhoeal diseases in children. Moreover, the S. boulardii probiotic was seen to be effective in diarrhoeal diseases in children with dehydration.

Real-world data on the effectiveness of antihypertensive drugs (AHDs) in India is limited. The present study aims to provide updated evidence regarding the effectiveness of olmesartan as monotherapy or in combination with other AHDs in Indian patients with essential hypertension.Electronic medical record data of adult patients who were diagnosed with essential hypertension (≥140/90 mmHg) and were prescribed olmesartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of olmesartan. Change in systolic and diastolic blood pressure (SBP and DBP) from baseline was the primary endpoint. Secondary endpoint was evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines. Readings were obtained before initiating olmesartan and after at least a month of therapy with olmesartan.Among the 459 included patients, majority were on olmesartan monotherapy or olmesartan+1AHD (91.7%). Mean (95% confidence interval [CI]) change in olmesartan monotherapy group was: SBP (-13.4 [-15.7, -11.1] mmHg) and DBP (-8.3 [-9.5, -7.1] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-11.7 [-15.1, -8.3] mmHg) and DBP (-6.6 [-8.3, -4.9] mmHg) (P0.001 for all). SBP and DBP goals were achieved by 40.4% and 50.3% of patients on olmesartan monotherapy and by 36.1% and 46.2% of patients on olmesartan+1AHD. Among patients with comorbid diabetes, mean (95% CI) change in olmesartan monotherapy group was: SBP (-15.5 [-18.6, -12.4] mmHg) and DBP (-8.7 [-10.2, -7.2] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-13.5 [-18.3, -8.7] mmHg) and DBP (-7.6 [-9.8, -5.4] mmHg) (P0.001 for all). SBP and DBP goals were achieved by 38.5% and 49.4% of patients on olmesartan monotherapy and by 31.7% and 42.9% of patients on olmesartan+1AHD.Olmesartan prescribed as mono- or add-on therapy during routine clinical practice significantly reduced blood pressure in Indian patients with essential hypertension as well as in patients with comorbid diabetes.

Doxycycline acts against a broad range of gram-positive, gramnegative and 'atypical' bacteria as well as some protozoan pathogens such as malaria. In this era of increasing multidrug-resistance, recycling of old antimicrobials should be considered and need more focus in this domain of research. We, therefore, aimed to assess the antimicrobial susceptibility patterns of commonly isolated pathogens against doxycycline, azithromycin, cefuroxime, and amoxicillin from common clinical specimens by using laboratory-based diagnostic data from western India.The non-interventional retrospective study was conducted on secondary data extracted from multi-center diagnostic laboratory based in Mumbai, India. Susceptibility data of bacteria isolated from blood, urine, pus, and sputum were used in the study and culture positive samples were segregated. Antimicrobial susceptibility status of doxycycline was checked and compared with azithromycin, cefuroxime, and amoxicillin. Chi-square tests of significance were carried out to assess significant differences in susceptibility patterns. Association between variables was considered statistically significant if the p-value was0.05.Percentage susceptibility of collective bacterial isolates was found to be highest for doxycycline in all four specimens (93.1%). Individual percentage susceptibility was observed to be highest for sputum isolates (97.5%) followed by blood (93.8%), pus (92.7%) and urine (70.0%). The activity of doxycycline was found to be 93.5% for the samples resistant to azithromycin. Doxycycline also showed good susceptibility for the isolates resistant to amoxicillin and cefuroxime which was 75.9% and 64.8%, respectively.Several bacterial isolates from all four sources were found to be susceptible to Doxycycline. It has an important role in the form of a better alternative of major antimicrobial agents like azithromycin, cefuroxime, and amoxicillin against gram-positive cocci. Doxycycline appeared to show better activity against isolates which were resistant to other three antimicrobials.

