madman
Super Moderator
Real-World Adequacy of Glycaemic Control in Treatment-Naïve Greek Patients with Type 2 Diabetes Mellitus Initiating Treatment with Metformin Monotherapy at the Maximum Tolerated Dose: The Reload Study
ABSTRACT
Background Metformin, in the absence of contraindications or intolerance, is recommended as first-line treatment for patients with type 2 diabetes mellitus (T2DM). This observational, retrospective study assessed the real-world adequacy of glycaemic control in Greek patients with T2DM initiating metformin monotherapy at maximum tolerated dose.
Methods Included patients received metformin monotherapy for ≥ 24 months; relevant patient data were collected immediately prior to metformin initiation (baseline) and at other prespecified time points. The primary objective was to report, after 9 months of metformin treatment, the percentage of patients with baseline glycated haemoglobin (HbA1c) levels ≥ 6.5 % ( ≥ 48 mmol/mol) achieving HbA1c < 6.5 %. Secondary objectives included the assessment of time spent with poor glycaemic control and time to treatment intensification. A sensitivity analysis assessed the percentage of patients with baseline HbA1c ≥ 7 % ( ≥ 53 mmol/mol) achieving HbA1c < 7 % ( < 53 mmol/mol).
Results Of the enrolled patients (N = 316), 247 had baseline HbA1c ≥ 6.5 %; following 9 months on metformin, 90 (36.4 %) patients achieved HbA1c < 6.5 % (mean HbA1c change − 1.3 % [ − 14 mmol/mol]). Median time of exposure to HbA1c ≥ 6.5 % was 23.4 months and time to treatment intensification was 28.0 months. The sensitivity analysis revealed that the proportion of patients achieving HbA1c < 7.0 % was 50 % (mean HbA1c change − 1.6 % [ − 17 mmol/mol]).
Conclusion Irrespective of HbA1c target assessed, most patients with T2DM do not achieve the recommended HbA1c goals after 9 months on metformin while remained on monotherapy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.
In conclusion, this real-world study provides evidence that the adequacy of metformin monotherapy is suboptimal in Greek patients with T2DM. Despite the availability of treatment guidelines, clinical inertia appears to be common and it remains important to further explore the factors that contribute to this phenomenon.
ABSTRACT
Background Metformin, in the absence of contraindications or intolerance, is recommended as first-line treatment for patients with type 2 diabetes mellitus (T2DM). This observational, retrospective study assessed the real-world adequacy of glycaemic control in Greek patients with T2DM initiating metformin monotherapy at maximum tolerated dose.
Methods Included patients received metformin monotherapy for ≥ 24 months; relevant patient data were collected immediately prior to metformin initiation (baseline) and at other prespecified time points. The primary objective was to report, after 9 months of metformin treatment, the percentage of patients with baseline glycated haemoglobin (HbA1c) levels ≥ 6.5 % ( ≥ 48 mmol/mol) achieving HbA1c < 6.5 %. Secondary objectives included the assessment of time spent with poor glycaemic control and time to treatment intensification. A sensitivity analysis assessed the percentage of patients with baseline HbA1c ≥ 7 % ( ≥ 53 mmol/mol) achieving HbA1c < 7 % ( < 53 mmol/mol).
Results Of the enrolled patients (N = 316), 247 had baseline HbA1c ≥ 6.5 %; following 9 months on metformin, 90 (36.4 %) patients achieved HbA1c < 6.5 % (mean HbA1c change − 1.3 % [ − 14 mmol/mol]). Median time of exposure to HbA1c ≥ 6.5 % was 23.4 months and time to treatment intensification was 28.0 months. The sensitivity analysis revealed that the proportion of patients achieving HbA1c < 7.0 % was 50 % (mean HbA1c change − 1.6 % [ − 17 mmol/mol]).
Conclusion Irrespective of HbA1c target assessed, most patients with T2DM do not achieve the recommended HbA1c goals after 9 months on metformin while remained on monotherapy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.
In conclusion, this real-world study provides evidence that the adequacy of metformin monotherapy is suboptimal in Greek patients with T2DM. Despite the availability of treatment guidelines, clinical inertia appears to be common and it remains important to further explore the factors that contribute to this phenomenon.
