Shilpa (India)

IntroductionOral dutasteride has demonstrated superiority over finasteride in treating androgenetic alopecia (AGA). We have developed a novel topical dutasteride formulation, which has shown promising efficacy, safety, and tolerability in preclinical studies. The present study objective is to compare the efficacy and safety of dutasteride topical solutions (0.01%, 0.02%, and 0.05% w/v) with placebo and oral finasteride (1 mg/day) in AGA males.MethodsIn this phase II study, 135 AGA males (20-60 years of age) were randomized to receive dutasteride topical solution (0.01%, 0.02%, 0.05% w/v), finasteride (1 mg), or placebo daily for 24 weeks. The primary endpoint was target area hair count (TAHC) within 1 cm2 at the vertex at week 24. Secondary endpoints included TAHC at week 12 and target area hair width (TAHW), male hair growth questionnaire (MHGQ) score, and investigator global photography assessment (GPA) at week 12 and week 24.ResultsDutasteride topical solution demonstrated a dose-dependent increase in TAHC and TAHW vs placebo at week 24 (p≤0.01). The 0.05% dutasteride solution significantly improved TAHC vs finasteride at week 24 (p=0.0083). More patients in the 0.05% dutasteride group achieved a GPA score of ≥+2 and an MHGQ score ≤ 2 at week 24 than those on finasteride. No irritation was reported in active treatment groups. Dutasteride caused modest changes in serum testosterone/dihydrotestosterone, while finasteride caused moderate changes.ConclusionDutasteride topical solution (0.05% w/v) demonstrated to be more efficacious than finasteride (1 mg/day) in treating male AGA.

Background In India, influenza presents a significant burden of disease to the population at large. Influenza vaccination is a cost-effective means of preventing the disease, with quadrivalent vaccines providing broader protection against influenza by covering more strains, but generally at a higher list price, than older trivalent vaccines. Research design and methods Broadly, the economic burden of influenza can be categorized into treatment and productivity costs. We undertake a cost-benefit analysis to determine the cost-effectiveness of a quadrivalent influenza vaccine versus no vaccination amongst healthy adults and pregnant women from the perspective of both employers and the Employees’ State Insurance Company (ESIC) in India. Results Administration of the quadrivalent vaccine results in better outcomes in terms of productive days worked and disease infection rates amongst the target populations whilst incurring lower overall health resource utilization costs than when no vaccine is employed. In healthy adults, we estimate a saving of INR 13,730 per case averted from the corporate perspective and a saving of INR 11,211 from the ESIC perspective. Deterministic and probabilistic sensitivity analyses indicate that there is a high probability that these results hold true given the uncertainty in our model’s input parameters. Conclusions We find that for healthy adults and pregnant women, receiving a quadrivalent influenza vaccine is dominant over no vaccination in terms of cost-effectiveness that is, it results in better health outcomes at a lower overall cost.

Pneumococcal disease (PD) remains a significant public health concern, particularly in adults aged >50 years and individuals with comorbidities. India bears approximately 23% of the global burden of community-acquired pneumonia (CAP). The highest rates of morbidity and mortality are linked to Streptococcus pneumoniae-related invasive pneumococcal disease (IPD) in adults aged >50 years. Despite the availability of effective vaccines, including the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23), adult vaccination coverage in India remains suboptimal. A key barrier to adult vaccination is the lack of awareness, with over 80% of adults being unaware of the vaccines available for them. Many people still believe that vaccines are only for children, highlighting the need for better awareness among patients and healthcare providers. Additionally, the absence of dedicated adult vaccination centres limits access, making it crucial to establish such centres and involve trained personnel such as doctors, nurses, and pharmacists in raising awareness. Often, healthcare professionals (HCPs) do not consider underlying comorbidities as risk factors for the development of pneumococcal disease. Additionally, the evidence on vaccine efficacy is scattered. Given these challenges, there is a critical need for a comprehensive review synthesizing the available evidence on pneumococcal vaccination in high-risk and at-risk populations. This review aims to consolidate the most recent findings on the effectiveness of pneumococcal vaccination practices, highlighting the importance of adhering to vaccination guidelines to reduce the public health burden of PD.

