1. Effects of Manidipine and Delapril in Hypertensive Patients With Type 2 Diabetes Mellitus
- Author
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Ruggenenti, P, Lauria, G, Iliev, IP, Fassi, A, Ilieva, AP, Rota, S, Chiurchiu, C, Barlovic, DP, Sghirlanzoni, A, Lombardi, R, Penza, P, CAVALETTI, GUIDO ANGELO, Piatti, ML, Frigeni, B, Filipponi, M, Rubis, N, Noris, G, Motterlini, N, Ene Iordache, B, Gaspari, F, Perna, A, Zaletel, J, Bossi, A, Dodesini, AR, TREVISAN, ROBERTO, Remuzzi, G, DEMAND Study Investigators, Parvanova, IA, Petrov, II, Yakymchuk, S, Arnoldi, F, Prandini, S, Kocijancic, A, Pongrac, D, Prezelj, J, Gala, T, Kersnik, M, Trevisan, G, Lepore, G, Mondo, E, Inversi, F, Mangili, R, Bruno, S, Brusegan, V, Lecchi, V, Belviso, A, Genovese, S, Pareyson, D, Camozzi, F, Cavaletti, G, Marzorati, L, MARMIROLI, PAOLA LORENA, Mattavelli, L, Tadini, S, Gherardi, G, Calini, W, Diadei, O, Rossoni, D, Villa, D, Carminati, S, Agus, E, Remuzzi, A, Giuliano, GA, Ganeva, M, Cannata, AN, Carrara, F, Cella, C, Centemeri, E, Ferrari, S, Petrò, C, Savoldelli, E, Stucchi, N, Boccardo, P, Perico, N, Peracchi, S, Gelmi, S, Mecca, G, Imbimbo, B, Alberici, M, Gardini, F, Lauria, G., Ruggenenti, P, Lauria, G, Iliev, I, Fassi, A, Ilieva, A, Rota, S, Chiurchiu, C, Barlovic, D, Sghirlanzoni, A, Lombardi, R, Penza, P, Cavaletti, G, Piatti, M, Frigeni, B, Filipponi, M, Rubis, N, Noris, G, Motterlini, N, Ene Iordache, B, Gaspari, F, Perna, A, Zaletel, J, Bossi, A, Dodesini, A, Trevisan, R, Remuzzi, G, DEMAND Study, I, Parvanova, I, Petrov, I, Yakymchuk, S, Arnoldi, F, Prandini, S, Kocijancic, A, Pongrac, D, Prezelj, J, Gala, T, Kersnik, M, Trevisan, G, Lepore, G, Mondo, E, Inversi, F, Mangili, R, Bruno, S, Brusegan, V, Lecchi, V, Belviso, A, Genovese, S, Pareyson, D, Camozzi, F, Marzorati, L, Marmiroli, P, Mattavelli, L, Tadini, S, Gherardi, G, Calini, W, Diadei, O, Rossoni, D, Villa, D, Carminati, S, Agus, E, Remuzzi, A, Giuliano, G, Ganeva, M, Cannata, A, Carrara, F, Cella, C, Centemeri, E, Ferrari, S, Petrò, C, Savoldelli, E, Stucchi, N, Boccardo, P, Perico, N, Peracchi, S, Gelmi, S, Mecca, G, Imbimbo, B, Alberici, M, and Gardini, F
- Subjects
Adult ,Blood Glucose ,Male ,Dihydropyridines ,medicine.medical_specialty ,Diabetic neuropathy ,Urology ,Renal function ,Delapril ,Angiotensin-Converting Enzyme Inhibitors ,Kidney Function Tests ,Placebo ,Risk Assessment ,Severity of Illness Index ,Drug Administration Schedule ,Piperazines ,Body Mass Index ,Manidipine ,Double-Blind Method ,Internal medicine ,Diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Diabetic Nephropathies ,Nitrobenzenes ,Aged ,Dose-Response Relationship, Drug ,diabetes ,business.industry ,Hazard ratio ,Middle Aged ,Calcium Channel Blockers ,Prognosis ,medicine.disease ,Survival Rate ,Treatment Outcome ,Endocrinology ,Diabetes Mellitus, Type 2 ,Hypertension ,Indans ,Albuminuria ,Drug Therapy, Combination ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
To assess whether angiotensin-converting enzyme inhibitors and third-generation dihydropyridine calcium channel blockers ameliorate diabetic complications, we compared glomerular filtration rate (GFR; primary outcome), cardiovascular events, retinopathy, and neuropathy in 380 hypertensive type 2 diabetics with albuminuria 2 (IQR: 0.16–0.50 mL/min per 1.73 m 2 ) on combined therapy, 0.36 mL/min per 1.73 m 2 (IQR: 0.18–0.53 mL/min per 1.73 m 2 ) on delapril, and 0.30 mL/min per 1.73 m 2 (IQR: 0.12–0.50 mL/min per 1.73 m 2 ) on placebo ( P =0.87 and P =0.53 versus combined therapy or delapril, respectively). Similar findings were observed when baseline GFR values were not considered for slope analyses. Albuminuria was stable in the 3 treatment groups. The hazard ratio (95% CI) for major cardiovascular events between combined therapy and placebo was 0.17 (0.04–0.78; P =0.023). Among 192 subjects without retinopathy at inclusion, the hazard ratio for developing retinopathy between combined therapy and placebo was 0.27 (0.07–0.99; P =0.048). Among 200 subjects with centralized neurological evaluation, the odds ratios for peripheral neuropathy at 3 years between combined therapy or delapril and placebo were 0.45 (0.24–0.87; P =0.017) and 0.52 (0.27–0.99; P =0.048), respectively. Glucose disposal rate decreased from 5.8±2.4 to 5.3±1.9 mg/kg per min on placebo ( P =0.03) but did not change on combined or delapril therapy. Treatment was well tolerated. In hypertensive type 2 diabetic patients, combined manidipine and delapril therapy failed to slow GFR decline but safely ameliorated cardiovascular disease, retinopathy, and neuropathy and stabilized insulin sensitivity.
- Published
- 2011