Vildagliptin | place in therapy review Table 3 | Effects of vildagliptin on blood glucose and glycosylated hemoglobin (HbA1c) in active-controlled comparative studies (all level 2 evidence) Design Treatment and dose Double-blind, placebo-controlled RCT, 24 weeks Mean change from baseline in HbA1c (percentage points) % patients reaching HbA1c <7.0%a Placebo + P 30 mg qd –1.4 Placebo + P 30 mg qd 43% Placebo + P 30 mg qd –1.9 Outcome Mean change from baseline in fasting plasma glucose (mmol/L) Mean change from baseline in 4 h-postprandial plasma glucose (mmol/L) NR NR NR NR NR NR V 50 mg qd + P 15 mg qd –3.8 (P=0.024 vs placebo + P)b V 100 mg qd + P 30 mg qd –5.2 (P<0.001 vs placebo + P)b V 50 mg qd + P 45 mg qd –1.2b,c V 50 mg bid + P 45 mg qd –1.9 (P=0.008 vs placebo)b,c Reference Rosenstock et al. 2007a Rosenstock et al. 2007b Goeke et al. 2006; Schweizer et al. 2007 Baron et al. 2006; Garber et al. 2007b Placebo + P 30 mg qd (n=157) Placebo + V 100 mg qd (n=150) V 50 mg qd + P 15 mg qd (n=139) V 100 mg qd + P 30 mg qd (n=146) V 50 mg bid (n=459) R 8 mg qd (n=238) V 50 mg bid (n=526) M 1 g bid (n=254) Placebo + P 45 mg qd (n=138) V 50 mg qd + P 45 mg qd (n=124) V 50 mg bid + P 45 mg qd (n=136) Placebo + V 100 mg qd –1.1 (P<0.001 vs V 100 mg qd + P 30 mg qd) V 50 mg qd + P 15 mg V 50 mg qd + P qd –1.7 (P=0.039 vs 15 mg qd 54% placebo + P) V 100 mg qd + P 30 mg qd –1.9 (P<0.001 vs placebo + P) Placebo + V 100 mg qd 43% V 100 mg qd + P 30 mg qd 65% (P<0.001 vs placebo + V and placebo + P) NR NR V 50 mg bid –1.1 R 8 mg qd –1.3 V 50 mg bid –1.0 V 50 mg bid 35% V 50 mg bid –0.9 M 1 g bid –1.4 M 1 g bid 45% Placebo + P 45 mg qd –0.3 Placebo + P 45 mg qd 14.8% V 50 mg qd + P 45 mg V 50 mg qd + P qd –0.8 (P=0.001 vs 45 mg qd 28.7% placebo) (P=0.007 vs placebo) V 50 mg bid + P 45 mg qd –1.0 (P<0.001 vs placebo) V 50 mg bid + P 45 mg qd 36.4% (P<0.001 vs placebo) Placebo + V 100 mg qd –1.3 (P<0.001 vs V 100 mg qd + P 30 mg qd) V 50 mg qd + P 15 mg qd –2.4 (P=0.022 vs placebo + P) V 100 mg qd + P 30 mg qd –2.8 (P<0.001 vs placebo + P) V 50 mg bid –1.3 R 8 mg qd –2.3 (P<0.001 vs V) M 1 g bid –1.9 (P<0.001 vs V) Placebo + P 45 mg qd –0.5 V 50 mg qd + P 45 mg qd –0.8 V 50 mg bid + P 45 mg qd –1.1 Double-blind RCT, 24 weeks Double-blind RCT, 52 weeks Double-blind, placebo-controlled RCT, 24 weeks aOf patients with HbA1c ≥7.0% at baseline. bValue relative to placebo + P. c2h-postprandial plasma glucose. bid, twice daily; M, metformin; NR, not reported; P, pioglitazone; qd, once daily; R, rosiglitazone; RCT, randomized controlled trial; V, vildagliptin. many again when vildagliptin 100 mg once daily was combined with pioglitazone 30 mg once daily compared with either agent alone (Rosenstock et al. 2007a; Table 3). Fewer patients with a higher baseline HbA1c (>8.5%) achieved the target of <7.0% when vildagliptin 50 or 100 mg/day was added to metformin compared with those with intermediate (7.9–8.5%) baseline levels (7.5% and 16.3% versus 22.2% and 31.4%) (Bosi et al. 2007). 20 Although a similar reduction in HbA1c was achieved, vildagliptin 50 mg twice daily was not found to be noninferior to metformin 2 g daily (Goeke et al. 2006; Schweizer et al. 2007; Table 3). Vildagliptin appears to be as effective as pioglitazone (Baron et al. 2006; Garber et al. 2007b), and rosiglitazone (Rosenstock et al. 2007b) at reducing HbA1c (Table 3). © 2008 Core Medical Publishing Limited