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Cholesterol‐lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes – CORALL study
Author(s) -
WOLFFENBUTTEL B. H. R.,
FRANKEN A. A. M.,
VINCENT H. H.
Publication year - 2005
Publication title -
journal of internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.625
H-Index - 160
eISSN - 1365-2796
pISSN - 0954-6820
DOI - 10.1111/j.1365-2796.2005.01499.x
Subject(s) - medicine , apolipoprotein b , rosuvastatin , type 2 diabetes , atorvastatin , apolipoprotein a1 , body mass index , diabetes mellitus , cholesterol , randomized controlled trial , outpatient clinic , gastroenterology , endocrinology
. Objectives. To compare the efficacy of the newest cholesterol‐lowering drug, rosuvastatin (RSV) with atorvastatin (ATV) in subjects with type 2 diabetes. Design. A 24‐week, open‐label, randomized, parallel‐group, phase IIIb, multicentre study. Setting. Diabetes outpatient clinics of 26 hospitals in the Netherlands. Subjects. A total of 263 patients with type 2 diabetes treated with oral agents or insulin, age (mean ± SD) 60 ± 10 years, body mass index (BMI) 31.4 ± 6.1 kg m −2 , 46% males. Intervention. After a 6‐week dietary lead‐in period, patients were randomized to RSV ( n = 131) or ATV ( n = 132) treatment in a dose escalation scheme (RSV: 10, 20 and 40 mg or ATV: 20, 40 and 80 mg for 6 weeks each sequentially). Main outcome measures. Primary outcome was the change in apolipoprotein B (apoB) and apoB/apolipoprotein A1 (apoA1) ratio, which has been suggested a better predictor for cardiovascular events than total (TC) or low‐density lipoprotein cholesterol (LDL‐C). Secondary outcomes were the changes in other lipid parameters. Results. Baseline LDL‐C in the RSV and ATV groups was 4.23 ± 0.98 mmol L −1 and 4.43 ±0.99 mmol L −1 , whilst apoB/apoA1 was 0.86 ±0.22 and 0.92 ± 0.35, respectively. A greater reduction in apoB/apoA1 was seen with RSV (−34.9%, −39.2% and −40.5%) than with ATV (−32.4%, −34.7% and −35.8%, P < 0.05 at weeks 12 and 18). Significantly greater reductions in LDL‐C were also seen with RSV (−45.9%, −50.6% and −53.6%) than with ATV (−41.3%, −45.6% and −47.8%, all P < 0.05). The American Diabetes Association (ADA) LDL‐C goal of <2.6 mmol L −1 was reached by 82%, 84% and 92% of patients with RSV and 74%, 79% and 81% with ATV. Triglyceride reductions ranged from 16 to 24% and were not different between treatments. Both treatments were well‐tolerated: nine patients in the RSV and 11 in the ATV group withdrew from treatment because of adverse events after randomization. Conclusion. In subjects with type 2 diabetes, greater improvements of apoB/apoA1 and across the lipid profile were observed with RSV compared with ATV.