Efficacy of Super-Bioavailable Itraconazole and Conventional Itraconazole at Different Dosing Regimens in Glabrous Tinea Infection - A Randomized Clinical Trial.

Introduction: Itraconazole follows non-linear pharmacokinetics and hence is recommended once daily, but in real-world practice, is commonly prescribed as twice daily. Hence, this study aimed to evaluate the efficacy and safety of super-bioavailable-itraconazole-130 mg (SB-130) and conventional-itraconazole-200 mg (CITZ-200) once daily compared with conventional-itraconazole-100 mg (CITZ-100) twice daily in glabrous tinea. Methods: A total of 261 eligible patients were enrolled in this prospective, randomized, clinical study from December-2021 to August-2022 at seven centers in India. Efficacy and safety assessments were done at week-3 and 6, with follow-up at week-10 for relapse. The primary objective was to assess the proportion of patients who achieved complete cure at week-6 following treatment in all itraconazole groups. The secondary outcomes were safety and clinical and mycological cure rates. Results: Of 261 patients, 240 were included in the analysis. At week-6, 140 patients were completely cured; thus, overall cure rate was 58.33%. Fifty-five patients (69%) in SB-130 while 47/77 (61%) and 38/83 (46%) patients were completely cured in CITZ-200 and CITZ-100 groups respectively (p<0.05; SB-130: CITZ-100, p=0.32; SB-130: CITZ-200, p=0.058; CITZ-200: CITZ-100). There was no statistical difference in the mycological cure rate and area clearance rate between any of the groups (p=0.14); however, a statistically significant difference was noted for OD dosing over BD dosing in achieving clinical cure rates (p<0.05). A total of 13/140 patients (9%) relapsed following complete cure, with no statistically significant difference between any of the groups (p=0.50). All treatments were safe and well-tolerated, with no discontinuation. Conclusion: In this clinical study, moderate efficacy with all doses of ITZ was reported but was better with OD dosing. Although there was no statistical difference between SB-130 and CITZ-200, SB-130 may be preferred over CITZ-200 owing to the advantage of SB over the conventional ITZ.

The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-world Observational Study.

Objectives: The Indian Registry on Current Patient Profiles and Treatment Trends in Hypertension (Record) evaluated the current trends and outcomes related to hypertension (HTN) management at 3, 6, 12, and 24 months in India. This study highlights and evaluates the outcomes and trends noted at 24 months. Materials and methods: The detailed study methodology is provided in the earlier publication (interim analysis at 12 months). Aspects such as changes in the quality of life (QOL), percentage of patients reaching target blood pressure (BP), treatment pattern among patients with comorbid conditions, and difference in treatment patterns between public and private healthcare settings, at 24 months, were evaluated in the current study. Results: The study population included 2,000 patients (55.7% males) with a mean age of 54.45 years. Telmisartan (43.7%) and amlodipine + telmisartan (16.4%) were the most prescribed monotherapy and combination therapy among patients with newly diagnosed HTN. A significant decrease in both systolic BP (SBP) and diastolic BP (DBP) was noted in the overall patient population at 24 months (p < 0.001). The mean change in SBP and DBP was slightly higher at 24 months compared to 12 months. This was more evident among patients on combination therapy. A significant improvement in QOL was noted at 24 months. Conclusion: Treatment strategies in HTN management are changing and are associated with effective HTN control and improvements in QOL. However, there is a further need for improved awareness regarding the optimal usage of combination therapy for better management of uncontrolled HTN. How to cite this article: Rajadhyaksha GC, Reddy H, Singh AK, et al. The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-World Observational Study. J Assoc Physicians India 2023;71(11):43-49.