Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial

Colhoun, Helen M.; Betteridge, D. J.; Durrington, Paul N.; Hitman, G. A.; Neil, H. A. W.; Livingstone, Shona; Thomason, Margaret J.; Mackness, Michael I.; Charlton-Menys, Valentine; Fuller, John

doi:10.1016/s0140-6736(04)16895-5

Cited by 3,403 publications

(1,602 citation statements)

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“…This is supported by data from randomized clinical trials and meta‐analyses showing that treatment with statins reduces LDL‐C levels and ASCVD risk in individuals with DM 11, 12, 13. DM is commonly associated with diabetic dyslipidaemia, including elevated triglycerides and reduced levels of high‐density lipoprotein cholesterol (HDL‐C), and with an increased number of small dense LDL particles and apolipoprotein (apo) B‐containing particles, which is thought to contribute to the increased risk level associated with DM 3, 14.…”

Section: Introductionmentioning

confidence: 76%

Efficacy and safety of alirocumab among individuals with diabetes mellitus and atherosclerotic cardiovascular disease in the ODYSSEY phase 3 trials

Ganda

Plutzky

Sanganalmath

et al. 2018

Diabetes Obesity Metabolism

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AimsIndividuals with both diabetes mellitus (DM) and atherosclerotic cardiovascular disease (ASCVD) are at very high risk of cardiovascular events. This post‐hoc analysis evaluated efficacy and safety of the PCSK9 inhibitor alirocumab among 984 individuals with DM and ASCVD pooled from 9 ODYSSEY Phase 3 trials.Materials and methodsChanges in low‐density lipoprotein cholesterol (LDL‐C) and other lipids from baseline to Week 24 were analysed (intention‐to‐treat) in four pools by alirocumab dosage (150 mg every 2 weeks [150] or 75 mg with possible increase to 150 mg every 2 weeks [75/150]), control (placebo/ezetimibe) and background statin usage (yes/no).ResultsAt Week 24, LDL‐C changes from baseline in pools with background statins were −61.5% with alirocumab 150 (vs −1.0% with placebo), −46.4% with alirocumab 75/150 (vs +6.3% with placebo) and −48.7% with alirocumab 75/150 (vs −20.6% with ezetimibe), and −54.9% with alirocumab 75/150 (vs +4.0% with ezetimibe) without background statins. A greater proportion of alirocumab recipients achieved LDL‐C < 70 and < 55 mg/dL at Week 24 vs controls. Alirocumab also resulted in significant reductions in non‐high‐density lipoprotein cholesterol, apolipoprotein B and lipoprotein(a) vs controls. Alirocumab did not appear to affect glycaemia over 78‐104 weeks. Overall safety was similar between treatment groups, with a higher injection‐site reaction frequency (mostly mild) with alirocumab.ConclusionAlirocumab significantly reduced LDL‐C and other atherogenic lipid parameters, and was generally well tolerated in individuals with DM and ASCVD.

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Section: Introductionmentioning

confidence: 76%

Efficacy and safety of alirocumab among individuals with diabetes mellitus and atherosclerotic cardiovascular disease in the ODYSSEY phase 3 trials

Ganda

Plutzky

Sanganalmath

et al. 2018

Diabetes Obesity Metabolism

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“…1) so that the several large trials did not confound results from the smaller trials. Six long‐term trials18, 20, 21, 22, 23, 28 (see footnote to Table 1 for trial details) investigating the effect of atorvastatin on CV outcomes were analyzed both individually and pooled according to treatment group; the median study duration was 3.1–4.9 years. The remaining 52 short‐term studies (≤2 years) were pooled according to treatment group; the median study duration was 4–72 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Long‐term CV outcomes trials with atorvastatin,17, 18, 19, 20, 21, 22, 23 as well as other statins,24, 25 have demonstrated the safety of this class in a range of populations. However, compared with the wealth of evidence from Western populations, the availability of statin safety data from Asian populations is limited, which may be a contributing factor in the underutilization of statins for the treatment of dyslipidemia in this ethnic group.…”

Section: Introductionmentioning

confidence: 99%

Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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SummaryIntroductionData on statin safety in Asian patients are limited compared with evidence from Western populations.AimThis study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials.MethodsData from 52 short‐term trials (median exposure 4–72 weeks) and six long‐term cardiovascular outcomes trials (median exposure 3.1–4.9 years) conducted across the atorvastatin 10–80‐mg dose range were analyzed retrospectively to assess the incidence of safety endpoints.ResultsA total of 77 952 patients were identified (49 974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short‐term trials, the incidence of all‐causality adverse events (AEs) and serious AEs (SAEs) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment‐related AEs/SAEs were infrequent (2.0% across all doses). These observations were confirmed in the long‐term trials. Treatment‐related SAEs were rare (n = 4) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin‐treated Asian patients, and the incidence of myalgia was 1.8% in the short‐term studies and 6.7% in the long‐term trials. Elevations (>3× the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal AEs occurred in <2%.ConclusionThe incidence of AEs/SAEs with atorvastatin 10–40‐mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80‐mg is required owing to the limited number of Asian patients (n = 281; 11.2%) who received this dose.

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“…An analysis of a subgroup in a trial of hypertensive optimization therapy and other clinical trials of anti‐hypertensive therapy also showed that intensive blood pressure control reduced the risk of cardiovascular diseases in diabetic patients without significant vascular complications 28, 29. The British Heart Protection Study–subgroup analysis of diabetic patients 30, the Collaborative Atorvastatin Diabetes Study 31 and other large‐scale clinical studies 32 indicated that the use of statins to lower low‐density lipoprotein cholesterol (LDL‐C) could reduce the risk of cardiovascular diseases in diabetic patients without causing significant vascular complications. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study showed that the combination of statins and lipid‐lowering drug did not achieve additional cardiovascular benefits, as compared with statins alone 32.…”

Section: Primary Secondary and Tertiary Diabetes Preventionmentioning

confidence: 99%