Niti Mittal

BACKGROUND: While both clopidogrel and prasugrel inhibit platelet aggregation, their comparative pleiotropic effects on inflammatory and oxidative stress markers remain unclear. OBJECTIVE: To compare the anti-inflammatory and antioxidant potential of clopidogrel and prasugrel given as dual antiplatelet therapy (DAPT) along with aspirin in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). SUBJECTS AND METHODS: In this prospective cohort study, patients aged 18–65 years undergoing PCI for ACS and eligible candidates for DAPT were included. The two study groups were: aspirin + clopidogrel (AC group; n = 52) and aspirin + prasugrel (AP group; n = 52). A change in inflammatory (high-sensitivity C-reactive protein [hs-CRP]) and oxidative stress (total antioxidant capacity [TAOC]) markers at 4 weeks was compared to baseline in two groups. RESULTS: A total of 90 patients (46 in AC group and 44 in AP group) completed the study and were included in the analysis. AP group demonstrated a significantly greater reduction in hs-CRP levels at 4 weeks compared to AC group (−7.17 ± 5.95 in AP vs. −4.10 ± 3.81 mg/L in AC groups, P = 0.002). A relatively greater increase in TAOC was also seen in AP group though statistically insignificant (184.25 ± 274.03 in AP vs. 126.67 ± 198.49 in AC groups, P = 0.117). Bleeding and adverse events were comparable in two groups. CONCLUSIONS: Prasugrel-based DAPT showed significantly greater reduction in inflammation compared to clopidogrel-based DAPT, with comparable antioxidant benefit and hematological safety indicating a greater pleiotropic benefit of prasugrel than clopidogrel.

Emerging concepts on the role of insulin resistance (IR) in the pathogenesis of polycystic ovary syndrome (PCOS) have driven a shift in the therapeutic app

BACKGROUND Sacubitril/valsartan is a first-in-class angiotensin receptor neprilysin inhibitor (ARNI) which combines an angiotensin receptor blocker (valsartan) with sacubitril, an inhibitor of the enzyme neprilysin. By virtue of combined effect of blocking the action of angiotensin-II and inhibiting the breakdown of natriuretic peptides, ARNIs have beneficial role in heart failure (HF). AIM To evaluate the effect of sacubitril/valsartan on N-terminal pro-B-type natriuretic peptide (NT-pro BNP), inflammatory marker [high-sensitivity C-reactive protein (hs-CRP)], and quality of life when given as add-on to standard therapy in patients with HF. METHODS Sacubitril/valsartan as add-on therapy for improvement in HF study was a randomised controlled trial conducted from July 2023 to November 2024 in a public tertiary care hospital in India. Eligible patients were randomised in 1:1 ratio to either of the 2 study arms: (1) Group A (sacubitril/valsartan + standard treatment); and (2) Group B (standard treatment) for 12 weeks. Primary end point was change in NT-pro BNP levels at 12 weeks from baseline. Secondary endpoints included (1) Change in hs-CRP levels; (2) Change in World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF) score; and (3) Incidence of treatment-related adverse events or worsening HF. Statistical analysis was done using Statistical Package for the Social Sciences trial version 29.0 and P < 0.05 was considered significant. RESULTS Out of 124 patients screened, 80 were enrolled of which 25 patients in each group were available for per-protocol analysis. At baseline, both the groups were comparable. Sacubitril/valsartan group exhibited a statistically significant greater reduction in NT-pro BNP (-35.91 ± 28.01 vs 24.68 ± 31.86; P < 0.0001) and hs-CRP (-2.87 ± 3.22 vs 0.76 ± 1.60; P < 0.0001) levels at 12 weeks compared to standard treatment group. There was also a greater improvement in quality of life with sacubitril/valsartan group (overall change in WHOQOL-BREF: 13.16 ± 8.73 in sacubitril/valsartan vs -4.12 ± 6.25 in standard treatment arm). No major adverse events were reported in two groups. CONCLUSION Sacubitril/valsartan demonstrated significant improvements in HF biomarkers, inflammation, and quality of life without compromising safety supporting its role as an effective addition to standard HF therapy. Further research is needed to evaluate its long-term benefits on mortality and cardiac remodeling.

