OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa’s approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima¯).

OBJECTIVE: Early coronary artery disease (CAD) is associated with risk factors (RF). Offspring of parents with a RF have a greater prevalence of them. However, the distribution of RF in parents and siblings of patients with early CAD is unknown. METHODS: The study comprised the parents and siblings of 42 patients with early CAD (< 45 years), 29 males. Their mean age was 39.5±3.7 years. The following major RF were analyzed: smoking (> 5 cigarretes/day), hypercholesterolemia (total cholesterol > 200 mg/dL), hypertension (diastolic blood pressure > 90 mmHg), and diabetes (glycemia > 126 mg/dL). RESULTS: Of a total of 102 RF, 4, 3, 2, and 1 were observed in, respectively, 5, 15, 15, and 7 patients with early CAD, the most prevalent being smoking (86%) and hypercholesterolemia (83%). Diabetes was observed in 15 (36%) and hypertension in 16 (38%) patients. Smoking was more prevalent in the fathers (76%) and hypercholesterolemia in the mothers (30%). In 183 siblings, 131 RF were observed (1 patient with the disease had a mean of 4.7 siblings). The prevalences of smoking, hypertension, hypercholesterolemia, and diabetes in the siblings were, respectively, 32%, 18%, 14%, and 9%. The incidence of RF was as follows: 72 (39%) siblings had 1 RF, 25 (14%) siblings had 2 RF, and 3 (2%) siblings had 3 RF. In parents and their offspring, smoking was moderately correlated (r=0.43; P=0.02) with CAD. CONCLUSION: Smoking habit of parents is passed on to offspring, and, in association with hypercholesterolemia, it was the major cause of early CAD in offspring. High prevalence of smoking in offspring shows the potential responsibility of parents in the incidence of the disease in offspring.

OBJECTIVE: Statins have proved to be safe and effective in the secondary prevention of coronary artery disease, but the level of prescription and the reasons for nonadherence to treatment in many coronariopathy treatment centers has not been determined. The purpose of this study was to identify reasons for nonadherence to statin therapy. METHODS: We analyzed 207 consecutive patients with coronary artery disease and hypercholesterolemia (total cholesterol > or = 200mg/dL or LDL - cholesterol > or = 130mg/dL). Patients' average age was 61.7±10 year; 111 (53.6%) male were and 94 (46.6%) were female. We analyzed the level of prescription and adherence to treatment with statins. RESULTS: Statins were prescribed for 139 (67%) patients, but only 85 (41%) used the drug. In spite of being indicated, statins were not prescribed in 68 (33%) patients. Of 54 (26%) patients, nonadherent to statins, 67% did not use the drug due to its high cost, 31% due to the lack of instruction, and only 2% due to side effects. Total cholesterol (260.3±42.2 vs 226.4±51.9; p<0.0001) and LDL cholesterol (174.6±38.1 vs 149.6±36.1; p<0.0001) were lower in patients on medication. HDL-cholesterol increased from 37.6±9.6 to 41.5±12.9mg/dL (p=0.02), and triglycerides were not modified in patients using statins. CONCLUSION: The prescription of statins in patients with coronary artery disease and dyslipidemia is high; however, its adherence is far from satisfactory, due to the high cost of the medication. Reduction in total cholesterol and LDL cholesterol levels did not reach the targets recommended by the Brazilian Consensus on Dyslipidemia.