Background and objectives: There is an unmet need for topical treatments with good tolerability in management of acne vulgaris. The present study aimed to evaluate efficacy and safety of a novel tretinoin (microsphere, 0.04%) formulation in combination with clindamycin (1%) gel for treatment of acne vulgaris. Materials and methods: This phase 3 randomized, double-blind study included patients with moderate-to-severe acne. Patients were treated with tretinoin (microsphere, 0.04%) + clindamycin (1%) or one of the monotherapies (tretinoin, 0.025%; clindamycin, 1%). Key endpoints included percent change in lesion counts, and improvement in Investigator���s Static Global Assessment (ISGA) score. Results: 750 patients were randomized (combination, n = 300; tretinoin and clindamycin, each n = 150). At week 12, reductions in inflammatory (77%), non-inflammatory (71%) and total lesions (73%) were significantly greater with combination treatment versus either monotherapy (p p Conclusion: The once-daily, microsphere-based formulation was generally tolerable with a positive impact on therapeutic outcomes and patients��� compliance. ClinicalTrial Registration No.: CTRI/2014/08/004830

Background: Topical exposure to chemicals from cosmetics can lead to adverse skin effects or skin irritation. This study aimed to investigate the skin irritation and sensitizing potential of a moisturizer Venusia max lotion (paraben-free, alcohol-free, mineral oil-free, animal origin free (PAMA) free).Methods: In this single-center, non-randomized, observational study, skin irritation, and skin sensitization potential of a test product was assessed using the human repeat insult patch test (HRIPT) technique. Approximately 0.04 g of the test product and filter papers dipped in 0.9% isotonic saline solution (~0.04 ml of solution) were filled in different wells of patch chambers and applied occlusively, on the back of each participant. Scoring of the skin reactions in the induction phase and challenge phase was done using Draize and international contact dermatitis research group (ICDRG) scales respectively. Scores were compared to the baseline and the negative control (isotonic saline).Results: In total 234 participants (50 with sensitive skin), 224 and 221 participants completed the induction phase and challenge phase respectively. Scores for the induction phase for Venusia max lotion (PAMA free) and isotonic saline were 0.46 and 0.06 respectively. The mean cumulative score of erythema and oedema for Venusia max lotion (PAMA free) was below 2. For the challenge phase, none of the participants showed any positive reactions at any time point for test product and isotonic saline.Conclusions: Test product Venusia max lotion (PAMA free) found to be non-irritant and hypoallergenic. Thus, it can be used without fear of skin irritation or sensitization.

Objectives: Comedogenicity is a critical factor in making of cosmetics and skin care products. The term “acne cosmetica” was coined to link the relationship between female acne to the use of cosmetic formulations, stating that the ingredients used in the cosmetic formulations have the potential to evoke a comedogenic response or produce comedones. Therefore, it is important that a skin care product is non-comedogenic and efficacious at the same time. The main objective of this study is to evaluate the comedogenic potential of the test product (Venusia Max Cream – paraben free) when applied topically under occluded patch to the skin. Material and Methods: This was a randomized, double-blinded, comparative study conducted in 24 healthy female participants, with prominent follicular orifices on the upper back region. Comedogenic potential of the test product (Venusia Max Cream – paraben free) was evaluated in comparison to positive (coconut oil) and negative (glycerin) controls in women. Each participant received topical application of test and control products under occluded patch to the skin on the upper aspect of the back, 3 times weekly for 4 weeks. Cyanoacrylate biopsies were performed before and after treatment to determine the microcomedones histologically. Microcomedones were graded using light microscopy and results were analyzed based on scale rating (0–3). Results: The mean comedone grading was assessed between positive versus negative control, and positive control versus test product. The mean comedone grades were significantly less in test product 0.41 ± 0.50 and negative control 0.82 ± 0.73 in comparison to positive control 2.09 ± 0.68. The test product was least comedogenic in this study. Furthermore, no adverse events were reported during the study period. Conclusion: Based on the histological evidence, Venusia Max Cream (paraben free) is a non-comedogenic, plant-based intense moisturizing cream and its use in regular skin care routine can be beneficial, particularly for acne prone and dry skin as it improves the skin hydration levels.

