RESUMO
Hyperlipidemia is common in type 2 diabetic patients and is an independent risk factor for cardiovascular disease. The aim of this trial was to evaluate the efficacy and safety of once-daily atorvastatin 10-80 mg for the treatment of hyperlipidemia in type 2 diabetics with plasma low-density lipoprotein cholesterol (LDL-C) levels exceeding 3.4 mmol/l (130 mg/dl). One hundred and two patients met the study criteria and received 10 mg/day atorvastatin. Patients who reached the target LDL-C level of =2.6 mmol/l (100 mg/dl) maintained the same dosage regimen until they had completed 16 weeks of treatment. Patients not reaching the target LDL-C underwent dose titration to atorvastatin 20, 40 and 80 mg/day at Weeks 4, 8 and 12, respectively. All 88 patients who completed the study attained target LDL-C levels and 52 (59%) of patients achieved the target goal at the starting dose of atorvastatin 10 mg/day. In this group the differences between baseline and post-treatment values for LDL-C were 4.3+/-0.7 mmol/l (166+/-26 mg/dl) versus 2. 2+/-0.4 mmol/l (87+/-14 mg/dl) (P<0.0001), respectively, a decrease of 47%. Similar trends were observed for total cholesterol, triglycerides, very low-density lipoprotein cholesterol and apolipoprotein B levels. The safety profile of atorvastatin in these patients was highly favorable and similar to those reported with other statins. Only one patient withdrew due to a possible drug-related adverse event. These data confirm the marked efficacy and safety of atorvastatin in type 2 diabetic patients with hyperlipidemia and the efficacy of atorvastatin 10 mg in helping patients attain their LDL-C goal.
Assuntos
Anticolesterolemiantes/uso terapêutico , Diabetes Mellitus Tipo 2/complicações , Ácidos Heptanoicos/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipidemias/tratamento farmacológico , Pirróis/uso terapêutico , Anticolesterolemiantes/efeitos adversos , Atorvastatina , Feminino , Ácidos Heptanoicos/efeitos adversos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Hiperlipidemias/sangue , Hiperlipidemias/complicações , Lipídeos/sangue , Masculino , Pessoa de Meia-Idade , Pirróis/efeitos adversosRESUMO
OBJECTIVE: To evaluate the fibrinogen and lipids response to diet plus bezafibrate in insulin-resistant patients with arterial hypertension and mixed hyperlipidemia. METHODS: A randomized double blind parallel design was used during a 90 days treatment period. Fibrinogen, lipids, insulin and peptide C assays as well as a glucose tolerance test were done at the start and end of treatment. The 28 patients received a hypolipemic diet low in refined sugars with bezafibrate added (400 mg/day) in 15 and a placebo in 13. RESULTS: The groups were similar in age, blood pressure and BMI. At the end of treatment, fibrinogen, cholesterol, triglycerides and LDL-C were lower in both groups as compared to the initial values, but only in the bezafibrate group there were: a) significant decrease in triglycerides (64 mg/dL, p 0.01); and b) marginal changes in fibrinogen (decreased 35 mg/dL, p = 0.09), total cholesterol (decreased 26 mg/dL, p = 0.10) and glucose/insulin ratio (increased from 4.4 to 5.2, p = 0.09). Bezafibrate lowered slightly the insulin level but did not affect peptide C. A correlation of changes in fibrinogen levels and the 60 min insulin concentration in the glucose tolerance test was higher in the bezafibrate group (r = 0.61) than in the placebo group (r = 0.23). CONCLUSIONS: In insulin resistant patients with high cardiovascular risk, bezafibrate and a placebo added to a hypolipemic diet decreased plasma fibrinogen. Bezafibrate lowered significantly the levels of triglycerides in these patients.