Introduction. Calcium channel blockers have pedal edema as one of the confining factors of treatment. A real-world study may help evident reality of the situation in regular Indian clinical practice. The aim of the study is to assess effectiveness and incidence of pedal edema in essential hypertensive patients treated with amlodipine or cilnidipine monotherapy. Methods. Retrospective EMR data of adult essential hypertensive patients, prescribed amlodipine (n = 800) or cilnidipine (n = 800) as monotherapy, were analyzed. Incidence of pedal edema from baseline visit was analyzed in terms of dose and duration of treatment. The changes in systolic (SBP) and diastolic blood pressure (DBP) from baseline and proportion of patients achieving target BP goals were assessed. Results. In amlodipine and cilnidipine groups, mean changes in SBP and DBP from baseline to end of the study period were 28.4 and 15.1 mmHg and 24.3 and 13.5 mmHg, respectively ( value <0.05). More than 50% of patients in both groups achieved BP goal at the end of the study ( value 0.266). In amlodipine group, total 23.9% reported pedal edema, while in cilnidipine, 27.6% ( value 0.0863). At the end of the study, 3.5% and 8.2% of patients remain with pedal edema, respectively, in both groups (value <0.005). Conclusion. Amlodipine demonstrated greater BP reduction at a lower average dose, better efficacy, and tolerability in terms of pedal edema count as a lesser number of patients reported edema at the end of the study and a higher percentage of patients continued the prescribed baseline dosage regimen as compared to cilnidipine. Thus, the study established amlodipine as an effective and well-tolerated antihypertensive for Indians.

Pruritus is a common dermatological condition observed in patients with diabetes, making it a dermatometabolic condition. Being multiaethiological, pruritis is caused by autoimmune, genetic, infectious and various systemic diseases. The present survey aimed to understand the knowledge, attitude and practice toward pruritus among Indian physicians and patients with diabetes presenting with pruritus. A telephonic, cross-sectional, qualitative survey was conducted among physicians and patients across five cities in India from July–August 2020. An open-ended discussion guide was used for the interview; the data were analyzed to check for common themes and trends. A majority of the consulting physicians (CPs) believed that uncontrolled diabetes is the main causal factor for pruritus in patients with diabetes and reported that currently there are no standard tests or treatment guidelines for its management. CPs emphasized proper monitoring and counseling to overcome current challenges. Patients reported a negative impact of pruritus on their daily activities and quality of life. The survey concluded that poor management of diabetes is one of the main causal factors for patients with diabetes presenting with pruritus in India. CPs emphasized controlling diabetes along with symptomatic treatment. For patients, pruritus has multifaceted effects on their health, overall well-being, and quality of life.

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.

Objective: To discuss the potential risks and their mitigation strategies in the post-conduct phase of the trial. Background: Risk management is very important for the clinical trial (CT) to ensure that the trial delivers its desired outcome(s) in terms of achieving protocol objective and regulatory compliance. Methodology: Experienced members of the clinical operation team of a pharmaceutical major underwent a series of sessions to identify risks associated with the post-conduct phase of CT and developed mitigation strategies based on own experiences and guidance documents. The risks were categorized into major, minor and critical risks. Results: In the post-conduct phase of a clinical trial, critical risk identified were; failure to communicate to the stakeholder about premature termination of the trial, mismatch of statistical analysis results and protocol objective/ regulatory requirement, clinical study report (CSR) noncompliant with regulatory requirements or delay in CSR preparation. Safety checks suggested to mitigate these risks including the development of related checklist or shell of relevant documents and its review by clinical development, quality assurance (QA) and regulatory affairs (RA) team prior to finalization. Additionally, six major and five minor risk areas were identified and safety checks were suggested. Conclusion: Sponsors must act proactively to ensure a systematic approach to conduct various post conduct trial activities and the plans to mitigate the risks that could affect the quality and outcome of the clinical trial. Future Perspective: A close coordination with all stakeholders for timely anticipation of risks and execution of mitigation strategies are required for successful CT outcomes.

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 (418%, 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.

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.