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Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study.

Abstract

BACKGROUND

Guidelines for the prevention of coronary heart disease (CHD) advocate reductions in low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) levels as the primary goals. However, approximately 50% to 60% of patients fail to reach recommended cholesterol goals.

OBJECTIVES

The primary objective of this Direct Statin Comparison of LDL-C Values: An Evaluation of Rosuvastatin Therapy Compared with Atorvastatin (DISCOVERY) trial was to compare the efficacy of the 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors rosuvastatin calcium and atorvastatin calcium in achieving the 1998 Second Joint Task Force (JTF) of European and Other Societies on Coronary Prevention target for LDL-C. Secondary objectives included comparing the efficacy of rosuvastatin and atorvastatin in achieving the 1998 JTF-recommended goal for TC and modifying other lipid levels, and to compare the tolerability of the 2 statins.

METHODS

This 12-week, randomized, open-label, 2-arm, parallel-group trial was conducted at 210 centers in Finland, Iceland, and Ireland. Patients aged > or =18 years with a high risk for CHD and primary hypercholesterolemia (LDL-C >3.5 mmol/L [>135 mg/dL]) were randomized (2:1) to receive rosuvastatin 10 mg or atorvastatin 10 mg PO OD for 12 weeks. Before randomization, statin-naive patients underwent 6 weeks of dietary counseling, whereas patients receiving treatment with a starting dose of another lipid-lowering therapy but with an LDL-C level >3.1 mmol/L (>120 mg/dL) were switched to study drug immediately after they were determined eligible for the study Patients were assessed for fasting lipid levels at weeks 0 and 12, and the proportions of patients attaining 1998 and 2003 JTF lipid goals (1998: LDL-C, <3.0 mmol/L [<116 mg/dL]; TC, <5.0 mmol/L [<193 mg/dL]; 2003: LDL-C, <2.5 mmol/L [<97 mg/dL]; TC, <4.5 mmol/L [<174 mg/dL]) were calculated. Tolerability was monitored for the 12-week study and for an additional 36-week optional extension period.

RESULTS

One thousand twenty-four patients were randomized to treatment (568 men, 456 women; mean age, 60.7 years). Patient demographic characteristics were similar between the 2 treatment groups. The efficacy analysis consisted of 911 patients (504 men, 407 women; mean age, 60.7 years; mean body weight, 82.4 kg); 627 received rosuvastatin and 284 received atorvastatin. Compared with atorvastatin, rosuvastatin was associated with significantly greater reductions in LDL-C and TC (both, P < 0.05), and with a significantly greater increase in high-density lipoprotein cholesterol level (P < (105). A greater proportion of patients in the rosuvastatin group compared with the atorvastatin group reached the 1998 goals for LDL-C (83.4% vs 683%; P < 0.001) and TC (76.4% vs 59.5%; P < 0.001). Also, compared with the atorvastatin group, greater proportions of patients in the rosuvastatin group achieved the 2003 JTF goals for LDL-C and TC (both, P < 0.001). Both agents were well tolerated: serious drug-related events were observed in < or =3.0% of patients in each group, and no clinically significant differences were found between the 2 treatment groups.

CONCLUSIONS

In this study of selected patients at high risk for CHD and with primary hypercholesterolemia, rosuvastatin 10 mg/d for 12 weeks was associated with significantly greater reductions in LDL-C and TC levels compared with atorvastatin 10 mg/d. Furthermore, significantly more patients receiving rosuvastatin achieved the 1998 and 2003 JTF-recommended lipid targets compared with those receiving atorvastatin. Both agents were well tolerated.

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  • Authors+Show Affiliations

    ,

    Department of Medicine, University of Helsinki, PO Box 340 FIN-00029 HUS, Helsinki, Finland. timo.strandberg@hus.fi

    , ,

    Source

    Clinical therapeutics 26:11 2004 Nov pg 1821-33

    MeSH

    Atorvastatin
    Cholesterol, LDL
    Coronary Disease
    Female
    Fluorobenzenes
    Heptanoic Acids
    Humans
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Hypercholesterolemia
    Male
    Middle Aged
    Pyrimidines
    Pyrroles
    Rosuvastatin Calcium
    Sulfonamides
    Triglycerides

