Effectiveness of combined therapy with angiotensin-converting enzyme inhibitors and statins in reducing mortality in diabetic patients with critical limb ischemia: an observational study.
OBJECTIVE
To investigate the effect of combined treatment with angiotensin-converting enzyme inhibitors (ACE) and statins on mortality in diabetic patients with critical limb ischemia (CLI).


METHODS
Prospective observational study of 553 consecutive diabetic patients admitted because of CLI followed for a mean of 2.2 years. All patients underwent peripheral revascularization and antithrombotic therapy was prescribed or continued and therapy with statin and ACE was recorded. Mortality from any cause was assessed and Kaplan-Meier analyses were performed to compare the relationship between survival and recorded variables.


RESULTS
One hundred thirty-nine patients did not have therapy with statin or an ACE, 78 had therapy with statin without ACE, 164 had therapy with ACE without statin and 172 patients had therapy with both statin and ACE. One hundred thirty-six patients died, 45/139 with neither statin nor ACE, 40/164 with ACE only, 26/78 with statin only, and 25/172 with both statin and ACE. Multivariate analysis confirmed the independent role of age, history of stroke, renal insufficiency and dialysis. Combined treatment with ACE and statin appeared to have a protective role.


CONCLUSIONS
In patients with diabetes and CLI mortality after two years is high. Life expectancy was better in patients receiving combined therapy with ACE and statin but not with therapy with only a statin or an ACE.
Diabetic Foot Centre, IRCCS Policlinico Multimedica, Va Milanese 300, Sesto San Giovanni 20099, Milan, Italy.
Ezio
E
Faglia
Diabetic Foot Centre, IRCCS Policlinico Multimedica, Va Milanese 300, Sesto San Giovanni 20099, Milan, Italy. Electronic address: giacomo.clerici@multimedica.it.
Giacomo
G
Clerici
Diabetic Foot Centre, IRCCS Policlinico Multimedica, Va Milanese 300, Sesto San Giovanni 20099, Milan, Italy.
Alessia
A
Scatena
Diabetic Foot Centre, IRCCS Policlinico Multimedica, Va Milanese 300, Sesto San Giovanni 20099, Milan, Italy.
Maurizio
M
Caminiti
Diabetic Foot Centre, IRCCS Policlinico Multimedica, Va Milanese 300, Sesto San Giovanni 20099, Milan, Italy.
Vincenzo
V
Curci
Medical Statistics Unit, Milan University, Milan, Italy.
Alberto
A
Morabito
Fondazione Onlus DeaMedica, Pagani, SA, Italy.
Vincenzo
V
Prisco
Fondazione Onlus DeaMedica, Pagani, SA, Italy.
Rosaria
R
Greco
King's College Hospital, London, UK.
Mike
M
Edmonds
D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000401:mortality*; D017719:Diabetic Foot / Q000188:drug therapy* / Q000401:mortality*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D006435:Renal Dialysis; D016896:Treatment Outcome
D000806:Angiotensin-Converting Enzyme Inhibitors; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ace inhibitors Mortality; Critical limb ischemia; Diabetes; Medical therapy; Statins