Abstract

Presence of microalbuminuria [(MAU), urine albumin:creatinine ratio (ACR) 30–300 mg/g], in patients (pts) with hypertension (HTN) and type 2 diabetes (T2DM) is associated with a high risk of cardiovascular events. The effect of addition of a β-blocker to an ACE or ARB on ACR in pts with HTN and T2DM was a pre-specified secondary endpoint of the GEMINI trial. Metoprolol [(M), 50–200 mg bid] was compared to carvedilol [(C), 6.25–25 mg bid] on change in ACR. After wash-out of all antihypertensive medications except ACE/ARB pts were randomized (C:498;M:737; double-blinded), titrated to target BP (<130/80 mmHg) and followed for 5 months. Hydrochlorothiazide (12.5 mg) and dihydropyridine calcium antagonist were added if needed to achieve goal BP. Evaluable pts (n=930, C:388;M:542) were defined as having valid paired ACR at screening and month 5 (M5). At screening, ACR was normal in 78% (C) and 80% (M) of pts; MAU was present in 20% (C) and 18% (M); ∼3% per group had macroalbuminuria. Carvedilol reduced ACR (%change; 95%CI; p-value): -14.0%; -22.3%, -5.0%, 0.003 in all pts; metoprolol had no effect (2.5%; -6.1%, 11.9%; 0.579). The resultant percent treatment difference (C vs M) was 16.2%, 95%CI -25.3,-5.9, p=0.003. Of those pts with normalbuminuria at screening, significantly fewer pts progressed to MAU on carvedilol [6.6% (C) vs 11.1% (M)], and the odds of progressing to MAU were 47% smaller for subjects receiving carvedilol compared to those receiving metoprolol (odds ratio 0.53, 95% CI 0.30–0.93, p=0.03). BP at trial end was similar between groups (SBP/DBP± sd)C:131.4±12.7/ 77.6±8.6; M:131.7±13.9/76.7±8.4. Thus, in the presence of an ACE/ARB both beta blockers reduced BP adequately. However, carvedilol reduced MAU development as well as lowered existing ACR compared to metoprolol.

This content is only available as a PDF.
You do not currently have access to this article.