Impact of unrestricted use of troglitazone in the VA Northern California Health Care System: Computer-based analysis of the first 15 months

R. H. Noth, J. L. Meier, Arthur L Swislocki, J. R. Lopez

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Abstract

Troglitazone (TROG), the first of the new insulin-sensitizing thiazolidinediones, became available in the VANCHCS in 3/97. Unlike metformin which for safety concerns initialy in the VANCHCS was restricted to endocrinologists, TROG was unrestricted. Clinician interest in its unique action and patient demand from promotional advertising resulted in TROG use in 357 diabetics, 9% of all pharmacologically-treated diabetics in VANCHCS, through 6/98. Liver toxicity was a concern, and frequent liver function tests (LFTs) were advised. Analysis of the VANCHCS experience was carried out using VA computer clinical databases as the sole source of data. The population was predominantly white, older (63 ± 11 [SD] yrs) males (98%). Through 9/98, 91 failed to refill an Rx within 120 days after the last prescription, probably representing dropouts. Mean duration of treatment was 7.4 ± 4.7 months. Lab data were retrieved from 1 yr pre-Rx (LFTs - AST reported) or 4 mo pre-Rx (HbA1c) through 9/98. During this 30 mo., 327 had AST tested, 237 (448 tests) in the baseline period, 243 (726 tests) in the treatment periods. At least one AST value was elevated in 22 individuals during the baseline year, 7 of these over 1.5x the upper limit During treatment, 16 AST values were high, 7 were over 1.5x the upper limit. Only one diabetic had a value over 2x, and this occurred both in the baseline and treatment periods. HbA1c, reflecting glycemic control, was tested in 340 overall. Baseline 3 Months Rx 6 Months Rx 9+ Months Rx Mean HbA1c (%)± SE 9.33 ± 0.09 8.61 ± 0.11 8.52 ± 0.2 8.41 ± 0.12 n tested; p (vs Baseline, paired) 282 210; 2.67E-09 147; 8.27E-10 112; 3.5E-09 Mean max dose (mg/d); cost pt/mo 320; $71 371; $90 423; $105 TROG appeared to be safe, at least during the 18 month period analyzed; however, liver function testing was underutilized and abnormal values may have been missed. TROG, used in a variety of treatment strategies, had an efficacy in terms of HbA1c lowering about equal to metformin in a similar setting (VANCHCS 1995), but at a substantially greater current VA medication cost.

Original languageEnglish (US)
JournalJournal of Investigative Medicine
Volume47
Issue number2
StatePublished - Feb 1999

Fingerprint

troglitazone
Health care
Computer systems
Liver
Delivery of Health Care
Metformin
Liver Function Tests
Costs and Cost Analysis
Thiazolidinediones
Information Storage and Retrieval
Therapeutics
Prescriptions
Toxicity
Marketing
Costs
Databases
Insulin
Safety

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

@article{b198a16934a44232b88ebb127275ac6a,
title = "Impact of unrestricted use of troglitazone in the VA Northern California Health Care System: Computer-based analysis of the first 15 months",
abstract = "Troglitazone (TROG), the first of the new insulin-sensitizing thiazolidinediones, became available in the VANCHCS in 3/97. Unlike metformin which for safety concerns initialy in the VANCHCS was restricted to endocrinologists, TROG was unrestricted. Clinician interest in its unique action and patient demand from promotional advertising resulted in TROG use in 357 diabetics, 9{\%} of all pharmacologically-treated diabetics in VANCHCS, through 6/98. Liver toxicity was a concern, and frequent liver function tests (LFTs) were advised. Analysis of the VANCHCS experience was carried out using VA computer clinical databases as the sole source of data. The population was predominantly white, older (63 ± 11 [SD] yrs) males (98{\%}). Through 9/98, 91 failed to refill an Rx within 120 days after the last prescription, probably representing dropouts. Mean duration of treatment was 7.4 ± 4.7 months. Lab data were retrieved from 1 yr pre-Rx (LFTs - AST reported) or 4 mo pre-Rx (HbA1c) through 9/98. During this 30 mo., 327 had AST tested, 237 (448 tests) in the baseline period, 243 (726 tests) in the treatment periods. At least one AST value was elevated in 22 individuals during the baseline year, 7 of these over 1.5x the upper limit During treatment, 16 AST values were high, 7 were over 1.5x the upper limit. Only one diabetic had a value over 2x, and this occurred both in the baseline and treatment periods. HbA1c, reflecting glycemic control, was tested in 340 overall. Baseline 3 Months Rx 6 Months Rx 9+ Months Rx Mean HbA1c ({\%})± SE 9.33 ± 0.09 8.61 ± 0.11 8.52 ± 0.2 8.41 ± 0.12 n tested; p (vs Baseline, paired) 282 210; 2.67E-09 147; 8.27E-10 112; 3.5E-09 Mean max dose (mg/d); cost pt/mo 320; $71 371; $90 423; $105 TROG appeared to be safe, at least during the 18 month period analyzed; however, liver function testing was underutilized and abnormal values may have been missed. TROG, used in a variety of treatment strategies, had an efficacy in terms of HbA1c lowering about equal to metformin in a similar setting (VANCHCS 1995), but at a substantially greater current VA medication cost.",
author = "Noth, {R. H.} and Meier, {J. L.} and Swislocki, {Arthur L} and Lopez, {J. R.}",
year = "1999",
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language = "English (US)",
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journal = "Journal of Investigative Medicine",
issn = "1081-5589",
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TY - JOUR

T1 - Impact of unrestricted use of troglitazone in the VA Northern California Health Care System

T2 - Computer-based analysis of the first 15 months

AU - Noth, R. H.

