PMID- 20723229
OWN - NLM
STAT- MEDLINE
DCOM- 20110629
LR  - 20231103
IS  - 1477-7525 (Electronic)
IS  - 1477-7525 (Linking)
VI  - 8
DP  - 2010 Aug 19
TI  - Association of hypoglycemic symptoms with patients' rating of their 
      health-related quality of life state: a cross sectional study.
PG  - 86
LID - 10.1186/1477-7525-8-86 [doi]
AB  - BACKGROUND: To evaluate the association between patient-reported hypoglycemic 
      symptoms with ratings of their health-related quality of life state and 
      patient-reported adverse events in patients with type 2 diabetes mellitus (T2DM). 
      METHODS: This observational, multicenter, cross sectional study was based on a 
      sample of patients with T2DM from seven European countries who added sulfonylurea 
      or thiazolidinedione to metformin monotherapy between January 2001 and January 
      2006. Included patients were required to have at least one hemoglobin A1c (HbA1c) 
      measurement in the 12 months before enrollment and to not be receiving insulin. 
      Demographic and clinical data from medical records were collected using case 
      report forms. Questionnaires measured patient-reported hypoglycemic symptoms, 
      health-related quality of life (EuroQol visual analogue scale, EQ-5D VAS), and 
      treatment-related adverse events. RESULTS: A total of 1,709 patients were 
      included in the study. Mean patient age was 63 years, 45% were female, mean HbA1c 
      was 7.06%, and 28% were at HbA1c goal (HbA1c < 6.5%). Hypoglycemic symptoms 
      during the 12 months before enrollment were reported by 38% of patients; among 
      whom 68% reported their most severe symptoms were mild, 27% moderate, and 5% 
      severe. Adjusted linear regression analyses revealed that patients reporting 
      hypoglycemic symptoms had significantly lower EQ-5D VAS scores indicating worse 
      patient-reported quality of life (mean difference -4.33, p < 0.0001). Relative to 
      those not reporting symptoms, the adjusted decrement to quality of life increased 
      with greater hypoglycemic symptom severity (mild: -2.68, p = 0.0039; moderate: 
      -6.42, p < 0.0001; severe: -16.09, p < 0.0001). Patients with hypoglycemia 
      reported significantly higher rates of shakiness, sweating, excessive fatigue, 
      drowsiness, inability to concentrate, dizziness, hunger, asthenia, and headache 
      (p < 0.0001 for each comparison). CONCLUSIONS: Hypoglycemic symptoms and symptom 
      severity have an adverse effect on patients' rating of their health related 
      quality of life state. Hypoglycemic symptoms are correlated with 
      treatment-related adverse effects. Minimizing the risk and severity of 
      hypoglycemia may improve patients' quality of life and clinical outcomes. Results 
      are subject to limitations associated with observational studies including the 
      potential biases due to unobserved patient heterogeneity and the use of a 
      convenience sample of patients.
FAU - Alvarez-Guisasola, Fernando
AU  - Alvarez-Guisasola F
AD  - Outcomes Research, Merck & Co,, Inc,, Whitehouse Station, NJ, USA.
FAU - Yin, Donald D
AU  - Yin DD
FAU - Nocea, Gonzalo
AU  - Nocea G
FAU - Qiu, Ying
AU  - Qiu Y
FAU - Mavros, Panagiotis
AU  - Mavros P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100819
PL  - England
TA  - Health Qual Life Outcomes
JT  - Health and quality of life outcomes
JID - 101153626
SB  - IM
MH  - Activities of Daily Living
MH  - Aged
MH  - Cross-Sectional Studies
MH  - Diabetes Mellitus, Type 2/blood/*complications
MH  - Europe
MH  - Female
MH  - *Health Status Indicators
MH  - Humans
MH  - *Hypoglycemia/etiology
MH  - Life Style
MH  - Linear Models
MH  - Male
MH  - Middle Aged
MH  - Observation
MH  - *Quality of Life
MH  - Sickness Impact Profile
MH  - Surveys and Questionnaires
PMC - PMC2936440
EDAT- 2010/08/21 06:00
MHDA- 2011/06/30 06:00
PMCR- 2010/08/19
CRDT- 2010/08/21 06:00
PHST- 2010/02/03 00:00 [received]
PHST- 2010/08/19 00:00 [accepted]
PHST- 2010/08/21 06:00 [entrez]
PHST- 2010/08/21 06:00 [pubmed]
PHST- 2011/06/30 06:00 [medline]
PHST- 2010/08/19 00:00 [pmc-release]
AID - 1477-7525-8-86 [pii]
AID - 10.1186/1477-7525-8-86 [doi]
PST - epublish
SO  - Health Qual Life Outcomes. 2010 Aug 19;8:86. doi: 10.1186/1477-7525-8-86.