Persistent medication adherence and lifestyle changes compliance in patients with type 2 diabetes undergoing minor foot amputation and one-year all-cause mortality

Abstract

Abstract Background The 3-years mortality rate in patients with Type 2 diabetes (T2D) after minor amputations may reach 53–80%. The aim of the study was to evaluate the impact of persistent medication adherence and compliance with lifestyle recommendations on 1-year all-cause mortality in patients with T2D and peripheral artery disease (PAD) after minor foot amputation. Methods This is a prospective, single-center, observational cohort study including 785 consecutive T2D patients with PAD undergoing minor amputations and followed-up over 1 year (mean age 62.3±7.2 years; 62.8% males). Based on adherence and compliance, patients were divided into 4 groups: adherent/compliant (n=432), adherent/non-compliant (n=101), compliant/non-adherent (n=68), non-adherent/non-compliant (n=184). Secondary prevention recommendations included healthy diet, smoking cessation, physical exercise ≥30 min/day and >80% drug intake (wound healing, antidiabetic, cardiovascular treatment, dual antiplatelet and statin treatment). Cox proportional hazard models were used to examine how variables predict one-year all-cause mortality. Results One-year all-cause mortality was 16.9% (n=133) at 1-year follow-up (Figure 1). After adjusting for confounders, compared to adherent/compliant patients, all other groups had an increased risk of one-year mortality. In non-adherent/non-compliant patients HR=9.08 [95% CI 5.55, 14.86], p<0.001; in adherent/non-compliant patients HR=3.86 (95% CI [2.08, 7.14], p<0.001), in non-adherent/compliant patients HR=2.98 (95% CI [1.45, 6.08] p=0.003). After adjustment, age, history of myocardial infarction, foot infection also remained significant (Figure 2). Conclusion T2D and PAD patients who were persistently medication non-adherent and non-compliant to lifestyle changes recommendations had a nine-fold increased risk for one-year all-cause mortality after PFA, non-compliance only increased mortality 3.8-fold, and non-adherence only – 3.0-fold, which outline the importance of secondary preventive measures. Funding Acknowledgement Type of funding sources: None.