Key result
Verapamil added to trandolapril did not improve progression to persistent macroalbuminuria compared to trandolapril alone.
Why the study?
Does verapamil added to trandolapril prevent persistent macroalbuminuria in hypertensive type 2 diabetes patients with microalbuminuria?
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.
Answers are grounded in this paper and cite their sources.
Adding verapamil to trandolapril offers no renal benefit in hypertensive T2DM with microalbuminuria; challenges combination therapy and supports ACEI monotherapy.
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.
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Ruggenenti et al. (2010) conducted an 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.
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