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

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44 Citations (Scopus)

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)	177-183
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 - Sept 2008

Keywords

adverse effects of treatment
CARDS
lipids
statin
trials
type 2 diabetes
RANDOMIZED CONTROLLED-TRIAL
PLACEBO-CONTROLLED TRIAL
HIGH-DOSE ATORVASTATIN
MRC/BHF HEART PROTECTION
ARM ASCOT-LLA
LOWERING TREATMENT
COMPLETED TRIALS
STATIN THERAPY
CORONARY
PREVENTION

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3132/dvdr.2008.029

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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), 177-183. https://doi.org/10.3132/dvdr.2008.029

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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.",

keywords = "adverse effects of treatment, CARDS, lipids, statin, trials, type 2 diabetes, RANDOMIZED CONTROLLED-TRIAL, PLACEBO-CONTROLLED TRIAL, HIGH-DOSE ATORVASTATIN, MRC/BHF HEART PROTECTION, ARM ASCOT-LLA, LOWERING TREATMENT, COMPLETED TRIALS, STATIN THERAPY, CORONARY, PREVENTION",

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}",

year = "2008",

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doi = "10.3132/dvdr.2008.029",

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AU - Newman, Connie B.

AU - Szarek, Michael

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.

AU - Auster, Sheila

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 - lipids

KW - statin

KW - trials

KW - type 2 diabetes

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KW - PLACEBO-CONTROLLED TRIAL

KW - HIGH-DOSE ATORVASTATIN

KW - MRC/BHF HEART PROTECTION

KW - ARM ASCOT-LLA

KW - LOWERING TREATMENT

KW - COMPLETED TRIALS

KW - STATIN THERAPY

KW - CORONARY

KW - PREVENTION

U2 - 10.3132/dvdr.2008.029

DO - 10.3132/dvdr.2008.029

M3 - Article

SN - 1479-1641

VL - 5

SP - 177

EP - 183

JO - Diabetes and Vascular Disease Research

JF - Diabetes and Vascular Disease Research

IS - 3

ER -

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

Abstract

Keywords

UN SDGs

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