Type 2 diabetes (T2D) is a major public health problem globally, with significant socioeconomic ramifications for healthcare systems. Diabetes unquestionably contributes to both cardiovascular disease (CVD) and chronic renal disease. Hospitalization, low quality of life, and high mortality rate are inevitable in patients with this dual burden. As a result, the emphasis in diabetes care should also be on cardiorenal health. Glycemic control, as well as optimal management of cardiorenal risk factors and comorbidities, is required to eliminate cardiovascular (CV) morbidity and mortality related to T2D. Sitagliptin is a highly efficient and selective dipeptidyl peptidase-4 inhibitor (DPP-4i) that improves glycemic control while having a low risk of hypoglycemia. It has neutral effects on body weight, low proclivity for pharmacokinetic interactions, and a favorable safety profile. Numerous clinical trials have proven that sitagliptin is CV- and renal-safe in T2D patients, even in those with obesity, old age, renal impairment (RI), and preexisting CVD. It also corrects hyperglycemia-induced osmotic diuresis and excessive filtration. In people with T2D who are at high CV risk or moderate-to-severe renal insufficiency, sitagliptin is documented as a well-tolerated treatment that does not augment the risk of CV and renal complications. Sitagliptin may effectively manage CV and renal complications in diabetes patients, considering its CV and renal safety.

The global population is experiencing a metabolic explosion, with the prevalence of hyperuricemia (HU) as a metabolic disorder and a causal factor for noncommunicable diseases (NCD) increasing rapidly worldwide over the last 2 decades. This rise is attributed to diets high in purine, alcohol, red meat, high-fructose foods, and lifestyle changes. The connection between HU and various NCDs is now stronger than ever. As HU progresses, systemic inflammation arises, leading to endothelial dysfunction and end-organ damage-molecular changes that were previously unrecognized. HU is increasingly seen as a metabolic disorder, particularly a vascular disorder rather than just a crystallization disease. Asymptomatic HU is no longer considered benign, and it should not be equated with gout. It is crucial to diagnose HU early, at a high normal level, and manage it to prevent the development and complications of related extra-articular diseases. For broader recognition and significance, this high normal level of serum uric acid (UA) should be termed prehyperuricemia (PHU). Like prediabetes and prehypertension, PHU should be identified early, regardless of age and sex, with preventive actions implemented to maintain UA at a safer level.

Nimesulide, a potent nonsteroidal anti-inflammatory drug (NSAID), has garnered attention for its distinct mechanism of action, characterized by its selective inhibition of cyclooxygenase-2 (COX-2) and multifaceted pharmacological properties. Extensive clinical evidence supports its safety and efficacy in addressing acute pain syndromes. In this comprehensive review, we undertake a thorough examination of various dimensions surrounding nimesulide, encompassing its historical evolution, intricate mode of action, pharmacokinetic attributes, clinical efficacy in managing acute pain, and notably its safety profile. The historical backdrop of nimesulide's development and evolution is explored, shedding light on the contextual framework of its emergence as a therapeutic agent. A detailed elucidation of its molecular mechanisms elucidates its preferential COX-2 inhibition and its impact on inflammatory pathways, providing insights into its efficacy in pain modulation. Furthermore, a comprehensive analysis of nimesulide's pharmacokinetic properties is provided, highlighting its absorption, distribution, metabolism, and excretion dynamics, which contribute to its clinical efficacy and safety profile. This review meticulously evaluates the clinical evidence supporting nimesulide's effectiveness in alleviating acute pain across various etiologies. Moreover, particular emphasis is placed on scrutinizing its safety profile, drawing comparisons with other NSAIDs. Through a critical synthesis of available data, nimesulide emerges as possessing a favorable safety profile, distinguishing itself from its counterparts in terms of gastrointestinal and cardiovascular tolerability. In conclusion, this review underscores the promising safety and efficacy profile of nimesulide in the management of acute pain, positioning it as a valuable therapeutic option. The positive benefit-to-risk evaluation further reinforces its utility in clinical practice, offering clinicians a well-founded choice for addressing acute pain syndromes effectively.

