Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk

Rosen, Jeffrey B.; Ballantyne, Christie M.; Hsueh, Willa A.; Lin, Jianxin; Shah, Arvind K.; Lowe, Robert S.; Tershakovec, Andrew M.

doi:10.1186/s12944-015-0075-5

Lipids in Health and Disease

Table 3 Adverse experience summary of pooled treatment groups

From: Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk

Adverse Experience	Obesity				TG				HDL-C				SB/ DBP				FG				HOMA-IR
Adverse Experience	males/females								males/females
n (%)	males/females								males/females
	<40 in/<35in)		≥40 in/≥35in)		<150 mg/dL		≥150 mg/dL		≥40 mg/dL/ ≥50 mg/dL		<40 mg/dL/ <50 mg/dL		<130 mmHg/ <85 mgHg		≥130 mmHg/ ≥ 85 mmHg		<100 mg/dL		≥100 mg/dL		<2.72		2.72 - 4.81		>4.81
	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S	All A	E/All S
	n = 94	n = 56	n = 578	n = 392	n = 209	n = 144	n = 469	n = 306	n = 282	n = 190	n = 396	n = 260	n = 56	n = 36	n = 622	n = 414	n = 192	n = 147	n = 486	n = 303	n = 229	n = 142	n = 222	n = 151	n = 218	n = 154
With one or more AE	14 (14.9)	12 (21.4)	120 (20.8)	64 (16.3)	40 (19.1)	21 (14.6)	94 (20.0)	55 (18.0)	57 (20.2)	35 (18.4)	77 (19.4)	41 (15.8)	8 (14.3)	6 (16.7)	126 (20.3)	70 (16.9)	39 (20.3)	26 (17.7)	95 (19.5)	50 (16.5)	47 (20.5)	33 (23.2)	43 (19.4)	17 (11.3)	40 (18.3)	26 (16.9)
With drug-related AE^a	2 (2.1)	2 (3.6)	24 (4.2)	13 (3.3)	3 (1.4)	4 (2.8)	23 (4.9)	11 (3.6)	11 (3.9)	7 (3.7)	15 (3.8)	8 (3.1)	2 (3.6)	1 (2.8)	24 (3.9)	14 (3.4)	11 (5.7)	5 (3.4)	15 (3.1)	10 (3.3)	4 (1.7)	5 (3.5)	10 (4.5)	3 .0 (2.0)	11 (5.0)	7 (4.5)
With serious AE	1 (1.1)	0 (0)	8 (1.4)	1 (0.3)	2 (1.0)	1 (0.7)	7 (1.5)	0 (0)	4 (1.4)	0 (0)	5 (1.3)	1 (0.4)	1 (1.8)	0 (0)	8 (1.3)	1 (0.2)	3 (1.6)	1 (0.7)	6 (1.2)	0 (0)	3 (1.3)	0 (0)	3 (1.4)	1 (0.7)	2 (0.9)	0 (0)
With serious drug-related AE	0 (0)	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.2)	0 (0)	1 (0.4)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.5)	0 (0)	0 (0)	0 (0)
Discontinued due to AE	1 (1.1)	0 (0)	11 (1.9)	6 (1.5)	1 (0.5)	2 (1.4)	11 (2.3)	4 (1.3)	4 (1.4)	3 (1.6)	8 (2.0)	3 (1.2)	1 (1.8)	0 (0)	11 (1.8)	6 (1.4)	3 (1.6)	1 (0.7)	9 (1.9)	5 (1.7)	2 (0.9)	1 (0.7)	4 (1.8)	1 (0.7)	4 (1.8)	4 (2.6)
drug-related	0 (0)	0 (0)	7 (1.2)	4 (1.0)	0 (0)	1 (0.7)	7 (1.5)	3 (1.0)	2 (0.7)	3 (1.6)	5 (1.3)	1 (0.4)	1 (1.8)	0 (0)	6 (1.0)	4 (1.0)	2 (1.0)	1 (0.7)	5 (1.0)	3 (1.1)	1 (0.4)	0 (0)	2 (0.9)	1 (0.7)	3 (1.4)	3 (1.9)
serious	0 (0)	0 (0)	2 (0.3)	0 (0)	0 (0)	0 (0)	2 (0.4)	0 (0)	2 (0.7)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	2 (0.3)	0 (0)	0 (0)	0 (0)	2 (0.4)	0 (0)	0 (0)	0 (0)	1 (0.5)	0 (0)	1 (0.5)	0 (0)
serious drug-related	0 (0)	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.2)	0 (0)	1 (0.4)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.5)	0 (0)	0 (0)	0 (0)
Deaths	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Pre-specified^b m/n (%)
ALT or AST ≥ 3xULN, consecutive^c	0/92	1/55 (1.8)	2/559 (0.4)	5/385 (1.3)	0/203	1/142 (0.7)	2/454 (0.4)	5/300 (1.7)	2/273 (0.7)	5/186 (2.7)	0/384	1/256 (0.4)	0/53	1/35 (2.9)	2/604 (0.3)	5/407 (1.2)	1/188 (0.5)	2/143 (1.4)	1/469 (0.2)	4/299 (1.3)	0/222	3/141 (2.1)	2/216 (0.9)	1/147 0.7)	0/211	2/151 (1.3)
