Background: Objectives of the study were to assess the clinical characteristics of patients with superficial dermatophytic infections, and to evaluate the safety and effectiveness of super bioavailable (SB) itraconazole 50 mg. Methods: In this cross-sectional observational study, data of patients with superficial dermatophytic infections treated as per physician’s discretion was collected retrospectively from 71 centers across India between April 2021 and March 2022. Patient’s demographics, prescribing patterns of SB-itraconazole, and clinician-rated effectiveness and safety were evaluated. Results: Of 432 analyzed patients, 72.22% (n=312) had new infections, 27.77% (n=120) had recalcitrant/recurrent infections. Majority of the patients were males (66%) and aged 21-40 years (72.45%). Tinea corporis (27.08%) was the most common fungal infection followed by Tinea cruris (20.60%). SB-itraconazole was most commonly prescribed with water (63.88%; n=276); majority (55.8%) of the patients received SB-itraconazole post-meals. Majority of the patients achieved clinical (naïve: 71.47%; recalcitrant: 79.17%) cures within 4 weeks. The efficacy was excellent/good in 71.95% of patients who received SB-itraconazole as the first choice over conventional itraconazole for overall benefits as per the clinician’s global assessment; and in 87.22% of patients who received concomitant acid-lowering drugs. Most (83.33%) patients reported excellent/good compliance with SB-itraconazole. The clinicians’ rated this newer formulation of itraconazole (SB-itraconazole) as excellent/good in efficacy (83.33%) and safety (79.17%) for most patients. Conclusions: SB-itraconazole was effective and safe in patients with superficial dermatophytic infections. The effectiveness of SB-itraconazole was similar with high response rates for naïve and recalcitrant cases. Further, the efficacy was excellent/good in most patients receiving SB-itraconazole as the first choice over conventional itraconazole, or who received concomitant acid-lowering drugs.
Background: To understand the demographic profile of newly diagnosed type 2 diabetes mellitus (T2DM) patients and to evaluate the glycaemic status and initial treatment choices in this subset of T2DM patients.Methods: The ROD-IT-2 study was a real-world, retrospective, cross-sectional, observational study conducted at various centres across India between April 2021 and March 2022. The study outcomes included epidemiology, comorbidities, and management strategies preferred by Indian clinicians in these patients.Results: Data from 29,550 newly diagnosed T2DM patients were analyzed. The mean age of patients was 53.3 years, and majority were males (65%). Majority of patients (63.85%) were aged 40 to 60 years. More than half (53.11%) of the patients were either overweight (36.65%) or obese (16.76%). The mean glycated hemoglobin (HbA1c) was high (8.4%). Most (88.5%) patients had cardio-renal comorbidities. Hypertension was the most common comorbidity (45.7%) followed by dyslipidemia (32.1%). Chronic kidney disease (CKD) was also present in 31.2% patients. In the present study, 9.2% patients presented with microvascular complications at the time of diagnosis. Majority of newly diagnosed patients (79.7%) were treated with combination therapy. In patients who were prescribed dual drug combination therapy, metformin + dipeptidyl peptidase-4 inhibitor (DPP4i) was the preferred combination (42.71%) followed by metformin + sulfonylurea (31.37%).Conclusions: ROD-IT-2 study showed that mean HbA1c levels in T2DM patients still remain high in our population and cardio-renal comorbidities remain prevalent in newly diagnosed patients. Indian clinicians were found to prefer the combination therapy in newly diagnosed T2DM patients.
Background: The objectives of the study was to evaluate the demographic profile of benign prostatic hyperplasia (BPH) patients and prevalence of overactive bladder (OAB) among these patients. Methods: A real-world, retrospective, observational study (DEMO-2) on BPH patients was conducted across India from April-2021 to March-2022. Demographics, BPH characteristics, status of OAB, and their management were evaluated. Results: A total of 5881 BPH patients were included with a mean age of 65.3 years and mean BPH duration of 3.2 years. Majority (80.98%) of the patients had associated comorbidity; hypertension (50.2%), diabetes (26.9%) and dyslipidemia (13%) were the most common. Majority (63%) of the patients complained of incomplete bladder emptying. In BPH patients, 29.9% had OAB. These patients had a higher mean prostate volume (44.96 vs. 42.17 cc) and prostate specific antigen (PSA) levels (4.11 vs. 3.79 ng/ml) versus BPH patients without OAB. For BPH, tamsulosin was the most prescribed drug (85.90%) followed by dutasteride (66.90%); tamsulosin + dutasteride was most common combination therapy (32.6%). In BPH patients with OAB, 82% received OAB medications and solifenacin (63.9%) was the most common medication. Conclusions: Majority of the BPH patients were between the ages of 50-75 years. Tamsulosin was the most commonly prescribed medication in BPH patients. Combination of tamsulosin and dutasteride was the mainstay of treatment. OAB was seen in 29.9% of the BPH patients, and solifenacin was the most commonly utilized (63.1%) medication in BPH patients with OAB. About 18% of these patients did not receive any specific medication for OAB. Adequate treatment strategies need to be adopted for BPH patients with OAB.
