title: Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France.
abstract: BACKGROUND
  Hypoglycaemia from antihyperglycaemic drugs may have a significant impact on patients' health-related quality of life. Combination use of metformin and a sulphonylurea has become increasingly common; yet, the impact of hypoglycaemia on quality of life in these patients is not well documented.
  
  
  OBJECTIVE
  To examine patient-reported experience of hypoglycaemia, worry about hypoglycaemic symptoms and the impact of hypoglycaemia on patients' quality of life associated with use of sulphonylurea co-administered with metformin.
  
  
  METHODS
  This was an observational, cross-sectional, multi-centre study.
  
  
  METHODS
  A total of 98 primary care centres in France during October to December 2005.
  
  
  METHODS
  A total of 400 patients with type 2 diabetes, who were > or = 35 years old and who had been treated with metformin and a sulphonylurea for at least 6 months, completed questionnaires during their usual primary care office visit.
  
  
  METHODS
  Frequency and severity of hypoglycaemic symptoms in the past 6 months, the Worry subscale of the Hypoglycaemic Fear Survey-II (HFS-II) and the EuroQol-5 Dimensions (EQ-5D) questionnaire.
  
  
  RESULTS
  A total of 136 (34%) patients reported experiencing hypoglycaemia, of whom 78 (58%) experienced mild, 40 (30%) experienced moderate and 16 (12%) experienced severe or very severe symptoms. Mean score on the HFS-II Worry scale was higher for patients who reported having hypoglycaemia than for those who did not (19.0 vs. 10.2; p < 0.0001) and increased with severity of hypoglycaemic symptoms. In linear regression analyses, more severe symptoms of hypoglycaemia were significantly associated with higher scores on the HFS-II Worry scale (p = 0.0162) among patients with hypoglycaemic symptoms. Summary scores on the EQ-5D were lower for patients who reported hypoglycaemia than for those who did not (p = 0.0001) and, in multivariate analysis, the experience of hypoglycaemia was negatively associated with the EQ-5D summary score (p < 0.0001).
  
  
  CONCLUSIONS
  The occurrence and severity of hypoglycaemic symptoms were associated with increased patient worry about hypoglycaemia and lower health-related quality of life among type 2 diabetic patients being treated with both metformin and a sulphonylurea.
authors.affiliation: Department of Diabetology and Endocrinology, Hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Vexiau
authors.forename: P
authors.initials: P
authors.lastname: Mavros
authors.forename: G
authors.initials: G
authors.lastname: Krishnarajah
authors.forename: R
authors.initials: R
authors.lastname: Lyu
authors.forename: D
authors.initials: D
authors.lastname: Yin
mesh_terms: D003430:Cross-Sectional Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005602:France / Q000453:epidemiology; D005913:Glipizide / Q000627:therapeutic use; D005905:Glyburide / Q000627:therapeutic use; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology* / Q000523:psychology*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D013315:Stress, Psychological; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C057619:glimepiride; D008687:Metformin; D005905:Glyburide; D005913:Glipizide