Background/Objectives: While both clopidogrel and prasugrel inhibit platelet aggregation, their comparative pleiotropic effects on inflammatory and oxidative stress markers remain unclear. We aimed to compare the anti-inflammatory and antioxidant potential of clopidogrel and prasugrel given as dual antiplatelet therapy (DAPT) along with aspirin in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Methods: This was an investigator initiated, randomized, open-label, parallel-group con-trolled clinical trial. Patients aged 18–65 years undergoing PCI for ACS and eligible candidates for DAPT were randomised in 1:1 ratio to aspirin + clopidogrel (AC group) or aspirin + prasugrel (AP group). Primary objective was comparison of change in inflammatory (high sensitivity C reactive protein; hs-CRP) and oxida-tive stress (total antioxidant capacity; TAOC) markers at 4 weeks from baseline between the two groups. Secondary outcomes were incidence and severity of bleeding episodes and treatment related adverse events or therapy discontinuation. Data was subjected to per-protocol analysis. Statistical significance was defined as p< 0.05. Results: A total of 90 patients (46 in AC and 44 in AP groups) were available for PP analysis. AP group demonstrated a significantly greater reduction in hs-CRP levels at 4 weeks compared to AC group (p = 0.002). A relatively greater increase in TAOC was also seen in AP group though statistically insignificant (p = 0.117). The incidence of bleeding and adverse events was comparable in both the groups. Conclusions: Prasu-grel based DAPT showed significantly greater reduction in inflammation compared to clopidogrel based DAPT, with comparable antioxidant benefit and hematological safety. These findings support a greater addi-tional pleiotropic benefit of prasugrel than clopidogrel in ACS patients undergoing PCI.

Background: The evaluation of internationally comparable indicators of medicine use is important to devise strategies to promote the rational use of medicines (RUM). Methods: A cross-sectional study was conducted in a tertiary care hospital from January to June 2024. Prescriptions were collected from the outpatient pharmacy using systematic random sampling and analyzed for WHO/INRUD core prescribing indicators, index of rational drug prescribing (IRDP) and completeness (general, treatment and prescribers’ details). Results: Out of 844 prescriptions collected, 607 were analyzed. A total of 1837 drugs were prescribed, with a mean (SD) of 3.03 (1.51) drugs per prescription; 1378 (75%) drugs were prescribed as generic names; 125 prescriptions (20.59%) had an antibiotic prescribed; and injectables were given in 7 (1.15%) prescriptions. Of the total 1837 drugs, 1018 (55.4%) were mentioned in the National List of Essential Medicines (NLEM) 2022, while 934 (50.8%) were included in the Haryana state essential medicines list (2013–2014). The IRDP was calculated as 3.86. The mean (SD) completeness score of the prescriptions was 10.33 (0.8) (range 5 to 11). Conclusions: There was a high incidence of polypharmacy, brand name and non-essential drug prescribing, while antibiotic and injection use were in accordance with WHO standards.

Background: Evaluation of internationally comparable indicators of medicines use is important to devise strategies to promote rational use of medicines (RUM). Methods: A cross sectional study was conducted in a tertiary care hospital from January to June 2024. Prescriptions were collected from the outpatient pharmacy using systematic random sampling and analysed for WHO/INRUD core prescribing indicators, index of rational drug prescribing (IRDP) and completeness (general, treatment and prescribers’ details). Results: Out of 844 prescriptions collected, 607 were analysed. A total of 1837 drugs were prescribed with a mean (SD) of 3.03 (1.51) drugs per prescription. 1378 (75%) drugs were prescribed as generic names. 125 prescriptions (20.59%) had an antibiotic prescribed. Injectables were given in 7 (1.15%) prescriptions. Of the total 1837 drugs, 1018 (55.4%) were mentioned in National List of Essential Medicines (NLEM) 2022 while 934 (50.8%) were included in Haryana state essential medicines list (2013-2014). IRDP) was calculated as 3.86. The mean (SD) completeness score of the prescriptions was 10.33 (0.8) (range 5 to 11). Conclusion: There was a high incidence of polypharmacy, brand name and non-essential drug prescribing while antibiotic and injection use were in accordance with WHO standards.

