Patient-reported outcomes in a survey of patients treated with oral antihyperglycaemic medications: associations with hypoglycaemia and weight gain

Diabetes Obes Metab. 2009 Dec;11(12):1138-44. doi: 10.1111/j.1463-1326.2009.01123.x. Epub 2009 Sep 16.


Aim: To examine the association between medication side-effects (SEs) and patient-reported outcomes (PROs) among patients with type 2 diabetes treated with oral antihyperglycaemic agents (OAHAs).

Methods: A total of 1984 participants responded to an internet-based survey in the United States. Data were collected on hypoglycaemia 6 months and weight gain 12 months prior to the survey. Health-related quality of life (HRQoL) was measured using the EuroQol-5D (EQ-5D). Also administered were the Treatment Satisfaction Questionnaire for Medication v.1.4 (TSQM) and the Hypoglycaemia Fear Survey II (HFS).

Results: Symptoms of hypoglycaemia were reported by 62.9% of participants, and 36.9% reported weight gain. For those reporting hypoglycaemia, mean scores were lower for TSQM and EQ-5D and higher for HFS when compared with those with no symptoms (TSQM: 69.7 vs. 75.1; EQ-5D: 0.78 vs. 0.86; HFS: 17.5 vs. 6.2; all p < 0.0001). The same remained true when accounting for symptom severity, where severity was monotonically related with PRO scores (all p < 0.0001). Similarly, reported weight gain was associated with lower treatment satisfaction (69.0 vs. 73.3) and HRQoL (0.77 vs. 0.83), and increased fear of hypoglycaemia (15.7 vs. 11.8) (all p < 0.0001). In mixed linear regression analysis, the associations between medication SEs and PROs remained significant after adjusting for patient and disease characteristics.

Conclusions: Among patients with type 2 diabetes treated with OAHAs, self-reported hypoglycaemia and weight gain were associated with decreased treatment satisfaction and HRQoL. In addition, the presence of these SEs was associated with increased fear of hypoglycaemia.

MeSH terms

  • Administration, Oral
  • Anxiety / psychology
  • Body Weight / drug effects*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / psychology
  • Female
  • Humans
  • Hypoglycemia / chemically induced
  • Hypoglycemia / drug therapy*
  • Hypoglycemia / psychology*
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Internet
  • Male
  • Middle Aged
  • Quality of Life / psychology*
  • Surveys and Questionnaires
  • Treatment Outcome
  • United States
  • Weight Gain


  • Hypoglycemic Agents