Cipla (India)

Background:Heart failure (HF) remains a major public health challenge in India, with a need for effective and well-tolerated therapeutic strategies.Objective:The RESTORE-HF study evaluated the real-world effectiveness and safety of torsemide-spironolactone fixed-dose combination (FDC) in Indian patients with HF.Design:Prospective, multicenter, observational study.Methods:This study was conducted across 101 sites in India. Patients aged 18–75 years with HF with reduced ejection fraction and signs of congestion were enrolled and initiated on the torsemide-spironolactone FDC. Participants were followed over 3 weeks from baseline. The primary objective was the change in body weight. Secondary endpoints included changes in New York Heart Association (NYHA) functional class, edema, occurrence of adverse events (AEs), and physician and patient assessments of efficacy and tolerability.Results:Of the 1841 patients screened, 1752 were enrolled, and 1520 completed the study. The mean (SD) age of participants was 58.61 (9.45) years, of whom 61.05% were male. The study showed a significant reduction in mean body weight was observed from 75.54 kg at baseline to 73.13 kg at week 3 (mean difference: 2.41 kg; p < 0.0001). Additionally, an improvement in NYHA functional class and edema was observed over 3 weeks from baseline. Overall, 22.11% patients achieved no-edema stage. Only three mild AEs related to loose stools were reported, and no serious AEs or deaths occurred. Over 98% of physicians and patients rated the therapy favorably.Conclusion:The RESTORE-HF study demonstrated that the torsemide-spironolactone FDC may be associated with a mean body weight reduction of 2.41 kg and may be generally well-tolerated in Indian heart failure patients. Furthermore, the FDC may be linked to significant symptomatic improvement over 3 weeks in real-world clinical practice.

Guidelines recommend that the foundation four guideline-directed medical therapy (GDMT), which includes mineralocorticoid receptor antagonists (MRAs), should be initiated early in the treatment paradigm of heart failure due to mortality benefits and reduction in hospitalization for heart failure. However, the practical implementation of these guidelines in the real-world clinical scenario is lacking. Delay in initiating MRA is common, and patients often do not receive the optimum dose of MRA. The clinical considerations and guideline recommendations for early initiation and optimum dosing of MRA in HF can form the scientific basis for improving the correct usage of MRA in HF in real-world settings.

Background: Palatability is a crucial factor influencing adherence of medication in pediatric populations, especially for oral antibiotic suspensions. This study aimed to evaluate and compare the organoleptic properties of three co-amoxyclav 457 mg formulations: Product A (Advent), Product B (Comparator 1) and Product C (Comparator 2) in 55 healthy school-going children aged 6 to 9 years. Methods: Each product was administered at 15–20-minute intervals and responses were recorded using a structured questionnaire that included behavioural analysis, taste discrimination, ranking and compliance perception. Results: Product A showed the highest acceptability, with 94.5% of children displaying favourable facial expressions and 100% accepting the product. Based on taste, 91% rated product A as excellent or good, compared to 67% for product B and 82% for product C. Additionally, 85% of participants described product A’s taste as sweet, with a fruity orange aftertaste. Smell ratings were also highest for Product A, with 89% rating it excellent or good, versus 71% for product B and 73% for product C. Regarding aftertaste, 78% found product A sweet, while about 55% found products B and C sweet. Overall, 57% of children preferred product A and more than 90% assured they would complete the course if prescribed this formulation. Conclusions: These findings highlight the importance of organoleptic properties in pediatric antibiotic formulations. By considering organoleptic properties during prescribing, healthcare providers can significantly enhance adherence, leading to improved treatment outcomes and a reduced risk of antimicrobial resistance.

