Effect of intensive versus standard lipid-lowering treatment with atorvastatin on the progression of calcified coronary atherosclerosis over 12 months: A multicenter, randomized, double-blind trial

Axel Schmermund, Stephan Achenbach, Thomas Budde, Yuri Buziashvili, Andreas Förster, Guy Friedrich, Michael Henein, Gert Kerkhoff, Friedrich D Knollmann, Valery Kukharchuk, Avijit Lahiri, Roman Leischik, Werner Moshage, Michael Schartl, Winfried Siffert, Elisabeth Steinhagen-Thiessen, Valentin Sinitsyn, Anja Vogt, Burkhard Wiedeking, Raimund Erbel

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Abstract

BACKGROUND-: Recent clinical trials have suggested that intensive versus standard lipid-lowering therapy provides for additional benefit. Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification (CAC) in serial measurements. METHODS AND RESULTS-: In a multicenter, randomized, double-blind trial, 471 patients (age 61±8 years) who had no history of coronary artery disease and no evidence of high-grade coronary stenoses (>50% diameter reduction) were randomized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidenced by a CAC score ≥30. Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months. Progression of CAC volume scores could be analyzed in 366 patients. After pretreatment with 10 mg of atorvastatin for 4 weeks, 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group randomized to receive 80 mg of atorvastatin (P<0.001), whereas levels remained stable in the group randomized to receive 10 mg (108±23 at baseline, 109±28 mg/dL at the end of the study, P=NS). The mean progression of CAC volume scores, corrected for the baseline CAC volume score, was 27% (95% CI 20.8% to 33.1%) in the 80-mg atorvastatin group and 25% (95% CI 19.1% to 30.8%) in the 10-mg atorvastatin group (P=0.65). CAC progression showed no relationship with on-treatment LDL cholesterol levels. CONCLUSIONS-: We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis. Over a period of 12 months, intensive atorvastatin therapy was unable to attenuate CAC progression compared with standard atorvastatin therapy. The possibility remains that the time window was too short to demonstrate an effect.

Original languageEnglish (US)
Pages (from-to)427-437
Number of pages11
JournalCirculation
Volume113
Issue number3
DOIs
StatePublished - Jan 2006
Externally publishedYes

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Coronary Artery Disease
Coronary Vessels
Lipids
LDL Cholesterol
Therapeutics
X Ray Computed Tomography
Coronary Stenosis
Atorvastatin Calcium
Clinical Trials

Keywords

  • Atherosclerosis
  • Cholesterol
  • Drugs
  • Hypercholesterolemia

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

Effect of intensive versus standard lipid-lowering treatment with atorvastatin on the progression of calcified coronary atherosclerosis over 12 months : A multicenter, randomized, double-blind trial. / Schmermund, Axel; Achenbach, Stephan; Budde, Thomas; Buziashvili, Yuri; Förster, Andreas; Friedrich, Guy; Henein, Michael; Kerkhoff, Gert; Knollmann, Friedrich D; Kukharchuk, Valery; Lahiri, Avijit; Leischik, Roman; Moshage, Werner; Schartl, Michael; Siffert, Winfried; Steinhagen-Thiessen, Elisabeth; Sinitsyn, Valentin; Vogt, Anja; Wiedeking, Burkhard; Erbel, Raimund.

In: Circulation, Vol. 113, No. 3, 01.2006, p. 427-437.

Research output: Contribution to journalArticle

Schmermund, A, Achenbach, S, Budde, T, Buziashvili, Y, Förster, A, Friedrich, G, Henein, M, Kerkhoff, G, Knollmann, FD, Kukharchuk, V, Lahiri, A, Leischik, R, Moshage, W, Schartl, M, Siffert, W, Steinhagen-Thiessen, E, Sinitsyn, V, Vogt, A, Wiedeking, B & Erbel, R 2006, 'Effect of intensive versus standard lipid-lowering treatment with atorvastatin on the progression of calcified coronary atherosclerosis over 12 months: A multicenter, randomized, double-blind trial', Circulation, vol. 113, no. 3, pp. 427-437. https://doi.org/10.1161/CIRCULATIONAHA.105.568147
Schmermund, Axel ; Achenbach, Stephan ; Budde, Thomas ; Buziashvili, Yuri ; Förster, Andreas ; Friedrich, Guy ; Henein, Michael ; Kerkhoff, Gert ; Knollmann, Friedrich D ; Kukharchuk, Valery ; Lahiri, Avijit ; Leischik, Roman ; Moshage, Werner ; Schartl, Michael ; Siffert, Winfried ; Steinhagen-Thiessen, Elisabeth ; Sinitsyn, Valentin ; Vogt, Anja ; Wiedeking, Burkhard ; Erbel, Raimund. / Effect of intensive versus standard lipid-lowering treatment with atorvastatin on the progression of calcified coronary atherosclerosis over 12 months : A multicenter, randomized, double-blind trial. In: Circulation. 2006 ; Vol. 113, No. 3. pp. 427-437.
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abstract = "BACKGROUND-: Recent clinical trials have suggested that intensive versus standard lipid-lowering therapy provides for additional benefit. Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification (CAC) in serial measurements. METHODS AND RESULTS-: In a multicenter, randomized, double-blind trial, 471 patients (age 61±8 years) who had no history of coronary artery disease and no evidence of high-grade coronary stenoses (>50{\%} diameter reduction) were randomized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidenced by a CAC score ≥30. Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months. Progression of CAC volume scores could be analyzed in 366 patients. After pretreatment with 10 mg of atorvastatin for 4 weeks, 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group randomized to receive 80 mg of atorvastatin (P<0.001), whereas levels remained stable in the group randomized to receive 10 mg (108±23 at baseline, 109±28 mg/dL at the end of the study, P=NS). The mean progression of CAC volume scores, corrected for the baseline CAC volume score, was 27{\%} (95{\%} CI 20.8{\%} to 33.1{\%}) in the 80-mg atorvastatin group and 25{\%} (95{\%} CI 19.1{\%} to 30.8{\%}) in the 10-mg atorvastatin group (P=0.65). CAC progression showed no relationship with on-treatment LDL cholesterol levels. CONCLUSIONS-: We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis. Over a period of 12 months, intensive atorvastatin therapy was unable to attenuate CAC progression compared with standard atorvastatin therapy. The possibility remains that the time window was too short to demonstrate an effect.",
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T1 - Effect of intensive versus standard lipid-lowering treatment with atorvastatin on the progression of calcified coronary atherosclerosis over 12 months

