Efficacy and safety of atorvastatin in hyperlipidemic, type 2 diabetic patients. A 34-week, multicenter, open-label study

Aguilar-Salinas, Carlos A.; Gómez-Pérez, Francisco J.; Posadas‐Romero, Carlos; Vázquez-Chávez, C; Meaney, Eduardo; Gulı́as-Herrero, Alfonso; Guillén, Luz E.; Vega, Alma Alvarado; Pérez, Enrique Mendoza; Romero-Nava, Luis Eduardo; Gómez-Díaz, Rita A.; Salinas-Orozco, Saul; Moguel, Rafael; Novoa, Germán

doi:10.1016/s0021-9150(99)00502-x

Cited by 24 publications

(19 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…No consistent relationship between atorvastatin treatment and changes in glycated haemoglobin or other glycaemic measure has been reported in short-term trials that have examined the efficacy and safety of statin therapy in diabetic patients [30,[36][37][38][39]. These small studies, however, did not have the statistical power to identify HbA 1c changes as small as the 0.3% increase observed in AFORRD.…”

Section: Discussionmentioning

confidence: 99%

Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial

et al. 2008

View full text Add to dashboard Cite

Aims/hypothesis The aim of the study was to examine the impact of statin or omega-3-acid ethyl esters 90 (omega-3 EE90; omega-3-acid ethyl esters 90 refers to a mixture of ethyl esters of n-3 fatty acids) on estimated cardiovascular disease (CVD) risk in community-based people with type 2 diabetes but without known CVD and not taking lipid-lowering therapy. Methods A central computer randomised 800 patients in 59 UK general practices to atorvastatin (n=401, 20 mg/day) or placebo (n=399) and omega-3 EE90 (n=397, 2 g/day) or placebo (n=403) in a concealed factorial manner. Participants with LDL-cholesterol <2.6 mmol/l, triacylglycerol <1.5 mmol/l and estimated 10-year CVD risk <20% were compared at 4 months.Results Mean (SD) age was 63.5 (11.7) years, HbA 1c 6.9 (1.1) % and known diabetes duration (median [interquartile range]) was 4 (2-8) years. Fifty-seven per cent were men, 90% white and 74% had an estimated 10-year CVD risk ≥20%. Of 732 patients with 4-month data, more allocated atorvastatin (n=371) compared with placebo (n=361) achieved LDLcholesterol <2.6 mmol/l (91% vs 24%, p<0.001) and had estimated 10-year CVD risks <20% (38% vs 26%, p<0.001). No differences were seen between those allocated omega-3 EE90 (n=371) compared with placebo (n=361) for participants achieving triacylglycerol <1.5 mmol/l (65% vs 60%, p=0.18) or estimated 10-year CVD risks <20% (34% vs 30%, p=0.18). There were no side effects of note. Conclusions/interpretation Many community-based diabetic patients without known CVD remain at high CVD risk despite statin treatment and require additional risk-reduction strategies. The impact of omega-3 EE90 on CVD risk will remain uncertain until clinical endpoint trial results are available.

show abstract

Section: Discussionmentioning

confidence: 99%

Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial

et al. 2008

View full text Add to dashboard Cite

show abstract

“…In addition, uptitration was less likely in subjects where the statin Table 5 Overview of safety was initiated at doses above the recommended starting doses and when care was provided by a general practitioner. Studies on subjects with CHD or diabetes have reported that about 32-59% of subjects will achieve targets with a starting dose of atorvastatin of 10 mg [15,17,18,26,29]. However, an additional 29-51% of subjects will go on to achieve targets when titrated to higher doses of atorvastatin (20-80 mg) [17,18,26,29].…”

Section: Discussionmentioning

confidence: 99%

“…Studies on subjects with CHD or diabetes have reported that about 32-59% of subjects will achieve targets with a starting dose of atorvastatin of 10 mg [15,17,18,26,29]. However, an additional 29-51% of subjects will go on to achieve targets when titrated to higher doses of atorvastatin (20-80 mg) [17,18,26,29]. Brown et al reported that 32% of subjects at higher risk achieved LDL-C targets of <2.6 mmol/L (100 mg/dL) after 12 weeks of therapy, and with dose titration up to 80 mg of atorvastatin, 83% were able to achieve this target [26].…”

Section: Discussionmentioning

confidence: 99%

“…Tailoring the starting dose according to individual LDL-C reduction requirements may aid in the achievement of target LDL-C levels [12,15]. There is evidence to suggest that baseline LDL-C levels impact overall LDL-C reduction, [16][17][18] and that treatment with intensive lipid lowering therapy results in greater reductions in LDL-C and a higher proportion of subjects achieving targets compared with more moderate regimens [19][20][21][22][23][24][25][26][27][28][29]. Thus, selecting an initial starting dose calculated to achieve the required LDL-C reduction, may allow more patients to reach targets more quickly, reducing the need for dose increases, thus improving clinical outcomes and being more cost-effective in the long term [30,31].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Effect of individualizing starting doses of a statin according to baseline LDL-cholesterol levels on achieving cholesterol targets: The Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST) study

