Tight control of systolic blood pressure (SBP) to a target of less than 130 mmHg in diabetics with coronary artery disease (CAD) does not significantly reduce the incidence of cardiovascular (CV) events compared with usual control, and is associated with increased all-cause mortality, shows an analysis of INVEST.

In INVEST (International Verapamil SR ??” trandolapril Study), patients with diabetes and CAD were randomly assigned to receive antihypertensive therapy with either a calcium-channel blocker or a beta blocker, plus an ACE inhibitor and/or a thiazide diuretic. In extended follow-up of 6400 patients enrolled in the trial, those who achieved SBPs lower than 130 mmHg had cardiovascular outcomes equivalent to those who achieved SBPs between 130 and 140 mmHg.

But a subanalysis of 5077 patients from the USA showed that the tight BP control strategy was associated with an adjusted hazard ratio (HR) of 1.15 (p=0.036) for all-cause mortality compared with usual control, defined as a SBP lower than 140 mm Hg.

“We wonder whether it’s time to rethink lower BP goals in patients with diabetes and CAD,” said Rhonda Cooper-DeHoff from the University of Florida in Gainesville, Florida, USA, who presented the data during a late-breaking clinical trials session at the 2010 annual scientific sessions of the American College of Cardiology in Atlanta, Georgia, USA.

The findings appear to contravene the position of the American Diabetes Association, which has previously issued a position statement saying that “there is no threshold value for BP [in diabetics], and risk continues to decrease well into the normal range.”

INVEST was designed to determine whether lowering SBP below 130 mmHg could provide additional CV benefits, particularly among diabetic patients with CAD. The international trial enrolled 22,576 patients with CAD and hypertension, and randomly assigned them to receive either verapamil SR plus trandolapril and the thiazide diuretic hydrochlorothiazide [HCTZ], or atenolol plus HCTZ and trandolapril. Trandolapril was recommended for all diabetic patients in the study.

The analysis focused on mortality rates among a US cohort of diabetic patients followed for an extended period, from September 1997 through November 2008. To evaluate the effects of very low SBP, the authors further categorized on-treatment SBP in increments of 5 mmHg.

During the extended follow-up period of 22,700 patient-years, the investigators found that, as predicted, patients whose BP was not controlled on therapy had an approximately 50% higher risk for a composite endpoint of death, nonfatal myocardial infarction (MI) or nonfatal stroke compared with those in the usual-control group. There were no significant differences between the tight- or usual-control groups with regard to either nonfatal MI of nonfatal stroke.

But in a Cox regression analysis of all-cause mortality, both the 110 to less than 115 mmHg and the less than 110 mmHg SBP categories were associated with increased risk for death. Other factors associated with increased mortality risk were age, race, peripheral arterial disease, coronary heart failure, US residency, renal impairment, left-ventricular hypertrophy, and transient ischemia.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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