title: Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study.
abstract: OBJECTIVE
  This study was undertaken to evaluate (i) factors associated with patient-reported hypoglycaemia; (ii) association of patient-reported hypoglycaemic symptoms with treatment satisfaction and barriers to adherence and (iii) association between treatment satisfaction, adherence and glycaemic control among patients with type 2 diabetes who added a sulphonylurea or a thiazolidinedione to ongoing metformin.
  
  
  METHODS
  This observational, cross-sectional, multicentre study was conducted in seven countries (Finland, France, Germany, Norway, Poland, Spain and UK) from June 2006 to February 2007. Patients with type 2 diabetes who added a sulphonylurea or a thiazolidinedione to ongoing metformin therapy on a date (index date) from January 2001 through January 2006 and who had at least one haemoglobin A1C (HbA1C) measurement in the 12-month period before the visit date were eligible. Questionnaires were used to ascertain patients' reports of hypoglycaemic symptoms, treatment satisfaction, and treatment adherence. The Treatment Satisfaction Questionnaire for Medication was used to measure patients' treatment satisfaction. An adherence and barriers questionnaire was used to measure patients' adherence to treatment. Glycaemic control was based on documented HbA1C measurements within the prior 12 months.
  
  
  RESULTS
  The mean +/- s.d. age was 62.9 +/- 10.6 years, and the mean +/- s.d. duration of diabetes was 7.8 +/- 5.1 years. HbA1C in this population of patients who had failed metformin monotherapy and were treated with oral antihyperglycaemic agents was below the International Diabetes Federation goal of 6.5% in only 477 (27.9%) patients. Approximately 38% of patients reported hypoglycaemic symptoms during the past year. Hypoglycaemia was significantly more likely in patients with a history of macrovascular complications of diabetes (OR = 1.346; 95% CI = 1.050-1.725) and with no regular physical activity (OR = 1.295; 95% CI = 1.037-1.618). Patients reporting hypoglycaemia had significantly lower treatment satisfaction scores (71.6 +/- 17.6 vs. 76.3 +/- 16.8; p < 0.0001 for global satisfaction). Compared with their counterparts reporting no hypoglycaemic symptoms, patients with such symptoms were also significantly more likely to report barriers to adherence, including being unsure about instructions (37.0 vs. 30.5%; p = 0.0057). Patients at HbA1C goal had significantly higher treatment satisfaction and adherence compared with those who were not.
  
  
  CONCLUSIONS
  Patients' reports of hypoglycaemic symptoms are common in European outpatients with type 2 diabetes and are associated with significantly lower treatment satisfaction and with barriers to adherence. In addition, being at HbA1C goal is associated with treatment satisfaction and adherence.
authors.affiliation: Centro de Salud La Calzada II, Gijon, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Alvarez Guisasola
authors.forename: S
authors.initials: S
authors.lastname: Tofé Povedano
authors.forename: G
authors.initials: G
authors.lastname: Krishnarajah
authors.forename: R
authors.initials: R
authors.lastname: Lyu
authors.forename: P
authors.initials: P
authors.lastname: Mavros
authors.forename: D
authors.initials: D
authors.lastname: Yin
mesh_terms: D001786:Blood Glucose / Q000187:drug effects; D003430:Cross-Sectional Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005060:Europe / Q000453:epidemiology; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D012307:Risk Factors; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C089946:2,4-thiazolidinedione