T2 - A multicenter, randomized, double-blind trial

AU - Schmermund, Axel

AU - Achenbach, Stephan

AU - Budde, Thomas

AU - Buziashvili, Yuri

AU - Förster, Andreas

AU - Friedrich, Guy

AU - Henein, Michael

AU - Kerkhoff, Gert

AU - Knollmann, Friedrich D

AU - Kukharchuk, Valery

AU - Lahiri, Avijit

AU - Leischik, Roman

AU - Moshage, Werner

AU - Schartl, Michael

AU - Siffert, Winfried

AU - Steinhagen-Thiessen, Elisabeth

AU - Sinitsyn, Valentin

AU - Vogt, Anja

AU - Wiedeking, Burkhard

AU - Erbel, Raimund

PY - 2006/1

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N2 - BACKGROUND-: Recent clinical trials have suggested that intensive versus standard lipid-lowering therapy provides for additional benefit. Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification (CAC) in serial measurements. METHODS AND RESULTS-: In a multicenter, randomized, double-blind trial, 471 patients (age 61±8 years) who had no history of coronary artery disease and no evidence of high-grade coronary stenoses (>50% diameter reduction) were randomized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidenced by a CAC score ≥30. Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months. Progression of CAC volume scores could be analyzed in 366 patients. After pretreatment with 10 mg of atorvastatin for 4 weeks, 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group randomized to receive 80 mg of atorvastatin (P<0.001), whereas levels remained stable in the group randomized to receive 10 mg (108±23 at baseline, 109±28 mg/dL at the end of the study, P=NS). The mean progression of CAC volume scores, corrected for the baseline CAC volume score, was 27% (95% CI 20.8% to 33.1%) in the 80-mg atorvastatin group and 25% (95% CI 19.1% to 30.8%) in the 10-mg atorvastatin group (P=0.65). CAC progression showed no relationship with on-treatment LDL cholesterol levels. CONCLUSIONS-: We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis. Over a period of 12 months, intensive atorvastatin therapy was unable to attenuate CAC progression compared with standard atorvastatin therapy. The possibility remains that the time window was too short to demonstrate an effect.

AB - BACKGROUND-: Recent clinical trials have suggested that intensive versus standard lipid-lowering therapy provides for additional benefit. Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification (CAC) in serial measurements. METHODS AND RESULTS-: In a multicenter, randomized, double-blind trial, 471 patients (age 61±8 years) who had no history of coronary artery disease and no evidence of high-grade coronary stenoses (>50% diameter reduction) were randomized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidenced by a CAC score ≥30. Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months. Progression of CAC volume scores could be analyzed in 366 patients. After pretreatment with 10 mg of atorvastatin for 4 weeks, 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group randomized to receive 80 mg of atorvastatin (P<0.001), whereas levels remained stable in the group randomized to receive 10 mg (108±23 at baseline, 109±28 mg/dL at the end of the study, P=NS). The mean progression of CAC volume scores, corrected for the baseline CAC volume score, was 27% (95% CI 20.8% to 33.1%) in the 80-mg atorvastatin group and 25% (95% CI 19.1% to 30.8%) in the 10-mg atorvastatin group (P=0.65). CAC progression showed no relationship with on-treatment LDL cholesterol levels. CONCLUSIONS-: We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis. Over a period of 12 months, intensive atorvastatin therapy was unable to attenuate CAC progression compared with standard atorvastatin therapy. The possibility remains that the time window was too short to demonstrate an effect.

KW - Atherosclerosis

KW - Cholesterol

KW - Drugs

KW - Hypercholesterolemia

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