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Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin’s biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin’s biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin’s ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], ?3.3% to 5.4% and per protocol population: 1.2%; 95% CI, ?3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin’s ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin’s ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin’s biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis
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Background: Oxidative stress has an important role in the pathophysiology of diabetes mellitus (DM) Type-II. Oxidative stress has an important role in the progression of DM Type-II and its related complications such as retinopathy, neuropathy and many others. The present study was carried out to evaluate the effect of glipizide therapy on oxidative stress parameters in Type-II DM. Methods: Thirty newly diagnosed diabetes patients were given glipizide therapy on 1st day and continue for 3 months. 30 non-diabetic healthy volunteers served as a control. Plasma malondialdehyde (MDA), superoxide dismutase (SOD) and catalase levels were measured at the time of enrollment and at the end of 3 months of glipizide treatment. Result: The results are analyzed using paired t-test. Plasma MDA was significantly increased, whereas SOD and catalase were significantly reduced in newly diagnosed diabetic patients as compared to control. After 3 months of glipizide therapy, plasma MDA was significantly reduced, whereas SOD and catalase were significantly increased. Conclusion: Glipizide therapy significantly reduced oxidative free radicals and increased antioxidant mechanism, which reduced oxidative stress, progression DM-II and its related complication.
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Background: Oxidative stress has emerged as an important factor in the pathophysiology of hypertension. It also contributes to various complications associated with hypertension like vascular injury, atherosclerosis, renal dysfunction, and hypertensive end-organ damage. Present study was done to evaluate the effect of atenolol and enalapril, two commonly prescribed antihypertensive drugs, on oxidative stress in patients with hypertension. Method: Sixty newly diagnosed hypertensive patients were randomly assigned to either atenolol (n = 30) or enalapril therapy (n = 30) and followed up for the period of three months. Twenty normotensive healthy volunteers served as control. Plasma malondialdehyde, superoxide dismutase and catalase levels were measured at the time of enrollment and at the end of three months of antihypertensive treatment. Results: Plasma malondialdehyde was significantly increased whereas superoxide dismutase and catalase were significantly reduced in newly diagnosed hypertensive patients compared to controls. After three months of enalapril therapy, plasma malondialdehyde was significantly reduced and superoxide dismutase and catalase were significantly elevated. Atenolol therapy had no effect on these oxidative stress parameters. Conclusions: Enalapril therapy significantly reduced oxidative stress in contrast to atenolol. Thus enalapril therapy may prove beneficial compared to atenolol by preventing oxidative stress and related complications in hypertension in view of life long therapy required for the treatment of hypertension.