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Extended INVEST follow-up revealed considerable mortality with diabetes

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Patients with new-onset diabetes had a similar mortality rate to that of patients with baseline diabetes during extended five-year follow-up of INVEST, a trial that compared antihypertensive treatment regimens in patients with coronary artery disease and hypertension.

This finding “confirms the notion that there is a lag between onset of diabetes and adverse outcomes of death,” Rhonda M. Cooper-DeHoff, PharmD, Cardiology Today Editorial Board member, said during a presentation at the American College of Cardiology’s 58th Annual Scientific Sessions.

INVEST included 22,576 patients aged 50 years and older who were randomly assigned to one of two antihypertensive treatment strategies: verapamil SR plus trandolapril or atenolol plus hydrochlorothiazide.

Cooper-DeHoff presented mortality data on 17,131 patients enrolled in the United States: 5,000 had diabetes at baseline and 1,044 developed new-onset diabetes during the trial. Results are based on two follow-up periods: during INVEST (1997-2003) and extended follow-up (2003-2008).

“During follow-up in INVEST, the mortality in patients with diabetes at baseline was significantly greater than in those who developed new-onset diabetes during the study,” said Cooper-DeHoff, research professor and associate director of the Cardiovascular Clinical Trials Programs at University of Florida College of Medicine.

During INVEST follow-up, patients with new-onset diabetes had a death rate of 1.81 per 100 patient years compared with 5.09 for patients with baseline diabetes.

However, with the extended follow-up, the gap closed. The death rate for patients with new-onset diabetes was 2.92 per 100 patient years and for patients with baseline diabetes it was 3.75 per 100 patient years.

“During extended follow-up the mortality rate in those with new-onset diabetes approached [the rate of] those with baseline diabetes,” she said. This suggests that “new-onset diabetes that developed during the course of antihypertensive therapy is as high risk as baseline diabetes of other etiologies.”

Patients with new-onset diabetes had a higher risk for death over the long term (year 8, HR=2.47; 95% CI, 1.11-5.5) after adjusting for differences in baseline characteristics and compared with patients with baseline diabetes, Cooper-DeHoff told Cardiology Today.

Cooper-DeHoff noted several limitations of the follow-up study, including under-reporting of death rates during extended follow-up, undetermined causes of death and unknown adherence to BP treatment after INVEST ended.

She recommended choosing antihypertensive treatments that decrease the risk for diabetes to reduce morbidity and mortality in this patient population and extended follow-up of future studies. – by Katie Kalvaitis

For more information:

• Cooper-DeHoff RM. Long-term mortality associated with new onset diabetes in hypertensive CAD patients following exposure to antihypertensive medications: findings from the International Verapamil SR-Trandolapril Study (INVEST). #910-7. Presented at: American College of Cardiology’s 58th Annual Scientific Sessions; March 29-31, 2009; Orlando, Fla.