The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS)

Connie B Newman; Michael Szarek; Helen M Colhoun; D John Betteridge; Paul N Durrington; Graham A Hitman; H Andrew W Neil; David A Demicco; Sheila Auster; John H Fuller; Cards Investigators

doi:10.3132/dvdr.2008.029

The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS)

Connie B Newman, Michael Szarek, Helen M Colhoun, D John Betteridge, Paul N Durrington, Graham A Hitman, H Andrew W Neil, David A Demicco, Sheila Auster, John H Fuller, Cards Investigators

Research output: Contribution to journal › Article › peer-review

Abstract

The objective of this study was to evaluate the safety and tolerability of atorvastatin 10 mg compared with placebo in 2,838 patients with type 2 diabetes and no history of coronary heart disease who were enrolled in the Collaborative Atorvastatin Diabetes Study (CARDS) and followed for 3.9 years. The percentages of patients experiencing treatment-associated adverse events (AEs), serious AEs and discontinuations due to AEs in the atorvastatin (n=1,428) and placebo (n=1,410) groups were 23.0% vs. 25.4%, 1.1% vs. 1.1% and 2.9% vs. 3.4%, respectively. The most common treatment-associated AEs in the atorvastatin and placebo groups were digestive system-related (8.9% vs. 10.0%). All-cause and treatment-associated myalgia were reported in 4.0% and 1.0% of atorvastatin-treated patients, and 4.8% and 1.2% of placebo-treated patients. An analysis of selected AEs by tertiles of baseline low-density lipoprotein (LDL) cholesterol showed no relationship between LDL cholesterol levels and the incidence of myalgia, cancer or nervous system AEs in either treatment group. Overall, these data demonstrate that atorvastatin 10 mg was well tolerated in patients with type 2 diabetes during long-term treatment.

Original language	English
Pages (from-to)	177-83
Number of pages	7
Journal	Diabetes and Vascular Disease Research
Volume	5
Issue number	3
DOIs	https://doi.org/10.3132/dvdr.2008.029
Publication status	Published - Sep 2008

Keywords

Adult
Aged
Atorvastatin Calcium
Cholesterol, LDL
Diabetes Mellitus, Type 2
Double-Blind Method
Female
Gastrointestinal Diseases
Great Britain
Heptanoic Acids
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ireland
Male
Middle Aged
Muscular Diseases
Practice Guidelines as Topic
Pyrroles
Time Factors
Treatment Outcome

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Newman, C. B., Szarek, M., Colhoun, H. M., Betteridge, D. J., Durrington, P. N., Hitman, G. A., Neil, H. A. W., Demicco, D. A., Auster, S., Fuller, J. H., & Cards Investigators (2008). The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS). Diabetes and Vascular Disease Research, 5(3), 177-83. https://doi.org/10.3132/dvdr.2008.029

Newman, Connie B ; Szarek, Michael ; Colhoun, Helen M ; Betteridge, D John ; Durrington, Paul N ; Hitman, Graham A ; Neil, H Andrew W ; Demicco, David A ; Auster, Sheila ; Fuller, John H ; Cards Investigators. / The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS). In: Diabetes and Vascular Disease Research. 2008 ; Vol. 5, No. 3. pp. 177-83.

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abstract = "The objective of this study was to evaluate the safety and tolerability of atorvastatin 10 mg compared with placebo in 2,838 patients with type 2 diabetes and no history of coronary heart disease who were enrolled in the Collaborative Atorvastatin Diabetes Study (CARDS) and followed for 3.9 years. The percentages of patients experiencing treatment-associated adverse events (AEs), serious AEs and discontinuations due to AEs in the atorvastatin (n=1,428) and placebo (n=1,410) groups were 23.0% vs. 25.4%, 1.1% vs. 1.1% and 2.9% vs. 3.4%, respectively. The most common treatment-associated AEs in the atorvastatin and placebo groups were digestive system-related (8.9% vs. 10.0%). All-cause and treatment-associated myalgia were reported in 4.0% and 1.0% of atorvastatin-treated patients, and 4.8% and 1.2% of placebo-treated patients. An analysis of selected AEs by tertiles of baseline low-density lipoprotein (LDL) cholesterol showed no relationship between LDL cholesterol levels and the incidence of myalgia, cancer or nervous system AEs in either treatment group. Overall, these data demonstrate that atorvastatin 10 mg was well tolerated in patients with type 2 diabetes during long-term treatment.",

