Nebivolol Safe, Effective in Latinos With Hypertension: Presented at ASH (HYP)

A clinical trial of treatment of stage 1 to 2 hypertension in Latinos with nebivolol revealed significant reductions in both systolic and diastolic blood pressure.

Findings were presented here at the American Society of Hypertension (ASH) 25th Annual Scientific Meeting and Exposition.

Henry A. Punzi, MD, University of Texas Southwestern Medical School, Dallas, Texas, noted that Mexican-Americans have lower rates of hypertensive awareness, treatment, and control, compared with whites. They also have higher rates of diabetes, and Latino women, in general, have higher obesity rates, compared with white women.

Preclinical evidence obtained from human umbilical vein endothelial cells suggests that the mechanism for these trends, Dr. Punzi explained, is that Mexican Americans, compared with whites, have lower baseline levels of endothelial nitric oxide (NO) and impaired ability to synthesise NO. In vitro, nebivolol’s NO-mediated vasodilatory properties have been shown to restore endothelial function. “That’s the whole premise,” he said on May 3. “We are giving back to the artery its ability to dilate and constrict.”

Participants with a mean trough seated diastolic blood pressure (DBP) of 95 to 114 mm Hg and systolic blood pressure (SBP) <180 mm Hg were randomised in a double-blinded fashion to receive placebo (n = 135) or nebivolol (n = 141) starting at 5 mg/day for 8 weeks. Titration up to 40 mg/day was allowed after assessments at 2, 4, and 6 weeks.

The primary endpoint was mean change from baseline at week 8 in trough seated DBP.

Mean age was 50.4 years, with ~60% of subjects having a body mass index (BMI) of >=30 kg/m2. The largest percentages of patients were Cuban (~38%) and Mexican (27%). Baseline DBP was ~100 mm Hg, and baseline SBP was 156 mm Hg. Forty-eight percent of subjects required up-titration to 40 mg/day of nebivolol, and 22% remained at the initial 5-mg dose.

At week 8, DBP and SBP were reduced ~7 and ~9 mm Hg in the placebo group, and ~11 and ~14 mm Hg in the nebivolol group (P = .001 for nebivolol vs placebo for both DBP and SBP).

Treatment-emergent adverse events (AE) were similar for placebo and nebivolol (22.1% and 17.0%, respectively), with headache being the most frequent AE (5.9% placebo; 3.5% nebivolol).

“Nebivolol treatment for 8 weeks significantly reduced diastolic and systolic blood pressure in Hispanics with stage 1-2 hypertension,” said Dr. Punzi.

“It’s crucial in this population to use an agent that reverses the abnormal endothelial function and that is one without side effects that they will stay on,” he added. “This is the right drug for the right patient at the right dose.”

For most patients, nebivolol in combination with an angiotensin receptor blocker or angiotensin converting enzyme would be appropriate, Dr. Punzi said. In patients with a high BMI, diuretics are contraindicated because of their tendency to worsen insulin resistance.

[Presentation title: Efficacy and Safety of Nebivolol Monotherapy in Hispanics With Stage I-II Hypertension. Abstract PO-LB-009]
By Walter Alexander