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Appendix Table 2. Randomized, Controlled Trials of Lipid Interventions in Diabetic and Nondiabetic Populationsa

Study, Year (Reference) Intervention Sample Size (Diabetes Subgroup/Total), n/n Baseline Cardiovascular Risk Factorsb Mean Achieved LDL-C Level (SD), mg/dL Outcome: Relative Risk (95% CI) Quality Rating Comment
ALLHAT, 200250 Pravastatin titrated to achieve 25% reduction in LDL-C vs. usual care. 3,635/10,355b Total group (DM subgroup information NR):
   HTN: 100%
   History of CVD: 14.2%
   Smoking: 23.1%
   Mean LDL-C: 145.6 mg/dL (SD, 21.4)		 Pravastatin: 104.0 (29.1)
Usual care: 121.2 (34.6)		 All-cause mortality, pravastatin vs. usual carec:
   DM subgroup: 1.03 (0.86–1.22); P = NR
   Non-DM subgroup: 0.96 (0.84–1.1); P = NR.
CHD death or nonfatal MI:
   DM subgroup: 0.89 (0.71–1.10); P = NR
   Non-DM: 0.92 (0.76–1.10); P = NR.
Difference between DM and normoglycemia subgroups: P = NRd		 Fair Relatively small difference in LDL-C between intervention and usual care groups because of withdrawals in intervention group and off-protocol statin use in usual care group.
ASCOT, 200355, 200556 Atorvastatin, 10 mg, vs. placebo 2,532/10,305 DM/total group:
   HTN: 100%/100%
   Mean LDL-C: 28.7 mg/dL (SD, 27.3)/124.8 mg/dL (SD, 27.3)
   Smoking: 20.3%/32.2%
   Cerebrovascular disease: 7.5%/9.7%
   Peripheral vascular disease: 5.3%/5.0%
   Mean number of CVD risk factors: 4.1/3.7		 Atorvastatin: 83.9 (26.5)
Placebo: 117.8 (30.4)		 Nonfatal MI or fatal CHDc:
   DM subgroup: 0.84 (0.55–1.29); P = NR
   Non-DM subgroup: 0.56 (0.41–0.77); P = NR.
Total CVD events and procedures:
   DM subgroup: 0.77 (0.61–0.98); P = NR
   Non-DM subgroup: 0.80 (0.68–0.94); P = NR.
Difference between DM and normoglycemia subgroups: P = 0.82d		 Fair Study stopped early; relatively low number of total events in DM subgroup.
Heart Protection Study, 200357 Simvastatin, 40 mg, vs. placebo 5,963/20,536 DM/non-DM:
   Previous MI: 19%/51%
   Other history of CVD: 14%/28%
   Smoking: 67%/78%
   Blood pressure: 148/82 mm Hg/143/81 mm Hg
   Mean LDL-C: 124.8 mg/dL(SD, 32.0)/132.6 mg/dL(SD, 32.0)		 Simvastatin: 89.7
Placebo: 128.7		 Nonfatal MI or fatal CVDc:
   DM subgroup: 0.73 (0.62–0.85); P < 0.001
   Non-DM subgroup: 0.73 (0.66–0.81); P < 0.001.
Stroke:
   DM subgroup: 0.76 (0.61–0.94); P = 0.01
   Non-DM subgroup: 0.74 (0.64–0.86); P < 0.001.
Difference between DM and normoglycemia subgroups: P = 0.10d		 Good (for overall trial) Baseline characteristics differed significantly between DM and normoglycemic subgroups.
PROSPER, 200258 Pravastatin, 40 mg, vs. placebo 623/5,804 Total group (DM subgroup information NR):
   Previous angina: 26.9%
   Previous MI: 13.4%
   Cerebrovascular disease: 11.2%
   Vascular disease: 44.2%
   Mean LDL-C: 148.2 mg/dL (SD, 31.2)
   Hypertension: 61.9%
   Smoking: 26.8%		 Mean LDL at 3 months: pravastatin, 96.7; placebo, 146.6 Nonfatal MI, fatal CVD, nonfatal and fatal strokec:
   DM subgroup: 1.27 (0.90–1.80); P = NR
   Non-DM subgroup: 0.79 (0.69–0.91); P = NR. Difference between DM and normoglycemia subgroups: P = 0.015d		 Fair Little diabetes-specific information and relatively few persons with diabetes limit conclusions.

a  To convert LDL-C units to mmol/L, multiply value by 0.0259. ALLHAT = Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; ASCOT = Anglo-Scandinavian Cardiac Outcomes Trial; CHD = coronary heart disease; CVD = cardiovascular disease; DM = diabetes; HTN = hypertension; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; NR = not reported; PROSPER = Prospective Study of Pravastatin in the Elderly at Risk.
b  Including persons in the doxazosin group.
c  Primary outcome.
d  P value for interaction between DM and normoglycemia subgroups for primary outcome.

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