Approximately, 40% of gastroesophageal reflux disease (GERD) patients experience insufficient symptom relief from proton-pump inhibitors (PPI), resulting in PPI-refractory GERD (rGERD). To review the existing literature and develop an Indian expert group consensus statement on the place of vonoprazan in the management of rGERD. A panel of 35 leading Indian gastroenterologists extensively reviewed the literature to develop consensus statements for the management of rGERD in Indian patients, with a focus on the newly available potassium-competitive acid blocker (P-CAB), vonoprazan. This process involved two structured meetings in which experts deliberated on literature reviews and draft statements, which were further rigorously discussed and modified. Consensus was achieved through a voting process employing a five-point Likert scale, with results meticulously documented. The final statements unanimously approved by all participants and subsequently developed into a comprehensive manuscript. Based on the evidence, 14 statements were developed and confirmed by expert panelists for the assessment and management of rGERD. Among these 14 statements, 5 obtained Level A evidence, 4 received Level B, 4 were classified as Level C, and 1 as Level D. The consensus highlights the importance of symptom assessment, lifestyle modifications, and medication adherence, followed by a diagnostic procedure with upper gastrointestinal (GI) endoscopy. If needed, manometry or 24-hour pH impedance may be considered. Vonoprazan, a novel and reversible potassium-competitive acid blocker (P-CAB), has emerged as a potential alternative to proton pump inhibitors (PPIs), offering rapid, potent, and sustained acid suppression. Based on current evidence, a daily dose of 20 mg vonoprazan for 4-8 weeks is recommended as an initial treatment strategy for rGERD. The consensus endorses the use of vonoprazan to improve patient outcomes and quality of life, highlighting its important place in therapy for controlling rGERD in Indian patients.

Torsemide, a loop diuretic, is increasingly recognized for its role in managing essential hypertension. Its mechanism of action involves inhibiting the reabsorption of sodium and chloride ions in the ascending loop of Henle in the kidneys. By doing so, torsemide promotes diuresis, which refers to increased urine production, and subsequently lowers blood pressure. Studies have shown that torsemide is comparably effective to other antihypertensive agents in lowering blood pressure, with the added benefit of potentially improving renal function. However, while torsemide shows promise in hypertensive management, further research is necessary to fully understand its long-term effects and to establish optimal dosing strategies. Future research should focus on clarifying its role in long-term blood pressure control and refining its use in clinical practice to maximize efficacy and minimize adverse effects.

Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) are linked to the global diabetes epidemic, leading to increased disease progression and adverse health outcomes. The renaming of NAFLD to metabolic dysfunction-associated steatotic liver disease (MASLD) at the 2023 European Association for the Study of the Liver Congress highlights the complex relationship between metabolic disorders and liver health. Taking this into consideration, we aimed this study to identify prevalence and risk factors associated with the stages of NAFLD in individuals with T2DM in the Indian population. This observational, cross-sectional study was conducted on 1,521 T2DM patients at Dr Panikar's Speciality Care Centre, Mumbai, between September 1, 2022 and October 31, 2022. Demographic parameters such as age, gender, height, weight, and anthropometric parameters such as body mass index (BMI) and waist circumference were measured. Liver fibrosis and steatosis stages were identified by vibration-controlled transient elastography (VCTE) using FibroScan®. The prevalence of liver steatosis was 75.1% among the 1,521 diabetes cases [S0 (24.9%), S1 (15.1%), S2 (24%), and S3 (36%)], whereas the prevalence of liver fibrosis was 28.0% [F0 (72%), F1 (19%), F2 (5%), F3 (1.5%), and F4 (3.4%)]. The S1 (p = 0.012), S3 (p = 0.001), F1 (p = 0.001), and F2 (p = 0.001) grades showed significant gender-related changes, demonstrating a positive connection. Furthermore, waist circumference was associated with disease severity in both liver steatosis and fibrosis stages (p = 0.001), but BMI was solely associated with the degree of steatosis (p = 0.001). The mean age differences between these categories, however, did not reach statistical significance (p-values of 0.149 and 0.078, respectively, for the steatosis and fibrosis grades). The study reveals a high prevalence of NAFLD (steatosis and fibrosis) in T2DM patients, increasing the risk of advanced fibrosis. In T2DM patients with risk factors including waist circumference and BMI, appropriate screening and intervention are required.

