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 <i>follow-up</i>home visit (<i>BayPhar

<i>Background and aim:</i> Studies provide strong evidence for antidiabetic efficacy of certain drugs but adverse events (AEs) and drug-related problems (DRPs) limit their effectiveness. <i>Investigations:</i> 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 (<i>status quo</i>) and t1 ( <i>follow-up</i> after 4-6 weeks), patients were asked about AE/DRP typical for antidiabetics and their adherence. <i>Results:</i> 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.). <i>Conclusions:</i> "Advanced pharmaceutical care" decreased the number of "unchanged persisting" gastroenterological- and hypoglycemic-AE and DRP.