The Lancet has published the results of a study that examined the effect of a fixed combination of an angiotensin converting enzyme inhibitor (ACEI) and a diuretic on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus. This study has been reported in the general media.
The study recruited over 11,000 patients who were randomly assigned to active treatment with the combination of perindopril and indapamide or placebo. The primary endpoints were defined as death from cardiovascular disease, non-fatal stroke or non-fatal myocardial infarction, and new or worsening renal disease or new or worsening diabetic eye disease. The patients were followed up for 4 years with approximately 75% of patients remaining on the randomised treatment at the end of follow up.
The reported outcomes are as follows:
- Major macrovascular or microvascular events reduced by 9% (1.3% absolute risk reduction) [hazard ratio (HR) 0·91, 95% CI 0·83-1·00, p=0·04]
- Major macrovascular events reduced by 8% (Not significant) [HR 0·92; 95% CI 0·81-1·04, p=0·16]
- Major microvascular events reduced by 9% (Not significant) [HR 0·91; 95% CI 0·80-1·04, p=0·16]
- Death from cardiovascular disease was reduced by 18% (0.8% absolute risk reduction) [HR 0·82, 95% CI 0·68-0·98, p=0·03]
- Death from any cause reduced by 14% (1.2% absolute risk reduction) [HR 0·86, 95% CI 0·75-0·98, p=0·03]
The author of the paper concludes that, "routine administration of a fixed combination of perindopril and indapamide to patients with type 2 diabetes was well tolerated and reduced the risks of major vascular events, including death". However, it is notable that the study did not set a blood pressure target but simply added in the study drugs to existing therapy. The mean blood pressure in patients in the active arm differed from those patients in the placebo arm by 5.6/2.2mmHg. It is therefore possible that the differences observed were an effect of lower blood pressure rather than any drug specific action.
Action: This study demonstrates that lowering blood pressure in patients with type 2 diabetes reduces diabetic complications and deaths. Clinicians should ensure that patients with diabetes have their blood pressure controlled using the national targets as a minimum standard.