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However, the time to first primary event was not b f skinner different between the two treatment groups (HR 0. A similar number of primary prevention subjects in each group experienced a primary end point (10. Fewer secondary prevention subjects experienced a primary end point with atorvastatin (26. The b f skinner was somewhat more pronounced in the secondary prevention group. All-cause mortality was similar between the treatment groups skimner the 4-year treatment phase for pfizer germany total cohort (5.

Adverse events occurred with similar frequency in both treatment groups for the total, primary prevention, and secondary prevention groups. Serious adverse events were experienced by 37. Four atorvastatin-treated subjects experienced serious adverse events that were considered treatment related b f skinner, kidney failure, gastrointestinal bleeding, and transaminase elevation) versus three placebo-treated subjects (cholestatic jaundice, duodenal ulcer, and vertigo).

Myalgia rates were 3. The ASPEN did not find a significant reduction b f skinner the primary composite b f skinner point comparing 10 mg of atorvastatin with placebo (13. The reasons for this result may relate to the overall study design, the skinnerr of subjects b f skinner, the nature of the primary end point, and the protocol changes required because of changing treatment guidelines.

Therefore, the response to statin therapy in diabetic subjects without CHD appears to be conditioned by the intensity of their risk factors. Factors enhancing CHD rates among diabetic subjects include increasing duration of diabetes.

CHD rates in diabetic patients without CHD reach equivalence to those in nondiabetic patients with CHD after 10 years of diabetes in observational studies (3,7). In the ASPEN, the median duration of diabetes was 8 years. Also relevant is the varied risk profile of patients enrolled from different countries b f skinner the ASPEN, several of which would have had low background rates of CHD (20).

During the course of the ASPEN, a perception of heightened CVD risk in diabetes evolved b f skinner, and changing lipid treatment guidelines led to new m s treatments recommendation of lower LDL cholesterol target levels (21). Following the NCEP advisory of 2001 (21), the DSMB recommended that the study medication be discontinued for all secondary prevention subjects and primary prevention subjects with an adjudicated end point and that usual care be sjinner.

Concomitant lipid-lowering treatment in b f skinner placebo group was 26. The effect of a high statin drop-in rate had been reported previously in ekinner Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) and Fenofibrate Intervention and Event Lowering in Diabetes smell armpits study (22,23).

The use of nonstudy statin therapy in the usual care group of ALLHAT resulted in an LDL cholesterol reduction of only 16. Lower treatment thresholds and heightened CHD b f skinner awareness may have led to the recruitment of a low CVD risk group.

A lower risk primary prevention cohort would be expected to show less benefit from statin therapy, an expectation observed in the ASPEN primary prevention group. In fact, ASPEN had the lowest untreated rate of CHD death and nonfatal myocardial infarction of any secondary prevention study so far reported (15. These end points may have diluted the atorvastatin effect, which is evident in the clinical b f skinner points of fatal and nonfatal myocardial infarction (Fig.

The ASPEN corresponds most closely to the lipid-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) and the Collaborative Atorvastatin Diabetes Study (CARDS), both primary prevention studies. Furthermore, primary prevention patients in both CARDS and B f skinner were older and more hypertensive and included more smokers and men (14,15). Sample size and concomitant risk bear on the outcome of ASCOT and CARDS, as in the ASPEN.

The play of chance may also mitigate against a positive result in the ASPEN, given the low absolute event rates. The pathophysiology of CVD in diabetes must also be considered.

An excess of CHD is reported among diabetic subjects even at the lowest LDL cholesterol levels observed in the Multiple Risk Factor Intervention Trial (MRFIT) (28), meaning that some CHD sinner in diabetes may be due to glycemic b f skinner beyond remediation with LDL cholesterol lowering. Triglyceride and HDL cholesterol abnormalities are a further reason for CVD risk in diabetes beyond LDL cholesterol (29).

In summary, the primary end point in the ASPEN did b f skinner reach statistical significance in a combined cohort of primary and secondary prevention diabetic subjects recruited during a time of heightened awareness of CHD risk among individuals with diabetes.

The point estimate for CVD benefit observed in the secondary prevention cohort for fatal and nonfatal myocardial infarction was similar to that in other b f skinner and supports the rationale for statin therapy for these subjects.

For primary b f skinner subjects, the risk of CHD was low, and the results b f skinner that v with these characteristics are best managed in an individualized skiinner, focusing on all identifiable risk factors, as foreseen by the NCEP panel (30).

Robert Knopp, Seattle, WA, U. Finland: Jukka Mustonen and Amos Pasternack, H. Norway: Leiv Ose, Oslo. Switzerland: Skinber Golay, Geneva. Faas, and Karl D. Zedler, and Julie A. Wahl and Alain J. Cox b f skinner hazards for the primary composite end point and secondary composite and individual end points for all subjects and the primary and secondary artrece johnson populations.

Baseline and on-treatment characteristics of randomized subjectsWe acknowledge Fady Ntanios, David DeMicco, B f skinner Norton, and Don Luo (all employees of Pfizer), as well as Steve Dobson, for their contributions to this article.

The costs of publication of this article were defrayed in part by the payment of page charges. C Section 1734 solely to indicate this fact. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.



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