ABSTRACT
BACKGROUND: Patients with hematological malignancies that are highly proliferative and have high tumor burden are at high risk of developing hyperuricemia and tumor lysis syndrome (TLS), spontaneously and while undergoing chemotherapy. AIM: To assess the safety and efficacy of a new generic formulation of recombinant rasburicase in prevention and treatment of malignancy‑associated hyperuricemia. MATERIALS AND METHODS: An open‑label, multicenter, phase‑III study was conducted on 100 eligible patients with high risk for TLS. Rasburicase was administered 0.2 mg/kg intravenously over 30 min, daily, for 4 days. The outcome measures were percentage of reduction in plasma uric acid at 4 h after rasburicase, plasma uric acid area under the curve (AUC)0-96 h and incidence of adverse events. RESULTS: Eighty eight patients completed the study period of 10 days. After rasburicase administration, there was a 75.3 ± 28.5% of reduction in plasma uric acid at 4 h as compared to baseline. The plasma uric acid AUC0-96 h was 259.9 ± 215.5 mg/dL h. Safety of rasburicase was assessed on the basis of changes in vitals, hematological, and biochemical parameters from baseline to termination. Except for the plasma uric acid level, there was no significant difference in any of the parameters. Mild to moderate adverse events were reported in 29 patients. Three patients had serious adverse events (SAEs) unrelated to rasburicase. CONCLUSIONS: These results demonstrated that recombinant rasburicase that is indigenously developed is effective for prevention and management of hyperuricemia in patients who are at high risk of developing TLS.
ABSTRACT
BACKGROUND: Patients with hematological malignancies that are highly proliferative and have high tumor burden are at high risk of developing hyperuricemia and tumor lysis syndrome (TLS), spontaneously and while undergoing chemotherapy. AIM: To assess the safety and efficacy of a new generic formulation of recombinant rasburicase in prevention and treatment of malignancy‑associated hyperuricemia. MATERIALS AND METHODS: An open‑label, multicenter, phase‑III study was conducted on 100 eligible patients with high risk for TLS. Rasburicase was administered 0.2 mg/kg intravenously over 30 min, daily, for 4 days. The outcome measures were percentage of reduction in plasma uric acid at 4 h after rasburicase, plasma uric acid area under the curve (AUC)0-96 h and incidence of adverse events. RESULTS: Eighty eight patients completed the study period of 10 days. After rasburicase administration, there was a 75.3 ± 28.5% of reduction in plasma uric acid at 4 h as compared to baseline. The plasma uric acid AUC0-96 h was 259.9 ± 215.5 mg/dL h. Safety of rasburicase was assessed on the basis of changes in vitals, hematological, and biochemical parameters from baseline to termination. Except for the plasma uric acid level, there was no significant difference in any of the parameters. Mild to moderate adverse events were reported in 29 patients. Three patients had serious adverse events (SAEs) unrelated to rasburicase. CONCLUSIONS: These results demonstrated that recombinant rasburicase that is indigenously developed is effective for prevention and management of hyperuricemia in patients who are at high risk of developing TLS.
Subject(s)
Adult , Aged , Area Under Curve , Child , Female , Gout Suppressants/therapeutic use , Hematologic Neoplasms/complications , Humans , Hyperuricemia/drug therapy , Hyperuricemia/etiology , India , Male , Middle Aged , ROC Curve , Tumor Lysis Syndrome/prevention & control , Urate Oxidase/therapeutic use , Uric Acid/blood , Young AdultABSTRACT
Twelve new chalcones were synthesized by claisen-schmidid condensation and studies for their toxicity to fish. Some of the chalcones have exhibited moderate activity. The structures of synthetic compounds have been characterized by analytical and spectral data.
ABSTRACT
Myasthenia gravis is the prototype neuromuscular disease with immunological pathogenesis. The recognition and interpretation of the symptoms should be stressed as the diagnosis is initially achieved on clinical ground. Tests in the areas of immunology, electrophysiology and imaging further help the diagnosis, management and prognosis of the condition. The recent knowledge of immunology seems to point to variations in the immune abnormalities, but it remains to be seen whether the differences have clinical relevance. With the availability of intensive care units, the management of acute events in the myasthenic patients has improved considerably and the morbidity is reduced. Long term remissions are achievable in majority of patients, with supervised use of immunosuppression. In the modern times, the grave connotations of the name myasthenia gravis may be only rarely justified.