Amey Mane

Background: Gastroesophageal reflux disease (GERD) and dyspepsia are highly prevalent in India. Pantoprazole suppresses gastric acid secretion by inhibiting H+, K+-ATPase enzyme, yet patients experience inadequate symptom control with proton pump inhibitor (PPI) monotherapy. Levosulpiride, a selective dopamine D2 receptor antagonist, enhances gastrointestinal motility and visceral sensitivity, offering additional symptomatic relief. The aim of the study was to evaluate the safety and efficacy of a fixed-dose combination (FDC) of pantoprazole sodium 40 mg and levosulpiride sustained-release 75 mg for short-term therapy of GERD in patients unresponsive to PPI monotherapy. Methods: This phase IV, open-label, single-arm study was conducted at 11 sites across India. Of 540 screened patients, 509 were enrolled and received FDC once daily for 4 weeks. Safety was evaluated through adverse events (AEs) and serious AEs (SAEs). Efficacy was assessed using the Frequency Scale for the Symptoms of GERD (FSSG), Likert Scale, Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), and Modified Simpson Angus Scale (MSAS). Results: Of 509 patients, 492 completed the study. Seventy-nine AEs were documented in 69 patients, all mild-to-moderate and no SAEs were reported. The FDC demonstrated significant reduction in GERD symptom severity, with a mean (standard deviation) change from baseline of −16.99 (8.76) (P < 0.0001) on FSSG Scale at visit 4. Additionally, reductions were observed in acid reflux symptoms with a mean (SD) change from baseline of −9.15 (5.25) and dyspeptic symptoms −7.8 (4.05); both changes were statistically significant (P < 0.0001). The Likert Scale also demonstrated a significant reduction in symptom severity indicated by a mean (standard deviation) change from baseline of −1.26 (1.00) (P < 0.0001). At visit 4, CGI-I scores classified 196 patients as “very much improved”, while CGI-S indicated “normal” status in 173 patients. The absence of significant movement disorders, assessed by MSAS at visit 4, further supports the favorable safety profile of FDC in management of GERD. Conclusion: The FDC of pantoprazole and levosulpiride is well tolerated and effective for the short-term treatment of GERD in patients unresponsive to PPI therapy. Symptom reductions and favorable global assessments indicate therapeutic benefit of therapy in refractory GERD population.

Acid peptic disease (APD) is often associated with comorbidities. Choosing a proton pump inhibitor (PPI) is critical in such patients, given the frequent use of multiple concomitant medications in routine clinical practice. This real-world study was planned in India to understand drug utilization and prescription patterns of PPIs in APD patients with comorbidities. The aim was to evaluate the real-world drug utilization patterns of PPIs and to explore the adherence, effectiveness, and tolerability of pantoprazole in APD patients with comorbidities in India. This multicenter, retrospective, electronic medical record-based study analyzed data of adult APD patients with comorbidities treated with PPIs at four Indian outpatient clinics (January 2017-December 2020). Patients aged ≥18 years with at least two follow-up visits were included, and outcomes assessed included utilization patterns, adherence, effectiveness, and tolerability. The study included data from 687 patients with APD, who had a mean age of 47.8 years, and 56.6% of them were male. Patients had various comorbidities, and PPIs were co-prescribed with antidiabetics, antiplatelets, antihypertensives, antibiotics, and antithyroid drugs. Pantoprazole was the most commonly prescribed PPI (51.7%), followed by esomeprazole (20.2%), rabeprazole (13.0%), lansoprazole (9.2%), and omeprazole (6.0%). A greater proportion of patients treated with pantoprazole adhered to treatment when compared to other PPIs at follow-up visits. All APD symptoms significantly reduced at follow-up visit 2 compared to baseline across all PPIs (p < 0.05). All PPIs were well-tolerated, with adverse events consistent with their known profiles. This real-world study highlighted utilization patterns of PPIs and demonstrated that all PPIs are effective and well-tolerated in managing APD symptoms in patients with comorbidities. Pantoprazole was the most co-prescribed and preferred PPI amongst the prescribed PPIs. These findings provide real-world insights into how PPIs are utilized in Indian patients with APD and comorbidities and may help clinicians make informed decisions when selecting an appropriate PPI in routine practice. The study was registered in the Clinical Trial Registry of India (CTRI number: CTRI/2021/06/034237).