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15639694

    Citation

    Strandberg, Timo E., et al. "Twelve-week, Multicenter, Randomized, Open-label Comparison of the Effects of Rosuvastatin 10 Mg/d and Atorvastatin 10 Mg/d in High-risk Adults: a DISCOVERY Study." Clinical Therapeutics, vol. 26, no. 11, 2004, pp. 1821-33.
    Strandberg TE, Feely J, Sigurdsson EL, et al. Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study. Clin Ther. 2004;26(11):1821-33.
    Strandberg, T. E., Feely, J., & Sigurdsson, E. L. (2004). Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study. Clinical Therapeutics, 26(11), pp. 1821-33.
    Strandberg TE, et al. Twelve-week, Multicenter, Randomized, Open-label Comparison of the Effects of Rosuvastatin 10 Mg/d and Atorvastatin 10 Mg/d in High-risk Adults: a DISCOVERY Study. Clin Ther. 2004;26(11):1821-33. PubMed PMID: 15639694.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study. AU - Strandberg,Timo E, AU - Feely,John, AU - Sigurdsson,Emil L, AU - ,, PY - 2004/07/10/accepted PY - 2005/1/11/pubmed PY - 2005/3/30/medline PY - 2005/1/11/entrez SP - 1821 EP - 33 JF - Clinical therapeutics JO - Clin Ther VL - 26 IS - 11 N2 - BACKGROUND: Guidelines for the prevention of coronary heart disease (CHD) advocate reductions in low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) levels as the primary goals. However, approximately 50% to 60% of patients fail to reach recommended cholesterol goals. OBJECTIVES: The primary objective of this Direct Statin Comparison of LDL-C Values: An Evaluation of Rosuvastatin Therapy Compared with Atorvastatin (DISCOVERY) trial was to compare the efficacy of the 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors rosuvastatin calcium and atorvastatin calcium in achieving the 1998 Second Joint Task Force (JTF) of European and Other Societies on Coronary Prevention target for LDL-C. Secondary objectives included comparing the efficacy of rosuvastatin and atorvastatin in achieving the 1998 JTF-recommended goal for TC and modifying other lipid levels, and to compare the tolerability of the 2 statins. METHODS: This 12-week, randomized, open-label, 2-arm, parallel-group trial was conducted at 210 centers in Finland, Iceland, and Ireland. Patients aged > or =18 years with a high risk for CHD and primary hypercholesterolemia (LDL-C >3.5 mmol/L [>135 mg/dL]) were randomized (2:1) to receive rosuvastatin 10 mg or atorvastatin 10 mg PO OD for 12 weeks. Before randomization, statin-naive patients underwent 6 weeks of dietary counseling, whereas patients receiving treatment with a starting dose of another lipid-lowering therapy but with an LDL-C level >3.1 mmol/L (>120 mg/dL) were switched to study drug immediately after they were determined eligible for the study Patients were assessed for fasting lipid levels at weeks 0 and 12, and the proportions of patients attaining 1998 and 2003 JTF lipid goals (1998: LDL-C, <3.0 mmol/L [<116 mg/dL]; TC, <5.0 mmol/L [<193 mg/dL]; 2003: LDL-C, <2.5 mmol/L [<97 mg/dL]; TC, <4.5 mmol/L [<174 mg/dL]) were calculated. Tolerability was monitored for the 12-week study and for an additional 36-week optional extension period. RESULTS: One thousand twenty-four patients were randomized to treatment (568 men, 456 women; mean age, 60.7 years). Patient demographic characteristics were similar between the 2 treatment groups. The efficacy analysis consisted of 911 patients (504 men, 407 women; mean age, 60.7 years; mean body weight, 82.4 kg); 627 received rosuvastatin and 284 received atorvastatin. Compared with atorvastatin, rosuvastatin was associated with significantly greater reductions in LDL-C and TC (both, P < 0.05), and with a significantly greater increase in high-density lipoprotein cholesterol level (P < (105). A greater proportion of patients in the rosuvastatin group compared with the atorvastatin group reached the 1998 goals for LDL-C (83.4% vs 683%; P < 0.001) and TC (76.4% vs 59.5%; P < 0.001). Also, compared with the atorvastatin group, greater proportions of patients in the rosuvastatin group achieved the 2003 JTF goals for LDL-C and TC (both, P < 0.001). Both agents were well tolerated: serious drug-related events were observed in < or =3.0% of patients in each group, and no clinically significant differences were found between the 2 treatment groups. CONCLUSIONS: In this study of selected patients at high risk for CHD and with primary hypercholesterolemia, rosuvastatin 10 mg/d for 12 weeks was associated with significantly greater reductions in LDL-C and TC levels compared with atorvastatin 10 mg/d. Furthermore, significantly more patients receiving rosuvastatin achieved the 1998 and 2003 JTF-recommended lipid targets compared with those receiving atorvastatin. Both agents were well tolerated. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/15639694/Twelve_week_multicenter_randomized_open_label_comparison_of_the_effects_of_rosuvastatin_10_mg/d_and_atorvastatin_10_mg/d_in_high_risk_adults:_a_DISCOVERY_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0149-2918(04)80346-1 DB - PRIME DP - Unbound Medicine ER -