et al. 2007

View full text Add to dashboard Cite

Aims: To investigate whether selecting the starting dose of atorvastatin according to baseline and target (<2.6 mmol/L) LDL-cholesterol (LDL-C) values would allow high-risk subjects to achieve target LDL-C concentration within 12 weeks, with the initial dose or a single uptitration. Methods and results: Twelve-week, prospective, open-label trial that enrolled 2117 high-risk subjects (statin-free [SF] or statin-treated [ST]). Subjects with LDL-C >2.6 mmol/L (100 mg/dL) but ≤5.7 mmol/L (220 mg/dL) were assigned a starting dose of atorvastatin (10, 20, 40 or 80 mg/day) based on LDL-C and status of statin use at baseline, with a single uptitration at 6 weeks, if required. There was no washout for ST subjects. At study end, 80% of SF (82%, 82%, 83% and 72% with 10, 20, 40 and 80 mg, respectively) and 59% of ST (60%, 61% and 51% with 20, 40 and 80 mg, respectively) subjects reached LDL-C target. In the ST group, an additional 21-41% reduction in LDL-C was observed over the statin used at baseline. Atorvastatin was well tolerated. Conclusion: This study confirms that individualizing the starting dose of atorvastatin according to baseline and target LDL-C values (i.e. the required LDL-C reduction), allows a large majority of high-risk subjects to achieve target safely, within 12 weeks, with the initial dose or with a single titration.

show abstract

“…The CanACTFAST study used Canadian recommendations, which categorize risk based on the Framingham risk equations, and showed that a treatment strategy integrating CV risk and different starting dosages can be used to tailor a successful drug treatment approach that is appropriate across risk categories. Extending the range of patients who can benefit from such an approach is important because patients at low or moderate risk of CV events in the short term may be at high longterm risk due to the cumulative effects of a single risk factor and/or changes in risk factors over time (4).Consistent with other reports, the CanACTFAST approach of ensuring appropriate starting doses and timely dose adjustments increased the proportions of patients who attained lipid targets (11,18,19). However, patients do not always undergo a dose titration approach.…”

mentioning

confidence: 67%

Achieving cholesterol targets by individualizing starting doses of statin according to baseline low-density lipoprotein cholesterol and coronary artery disease risk category: The CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) study

Ur¹,

Langer²,

Rabkin³

et al. 2010

Canadian Journal of Cardiology

View full text Add to dashboard Cite

BACkgRoUND: Despite an increasing body of evidence on the benefit of lowering elevated levels of low-density lipoprotein cholesterol (LDL-C), there is still considerable concern that patients are not achieving target LDL-C levels. oBJECTIvE: The CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) trial tested whether an algorithm-based statin dosing approach would enable patients to achieve LDL-C and total cholesterol/high-density lipoprotein cholesterol (TC/HDL-C) ratio targets quickly. METhoDS: Subjects requiring statin therapy, but with an LDL-C level of 5.7 mmol/L or lower, and triglycerides of 6.8 mmol/L or lower at screening participated in the 12-week study, which had two open-label, six-week phases: a treatment period during which patients received 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin based on an algorithm incorporating baseline LDL-C value and cardiovascular risk; and patients who achieved both LDL-C and TC/HDL-C ratio targets at six weeks continued on the same atorvastatin dose. Patients who did not achieve both targets received dose uptitration using a single-step titration regimen. The primary efficacy outcome was the proportion of patients achieving target LDL-C levels after 12 weeks. RESULTS: Of 2016 subjects screened at 88 Canadian sites, 1258 were assigned to a study drug (1101 were statin-free and 157 were statin-treated at baseline). The proportion of subjects who achieved LDL-C targets after 12 weeks of treatment was 86% (95% CI 84% to 88%) for statin-free patients and 54% (95% CI 46% to 61%) for statin-treated patients. Overall, 1003 subjects (80%; 95% CI 78% to 82%) achieved both lipid targets. CoNCLUSIoNS: Algorithm-based statin dosing enables patients to achieve LDL-C and TC/HDL-C ratio targets quickly, with either no titration or a single titration. hISToRIQUE : Malgré un ensemble de preuves croissant sur les bienfaits d'abaisser les taux élevés de cholestérol à lipoprotéines de basse densité (C-LDL), on s'inquiète encore beaucoup du fait que les patients n'atteignent pas les taux de C-LDL ciblés. oBJECTIF : L'étude CanACTFAST sur l'atteinte des cibles de cholestérol par les Canadiens au moyen du titrage stratifié d'atorvastatine était conçue pour évaluer si une posologie de statines calculée à l'aide d'un algorithme permettrait aux patients d'atteindre rapidement les cibles de C-LDL et de ratio entre le cholestérol total et le cholestérol à lipoprotéines de haute densité (CT/C-HDL). MÉThoDoLogIE : Les sujets qui avaient besoin d'une thérapie aux statines, mais dont le taux de C-LDL était de 5,7 mmol/L ou moins et le taux de triglycérides, de 6,8 mmol/L ou moins au moment du dépistage, ont participé à l'étude de 12 semaines, pourvue de deux phases ouvertes de six semaines : une période de traitement pendant laquelle les patients recevaient 10 mg, 20 mg, 40 mg ou 80 mg d'atorvastatine selon un algorithme intégrant la valeur de C-LDL de départ et le risque cardiovasculaire; les patients qui avaient atteint les cibles de C-LDL et de ratio CT...

show abstract

Efficacy and safety of atorvastatin in hyperlipidemic, type 2 diabetic patients. A 34-week, multicenter, open-label study

Cited by 24 publications

References 26 publications

Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial

Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial

Effect of individualizing starting doses of a statin according to baseline LDL-cholesterol levels on achieving cholesterol targets: The Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST) study

Achieving cholesterol targets by individualizing starting doses of statin according to baseline low-density lipoprotein cholesterol and coronary artery disease risk category: The CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) study

Contact Info

Product

Resources

About