ABCD 1996

Methods	Country: USA Setting/Design: Multicentre Time frame: NS Randomisation method: Permuted block randomisation within strata Blinding ‐ Participants: No ‐ Investigators: No ‐ Outcome assessors: No ‐ Data analysis: No Intention‐to‐treat: No Follow‐up period: 5‐7 years Loss to follow‐up: NS
Participants	Inclusion criteria Age: 40‐74 years DM: Type 2 Mean BP: 80‐89 mm Hg Patients are likely to complete 5‐7 years of study; patients willing to participate after a complete discussion of the study and who have signed the consent from; patients unlikely to move from Denver area within the next 5 years Enalapril group 1 Number: 52 Age: 49.8 (43‐58) Sex (M/F): 30/22 Placebo group Number: 51 Age: 50.3 (45‐55) Sex (M/F): 30/21 Exclusion criteria Pregnant or lactating females. Women of childbearing potential not using reliable contraception; potential pregnancy during the study Allergies to dihydropyridines or ACEi Recent or current substance abusers State of mental or physical competence inadequate to comply the study Second to third‐degree uncorrected heart block MI or CVA within the previous 6 months or CAB surgery within the previous 3 months Unstable angina pectoris within the previous six months Congestive heart failure (NYHA III or IV) Treatment with ACEi or CCB Accelerated/malignant hypertension (current the previous 5 years) Current severe peripheral vascular disease manifested by gangrene or imminent amputation Imminent or recent aortic dissection and/or previous mesenteric infarction HD or peritoneal dialysis and/or SCr > 3 mg/dL Bilateral renal artery stenosis or renal artery stenosis in a solitary functioning kidney Organ transplant recipients Significant hyperkalaemia (3 or more measurements > 6 mEq/L) Progressive nephropathic diseases other than diabetic nephropathy Severe liver disease History of malignancies or active cancer DBP < 80 mm Hg off antihypertensive agents Isolated systolic hypertension (SBP mean > 160 mm Hg and DBP mean < 90 mm Hg off all antihypertensive agents)
Interventions	Enalapril group 1 Intensive treatment: DBP target 75 mm Hg 5 mg/d titrated to 10, 20 and then 40 mg/d as initial medication plus placebo Control group Moderate BP control: DBP target 80‐89 mm Hg Placebo Co‐interventions If study intervention alone did not achieve the target BP, then open‐labeled antihypertensive medication were added in a step‐wise manner. Additional antihypertensive agents added at the descretion of tne medical director but did not include a CCB or ACEi
Outcomes	GFR UAE Creatinine clearance BP Retinopathy Neuropathy CVE Laboratory measurements
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate