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Table F-28

Adverse events and adherence to treatment using BAS plus statin compared with statin monotherapy

TrialPopulationCombination Statin Dose (mg/day)BAS Max Dose (mg/day)Combo NMonotherapy Statin Dose (mg/day)Mono NFollow- up (wk)Trial Baseline LDL-c (mg/dL)Combo/mono: number of participants with events Odds ratio (95% CI)AACJadad ScoreITTA
Relative probability of participants adhering to treatment
Eriksson (1998)190
PaCt trial Europe Pharm. Fund Multicenter
Participants with 1o HC, heterogeneous CHD risk estimatesPravastatin 20C-amine 8–16261Pravastatin 20–4081296212227/765
0.41 (0.26, 0.65)
yes3no
Heinonen (1996)164
Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Atorvastatin 10C-pol 2020Atorvastatin 10421221115/38
0.32 (0.07, 1.34)
unclear1no
Ballantyne (2004_a)122
North America Pharm. Fund Multicenter
Participants with severe HC (LDL-c 190–400 mg/dL), all with prior statin useRosuvastatin 80C-amine 1675Rosuvastatin 8069625938/63
0.10 (0.04, 0.25)
yes2no
Johansson (1995)137
Europe Pharm. Fund Multicenter
Participants with moderate to severe HCSimvastatin 20C-pol 5–1057Simvastatin 40264–1222141/23
0.33 (0.09, 1.27)
unclear2no
Hunninghake (2001)133
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Atorvastatin 10C-lam 3.8g19Atorvastatin 10–8039418417/35
0.97 (0.16, 5.84)
unclear4yes
Hunninghake (2001)133
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Atorvastatin 10C-lam 3.8g19Atorvastatin 8020418417/18
0.94 (0.12, 7.5)
unclear4yes
Relative probability of participants experiencing an adverse event
Sprecher (1994_1)52
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), not on lipid- lowering medicationFluvastatin 10C-amine 8–1636Fluvastatin 10392420931/18
7.23 (2.32, 22.5)
unclear3no
Sprecher (1994_2)52
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), not on lipid- lowering medicationFluvastatin 20C-amine 8–1637Fluvastatin 20382420930/20
3.86 (1.36, 10.9)
unclear3no
Ballantyne (2004)122
North America Pharm. Fund Multicenter
Participants with severe HC (LDL-c 190–400 mg/dL), all with prior statin useRosuvastatin 80C-amine 1676Rosuvastatin 8071625942/25
2.27 (1.17, 4.4)
yes2no
Knapp (2001_1)172
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 10C-lam 3.834Simvastatin 1035618721/22
0.95 (0.36, 2.5)
yes5no
Knapp (2001_2)172
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 20C-lam 2.334Simvastatin 2039618725/23
1.93 (0.72, 5.2)
yes5no
Johansson (1995)137
Europe Pharm. Fund Multicenter
Participants with moderate to severe HCSimvastatin 20C-pol 5–1057Simvastatin 40264–1222131/13
1.19 (0.47, 3.0)
unclear2no
Relative probability of participants withdrawing from treatment due to an adverse event
Simons (1998)198
The Six Cities Study Pharm. fund
Participants with severe HC (LDL-c ≥190 mg/dL)Simvastatin 40C-amine 444Atorvastatin 8092303436/1
14.37 (1.67, 123.4)
unclear1no
Sprecher (1994)52
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), not on lipid- lowering medicationFluvastatin 10–20C-amine 8–1673Fluvastatin 10–2077242091/4
0.25 (0.03, 2.32)
unclear3no
PMSG II (1993)191
Pravastatin Multicenter Study Group II North America Pharm. fund
Participants with moderate HC (LDL-c ≥160mg/dL), excluding those with hypersensitivity to C-aminePravastatin 40C-amine 2464Pravastatin 40–8012616–242351/2
0.98 (0.09, 11.1)
unclear3no
Heinonen (1996)164
Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Atorvastatin 10C-pol 2020Atorvastatin 1042122110/1
0.67 (0.03, 17.3)
unclear1no
Ballantyne (2004_a)122
North America Pharm. Fund Multicenter
Participants with severe HC (LDL-c 190–400 mg/dL), all with prior statin useRosuvastatin 80C-amine 1676Rosuvastatin 807162592/0
4.80 (0.23, 101.7)
yes2no
Knapp (2001_1)172
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 10C-lam 3.835Simvastatin 103661871/1
1.03 (0.06, 17.1)
yes5no
Knapp (2001_2)172
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 20C-lam 2.337Simvastatin 203961873/0
8.01 (0.40, 160.7)
yes5no
Davidson (2001)185
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Atorvastatin 10C-lam 3.850Atorvastatin 10–802641704/0
5.13 (0.27, 99.0)
unclear4no
Hunninghake (2001)133
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Lovastatin 10C-lam 3.819Lovastatin 103941841/3
0.67 (0.06, 6.9)
unclear4yes
Hunninghake (2001)133
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Atorvastatin 10C-lam 3.8g19Atorvastatin 802041841/1
1.06 (0.06, 18.2)
unclear4yes
Relative probability of participants experiencing elevated serum AST and/or ALT > 3 times ULN and/or hepatitis
Simons (1998)198
The Six Cities Study Pharm. fund
Participants with severe HC (LDL-c ≥190 mg/dL)Simvastatin 40C-amine 444Atorvastatin 8092303430/0unclear1no
Davidson (2001)185
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Lovastatin 10C-lam 3.8g50Lovastatin 102641700/0unclear4no
Relative probability of participants experiencing myalgia
Ito (1997)108
North America Pharm. fund
Participants with moderate HC, history of CAD, all with prior statin usePravastatin 20C-amine 1028Pravastatin 4031121810/3
0.14 (0.01, 2.9)
unclear1no
Simons (1992)173
Europe Pharm. Fund Single centre
Participants with primary HC, already in use of statinsSimvastatin 40C-pol 5–1039Simvastatin 4022122901/1
0.55 (0.03, 9.3)
unclear4no
Ballantyne (2004)122Participants with severe HC (LDL-c 190–400 mg/dL), all with prior statin useRosuvastatin 80C-amine 1676Rosuvastatin 807162591/0
2.84 (0.11, 70.9)
yes2no
Davidson (2001)185
North America Pharm. Fund Multicenter
Participants with moderate HC (LDL-c ≥160mg/dL)Lovastatin 10C-lam 3.8g50Lovastatin 102641702/3
0.32 (0.05, 2.0)
unclear4no
Relative probability of participants experiencing CPK greater than 10 times the upper limit of normal
Simons (1998)198
The Six Cities Study Pharm. fund
Participants with severe HC (LDL-c ≥190 mg/dL)Simvastatin 40C-amine 444Atorvastatin 8092303430/0unclear1no
Ballantyne (2004)122
North America Pharm. Fund Multicenter
Participants with severe HC (LDL-c 190–400 mg/dL), all with prior statin useRosuvastatin 80C-amine 1676Rosuvastatin 807162590/0yes2no

From: Appendix F, Included Evidence

Cover of Comparative Effectiveness of Lipid-Modifying Agents
Comparative Effectiveness of Lipid-Modifying Agents [Internet].
Comparative Effectiveness Reviews, No. 16.
Sharma M, Ansari MT, Soares-Weiser K, et al.

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