Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis

Engel, Samuel S; Golm, Gregory T; Shapiro, Deborah; Davies, Michael J; Kaufman, Keith D; Goldstein, Barry J

doi:10.1186/1475-2840-12-3

Cardiovascular Diabetology

Table 2 Studies and treatment arms included in pooled analysis

From: Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis

Study	Study design	Sitagliptin 100 mg/day group^§ (N = 7195)	n	Non-exposed group (N = 6267)^§	n	Reference*
P010: twice-daily dose-range finding	106-week active-controlled period	-Sitagliptin 50 mg b.i.d. switched to sitagliptin 100 mg q.d.	122	-Glipizide	123	[27]^†
P014: once-daily dose-range finding	12-week placebo-controlled period and 94-week active-controlled period	-Sitagliptin 100 mg q.d.	110	-Placebo (12 weeks) switched to metformin (94 weeks)	111	[63]^††
		-Sitagliptin 50 mg b.i.d. switched to sitagliptin 100 mg q.d.	111
P019: placebo-controlled add-on to pioglitazone study	24-week placebo-controlled period	-Sitagliptin 100 mg q.d.	175	-Placebo	178	[64]^††
P020: placebo-controlled add-on to metformin study	24-week placebo-controlled period and 80-week active-controlled period	-Sitagliptin 100 mg q.d.	464	-Placebo (24 weeks) switched to glipizide	237	[65]^††
P021: placebo-controlled monotherapy study	24-week placebo-controlled period	-Sitagliptin 100 mg q.d.	238	-Placebo	253	[66]^††
P023: placebo-controlled monotherapy study	18-week placebo-controlled period and 36-week active-controlled period	-Sitagliptin 100 mg q.d.	205	-Placebo (18 weeks) switched to pioglitazone (36 weeks)	110	[67]^††
P024: active-controlled add-on to metformin study	104-week active-controlled period	-Sitagliptin 100 mg q.d.	588	-Glipizide	584	[28, 29]^†
P035: placebo-controlled add-on to glimepiride, alone or in combination with metformin study	24-week placebo-controlled period and 30-week active-controlled period	-Sitagliptin 100 mg q.d.	222	-Placebo (24 weeks) switched to pioglitazone (30 weeks)	219	[68]^††
P036: placebo- and active-controlled study of initial combination use of sitagliptin and metformin	24-week placebo-controlled period; 80-week active-controlled period	-Sitagliptin 100 mg q.d.	179	-Placebo (24 weeks) switched to metformin (80 weeks)	176	[69–71]^††
		-Sitagliptin 50 mg b.i.d. + metformin 500 mg b.i.d.	190	-Metformin 500 mg b.i.d.	182
		-Sitagliptin 50 mg b.i.d. + metformin 1000 mg b.i.d.	182	-Metformin 1000 mg b.i.d.	182
P040: placebo-controlled monotherapy study	18-week placebo-controlled period	-Sitagliptin 100 mg q.d.	352	-Placebo	178	[72]^††
P047: placebo-controlled monotherapy study in elderly patients	24-week placebo-controlled period	-Sitagliptin 100 mg q.d.	91	-Placebo	92	[73]^††
P049: active-controlled monotherapy study	24-week active-controlled period	-Sitagliptin 100 mg q.d.	528	-Metformin	522	[74]
P051: placebo-controlled add-on to insulin, alone or in combination with metformin study	24-week placebo-controlled period	-Sitagliptin 100 mg q.d.	322	-Placebo	319	[75]^††
P052: placebo-controlled add-on to metformin and rosiglitazone study	54-week placebo-controlled period	-Sitagliptin 100 mg q.d.	170	-Placebo	92	[76]^††
P053: placebo-controlled add-on to metformin study	30-week placebo-controlled period	-Sitagliptin 100 mg q.d.	96	-Placebo	94	[77]^††
P061: placebo- and active-controlled mechanism of action factorial study	12-week placebo-controlled period	-Sitagliptin 100 mg q.d.	52	-Pioglitazone	54	[78]^††
		-Sitagliptin 100 mg q.d. + pioglitazone	52	-Placebo	53
P064: active-controlled study of initial combination use of sitagliptin and pioglitazone	54-week active-controlled period	-Sitagliptin 100 mg q.d. + pioglitazone	261	-Pioglitazone	259	[79, 80]^††
P066: active-controlled study of combination use of sitagliptin/metformin FDC	32-week active-controlled period	-Sitagliptin 50 mg + metformin 1000 mg b.i.d. (FDC)	261	-Pioglitazone 45 mg q.d.	256	[81]
P068: active-controlled study of sitagliptin and combination use of sitagliptin/metformin FDC	40-week active-controlled period	-Sitagliptin 100 mg q.d. switched to sitagliptin 50 mg + metformin 1000 mg b.i.d. (FDC)	244	-Pioglitazone 15 mg q.d. titrated up to 45 mg q.d.	247	[82]
P074: placebo-controlled add-on to metformin study	24-week placebo-controlled period	-Sitagliptin 100 mg q.d.	197	-Placebo	198	[83]^††
P079: active-controlled study of initial combination use of sitagliptin/metformin FDC	44-week active-controlled period	-Sitagliptin 50 mg + metformin 1000 mg b.i.d. (FDC)	625	-Metformin 1000 mg b.i.d. (FDC)	621	[84, 85]^††
P102: active-controlled study of initial combination use of sitagliptin and pioglitazone	54-week active-controlled period	-Sitagliptin 100 mg q.d.	231			[86]^††
		-Sitagliptin 50 mg b.i.d. + pioglitazone 15 mg q.d.	230	-Pioglitazone 15 mg q.d.	230
		-Sitagliptin 50 mg b.i.d. + pioglitazone 30 mg q.d.	231	-Pioglitazone 30 mg q.d.	233
		-Sitagliptin 50 mg b.i.d. + pioglitazone 45 mg q.d.	230	-Pioglitazone 45 mg q.d.	230
P128: placebo-controlled add-on to metformin and pioglitazone study	26-week placebo-controlled period	-Sitagliptin 100 mg q.d.	157	-Placebo	156	[87]^††
P801: placebo- and active-controlled add-on to metformin study	18-week placebo-controlled period	-Sitagliptin 100 mg q.d.	94	-Rosiglitazone 8 mg q.d.	87	[88]^††
				-Placebo	91
P803: active-controlled add-on to metformin study	30-week active-controlled period	-Sitagliptin 100 mg q.d.	516	-Glimepiride	518	[30]^†

* References are for the initial phases of the studies that had extension or continuation phases, unless a reference is provided for the results beyond the initial phase.
^§ This column reflects the blinded treatment(s) to which patients were randomised. For studies identified in column 1 as "add-on" studies, all patients also received the active therapy indicated in column 1 (open-label).
^† Studies included in the primary Sitagliptin vs. Sulphonylurea comparison.
^†† Studies included in the primary Sitagliptin vs. Placebo comparison. This comparison included studies where patients were randomised to sitagliptin or placebo as monotherapy (e.g., P021) or as add-on therapy (e.g., P019), as well as studies where patients were randomised to sitagliptin + active agent or active agent (e.g., P102). The control groups of studies in the latter category included a sitagliptin-matched placebo for purposes of blinding. For studies where the placebo control group switched to active therapy at a post-randomisation time point (e.g., P020), only the placebo-controlled portion of the study was included.
q.d. = once daily; b.i.d. = twice daily; FDC = fixed-dose combination tablet.

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ISSN: 1475-2840

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