ABSTRACT
PURPOSE: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab(TM). We expected to obtain same results as with ReoPro(R) in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI). PATIENTS AND METHODS: Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab(TM) was given to 84 patients (58.7+/-10.6 years, M:F=68:16)and ReoPro(R)(59.0+/-10.5 years, M:F=30:10) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events. RESULTS: The number of Clotinab(TM) patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro(R) group. The probability of MACE onset in Clotinab(TM) was estimated to be less than 5%. There was no clinically significant result in tolerability variables. CONCLUSION: Clotinab(TM) is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Acute Coronary Syndrome/surgery , Angioplasty, Balloon, Coronary , Antibodies, Monoclonal/adverse effects , Drugs, Investigational/adverse effects , Immunoglobulin Fab Fragments/adverse effects , Myocardial Ischemia/prevention & control , Platelet Aggregation Inhibitors/adverse effects , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Prospective Studies , Risk Factors , Treatment OutcomeABSTRACT
Um estudo duplo cego com 96 pacientes, divididos em quatro grupos, foi realizado com intuito de avaliar a eficácia do medicamento Listerine no controle da placa bacteriana e da gengivite. Para cada grupo foi entregue um lote de medicamentos identificados por letras, onde apenas o coordenador e o fabricante sabiam qual era o Listerine e qual o placebo. Cada grupo possuia um examinador que executou o índice de placa gengival e, após dois meses, o mesmo examinador realizou os mesmos indices para comparaçäo. Os resultados revelaram que o medicamento Listerine parace näo justificar sua utilizaçäo frente ao controle da placa da inflamaçäo gengival