<p><strong>Background:</strong> 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.</p><p><strong>Methods:</strong> 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.</p><p><strong>Results:</strong> 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.</p><p><strong>Conclusions</strong>: 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.</p>
Background/Aims Tumor necrosis factor (TNF) blocking therapies like etanercept (ETN) have revolutionized the management of ankylosing spondylitis (AS). Clinical trials suggest that Etanercept exhibits beneficial effects in terms of improving disease severity of AS patients. Etanercept has also been shown to have a good safety profile as compared to other TNF inhibitors in terms of risk of tuberculosis (TB) which seems to be an important aspect especially in India, considering the high prevalence of TB here. Despite having an established efficacy and safety profile, data regarding patient profile of AS patients who are prescribed etanercept is not clear. Methods This retrospective, multicentric, cross sectional, data collection form based observational study was planned to evaluate the patient profile of AS patients who are prescribed etanercept in India. Results Retrospective data of 423 AS patients was collected across 48 centers in India. Mean age of AS patients prescribed ETN was 53.26±8.60 years. 84.63% patients were males while the remaining 15.37% were females. To some extent, this can be attributed to the epidemiology of AS which is seen more commonly in males. Average height and weight of the patients were 68.30±7.11 kg and 166.75±3.98 cm respectively. Mean Body mass index (BMI) of the patient group was 24.59±2.66 kg/m2. 6.38% patients were obese while 21.27% patients were in the overweight category. Most of the patients had a medication history of taking some or other non-steroidal anti-inflammatory drug (NSAID) (95.98%). Other drugs which were previously consumed by the patients included sulfasalazine (74.47%), methotrexate (26.95%), steroids (13.95%). 11.11% of patients had a previous medication history of biologic medications including infliximab (6.86%), adalimumab (2.84%), secukinumab (0.95%) and golimumab (0.47%). Most common comorbid disorder reported in the patient group was hypertension (15.60%). Other comorbidities were diabetes mellitus (7.32%), inflammatory bowel disorder (4.3%) and psoriasis (1.65%). Erythrocyte sedimentation rate (ESR) was done in 29.74% of the patients with a mean value of 20.42 ±10.35 mm/hr. C-reactive protein (CRP) was done in 25.76% patients with a mean value of 10.82±4.27 mg/L was reported.HLA-B27 antigen testing was done only for 13.23% patients. Among patients who were subjected to HLA-B27 testing, 78.57% were HLA-B27 positive while the remaining 21.43% patients were HLA-B27 negative. 95.03% of the patients were prescribed ETN dose of 50mg/week through subcutaneous route while 4.97% of patients received ETN dose of 25mg twice weekly. Sulfasalazine was prescribed in 78.72% of these patients and was the most commonly co-prescribed drug along with ETN. Other commonly co-prescribed medications included NSAIDS (32.62%), methotrexate (28.37%) and steroids (5.67%). Conclusion Etanercept is commonly used in patients not responding to NSAIDS & sulfasalazine. It is even used in patients who have been on biologics previously. Disclosure A.B. Jain: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India. S. Warudkar: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India. N. Dave: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India. A. Chaturvedi: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India.
Background and Aims Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are a new class of oral medicines for the management of anemia in CKD patients. These agents are found to be efficacious in the management of renal anemia, however safety is still under scrutiny. While, ESAs (Erythropoietin stimulating agents) are available since long with a well-established clinical profile. This network meta-analysis aimed to compare the safety and efficacy of HIF-PHI vs ESA in CKD patients with anemia not undergoing dialysis. Method An electronic database search was carried out in EBM (Evidence Based Medicine) Reviews, Cochrane Library and PubMed from inception to July 2022 for phase III clinical trials comparing six different HIF-PHIs and ESA for treating anemia in non-dialysis-dependent (NDD) CKD patients. The outcomes included the serious adverse events (SAEs) and change in hemoglobin (Hb) levels. Results Total 163 records were identified out of which 6 studies involving a total of 6847 patients were eligible for analysis. Compared to ESA, all HIF-PHIs increased risk for SAEs (daprodustat of RR, 1.21[95% CI, 0.825–1.77]; desidustat, 1.38[95% CI, 0.695–2.76]; enarodustat, 1.29[95% CI, 0.568–3.02]; molidustat, 1.02[95% CI, 0.585–1.74]; roxadustat, 1.29[95% CI, 0.674–2.57] and vadadustat, 1.01[95% CI, 0.693–1.47]) although these differences were statistically non-significant. When change in Hb was analyzed, there was no statistically significant difference between the two groups. The mean difference in change in HB with various HIFs as compared to ESA were: daprodustat (MD: 0.0796, 95% CI −0.676–0.838), desidustat (MD: 0.120, 95% CI: −0.626–0.883), enarodustat (MD: -0.600, 95% CI: −1.36–0.157), molidustat (MD: -0.309, 95% CI: −1.07–0.449), roxadustat (MD: -0.0702, 95% CI: −0.831–0.692) and vadadustat (MD: -0.0402, 95% CI: −0.802–0.720). Conclusion In terms of safety, HIF PHIs were associated with more SAEs compared to ESA although these differences are not statistically significant. Comparing efficacy, HIF-PHIs and ESA both effectively increase Hb level in NDD-CKD patients without any significant difference. Results of our network meta-analysis suggest the need for larger and long-term studies comparing HIF-PHIs with ESAs to have better understanding of their comparative efficacy and safety profiles.
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