PMID- 20799756
OWN - NLM
STAT- MEDLINE
DCOM- 20110131
LR  - 20221207
IS  - 1179-2027 (Electronic)
IS  - 1170-7690 (Linking)
VI  - 28
IP  - 9
DP  - 2010
TI  - An economic evaluation of colesevelam when added to metformin-, insulin- or 
      sulfonylurea-based therapies in patients with uncontrolled type 2 diabetes 
      mellitus.
PG  - 765-80
LID - 10.2165/11539600-000000000-00000 [doi]
AB  - BACKGROUND: Several early studies demonstrated that bile acid sequestrants were 
      useful for lowering lipid levels in patients with hypercholesterolaemia and may 
      also be useful for lowering glucose levels in patients with type 2 diabetes 
      mellitus (T2DM) uncontrolled on existing treatment (metformin-, insulin- or 
      sulfonylurea-based therapies). OBJECTIVE: This study modelled efficacy and safety 
      data from the three clinical trials to evaluate the cost effectiveness to US 
      Managed Care Organizations of add-on treatment with colesevelam for reducing 
      diabetes-related complications. METHODS: Three randomized controlled trials in 
      patients with T2DM and one in hyperlipidaemia established that colesevelam 
      lowered both glycaemic and lipid parameters in adult patients participating in 
      the studies. The validated 'diabetic risk equation' (DRE) and the 'LIPID 
      cardiovascular risk equation' (LCRE) were used to translate the observed clinical 
      benefits (surrogate markers related to T2DM [glycosylated haemoglobin HbA(1c) 
      and fasting plasma glucose] and cardiovascular disease [low-density lipoprotein 
      cholesterol LDL-C]). Performing an appropriate economic evaluation required the 
      use of both the DRE and the LCRE. These equations parameterize the clinical 
      efficacy measures as continuous, facilitating their application to clinical trial 
      results as well as the replication of other well established epidemiological 
      data. Tobit regressions were applied to a large commercially available managed 
      care administrative claims database (2000-6), Integrated Health Care Services 
      (IHCS), to evaluate the incremental costs associated with each type of diabetic 
      complication. Costs were inflated to 2010 values using the Healthcare Consumer 
      Price Index, while second- and third-year cost savings were discounted at 5% to 
      the current year. Bootstrap sampling with 5000 samples of 100 patients per cohort 
      was conducted, varying the number of events avoided as well as their associated 
      cost. RESULTS: With established metformin-, insulin- or sulfonylurea-based 
      therapies, the addition of colesevelam significantly reduced HbA(1c) by 
      approximately 0.5% (p < 0.001) in all three studies. In addition, colesevelam 
      reduced placebo-adjusted LDL-C by 12.8-16.7% (p < 0.001). Using the DRE and LCRE 
      equations, the total savings from reductions in diabetes-related and 
      cardiovascular events were $US3543, $US4074 and $US3855 for colesevelam added to 
      metformin-, insulin- and sulfonylurea-based regimens in patients with normal 
      lipid levels. After subtracting the cost of colesevelam, first-year savings were 
      $US1326, $US1852 and $US1629 in the metformin, insulin and sulfonylurea studies, 
      respectively, for patients with raised lipid levels. CONCLUSIONS: In adult 
      patients with T2DM, the addition of colesevelam to metformin-, insulin- or 
      sulfonylurea-based therapies significantly improves glycaemic control while also 
      reducing LDL-C, and these improvements could translate into substantial cost 
      reductions due to reductions in the rates of diabetes-related and cardiovascular 
      complications.
FAU - Simons, W Robert
AU  - Simons WR
AD  - Global Health Economics & Outcomes Research, Inc., Summit, New Jersey 07901, USA. 
      rsimons@globalhealtheconomics.com
FAU - Hagan, Michael A
AU  - Hagan MA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Pharmacoeconomics
JT  - PharmacoEconomics
JID - 9212404
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Insulin)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 48G762T011 (Allylamine)
RN  - 9100L32L2N (Metformin)
RN  - P4SG24WI5Q (Colesevelam Hydrochloride)
MH  - Adult
MH  - Aged
MH  - Allylamine/administration & dosage/*analogs & derivatives/economics/therapeutic 
      use
MH  - Cardiovascular Diseases/economics/prevention & control
MH  - Cholesterol, LDL/blood
MH  - Colesevelam Hydrochloride
MH  - Cost-Benefit Analysis/methods
MH  - Databases, Factual
MH  - Diabetes Complications/economics/prevention & control
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/*economics
MH  - Drug Therapy, Combination/economics/methods
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Health Care Costs
MH  - Humans
MH  - Hypercholesterolemia/blood/drug therapy
MH  - Insulin/administration & dosage/economics/*therapeutic use
MH  - Male
MH  - Metformin/administration & dosage/economics/*therapeutic use
MH  - Middle Aged
MH  - *Models, Economic
MH  - Randomized Controlled Trials as Topic
MH  - Risk
MH  - Sulfonylurea Compounds/administration & dosage/economics/*therapeutic use
MH  - Treatment Outcome
MH  - United States
EDAT- 2010/08/31 06:00
MHDA- 2011/02/01 06:00
CRDT- 2010/08/31 06:00
PHST- 2010/08/31 06:00 [entrez]
PHST- 2010/08/31 06:00 [pubmed]
PHST- 2011/02/01 06:00 [medline]
AID - 2 [pii]
AID - 10.2165/11539600-000000000-00000 [doi]
PST - ppublish
SO  - Pharmacoeconomics. 2010;28(9):765-80. doi: 10.2165/11539600-000000000-00000.