Assessment of the effectiveness and safety of fixed-dose combination of alogliptin and pioglitazone in real clinical practice: results of the PROsperity study

OBJECTIVE. To evaluate the therapeutic efficacy and safety of the new fixed-dose combination of alogliptin and pioglitazone, in patients with type 2 diabetes mellitus, in real-world clinical practice. MATERIALS AND METHODS. A multicenter, observational, non-interventional, prospective study of the only fixed-dose combination of alogliptin and pioglitazone, available under the brand name «Incresync», was conducted in the Russian Federation. The study included two dosage regimens (25 mg+15 mg and 25 mg+30 mg, respectively) of the medication (PROsperity). The study included 1,999 patients who were observed in 52 research centers in the Russian Federation over a period of six months (24 weeks). Inclusion criteria: patients aged 18 or older with newly diagnosed type 2 diabetes mellitus or who had not achieved glycemic targets with previous treatment, and exclusion criteria: contraindications to using alogliptin or pioglitazone. Study design: Initially, after 3 and 6 months of incresync therapy, researchers recorded the target and current levels of HbA1c, fasting and post-prandial glycemic indices, as well as a wide range of cardiorenal-metabolic markers, including assessments of lipid profile, renal function, blood pressure, cardiovascular risk factors, concurrent medication, insulin resistance (HOMA-IR), and anthropometric measurements such as body weight and waist circumference, on the background of treatment. Two key glycemic indicators were chosen as the primary endpoints for evaluating the efficacy of T2DM treatment: 1) changes in HbA1C after 3 and 6 months of incresync treatment; 2) the proportion of patients who achieved individual HbA1c targets after 6 months. Secondary endpoints included assessment of other glycemic and non-glycemic markers, including the dynamics of these markers. In the case of combined therapy, the dosage regimens and duration of nternational nonproprietary name (INN) treatment were recorded for all hypoglycemic drugs. RESULTS. The average duration of the disease was 68.4±62.0 months. At the end of the study, after 6 months, the average decrease in HbA1c levels was -1.3%, compared to the initial level of 8.2%. This decrease was statistically significant (p<0.001). In the group of patients who started with a dose of 25+30 mg HbA1C reduction was more pronounced, amounting to -1.5% compared to baseline levels of 8,2% (also statistically significant p<0.001). The maximum reduction in HbA1C (-2,8%) was seen in patients with baseline HbA1C >9,0% (n=300, which is 15% of the total sample). Overall, 70,2 % of patients achieved goal HbA1C (<7,0%), including 80,1 % of those treated with Incresync 25 mg+30 mg (n=915, which is 46% of the total sample). Also, improvements of blood lipids, reduction of insulin resistance, systolic blood pressure and body weight were seen during 6 months of Incresync treatment. The use of Incresync was characterized by a favorable safety profile: 23 adverse events (~1%) were registered during the study period, which were mainly mild and non-specific and did not require discontinuation of therapy. After end of the study, 94% of patients remained on Incresync therapy, and 94% of physicians rated it as “very effective” or “effective”. CONCLUSION. The results of the multicenter, observational, non-interventional «PROsperity» study confirm the high efficacy and safety of Incresync. This allows the new combination to be considered the next step in the treatment for all groups of patients with type 2 diabetes mellitus who have not reached the target glycemic control on previous therapy.