A retrospective observational study was undertaken to assess the changing trends in the incidence of metabolic syndrome (MetS) in Asian-Indian patients with newly diagnosed type 2 diabetes (T2D) using Adult Treatment Panel III of the National Cholesterol Education Program (NCEP-ATP III), World Health Organization (WHO), and the International Diabetes Federation (IDF) criteria. The overall and gender-wise pattern of MetS and its components were also evaluated. Newly diagnosed T2D patients (n = 10,950)visiting Dr Panikar's Diabetes Care Centre from 2004 to 2019 with retrievable electronic medical records were selected. The incidence of MetS in these patients was studied using NCEP-ATP III, WHO, and IDF criteria in three separate timelines, namely, group I (2004-2008), group II (2009-2013), and group III (2014-2019). Overall and gender-wise, the incidence of various components of the MetS was also studied and compared across the three groups. All data were analyzed by using the Statistical Software Statistical Package for the Social Sciences (SPSS) version 10.0. Continuous variables were summarized by the number of observations (mean, standard deviation or median with minimum and maximum) and categorical values (calculating frequencies with percentages). Chi-square was used to estimate the incidence of MetS using different criteria and gender-wise patterns of the MetS components for the three periods. Other variables, such as mean body mass index (BMI), were assessed by applying variance analysis (ANOVA test). All values were reported based on a two-sided ANOVA test, and all the statistical tests were interpreted at a 5% level of significance. In the current study, the overall incidence of MetS observed among the study population was 80.9, 65.4, and 69.8% using NCEP-ATP III, WHO, and IDF criteria, respectively. The incidence of MetS across the three timelines (i.e., from 2004 to 2019) with all the diagnostic criteria showed a steady increase. An analysis of the individual components of MetS revealed a high incidence of central obesity across all subgroups, followed by hypertension and dyslipidemia. Central obesity was prevalent in nearly 85.9% of patients in 2014-2019 vs 78.6% in the 2004-2008 subgroup. Similarly, the incidence of hypertension and overall dyslipidemia [i.e., high triglycerides (TGs) and low high-density lipoprotein-cholesterol (HDL-C)] was 77.8% and 68.2% in the former vs 67.9% and 59.6% in the latter, respectively. The incidence of all three MetS components, along with fasting sugar, showed a statistically significant and progressive increase over the years, with prevalence in group III (2014-2019) being the highest. Women were found to be more centrally obese and more dyslipidemic compared to men, whereas men were found to be more hypertensive. The study shows a high incidence of MetS in Asian-Indian patients with newly diagnosed T2D. The incidence of MetS was significantly higher with the NCEP-ATP III diagnostic criteria than with WHO and IDF criteria. A steady rise in the incidence of MetS was observed over the study period of 2004-2019. Among the components of MetS, the incidence of central obesity, elevated TG levels, and low HDL-C were found to be higher in the female population than in males, whereas the incidence of hypertension was higher in males. Stringent lifestyle measures, along with appropriate pharmacological management, might help mitigate the risks associated with MetS.