title: Efficacy and safety of atorvastatin in hyperlipidemic, type 2 diabetic patients. A 34-week, multicenter, open-label study.
abstract: 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.
authors.affiliation: Instituto Nacional de la Nutrición 'Salvador Zubirán' de la SSA (Secretaría de Salud), Mexico City, Mexico. caas@aztlan.innsz.mx
authors.forename: C A
authors.initials: CA
authors.lastname: Aguilar-Salinas
authors.forename: F J
authors.initials: FJ
authors.lastname: Gómez-Pérez
authors.forename: C
authors.initials: C
authors.lastname: Posadas-Romero
authors.forename: C
authors.initials: C
authors.lastname: Vázquez-Chávez
authors.forename: E
authors.initials: E
authors.lastname: Meaney
authors.forename: A
authors.initials: A
authors.lastname: Gulías-Herrero
authors.forename: L E
authors.initials: LE
authors.lastname: Guillén
authors.forename: A
authors.initials: A
authors.lastname: Alvarado Vega
authors.forename: E
authors.initials: E
authors.lastname: Mendoza Pérez
authors.forename: L
authors.initials: L
authors.lastname: Eduardo Romero-Nava
authors.forename: R
authors.initials: R
authors.lastname: Angélica Gómez-Díaz
authors.forename: S
authors.initials: S
authors.lastname: Salinas-Orozco
authors.forename: R
authors.initials: R
authors.lastname: Moguel
authors.forename: G
authors.initials: G
authors.lastname: Novoa
mesh_terms: D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069059:Atorvastatin; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005260:Female; D006538:Heptanoic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D011758:Pyrroles; D000069059:Atorvastatin