Evidence Table 3

Head-to-head trials of pioglitazone vs rosiglitazone (New for Update #1)

Author, yearInclusion CriteriaExclusion CriteriaBaseline DemographicsBaseline CharacteristicsOther Medications at BaselineInterventionTotal Daily DoseSample SizeOutcome MeasureResults
Chappuis, 2007Patients with T2DM for a duration of at least 6 mos ad under stable metabolic control (HbA1c 6.5–9%).They had to be on a maximum of 2 oral anti diabetic agents.Patients treated with insulin or glitazones, or exhibiting symptoms of heart failure (NYHA class III or IV), active neoplasia, unstable cardio vascular disease, or severely impaired liver or kidney functionMean age:NR;
Male: 58.82%;
Female:
41.18%; White: %;
Black:
A1c:7.6; Weight:NR;
BMI:29.3; Duration of diabetes:
Antihypertensives:NR%
Lipid lowering:NR%
Insulin:NR%
Metformin:96%
Sulfonylureas:71%%
Acarbose: % Or
Pioglitazone monotherapy30 mg for 4 wks17BMI at 12 weeksChange in BMI from baseline: +0.5 (SD 0.6), p=0.15 , vs Rosi
45 mg for 8 wks17HbA1c at 12 weeks% Change in HbA1c from baseline: −0.3 (SD 0.6), p=0.43 vs. Rosi
Rosiglitazone monotherapy4 mg for 4 wks17BMI at 12 weekschange in BMI from baseline: +0.3 (SD 0.5)
8 mg for 8 wks17HbA1c at 12 weeks% change in HbA1c from baseline − 0.5(SD 0.6)
Derosa (J Int Med Research) 2006, 2006, 2007, 2007, 2006aCaucasians >=18 yrs with T2DM according to ADA criteria with a duration >=6 mos and who had poor glycemic control (HbA1c>7.5%) or had experienced adverse effects with diet and metformin given at up to the maximum tolerated dose. Pts had metabolic syndrome according to National Cholesterol Education Program Adult Tx Panel III classification, and presented with Triglyceridemia and hypertension according to the WHO criteria, fasting C-peptide level>1.0ng/ml and were overweight (BMI 25.0–28.1 kg/m2).Hx of ketoacidosis or had unstable or rapidly progressive diabetic retinopathy, nephropathy or neuropathy, impaired hepatic function, impaired renal function or severe anemia. Pts with serious cardiovascular disease or cerebrovascular conditions within 6 mos before study enrolment were also excluded.Mean age: ; Male:
.%; Female:
.%; White: %;
Black:
A1c: ; Weight: ; BMI: ;
Duration of diabetes:
Antihypertensives: %
Lipid lowering: %
Insulin: % Metformin: %
Sulfonylureas: %
Acarbose: % Oral hyp
Pioglitazone combination therapy15 mg103BMI at 12 monthsfinal: 26.6 (SD 1.1). Change from baseline: − 0.3, p>0.05 (from J. of clinical Ther)
48AST & ALT at 12 months25(SD 8), 26 (SD9), p>0.05, change from baseline: −3, −2
HCT at 12 monthsFinal: 8.6(SD3.8), p<0.05 vs baseline, change from baseline: −2.3
HbA1c at 12 monthsFinal: 6.8 (SD 0.3), p<0.01 vs. baseline, change from baseline: −1.4
Improvements in plasma level of HbA1c at 12 mos: 17.1%, p<0.01 vs. basline, p=NS between Pio and Rosi
Rosiglitazone combination therapy4mg48AST & ALT at 12 monthsfinal: 25(SD 9), 27(SD 10), p>0.05, change from baseline: −2, −2
HCT at 12 monthsFinal: 8.0(SD 3.4), p<0.05 vs baseline, change from baseline: −2.4
HbA1c at 12 monthsImprovements in plasma level of HbA1c at 12 mos: 16.0%, p<0.01 vs baseline
48BMI at 12 monthsfinal 6.8 (SD 0.5), change from baseline: − 1.3, p<0.001
Final: 26.0 (SD 1.2), change from baseline: −0.4

From: Evidence Tables

Cover of Drug Class Review: Thiazolidinediones
Drug Class Review: Thiazolidinediones: Final Report Update 1 [Internet].
Norris SL, Carson S, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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