Background: Nonalcoholic fatty liver disease (NAFLD) and its progressive form, nonalcoholic steatohepatitis (NASH), represent an increasing clinical and public health burden in India. Despite their high prevalence, there are limited data on their diagnostic and management approaches among Indian health care providers. Real-world evidence on how Indian gastroenterologists and hepatologists diagnose and manage these conditions remains limited. Objective: This study aimed to understand the current disease perspectives, diagnostic modalities, and management practices for NAFLD and NASH among Indian hepatologists and gastroenterologists. Methods: A nationwide, web-based cross-sectional survey was conducted online between May 2023 and July 2023 among practicing gastroenterologists and hepatologists from health care setups, clinics, and hospitals located across India. The structured, self-administered questionnaire included 34 items covering 3 domains: disease perspectives (n=16), diagnostic modalities (n=4), and management strategies (n=14). Descriptive statistics were used to summarize responses as counts and percentages. Results: A total of 609 physicians completed the online survey (gastroenterologists: n=556, 91.3%; hepatologists: n=53, 8.7%). For 336 (55.2%) physicians, NAFLD accounted for 25% to 50% of the patients consulted per month, and 220 (36.1%) physicians reported that 10% to 20% of patients with NAFLD had NASH. Obesity (n=583, 95.7%) and diabetes (n=579, 95.1%) were cited as leading risk factors for NAFLD. Transient elastography was the diagnostic tool preferred by 558 (91.6%) physicians, followed by NAFLD fibrosis score (n=378, 62.1%) and Fibrosis-4 score (n=356, 58.5%); only 154 (25.3%) physicians used liver biopsy. For treatment, 414 (68%) physicians managed patients using pharmacotherapy and dietary and lifestyle modifications, while 195 (32%) relied on lifestyle modification alone. Antioxidant vitamins (n=543, 89.2%) and saroglitazar (n=522, 85.7%) were the most frequently prescribed therapies. The main barriers to optimal NASH management reported were lack of patient awareness (n=466, 76.5%) and limited availability of effective pharmacological options (n=303, 49.8%). Conclusions: This large, nationwide survey highlights that NAFLD and NASH constitute a major part of gastroenterology and hepatology practice in India. Although transient elastography and pharmacological agents such as saroglitazar and vitamin E are widely used, considerable heterogeneity exists in diagnostic and management approaches. The lack of patient awareness and effective treatment options remain the major hurdles in managing NAFLD and NASH. These findings underscore the need for the wider implementation of existing India-specific consensus recommendations, continued physician education, and future research focusing on tailored interventions in the management of NAFLD and NASH for the Indian population.