ALT ≥ 3xULN, consecutive^c	0/92	0/55	2/558 (0.4)	1/385 (0.3)	0/203	0/142	2/453 (0.4)	1/300 (0.3)	2/272 (0.7)	0/186	0/384	1/256 (0.4)	0/53	0/35	2/603 (0.3)	1/407 (0.2)	1/188 (0.5)	1/143 (0.7)	1/468 ( 0.2)	0/299	0/222	1/141 (0.7)	2/216 (0.9)	0/147	0/210	0/151
AST ≥ 3xULN, consecutive^c	0/92	1/55 (1.8)	1/559 (0.2)	4/385 (1.0)	0/203	1/142 (0.7)	1/454 (0.2)	4/300 (1.3)	1/273 (0.4)	5/186 (2.7)	0/384	0/256	0/53	1/35 (2.9)	1/604 (0.2)	4/407 (1.0)	0/188	1/143 (0.7)	1/469 (0.2)	4/299 (1.3)	0/222	2/141 (1.4)	1/216 (0.5)	1/147 (0.7)	0/211	2/151 (1.3)
CK ≥ 10xULN	0/92	1/55 (1.8)	0/559	0/385	0/203	0/142	0/454	1/300 (0.3)	0/273	1/186 (0.5)	0/384	0/256	0/53	0/35	0/604	1/407 (0.2)	0/188	1/143 (0.7)	0/469	0/299	0/222	1/141 (0.7)	0/216	0/147	0/211	0/151
CK ≥ 10xULN with muscle symptoms	0/92	0/55	0/559	0/385	0/203	0/142	0/454	0/300	0/273	0/186	0/384	0/256	0/53	0/35	0/604	0/407	0/188	0/143	0/469	0/299	0/222	0/141	0/216	0/147	0/211	0/151
CK ≥ 10xULN with drug-related muscle symptoms	0/92	0/55	0/559	0/385	0/203	0/142	0/454	0/300	0/273	0/186	0/384	0/256	0/53	0/35	0/604	0/407	0/188	0/143	0/469	0/299	0/222	0/141	0/216	0/147	0/211	0/151
Hepatitis-related AEs	0/94	0/56	0/578	0/392	0/209	0/144	0/469	0/306	0/282	0/190	0/396	0/260	0/56	0/36	0/622	0/414	0/192	0/147	0/486	0/303	0/229	0/142	0/222	0/151	0/218	0/154
Gallbladder-related AEs	0/94	0/56	1/578 ( 0.2)	0/392	0/209	0/144	1/469 ( 0.2)	0/306	1/282 (0.4)	0/190	0/396	0/260	0/56	0/36	1/622 (0.2)	0/414	0/192	0/147	1/486 (0.2)	0/303	0/229	0/142	1/222 (0.5)	0/151	0/218	0/154
Gastrointestinal-related AEs	4/94 (4.3)	4/56 (7.1)	24/578 (4.2)	21/392 (5.4)	8/209 (3.8)	8/144 (5.6)	20/469 (4.3)	17/306 (5.6)	10/282 (3.5)	14/190 (7.4)	18/396 (4.5)	11/260 (4.2)	1/56 (1.8)	1/36 (2.8)	27/622 (4.3)	24/414 (5.8)	10/192 (5.2)	11/147 (7.5)	18/486 (3.7)	14/303 ( 4.6)	10/229 (4.4)	12/142 (8.5)	12/222 (5.4)	5/151 (3.3)	6/218 (2.8)	8/154 (5.2)
Allergic reaction or rash AEs	1/94 (1.1)	1/56 (1.8)	5/578 (0.9)	4/392 (1.0)	2/209 (1.0)	1/144 (0.7)	4/469 (0.9)	4/306 (1.3)	2/282 (0.7)	5/190 (2.6)	4/396 (1.0)	0/260	0/56	0/56	6/622 (1.0)	5/414 (1.2)	3/192 (1.6)	0/147	3/486 (0.6)	5/303 (1.7)	1/229 (0.4)	1/142 (0.7)	2/222 (0.9)	2/151 (1.3)	3/218 (1.4)	2/154 (1.3)

Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories
E = Ezetimibe 10 mg; All Atorva = Atorvastatin(10,20,40 mg) pooled across all doses; E/All Simva = Ezetimibe/Simvastatin(10/20, 10/40 mg) pooled across all doses; n = Number of randomized and treated patients in each treatment group
^aDetermined by the investigator to be possibly, probably, or definitely related to the drug
^bFor laboratory safety (ALT, AST, CK), patients must have taken at least one dose of study medication and have at least one postbaseline measurement within 14 days of the last dose of study therapy to be included in the analysis
% = m/n x 100 = (number of patients within the Tier 1 adverse event category / number of treated patients [with one or more laboratory tests postbaseline, if parameter is a laboratory parameter]) × 100
^cThis category includes those patients with (a) two consecutive measurements ≥3xULN, (b) a single, last measurement ≥3xULN, or (c) a measurement ≥3xULN followed by a measurement <3xULN that was taken more than 2 days after the last dose of study medication

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