(1) Background: Antibiotic surveillance data are crucial to map out strategies to promote their optimal use at hospital and community levels. We conducted a comprehensive analysis of longitudinal trends in antibiotic consumption over 7 years at a core “National Antimicrobial Consumption Network” site in North India. (2) Methods: In-patient antibiotic consumption data (2017–2023) were obtained from the hospital’s central drug store and organised as follows: defined daily dose per 100 bed-days; antibiotic consumption as per the WHO access, watch and reserve classification; trends in overall and different antibiotic classes’ consumption; paediatric formulations of antibiotics; and hospital’s annual expenditure on antibiotics. (3) Results: During the 7-year study period, no significant trend could be observed in the overall antibiotic consumption (average annual percent change, AAPC: 9.22; 95% CI: −16.46, 34.9) and cost (AAPC: 13.55; −13.2, 40.3). There was a higher proportion of the consumption of antibiotics in the “reserve” group from 2021 onwards compared to previous years, but the overall trend over 7 years was not significant (AAPC: 319.75; −137.6, 777.1). Antibiotic combinations, classified under the WHO “not recommended” category, comprised a significant proportion of antibiotics consumed. A remarkably increased consumption of azithromycin and doxycycline was recorded during 2020 and 2021, coinciding with the COVID-19 pandemic. (4) Conclusions: Some recommendations to optimise antibiotic use are promoting the use of narrow spectrum “access” group agents; linking antimicrobial resistance and consumption data to formulate effective therapeutic and prophylactic antibiotic use guidelines; and the adoption of restrictive antibiotic policy.

Background: Health literacy plays an important role in determining healthcare and medication outcomes. There is a lack of an appropriate, validated scale to assess health literacy status among the Hindi-speaking population. We translated and validated the English version of the All Aspects of Health Literacy Scale (AAHLS) into Hindi. Methods: We translated the scale as per WHO guidelines on translation and adaptation of instruments. We did preliminary pilot testing in 30 bilingual subjects and evaluated cross-language concordance of the scale. The final translated scale so obtained after cross-cultural adaptation was tested in a validation study on 130 subjects from the outpatient department of internal medicine in which test–retest repeatability, construct validity, discriminant validity and internal consistency were assessed. Analysis was done using paired t-test, one-way ANOVA, Cronbach α and intra-class correlation coefficient. Results: An excellent correlation between Hindi and English versions of the scale for various factors ensured cross-language concordance. Hundred percentage response rate was observed in the validation study. The scale showed good internal consistency (Cronbach α=0.99). The difference in total mean AAHLS score was not statistically significant across different age groups, genders and educational levels. Factor analysis showed a positive correlation among four factors/components of health literacy. For test–retest reliability, the intra-class correlation coefficient for all the items in different factors was significant (range 0.88–1.00; pr=0.274, p=0.002) and communicative (r=0.283, p=0.001) sub-scores revealed a good construct validity. Conclusion: The Hindi translated version of the AAHLS scale is a valid and reliable tool to assess health literacy in the Hindi-speaking population.

(1) Background: There is a need to assess the availability of essential antimicrobials, as the availability of an antimicrobial is a critical element of its rational use. We aimed to assess the availability of antimicrobials listed in the National List of Essential Medicines 2015, India (primary list), and a selected (secondary) list comprised of agents indicated for commonly encountered infectious illnesses in various healthcare settings and to identify the reasons for their non-availability. (2) Methods: A cross-sectional survey of 25 public, private, and other sector pharmacies was carried out in Rohtak, a district of the North Indian state of Haryana, from April to June 2022. (3) Results: Most of the antimicrobials surveyed were optimally available in various sector pharmacies with the exception of benzathine benzylpenicillin, benzylpenicillin, cloxacillin, cefazolin, cefuroxime, cefadroxil, amphotericin B, and antimalarials. The most frequent reasons for limited availability were low demand, no prescriptions, and the non-listing of drugs in the state’s essential medicine list. (4) Conclusions: Enough evidence needs to be generated with respect to the status of availability of essential antimicrobials from different regions of India as well as other lower-middle-income countries to devise measures for ascertaining better availability of these agents, especially antibiotics at regional, national, and global scales.