Objectives: The objectives of the study were to evaluate skin hydration and transepidermal water loss (TEWL), after the application of the test product (Venusia Max Lotion [Paraben, Alcohol, Mineral Oil, and Animal Origin (PAMA)] free). Material and Methods: The study was a single-center, non-randomized, observational study. Test product was compared to control sites after application on volar forearms of women with dry skin. Hydration and TEWL measurements at baseline, after 12 hours, 24 hours and 36 hours of product application were done under the occluded and unoccluded condition. Results: The study was completed with 30 female subjects. Increase in the mean MMSC values was significantly greater on test product site as compared to control site, at all-time points. For TEWL readings over 36 h, when kept occluded and unoccluded, respectively, there were no significant differences in TEWL readings between the test product site and control site at any time points. Conclusion: The test product, Venusia Max Lotion (PAMA free), can be useful in maintaining the skin barrier properties and significantly improving skin hydration in individuals with dry skin or dry skin-related conditions.

Background: India contributes significantly towards a large part of the worldwide epidemic of hypertension (HTN) and its associated complications. As, there are limited longitudinal studies available in India to understand its occurrence over time, this Pan-India longitudinal study will aid to assess the real world outcomes of HTN across the country.Methods: This was a prospective, multi-centered, longitudinal, observational study investigating a large COHORT of people with HTN across India over a period of one year. The primary objective of this study was to evaluate blood pressure (BP) control and clinical outcomes in high-risk hypertensive patients distributed over 5 visits (including baseline visit). The secondary objective is to assess the co-morbidities/risk factors in different clinical settings across India. Participants (4,000) with HTN will be included from 200 centres across India and data will be recorded for the use of anti-hypertensives, demographics, socio-economic status, anthropometric measurements, family history, personal history, risk factors, co-morbid conditions and physician treatment preferences. Overall, clinical practice patterns were assessed for their relationship with clinical outcomes.Conclusions: This study is expected to reveal the trends in complications associated with HTN, treatment strategies used by physicians, and correlation among treatment, control and complications of HTN within the Indian context. The outcome of this study will help to identify the burden of HTN, along with pin-pointing the emergence of early-onset complications and dose titration patterns. This will eventually help to develop person-centred care and facilitate public health agencies to invest appropriate resources in the management of high-risk HTN across India.Trial registration: Since this is a real world evidence study no trial registration was needed as per Indian regulations.

Excess body weight is a leading cause of metabolic complications such as hypertension and dyslipidemia in T2DM patients. Available antihyperglycemic agents have minimal or no impact on these complications and a majority are known to trigger weight gain, thereby exerting a paradoxical effect on overall metabolic status. This review introduces the concept of 'KgA1c paradox' and underscores the significance of resolving this paradox for comprehensive T2DM management. It provides a therapeutic rationale for inclusion of sodium glucose cotransporter 2 inhibitors in the T2DM treatment algorithm as these agents have demonstrated favorable glycemic effects along with reduction in body weight.

Background: Tinea corporis and cruris are estimated to affect 22% to 55% of the Indian population. This real-world study was conducted to evaluate the effectiveness and safety of eberconazole 1% cream among Indian patients.Methods: In this prospective, single-arm, observational study, patients with Tinea corporis and cruris aged ≥18 years were prescribed eberconazole 1% cream (Ebernet®, Dr. Reddy’s Laboratory, India) for up to 3 weeks. The primary endpoint was proportion of patients with improvement in total signs and symptoms score with 2 weeks of treatment. The key secondary endpoint was mean percent reduction in individual signs and symptoms score (erythema, itching, scaling) from baseline to the end of the 1st, 2nd, and 3rd week. A post-hoc analysis was performed on a subgroup of patients (completer set [CS]) who reported application of eberconazole 1% cream for 3 weeks in the study. There were no adverse effects reported.Results: Of 120 enrolled patients;104 (86.7%) were included in the full analysis set (FAS) and 76 (63.3%) patients were included in the CS. After 2 weeks of treatment, total signs and symptoms scoreConclusions: The evidence from this real-world observational study and a post-hoc analysis suggests that eberconazole 1% cream is effective and safe treatment option in the management of Tinea corporis and cruris in Indian patients.