Verapamil added to trandolapril did not improve progression to persistent macroalbuminuria compared to trandolapril alone (13% vs 10.5%; HR 1.07; 95% CI 0.54-2.12; P=0.852).
RCT (n=281)
double-blind
parallel-group
Yes
Does verapamil added to trandolapril prevent persistent macroalbuminuria in hypertensive type 2 diabetes patients with microalbuminuria?
The addition of verapamil to trandolapril did not improve renal or cardiovascular outcomes in hypertensive patients with type 2 diabetes and microalbuminuria.
Effect estimate: HR 1.07 (95% CI 0.54-2.12)
Absolute Event Rate: 13% vs 10.5%
p-value: p=0.852
Objectives To address whether nondihydropyridine calcium-channel blocker added-on angiotensin-converting-enzyme inhibitor therapy ameliorates albuminuria and cardiovascular outcomes in type 2 diabetes patients. Design The Bergamo Nephrologic Diabetes Complications Trial-B was a multicentre, prospective, double-blind, parallel-group trial comparing renal and cardiovascular outcomes in 281 hypertensive type 2 diabetes patients with microalbuminuria randomized to at least 2-year VeraTran (verapamil/trandolapril 180 mg/2 mg daily) or trandolapril (2 mg daily, identical image) treatment. Main outcome was persistent macroalbuminuria (albuminuria >200 μg/min in two consecutive visits). Treatment targets were SBP/DBP less than 120/80 mmHg and HbA1C less than 7%. Results Over a median follow-up of 4.5 years, 18 patients (13%) on VeraTran vs. 15 (10.5%) on trandolapril unadjusted hazard ratio (95% confidence interval [CI) 1.07 (0.54–2.12), P = 0.852] progressed to macroalbuminuria, respectively; 62 (44.9%) vs. 71 (49.7%) 0.80 (0.57–1.12), P = 0.198 regressed to normoalbuminuria (urinary albumin excretion <20 μg/min), and 20 (14.5%) vs. 21 (14.7%) hazard ratio 0.93 (0.50–1.72), P = 0.816 had major cardiovascular events. BP and metabolic control were similar between groups. Patients with cardiovascular events were significantly less 13 (9.8%) vs. 28 (18.9%), hazard ratio: 0.37 (0.19–0.71), P = 0.003 among those regressing to normoalbuminuria than those without regression. Difference was independent of treatment allocation and was significant also after adjusting for baseline characteristics 0.40 (0.20–0.79), P = 0.009, follow-up SBP 0.40 (0.20–0.80), P = 0.010 or DBP 0.36 (0.18–0.73), P = 0.004 BP or HbA1C 0.43 (0.21–0.88), P = 0.021. Conclusion In hypertensive type 2 diabetes patients with microalbuminuria, verapamil added-on trandolapril did not improve renal or cardiovascular outcomes. Independent of verapamil, trandolapril normalized albuminuria in half of patients and this translated into significant cardioprotection.
Ruggenenti et al. (Tue,) conducted a rct in hypertensive type 2 diabetes with microalbuminuria (n=281). VeraTran (verapamil/trandolapril) vs. trandolapril (2 mg daily) was evaluated on persistent macroalbuminuria (albuminuria >200 μg/min in two consecutive visits) (HR 1.07, 95% CI 0.54-2.12, p=0.852). Verapamil added to trandolapril did not improve progression to persistent macroalbuminuria compared to trandolapril alone (13% vs 10.5%; HR 1.07; 95% CI 0.54-2.12; P=0.852).