BackgroundChronic obstructive pulmonary disease (COPD) is a significant public health concern, and inhalation therapy is a critical component of its management. However, using an inhaler is challenging, especially for patients with COPD, who are often elderly and experience reduced dexterity, visual and cognitive impairment, and difficulty synchronizing inhalation with dose actuation. Synchrobreathe® is an easy-to-use, breath-actuated inhaler that releases medication during inhalation, addressing these challenges. Although its use in asthma is well documented, evidence in COPD is limited.MethodsThis prospective, multicenter, observational study carried out during August 2021 and August 2022 evaluated the clinical outcomes of the budesonide/formoterol combination (BUD/FORM) delivered through Synchrobreathe® in patients with COPD in India. The primary endpoint was disease control, that is, change from baseline in COPD Assessment Test (CAT) score at 12 weeks. Secondary endpoints included changes in CAT and modified Borg Dyspnea Scale (mBDS) scores and device usability. Adverse events were monitored over 12 weeks.ResultsIn the study population (N = 250), significant reductions from baseline were observed in mean CAT (−6.56 ± 0.33; p < 0.001) and mBDS (−1.60 ± 0.09; p < 0.0001) scores at 12 weeks. Almost all (98%) patients were satisfied with Synchrobreathe® and preferred it over their previous inhalers. No significant adverse events were reported.ConclusionBUD/FORM delivered through Synchrobreathe® significantly improved CAT and mBDS scores, with no reported serious adverse events in patients with COPD. Its simple usage makes it an effective option for this patient population.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40801-025-00522-w.

Aim: To understand the clinical perceptions and role of a combination of bilastine and montelukast in the management of allergic rhinitis (AR). Methods: A cross-sectional, observational survey was conducted through a digital questionnaire among 445 healthcare practitioners (HCPs) in India from May to October 2024. The questionnaire consisted of 15 questions that asked physicians to share their insights on the prevalence, diagnosis, and management of AR, as well as their perception of efficacy, safety, and recommended patient profile for bilastine-montelukast combination. Data were collected and analyzed using descriptive statistics, expressed as frequencies and percentages. Results: Among 445 HCPs (ear, nose, throat, chest, and consulting physicians), the majority (40%) reported an AR prevalence of 21-30% in their practice. Sneezing was the most reported AR symptom (67.19%). For managing mild intermittent/persistent AR, 45.39% preferred antihistamines, while 53.71% favored a combination of antihistamines and leukotriene receptor antagonists for moderate intermittent/persistent AR. Approximately 87% of HCPs preferred the bilastine-montelukast combination for AR management, citing its nonsedative properties, superior nasal congestion control, cardiac safety, and compatibility with renal or hepatic impairments. Around 61% supported its use for various AR patient profiles, including those with asthma, mild-to-moderate AR with any cardiac or renal dysfunction, moderate-to-severe AR not controlled with intranasal corticosteroids, mild-to-moderate intermittent AR, and persistent AR. The ideal duration of this combination was reported to be 3–4 weeks by 44% of HCPs. Most HCPs expressed satisfaction with this combination’s efficacy (88.8%) and safety (92.3%). The most reported adverse events were gastrointestinal disturbances and fatigue (30%), followed by neuropsychiatric events (7%). Conclusion: A combination of bilastine-montelukast was preferred by most HCPs in the management of AR across diverse patient profiles and was found to be effective and well-tolerated. Clinical significance: The study emphasizes a strong preference for the combination of bilastine and montelukast in managing AR. It highlights their nonsedative properties, superior control of nasal congestion, cardiac safety, and compatibility for patients with renal or hepatic impairments. Additionally, there is a high level of physician satisfaction regarding the efficacy and safety of this treatment, reinforcing its importance as an option for managing AR.

