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Table 5 Adverse event summary

From: Response by sex to statin plus ezetimibe or statin monotherapy: A pooled analysis of 22,231 hyperlipidemic patients

 

Full Cohort

Male

Female

 

Adverse events, n (%)

Statin

Statin/EZ

Between treatment p-value

P-value for effect of sex

Statin

statin/EZ

Between

Treatment

p-value

Statin

Statin/EZ

Between

treatment

p-value

 

N = 10517

N = 11714

  

N = 5380

N = 6129

 

N = 5137

N = 5585

 

≥1

3455 (32.9)

3717 (31.7)

0.849

< 0.001

1537 (28.6)

1779 (29.0)

0.173

1918 (37.3)

1938 (34.7)

0.114

Drug related*

833 (7.9)

961 (8.2)

0.181

< 0.001

349 (6.5)

456 (7.4)

0.025

484 (9.4)

505 (9.0)

0.819

Serious

145 (1.4)

187 (1.6)

0.220

0.370

74 (1.4)

107 (1.7)

0.122

71 (1.4)

80 (1.4)

0.091

Serious drug related

6 (0.1)

13 (0.1)

0.148

0.908

2 (0.0)

8 (0.1)

0.075

4 (0.1)

5 (0.1)

0.784

Discontinuations† due to AEs

219 (2.1)

263 (2.2)

0.286

< 0.001

91 (1.7)

105 (1.7)

0.828

128 (2.5)

158 (2.8)

0.229

Drug related*

136 (1.3)

177 (1.5)

0.117

< 0.001

49 (0.9)

69 (1.1)

0.234

87 (1.7)

108 (1.9)

0.288

Serious

34 (0.3)

38 (0.3)

0.906

0.320

18 (0.3)

23 (0.4)

0.659

16 (0.3)

15 (0.3)

0.746

Serious drug related

6 (0.1)

7 (0.1)

0.864

0.749

2 (0.0)

4 (0.1)

0.485

4 (0.1)

3 (0.1)

0.689

   Deaths

5 (0.0)

7 (0.1)

0.702

0.655

4 (0.1)

3 (0.0)

0.582

1 (0.0)

4 (0.1)

0.197

   Gastrointestinal-related‡

861 (8.2)

889 (7.6)

0.367

< 0.001

339 (6.3)

390 (6.4)

0.636

522 (10.2)

499 (8.9)

0.113

   Gallbladder-related§

9 (0.1)

11 (0.1)

0.824

0.014

2 (0.0)

3 (0.0)

0.754

7 (0.1)

8 (0.1)

0.940

   Allergic reaction or rash║

175 (1.7)

213 (1.8)

0.194

< 0.001

70 (1.3)

90 (1.5)

0.326

105 (2.0)

123 (2.2)

0.382

   Hepatitis-related¶

24 (0.2)

39 (0.3)

0.079

0.030

13 (0.2)

27 (0.4)

0.038

11 (0.2)

12 (0.2)

0.858

ALT ≥ 3 × ULN, consecutive, m/n (%)

31/10341

(0.3)

50/11512

(0.4)

0.519

0.241

15/5289

(0.3)

34/6031

(0.6)

0.111

16/5052

(0.3)

16/5481

(0.3)

0.611

AST ≥ 3 × ULN, consecutive, m/n (%)

23/10342

(0.2)

30/11512

(0.3)

0.087

0.100

7/5290

(0.1)

16/6031

(0.3)

0.018

16/5052

(0.3)

14/5481

(0.3)

0.873

ALT or AST ≥3 × ULN, consecutive, m/n (%)

36/10342

(0.3)

64/11512

(0.6)

0.018

0.185

17/5290

(0.3)

41/6031

(0.7)

0.006

19/5052

(0.4)

23/5481

(0.4)

0.649

CK ≥ 10 × ULN, m/n (%)

13/10342

(0.1)

9/11514

(0.1)

0.337

0.028

9/5290

(0.2)

7/6033

(0.1)

0.543

4/5052

(0.1)

2/5481

(0.0)

0.395

Myopathy#, m/n (%)

4/10342

(0.04)

3/11512

(0.03)

0.667

0.699

2/5290

(0.04)

2/6031

(0.02)

0.985

2/5052

(0.04)

1/5481

(0.02)

0.517

Rhabdomyolysis^, m/n (%)

0/10342

(0.00)

0/11512

(0.00)

N/A

N/A

0/5290

(0.00)

0/6031

(0.00)

N/A

0/5052

(0.00)

0/5481

(0.00)

N/A

  1. ALT = alanine aminotransferase, ALT = aspartate aminotransferase, CK = creatine kinase ULN = upper limit of normal
  2. % = m/n × 100 = (number of patients within the AE category/number of treated patients) × 100
  3. *Determined by the investigator to be related to the drug
  4. †Study medication withdrawn
  5. ‡For gastrointestinal-related clinical adverse events, the preferred terms (preferred Medra terms) were pre-identified for collective review, including e.g. abdominal discomfort, abdominal distension, abdominal pain, abdominal tenderness, colitis, colonic polyp, constipation, dental caries, dental discomfort, diarrhoea, diverticulum, duodenitis, dyspepsiea, dysphagia, erosive duodenitis, faeces discolored, flatulence, flood poisoning, gastitis, gastoesophageal reflux disease, gingival pain, haemorrhoids, hiatus hernia, nausea, oesophageal stenosis, rectal haemorrhage, tooth loss, toothache, and vomiting.
  6. §For gallbladder-related clinical adverse events the preferred terms (preferred Medra terms) were pre-identified for collective review, including e.g. bile duct obstruction, bile duct stenosis, bile duct stone, biliary colic, cholangitis, cholecystectomy, cholecystitis, cholelithiasis, gallbladder disorder, and gallbladder perforation
  7. â•‘For allergic reaction or rash the preferred terms (preferred Medra terms) were pre-identified for collective review, including e.g. analphylaxis, angioedema, dermatitis, dermagraphism, drug hypersensitivity, eczema, eosinophilia, erythema, face oedema, hypersensitivity, palmar erythema, periorbital oedema, photodermatosis, photosensitivity, pigmentation disorder, pruritis, rash, rosacea, skin disorder, skin exfoliation, skin hyperpigmentation, skin inflammation, skin lesion, subcutaneious nodule, systemic lups erythematosus rash, and urticaria
  8. ¶In addition to review of the effects of ezetimibe + statin on laboratory parameters associated with liver function, potentially "hepatitis-related" clinical adverse event terms (preferred Medra terms) were pre-identified for collective review, e.g., cholestasis, hepatic necrosis, hepatocellular injury, cytolytic hepatitis, hepatitis, hepatomegaly, hepatic cyst, hepatitis cholestatic, jaundice, hepatic failure, hepatitis fulminant, jaundice cholestatic, hepatic lesion, and, hepatitis infectious.
  9. #Myopathy is defined as CK elevation > 10XULN with associated muscle symptoms with no other explanatory cause.
  10. ^Rhabdomyolysis is defined as myopathy with associated evidence of renal damage.
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Lipids in Health and Disease

ISSN: 1476-511X