Risk Predictors of Lower-limb Amputation in Patients with Type 2 Diabetes Mellitus in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study

46 Risk Predictors of Lower-limb Amputation in Patients with Type 2 Diabetes Mellitus in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study K. Rajamani 1,∗, L. Li 1, J. Best 2, M. Voysey1, R. Ting1, M. D’Emden3, M. Laakso4, J. Baker 5, A. Keech1 1NHMRCClinical TrialsCentre,University of Sydney, Sydney, Australia 2 School of Medicine, University of Melbourne, Melbourne, Australia 3 Royal Brisbane and Women’s Hospital, Brisbane, Australia 4 Department of Medicine, University of Kuopio, Kuopio, Finland 5 Middlemore Hospital, Auckland, New Zealand Introduction: Lower limb amputations associated with type 2 diabetes havemajor implications for morbidity and mortality. The aim of this analysis was to identify important risk predictors for future lower limb amputation on the basis of a large cohort of 9795 patients with type 2 diabetes mellitus in the FIELD study. Methods: Patients were randomised to receive fenofibrate 200mg/day or matching placebo over five years, and amputation events (a prespecified tertiary endpoint) were documented at six-monthly intervals. Time to cardiovascular disease events and death according to the predicted risk of amputation was also evaluated. Multi47 Single-pill Combination of Telmisartan 80mg/Amlodipine 10mg Provides Superior Blood Pressure Reductions in Patients with Severe Hypertension: Teamsta Severe HTN Study J. Neutel 1, G.Mancia 2, H. Black3, B. Dahlof 4, H. Defeo5, L. Ley6,∗, R. Vinisko5 1Orange County Research Center, CA, USA 2 University of Milano-Bicocca, San Gerardo Hospital, Milan, Italy 3 New York University School of Medicine, NY, USA 4 Sahlgrenska University Hospital/Ostra, Sweden 5 Boehringer Ingelheim Pharmaceuticals Inc, CT, USA 6 Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany Purpose: Investigate the efficacy and safety of the singlepill combination of telmisartan 80mg/amlodipine 10mg (T80/A10) vs. its respective monotherapy components in patients with severe hypertension. Methods: An eight-week, double-blind, parallel-group study, in 858 patients aged ≥18 years with severe hypertension (i.e. SBP ≥180 and DBP ≥95mmHg) randomised to T80/A10 (n= 421) or to monotherapy with T80 (n= 217) or A10 (n= 220). The primary endpoint was change from baseline in seated trough cuff SBP. Results: Baseline characteristics were comparable between the treatment groups. At eight weeks, signifivariable proportional-hazards regression analysis using exhaustive-search methods was used to develop predictive models. Results:Themain predictors of the first on-study amputation were a history of previous diabetic skin ulcer or nontraumatic amputation (hazard ratio (HR) 5.6), neuropathy (HR 3.0), peripheral vascular disease (HR 2.6), age over 65 years (HR 2.04) and height (HR 1.5 per 10 cm taller) (all P< 0.001). Other significant predictors included smoking, albuminuria, HBA1c, retinopathy and PTCA. Increasing risk of cardiovascular disease events and death was associated with increasing model-predicted amputation risk (P< 0.0001). Conclusion: Classical markers of macrovascular and microvascular risk predicted amputations. We also identified height as a major predictor of diabetic amputations, independent of the presence of neuropathy, confirming a previous report from an observational study. These findings could enablemore aggressive targeting of modifiable risk factors among patients at high risk of amputations and cardiovascular events who would benefit most from therapeutic intervention. doi:10.1016/j.hlc.2011.05.049 cantly greater reductions from baseline in seated trough SBP/DBP were observed with T80/A10 vs. T80 or A10 monotherapy, with superior reductions evident at one week. BP control and response rates were consistently higherwithT80/A10vs.T80orA10alone.T80/A10waswell tolerated, with similar rates of common adverse events (AEs) vs. T80 or A10monotherapy. Treatment-related AEs were less frequent with T80/A10 (12.6%) vs. A10 (16.4%), with a numerically lower incidence of peripheral oedema and rate of treatment discontinuation. T80/A10 single-pill T80 A10 Baseline SBP/DBP (±SD, mmHg) 185.4± 4.6/103.2± 6.3 185.6± 4.5/103.5± 6.8 185.1± 4.5/103.5± 6.2