<bold>Background:</bold> Fluticasone-Furoate/Vilanterol/Umeclidnium, a once-daily ICS/LABA/LAMA fixed-dose combination, is currently available as a multi-dose-DPI (Trelegy Ellipta®). Recently, the combination has been developed by Cipla Ltd. in a multi-dose-DPI (Voltido Trio Ciphaler®). <bold>Aim:</bold> To evaluate the in-vitro performance of Voltido Trio Ciphaler® (Cipla-Ltd) with Trelegy Ellipta® (GSK Pharmaceticals Ltd.) <bold>Methods:</bold> Performance of the devices was compared using random samples for assessment of fine particle dose (FPD), mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). The values were measured using Next Generation Impactor (Copley-Scientific) at 76 L/min(flow rate at 4 kPA pressure drop of respective device) for Ciphaler® and 60 L/min for Ellipta®. The mean of three readings taken for each parameter was calculated. <bold>Results:</bold> The delivered dose, FPD, MMAD, and GSD for fluticasone furoate, vilanterol and umeclidinium delivered with Voltido Trio Ciphaler® and Trelegy Ellipta® are shown below. <fig><object-id>erj;66/suppl_69/PA352/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig> <bold>Conclusion:</bold> The delivered dose, FPD, MMAD and GSD of fluticasone furoate, vilanterol and umeclidinium delivered by the two devices were similar at specified flow rates, suggesting similar drug delivery into the lungs under ideal conditions using correct inhaler technique.

Acalabrutinib, an anti-cancer drug, was approved by the USFDA in 2017.

This book is intended for readers with some prior knowledge of analytics and its potential to transform data-driven decision-making. The field of analytics encompasses a wide range of techniques and applications that enable organizations to extract insights from data and make informed decisions. This chapter begins with an introduction to the fundamental concepts of analytics, including what analytics is and why it is essential in today’s data-driven world. It then explores the role of analytics in decision-making, highlighting the game changers and innovators who have harnessed the power of analytics to drive significant improvements and innovations. Further sections delve into predictive analytics, discussing methods for predicting binary outcomes, and examining various predictive models such as decision trees. The chapter also provides insights from experts across different industries, including finance, manufacturing, healthcare, telecommunications, supply chain, digital analytics, and information technology. By the end of this chapter, readers will have a comprehensive understanding of the power and application of analytics, equipped with the foundational knowledge to delve deeper into specialized areas covered in subsequent chapters.

Abstract Background: Multiple dipeptidyl peptidase-4 inhibitors (DPP4is) are available in India. The class of DPP4i presents as a heterogeneous group with differences among the molecules. Thus, there is a need to evaluate the choice of DPP4i and its combinations among Indian clinicians. This survey aims to assess the choice of DPP4i and its combinations among Indian clinicians in the management of patients with type 2 diabetes mellitus (T2DM). Methodology: This was a cross-sectional questionnaire-based survey of clinicians in India conducted between December 2022 and March 2023. Data were analyzed and expressed using descriptive statistics. Results: Among the 1033 clinicians in the survey, the majority (71.73%) were in the age group of 31–50 years, 66.6% had a postgraduate degree in medicine, and 74.93% had a private consulting practice. Almost half of the participants opined that the response of DPP4i is similar in T2DM patients irrespective of age (47.24%) and body mass index (46.95%). Among the various DPP4i available in India, sitagliptin was opined to provide greater glycated hemoglobin reduction (72.80%), faster reduction in blood glucose (71.25%), and greater improvement in glycemic variability (73.28%) by the majority of the clinicians. Most clinicians opined sitagliptin as the preferred DPP4i in T2DM patients irrespective of age and in various comorbidities. Around 65.25% of clinicians opined that sitagliptin was associated with fewer adverse events in patients with T2DM. In terms of combination therapy, the majority of the clinicians opined sitagliptin/dapagliflozin was most preferred in T2DM patients (81.51%: In T2DM with atherosclerotic cardiovascular disease, 79.28%: In T2DM with heart failure, 53.63%: In T2DM with chronic kidney disease) among the various DPP4i/sodium–glucose cotransporter 2 inhibitors (SGLT2i) available in India. Conclusions: The survey conducted among over 1000 clinicians across India is suggestive of sitagliptin and sitagliptin/dapagliflozin being the preferred DPP4i and DPP4i/SGLT2i, respectively, among Indian clinicians for the management of a wide range of patients with T2DM.