BACKGROUND Nonalcoholic fatty liver disease (NAFLD) and its progressive form, nonalcoholic steatohepatitis (NASH), represent an increasing clinical and public health burden in India. Despite their high prevalence, there are limited data on their diagnostic and management approaches among Indian health care providers. Real-world evidence on how Indian gastroenterologists and hepatologists diagnose and manage these conditions remains limited. OBJECTIVE This study aimed to understand the current disease perspectives, diagnostic modalities, and management practices for NAFLD and NASH among Indian hepatologists and gastroenterologists. METHODS A nationwide, web-based cross-sectional survey was conducted online between May 2023 and July 2023 among practicing gastroenterologists and hepatologists from health care setups, clinics, and hospitals located across India. The structured, self-administered questionnaire included 34 items covering 3 domains: disease perspectives (n=16), diagnostic modalities (n=4), and management strategies (n=14). Descriptive statistics were used to summarize responses as counts and percentages. RESULTS A total of 609 physicians completed the online survey (gastroenterologists: n=556, 91.3%; hepatologists: n=53, 8.7%). For 336 (55.2%) physicians, NAFLD accounted for 25% to 50% of the patients consulted per month, and 220 (36.1%) physicians reported that 10% to 20% of patients with NAFLD had NASH. Obesity (n=583, 95.7%) and diabetes (n=579, 95.1%) were cited as leading risk factors for NAFLD. Transient elastography was the diagnostic tool preferred by 558 (91.6%) physicians, followed by NAFLD fibrosis score (n=378, 62.1%) and Fibrosis-4 score (n=356, 58.5%); only 154 (25.3%) physicians used liver biopsy. For treatment, 414 (68%) physicians managed patients using pharmacotherapy and dietary and lifestyle modifications, while 195 (32%) relied on lifestyle modification alone. Antioxidant vitamins (n=543, 89.2%) and saroglitazar (n=522, 85.7%) were the most frequently prescribed therapies. The main barriers to optimal NASH management reported were lack of patient awareness (n=466, 76.5%) and limited availability of effective pharmacological options (n=303, 49.8%). CONCLUSIONS This large, nationwide survey highlights that NAFLD and NASH constitute a major part of gastroenterology and hepatology practice in India. Although transient elastography and pharmacological agents such as saroglitazar and vitamin E are widely used, considerable heterogeneity exists in diagnostic and management approaches. The lack of patient awareness and effective treatment options remain the major hurdles in managing NAFLD and NASH. These findings underscore the need for the wider implementation of existing India-specific consensus recommendations, continued physician education, and future research focusing on tailored interventions in the management of NAFLD and NASH for the Indian population.

Background: Probiotics are co-prescribed with co-amoxiclav to prevent antibiotic-associated diarrhea (AAD). The study assesses the co-prescription pattern of probiotics with co-amoxiclav in pediatric patients with respiratory tract infections (RTIs). Methods: This was a mixed methods research study with a retrospective study and a prospective survey. The retrospective part included a multicenter, observational, real-world study utilizing patients’ electronic medical records for three years (2018-2020) from seven outpatient pediatric clinics and hospitals. The qualitative evaluation was performed with a predefined questionnaire. Results: The patients having RTIs (N=984) were prescribed Clamp® (46.7%), CAA (23.8%), and CAM (29.5%). The mean age of the patients was 4.05 years, with 59.25% males and most patients having upper RTIs. Co-amoxiclav was prescribed twice daily for one to 15 days. A significantly lesser number of probiotic co-prescriptions were observed with Clamp® (19.57%) than with CAA (38.46%) and CAM (29.31%) at baseline (p<0.001). Similar findings were observed for follow-up visits one and two. Saccharomyces boulardii, Bacillus clausii, and lactic acid bacillus were the most commonly co-prescribed probiotics. The qualitative evaluation indicated that most clinicians were aware of the co-amoxiclav-related gastrointestinal side effects and the benefits of probiotics in preventing them. Conclusion: The frequency of co-prescriptions of probiotics with Clamp® among pediatric patients with RTIs was significantly less, potentially indicating better gastrointestinal tolerability.

Topical corticosteroids play a key role in managing steroid responsive dermatoses (SRD). Current topical corticosteroid therapies are associated with various disadvantages. The current consensus article aims at providing a collation of evidence-based literature and clinical insights of the experts, regarding the efficacy, safety and usage of clobetasol propionate (CP) 0.025% cream in the management of SRD like plaque psoriasis. Clinical evidences suggest that the novel formulation of CP 0.025% cream has comparable efficacy and a better safety profile vs CP 0.05% cream in the management of plaque psoriasis. According to the doctors' experience, CP 0.025% can be used as first-line treatment for the management of SRD. In children 12-18-year-olds, CP 0.025% may be used cautiously, considering risk-benefit ratio. CP 0.025% may also be used as a maintenance therapy, after disease is brought under control with systemic therapy. Using moisturisers, salicylic acid, calcipotriol or tacrolimus as concomitant therapy with CP 0.025% cream may be beneficial in the management of SRD. In various comorbidities like diabetes and hypertension, CP 0.025% cream may be a better alternative verses CP 0.05% cream. Clinical evidences and experts suggest that for management of SRD, clobetasol propionate 0.025% cream can be recommended as a formulation with comparable efficacy and better safety profile versus CP 0.05% cream.

Background: 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.