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author = "Newman, {Connie B} and Michael Szarek and Colhoun, {Helen M} and Betteridge, {D John} and Durrington, {Paul N} and Hitman, {Graham A} and Neil, {H Andrew W} and Demicco, {David A} and Sheila Auster and Fuller, {John H} and {Cards Investigators}",

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The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS). / Newman, Connie B; Szarek, Michael; Colhoun, Helen M; Betteridge, D John; Durrington, Paul N; Hitman, Graham A; Neil, H Andrew W; Demicco, David A; Auster, Sheila; Fuller, John H; Cards Investigators.

In: Diabetes and Vascular Disease Research, Vol. 5, No. 3, 09.2008, p. 177-83.

Research output: Contribution to journal › Article › peer-review

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AU - Colhoun, Helen M

AU - Betteridge, D John

AU - Durrington, Paul N

AU - Hitman, Graham A

AU - Neil, H Andrew W

AU - Demicco, David A

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AU - Fuller, John H

AU - Cards Investigators

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N2 - The objective of this study was to evaluate the safety and tolerability of atorvastatin 10 mg compared with placebo in 2,838 patients with type 2 diabetes and no history of coronary heart disease who were enrolled in the Collaborative Atorvastatin Diabetes Study (CARDS) and followed for 3.9 years. The percentages of patients experiencing treatment-associated adverse events (AEs), serious AEs and discontinuations due to AEs in the atorvastatin (n=1,428) and placebo (n=1,410) groups were 23.0% vs. 25.4%, 1.1% vs. 1.1% and 2.9% vs. 3.4%, respectively. The most common treatment-associated AEs in the atorvastatin and placebo groups were digestive system-related (8.9% vs. 10.0%). All-cause and treatment-associated myalgia were reported in 4.0% and 1.0% of atorvastatin-treated patients, and 4.8% and 1.2% of placebo-treated patients. An analysis of selected AEs by tertiles of baseline low-density lipoprotein (LDL) cholesterol showed no relationship between LDL cholesterol levels and the incidence of myalgia, cancer or nervous system AEs in either treatment group. Overall, these data demonstrate that atorvastatin 10 mg was well tolerated in patients with type 2 diabetes during long-term treatment.

AB - The objective of this study was to evaluate the safety and tolerability of atorvastatin 10 mg compared with placebo in 2,838 patients with type 2 diabetes and no history of coronary heart disease who were enrolled in the Collaborative Atorvastatin Diabetes Study (CARDS) and followed for 3.9 years. The percentages of patients experiencing treatment-associated adverse events (AEs), serious AEs and discontinuations due to AEs in the atorvastatin (n=1,428) and placebo (n=1,410) groups were 23.0% vs. 25.4%, 1.1% vs. 1.1% and 2.9% vs. 3.4%, respectively. The most common treatment-associated AEs in the atorvastatin and placebo groups were digestive system-related (8.9% vs. 10.0%). All-cause and treatment-associated myalgia were reported in 4.0% and 1.0% of atorvastatin-treated patients, and 4.8% and 1.2% of placebo-treated patients. An analysis of selected AEs by tertiles of baseline low-density lipoprotein (LDL) cholesterol showed no relationship between LDL cholesterol levels and the incidence of myalgia, cancer or nervous system AEs in either treatment group. Overall, these data demonstrate that atorvastatin 10 mg was well tolerated in patients with type 2 diabetes during long-term treatment.

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KW - Gastrointestinal Diseases

KW - Great Britain

KW - Heptanoic Acids

KW - Humans

KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors

KW - Ireland

KW - Male

KW - Middle Aged

KW - Muscular Diseases

KW - Practice Guidelines as Topic

KW - Pyrroles

KW - Time Factors

KW - Treatment Outcome

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DO - 10.3132/dvdr.2008.029

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