A multicenter randomized controlled trial in patients with type 2 diabetes mellitus to evaluate an "advanced pharmaceutical care" intervention for the prevention of adverse effects and drug-related problems in a follow-uphome visit (BayPharmCareDiabetesTrail).

Background and aim: Studies provide strong evidence for antidiabetic efficacy of certain drugs but adverse events (AEs) and drug-related problems (DRPs) limit their effectiveness. Investigations: Patients with type-2 diabetes mellitus of community pharmacies were invited to participate in a multicenter controlled trial and were randomized either to receive "basic care" (control group, CG) or "advanced pharmaceutical care" (intervention group, IG). In two home visits at t0 (status quo) and t1 ( follow-up after 4-6 weeks), patients were asked about AE/DRP typical for antidiabetics and their adherence. Results: Totally, 130 patients were randomized to CG or IG (median age 73 vs. 67 years, n. s., 32 vs. 27 women, n. s.). At t0, 57 gastrointestinal-AE occurred in 33 patients (CG) vs. 56/31 (IG, n. s.). At t1, 57 "unchanged persisting" gastrointestinal-AE occurred in 32 patients (CG) vs. 25/17 (IG, p=0.006) and 59 "overall persisting" gastrointestinal-AE in 33 patients (CG) vs. 39/25 (IG, n. s.). At t0, 11 hypoglycemic-AE occurred in 9 patients (CG) vs. 13/10 (IG, n. s.). At t1, 10 "unchanged persisting" hypoglycemic-AE occurred in 9 patients (CG) vs. 2/2 (IG, p=0.028) and 10 "overall persisting" hypoglycemic-AE in 9 patients (CG) vs. 5/4 (IG, n. s.). At t0, 135 DRP occurred in 36 patients (CG) vs. 147/43 (IG, n. s.). At t1, 133 DRP occurred in 34 patients (CG) vs. 41/19 (IG, p=0.005). At t0, 58 patients (CG) vs. 50 patients (IG) self-reported to be adherent (n. s.) and at t1, 60 patients (CG) vs. 59 (IG, n. s.). Conclusions: "Advanced pharmaceutical care" decreased the number of "unchanged persisting" gastroenterological- and hypoglycemic-AE and DRP.