AU - Meier, J. L.

AU - Swislocki, Arthur L

AU - Lopez, J. R.

PY - 1999/2

Y1 - 1999/2

N2 - Troglitazone (TROG), the first of the new insulin-sensitizing thiazolidinediones, became available in the VANCHCS in 3/97. Unlike metformin which for safety concerns initialy in the VANCHCS was restricted to endocrinologists, TROG was unrestricted. Clinician interest in its unique action and patient demand from promotional advertising resulted in TROG use in 357 diabetics, 9% of all pharmacologically-treated diabetics in VANCHCS, through 6/98. Liver toxicity was a concern, and frequent liver function tests (LFTs) were advised. Analysis of the VANCHCS experience was carried out using VA computer clinical databases as the sole source of data. The population was predominantly white, older (63 ± 11 [SD] yrs) males (98%). Through 9/98, 91 failed to refill an Rx within 120 days after the last prescription, probably representing dropouts. Mean duration of treatment was 7.4 ± 4.7 months. Lab data were retrieved from 1 yr pre-Rx (LFTs - AST reported) or 4 mo pre-Rx (HbA1c) through 9/98. During this 30 mo., 327 had AST tested, 237 (448 tests) in the baseline period, 243 (726 tests) in the treatment periods. At least one AST value was elevated in 22 individuals during the baseline year, 7 of these over 1.5x the upper limit During treatment, 16 AST values were high, 7 were over 1.5x the upper limit. Only one diabetic had a value over 2x, and this occurred both in the baseline and treatment periods. HbA1c, reflecting glycemic control, was tested in 340 overall. Baseline 3 Months Rx 6 Months Rx 9+ Months Rx Mean HbA1c (%)± SE 9.33 ± 0.09 8.61 ± 0.11 8.52 ± 0.2 8.41 ± 0.12 n tested; p (vs Baseline, paired) 282 210; 2.67E-09 147; 8.27E-10 112; 3.5E-09 Mean max dose (mg/d); cost pt/mo 320; $71 371; $90 423; $105 TROG appeared to be safe, at least during the 18 month period analyzed; however, liver function testing was underutilized and abnormal values may have been missed. TROG, used in a variety of treatment strategies, had an efficacy in terms of HbA1c lowering about equal to metformin in a similar setting (VANCHCS 1995), but at a substantially greater current VA medication cost.

AB - Troglitazone (TROG), the first of the new insulin-sensitizing thiazolidinediones, became available in the VANCHCS in 3/97. Unlike metformin which for safety concerns initialy in the VANCHCS was restricted to endocrinologists, TROG was unrestricted. Clinician interest in its unique action and patient demand from promotional advertising resulted in TROG use in 357 diabetics, 9% of all pharmacologically-treated diabetics in VANCHCS, through 6/98. Liver toxicity was a concern, and frequent liver function tests (LFTs) were advised. Analysis of the VANCHCS experience was carried out using VA computer clinical databases as the sole source of data. The population was predominantly white, older (63 ± 11 [SD] yrs) males (98%). Through 9/98, 91 failed to refill an Rx within 120 days after the last prescription, probably representing dropouts. Mean duration of treatment was 7.4 ± 4.7 months. Lab data were retrieved from 1 yr pre-Rx (LFTs - AST reported) or 4 mo pre-Rx (HbA1c) through 9/98. During this 30 mo., 327 had AST tested, 237 (448 tests) in the baseline period, 243 (726 tests) in the treatment periods. At least one AST value was elevated in 22 individuals during the baseline year, 7 of these over 1.5x the upper limit During treatment, 16 AST values were high, 7 were over 1.5x the upper limit. Only one diabetic had a value over 2x, and this occurred both in the baseline and treatment periods. HbA1c, reflecting glycemic control, was tested in 340 overall. Baseline 3 Months Rx 6 Months Rx 9+ Months Rx Mean HbA1c (%)± SE 9.33 ± 0.09 8.61 ± 0.11 8.52 ± 0.2 8.41 ± 0.12 n tested; p (vs Baseline, paired) 282 210; 2.67E-09 147; 8.27E-10 112; 3.5E-09 Mean max dose (mg/d); cost pt/mo 320; $71 371; $90 423; $105 TROG appeared to be safe, at least during the 18 month period analyzed; however, liver function testing was underutilized and abnormal values may have been missed. TROG, used in a variety of treatment strategies, had an efficacy in terms of HbA1c lowering about equal to metformin in a similar setting (VANCHCS 1995), but at a substantially greater current VA medication cost.

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