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Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria
J Hypertens. 2011 Feb;29(2):207-16. -
Benedict BRuggenenti P, Fassi A, Ilieva AP, Iliev IP, Chiurchiu C, Rubis N, Gherardi G, Ene-Iordache B, Gaspari F, Perna A, Cravedi P, Bossi A, Trevisan R, Motterlini N, Remuzzi G; BENEDICT-B Study Investigators. Collaborators (74) Remuzzi G, Ruggenenti P, Nastasi G, Ongaro A, Querci F, Anabaya A, Trevisan R, Dodesini AR, Lepore G, Nosari I, Aros Espinoza CA, Fassi A, Belviso A, Parvanova A, Iliev IP, Cravedi P, Chiurchiu C, Arnoldi F, Mosconi L, Monducci M, Bossi A, Parvanova A, Iliev IP, Facchetti M, Brusegan V, Inversi F, Bertone V, Mangili R, Bruno S, Filipponi M, Iliev IP, Tadini S, Rubis N, Gherardi G, Calini W, Diadei O, Lesti M, Noris G, Pagani K, Rossoni D, Villa D, Gaspari G, Gelmi S, Gervasoni G, Remuzzi A, Ene-Iordache B, Gambara V, Perna A, Motterlini N, Ganeva M, Zamora J, Dimitrov BD, Gaspari F, Carrara F, Centemeri E, Ferrari S, Pellegrino M, Stucchi N, Petrò C, Locatelli C, Cannata A, Savoldelli E, Boccardo P, Minetti L, Remuzzi G, Legler UF, Kalsch B, Nehrdich D, Nicolucci A, Perna A, Ruggenenti P, Bakris GL, Kay R, Viberti GC. Source Mario Negri Institute for Pharmacological Research, Clinical Research Center for Rare Diseases Aldo e Cele Daccò, Villa Camozzi, Ranica, Italy.

Chez les patients diabétiques de type 2 hypertendus avec microalbuminurie, l'association Verapamil + Trandolapril ne modifie pas la survenue d'événements cardiovasculaires ou rénaux. Indépendamment du Verapamil.
le Trandolapril a normalisé la protéinurie chez la moitié des patients, et a entraîné chez ces patients une cardioprotection significative.

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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