Outcomes of adding second hypoglycemic drug after metformin monotherapy failure among type 2 diabetes in Hungary.
OBJECTIVE
The objective of this observational study was to assess the status of glycemic control and associated patient-reported outcomes in ambulatory Hungarian patients with type 2 diabetes mellitus (T2DM) who were prescribed either a sulfonylurea (SU) or a thiazolidinedione (TZD) in addition to the prior metformin (MF) monotherapy.


METHODS
Type 2 diabetics aged > or = 30 years and who had added an SU or TZD to previous MF monotherapy at least 1 year prior to the visit date were identified during January 2006 to March 2007. Information on HbA1c (A1C), medication use and co-morbid conditions was extracted from the medical record up to 6 months prior to the addition of SU or TZD to MF (baseline), and a minimum of one year after the initiation of either SU or TZD. Glycemic control (A1C < 6.5%) was assessed using the last available A1C value in the medical record. Self-reported hypoglycemia, health-related quality of life (HRQoL) and treatment satisfaction were also assessed.


RESULTS
A total of 414 patients (82% SU+MF and 18% TZD+MF) with a mean age of 60.5 years (SD = 9.4 years) participated in the study. About 27% of patients reported hypoglycemic episodes, with about one-third reporting episodes that resulted into interruption of activities or required medical/non-medical assistance. Three quarters of patients were not at glycemic goal and BMI was the only factor significantly associated with failure to have an A1C level < 6.5%. Patients' HRQoL was significantly associated with self-reported hypoglycemic episodes (p = 0.017), and duration of diabetes (p = 0.045).


CONCLUSIONS
Nearly 75% of patients were not at A1C goal of < 6.5% despite using two oral anti-hyperglycemic medications. Approximately 9% of patients reporting hypoglycemia required some kind of medical/non-medical assistance. Greater BMI at baseline was associated with an A1C level > or = 6.5%. Finally, self- reports of hypoglycemia and duration of diabetes were associated with low HRQoL.
Jermendy
György
G
The Ohio State University, Columbus, OH 43210, USA. not@valid.com
Erdesz
Diana
D
Nagy
Laszlo
L
Yin
Don
D
Phatak
Hemant
H
Karve
Sudeep
S
Engel
Samuel
S
Balkrishnan
Rajesh
R
D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D006814:Hungary; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011788:Quality of Life; D018434:Sickness Impact Profile; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C089946:2,4-thiazolidinedione