Efficacy of pharmacotherapy follow-up care in Brazilian patients with type 2 diabetes mellitus: a randomized controlled trial

Abstract

Objective: To evaluate the efficacy of pharmaceutical care in improving outcomes of Brazilian outpatients with type 2 diabetes mellitus. Methods: In this single-blind, controlled trial, 71 outpatients were randomized into two groups: pharmaceutical care intervention (managed using pharmacotherapy follow-up protocol); and control (managed using standard dispensing procedures). Outcomes included hospitalization, severe complication (retinopathy, renal insufficiency, hypoglycemia, coronaropathy or foot lesion), and the values of A1c hemoglobin (HbA1c), capillary glycaemia (CG), blood pressure (BP), total cholesterol (TC) and body mass index (BMI). All patients were followed for 12 months and drug-related problems (DRP) were described in intervention group. The groups were compared using the Student´s t-test, Tukey-Kramer, Chi-square and Fisher exact tests. Results: No significant difference in baseline clinical characteristics of the intervention (n= 36) and control groups (n= 35) (p>0.05). The groups did not differ for the outcome hypoglycemia, CG, BP, HbA1c, TC and BMI (p>0.05), but CG and HbA1c levels decreased at 3, 6 and 12 months, in both groups (p≤0.05). A total of 56 DRP were observed in intervention group and the pharmacist resolved approximately 60% of these. Conclusion: Improvements in the glycemic parameters of outpatients with type 2 diabetes mellitus attended within a community pharmacy were observed. Studies involving larger samples are needed to confirm the benefits of pharmacotherapy follow-up care for key clinical outcomes in these patients. The trial was registered in Clinicaltrials.gov: Record NCT03196336.