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Table 1. Glitazone trials with available end-of-treatment histology.
Study Drug dose Comparator Treatment n (drug/ % with Normal Professional Run-in
per day n duration comparator) diabetes ALT diet period
n for end of included counselling*
treatment
histology
Randomized controlled trials
Sanyal, Pioglita- Vitamin E 6 months 18 (9/9) 0 Yes Yes Yes
2004 [13] zone n=10 (no
30 mg + results)
vitamin E,
n= 10 Yes
Belfort, Pioglita- Placebo 6 months 47 (26/21) 50 § No Yes No
2006 [10] zone 45 mg, n= 24,
n= 29 (total 55) Yes
(no
Ratziu, Rosiglita- Placebo 1 year 63 (32/31) 33 No No results)
2008 [11] zone n=32 No
8 mg, n=32
No
Aithal, Pioglita- Placebo 1 year 61(31/30) 0 Yes No
2008 [12] zone n=37 No
30 mg,
n=37 Yes
Sanyal, Pioglita- Placebo 2 years 142 (70/72) 0 Yes No
2010 [9] zone n=84
30 mg,
n=80
Open-label trials
Caldwell, Troglita- none 6 months 7 10 No No
2001 zone
[14] 400 mg,
n=10
Neusc- Rosiglita- none 12 22 24 Yes No
wander- zone months
Tetri, 8 mg, n=25
2003 [15]
Promrat, Pioglita- none 1 year 18 0 No No
2004 zone
[16] 30 mg,
n=18
* i.e. follow-up visits with a dietician. § the remaining 50% were glucose intolerant [17]
70 Postgraduate Course Syllabus • Metabolic Liver Disease
Study Drug dose Comparator Treatment n (drug/ % with Normal Professional Run-in
per day n duration comparator) diabetes ALT diet period
n for end of included counselling*
treatment
histology
Randomized controlled trials
Sanyal, Pioglita- Vitamin E 6 months 18 (9/9) 0 Yes Yes Yes
2004 [13] zone n=10 (no
30 mg + results)
vitamin E,
n= 10 Yes
Belfort, Pioglita- Placebo 6 months 47 (26/21) 50 § No Yes No
2006 [10] zone 45 mg, n= 24,
n= 29 (total 55) Yes
(no
Ratziu, Rosiglita- Placebo 1 year 63 (32/31) 33 No No results)
2008 [11] zone n=32 No
8 mg, n=32
No
Aithal, Pioglita- Placebo 1 year 61(31/30) 0 Yes No
2008 [12] zone n=37 No
30 mg,
n=37 Yes
Sanyal, Pioglita- Placebo 2 years 142 (70/72) 0 Yes No
2010 [9] zone n=84
30 mg,
n=80
Open-label trials
Caldwell, Troglita- none 6 months 7 10 No No
2001 zone
[14] 400 mg,
n=10
Neusc- Rosiglita- none 12 22 24 Yes No
wander- zone months
Tetri, 8 mg, n=25
2003 [15]
Promrat, Pioglita- none 1 year 18 0 No No
2004 zone
[16] 30 mg,
n=18
* i.e. follow-up visits with a dietician. § the remaining 50% were glucose intolerant [17]
70 Postgraduate Course Syllabus • Metabolic Liver Disease