A Real-World Perspective of Co-amoxiclav Prescription Pattern With Probiotics for Pediatric Patients With Respiratory Tract Infections: Results of Quantitative and Qualitative Approach in Indian Outpatient Settings.

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.

A real-world retrospective study of omeprazole-domperidone combination in managing acid peptic disease with PRoton-pump Inhibitors in patients with type 2 DiabEtes mellitus (PRIDE-2).

Background: Proton-pump inhibitors, along with a prokinetic agent, are widely used to provide symptomatic relief amongst patients with acid peptic disease (APD). This article evaluates the effectiveness and safety of the omeprazole-domperidone combination amongst patients with type 2 diabetes mellitus for the management of APD. Methods: PRIDE-2 (PRoton-pump Inhibitor in patients with type 2 DiabEtes mellitus) is a retrospective study reviewing electronic medical records of patients with type 2 diabetes mellitus and APD who were receiving the omeprazole-domperidone combination and visiting multiple Indian healthcare settings between March 2018 and April 2021. The effectiveness outcome of the therapy was evaluated in terms of resolution of APD symptoms at visit 5 (120 days after baseline visit) compared with visit 1 (baseline visit). Safety was determined in terms of reported adverse events (AEs) during the treatment period (120 days). Results: A total of 174 patients were included in the study. The mean age of the patients was 51.5±9.6 years, with the majority (59.8%) being men. A significant proportion of patients reported relief from APD symptoms, including abdominal pain (91.6%), epigastric burning (68.7%), nausea (89.5%), flatulence (100.0%), loss of appetite (93.6%), and altered bowel movements (94.7%) (p<0.001 for each) at visit 5 compared with visit 1. No serious AEs were reported. Conclusion: Omeprazole-domperidone combination was beneficial in providing symptomatic relief to patients with diabetes and APD. The combination therapy was well tolerated, with few reports of minor AEs.

Demographic Profile and Prescribing Patterns of Anti-epileptic Drugs in Indian Epilepsy Patients: Electronic Medical Record-Based Nation-Wide Retrospective Cohort Study.

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 Retrospective, Observational, EMR-Based Real-World Evidence Study to Assess the Incidence of Pedal Edema in Essential Hypertensive Patients on Amlodipine or Cilnidipine.

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 (p value <0.05). More than 50% of patients in both groups achieved BP goal at the end of the study (p value 0.266). In amlodipine group, total 23.9% reported pedal edema, while in cilnidipine, 27.6% (p value 0.0863). At the end of the study, 3.5% and 8.2% of patients remain with pedal edema, respectively, in both groups (pvalue <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.

Knowledge, Attitude and Practice for Pruritus Management in Physicians and Patients with Diabetes.

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.

An Evidence-Based Retrospective Study for the Management of Acid Peptic Disease With Omeprazole, a Proton Pump Inhibitor, in Indian Patients With Type 2 Diabetes Mellitus (PRIDE-1).

Background In this study, we aimed to assess the effectiveness of omeprazole therapy in the management of acid peptic disease (APD) among type 2 diabetes mellitus (T2DM) patients. Methodology In this multicenter retrospective study, electronic medical records (EMRs) of T2DM patients with APD who were prescribed omeprazole between March 2018 and April 2021 at multiple Indian healthcare settings were reviewed. The resolution of APD symptoms was assessed at visit five (120 days after the index visit) and compared to visit one (index visit). Safety was established in terms of reported adverse events during the study period. Results Overall, 174 patients were included. The majority of patients (63.8%) were males with a mean age of 48.6 ± 11.03 years. After receiving omeprazole therapy, a significant number of patients reported improvement in symptoms such as abdominal pain (98.2%), epigastric burning (74.2%), altered bowel movements (62.1%), and nausea (80.5%) (p < 0.001 for each). Complete resolution was observed in all patients who complained about flatulence (100.0%) and loss of appetite (100.0%) (p < 0.001 for each). The drug was found to be well tolerated. Conclusions Omeprazole therapy was well tolerated and highly effective in resolving APD symptoms among T2DM patients receiving fixed oral hypoglycemic agents.

Assessment of Patient, Physician, Caregiver, and Healthcare Provider-Related Factors Influencing "Glycemic Happiness" of Persons with Type 2 Diabetes Mellitus: An Observational Survey.

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.

An Industry Perspective on Risks and Mitigation Strategies Associated with Post Conduct Phase of Clinical Trial.

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.

Potential Risks and Mitigation Strategies During the Conduct of a Clinical Trial: An Industry Perspective.

BACKGROUND: Every phase of a clinical trial should be designed in compliance with good clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics are an integral part of a successful clinical trial which must be considered. Therefore, risk monitoring is an essential tool to identify the risks associated with conduct of any trial. This article is a result of extensive research conducted by a reputed pharmaceutical company to identify the potential stages of risks associated with the conduct phase of trial that could impact the overall quality and safety of a trial. METHODS: The skillful and experienced team members of a reputed pharmaceutical company involved in conducting clinical trials underwent brainstorming sessions to assess and categorize the risks associated with each stage of conduct phase of a clinical trial. They also developed a mitigation plan based on their experiences, best practices and applicable guidance documents. RESULTS: During conduct phase, risks are associated with preparation of site master and trial master file, courier of study supply to site(s) including investigational product prior to site initiation visit, patient recruitment, telephonic monitoring, adverse or serious adverse event monitoring, site monitoring visit(s), collected case report form pages forward to data management vendor, data query clarification and site close-out visit. CONCLUSION: A close working relationship with all the persons associated with the clinical trial, timely monitoring and prospective mitigation planning is required for the conduct of a high quality trial.