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Nebivolol had neutral effect on blood glucose
The beta-blocker is unique because it induces enhanced nitric oxide bioavailability.
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CHICAGO — Nebivolol, an investigational vasodilating beta-blocker, had a neutral effect on blood glucose in two 12-week clinical studies of patients with hypertension, according to George Bakris, MD.
Nebivolol (Forest Laboratories) is already approved in several European countries and a new drug application was submitted to the FDA.
Because it induces enhanced nitric oxide bioavailability, nebivolol is unique among beta-blockers, according to Bakris. It is a beta 1-selective beta-blocker that has been shown to increase nitric oxide bioavailability in endothelial cells.
Bakris, director, hypertensive diseases center in the section of endocrinology, diabetes and metabolism at the University of Chicago-Pritzer School of Medicine, reported the data at the American Diabetes Association 67th Annual Scientific Sessions.
The data were from two randomized, multicenter, placebo-controlled studies that lasted 12 weeks. The two studies had 1,494 participants with stage I or stage II hypertension. Participants received nebivolol as either monotherapy or add-on therapy.
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In the nebivolol monotherapy study, any previous antihypertensive therapy was discontinued for up to 42 days before patients (n=825) were randomly assigned to nebivolol, 1.25 mg/day to 40 mg/day, or placebo. In the add-on study, patients (n=669) on a stable antihypertensive regimen were randomly assigned to concomitant nebivolol, 5 mg/day to 20 mg/day, or placebo. Blood glucose levels were measured at baseline and at the end of 12 weeks.
No effect on blood glucose
Patients randomly assigned to nebivolol in the monotherapy study had dosage-dependent increases in mean blood glucose values of 0.8 mg/dL to 7.2 mg/dL, which was not significantly different from the 7.1 mg/dL increase observed in patients randomly assigned to placebo.
Similar results were obtained in the add-on study, in which patients randomly assigned to placebo had a mean increase of 2.6 mg/dL in blood glucose values compared with an increase of 0.7 mg/dL (20 mg/day) to 1.9 mg/dL (5 mg/day) in the nebivolol groups.
“Beta-blockers have been indicted by European hypertension guidelines as not being appropriate for first-line therapy of hypertension,” Bakris said. “I don’t disagree with that, but there’s no reason to avoid them, especially in the types of patients I treat — those with chronic kidney disease and diabetes — because there are good clinical trial data to show that they decrease cardiovascular events and mortality.
“Carvedilol (Coreg, GlaxoSmithKline) and nebivolol are the two beta-blockers that preserve glycemic control, making them the most appropriate for patients with diabetes,” he said. “Nebivolol affects nitric oxide, which carvedilol does not. Whether that is its primary mode of vasodilation is not 100% proven. Additionally, both carvedilol and nebivolol have antioxidant properties; however, data from animal studies suggest that nebivolol is relatively more potent as an antioxidant.”
Data from previous efficacy studies of nebivolol that were presented earlier this year at the American Society of Hypertension’s 22nd Annual Scientific Meeting demonstrated BP-lowering that is equal to or superior to other beta-blockers and antihypertensive agents in other classes, with average reductions in systolic and diastolic BP of about 15 mm Hg at the end of one year.
As shown by the results of the two studies presented at the American Diabetes Association meeting, nebivolol was well tolerated, with no increase in the incidence of fatigue, bradycardia, cold extremities, sleep difficulty or weight gain compared with placebo. There were also no changes in lipid values.
Dr. Bakris is a paid consultant for Forest Laboratories and GlaxoSmithKline.
For more information:
- Bakris G. Glucose control in hypertensive patients treated with the vasodilating, selective beta blocker, nebivolol. #2263-PO. Presented at: the 67th Scientific Sessions of the American Diabetes Association; June 22-26, 2007; Chicago