Table F-24

Longer-term outcomes (clinical outcomes, serious adverse events and cancer) using BAS plus statin therapy compared with statin monotherapy

TrialPopulationCombination Statin Dose (mg/day)BAS (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
All-cause Mortality, all trials
Sprecher (1994_1)52
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥ 160mg/dL), not on lipid- lowering medicationFluvastatin 10C-amine 8–1636Fluvastatin 1039242090/1
0.35 (0.01, 8.9)
unclear3No
Sprecher (1994_2)52
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL), not on lipid- lowering medicationFluvastatin 20C-amine 8–1637Fluvastatin 2038242090/0unclear3No
Knapp (2001_1)172
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 10C-lam 3.835Simvastatin 103661870/0yes5No
Knapp (2001_2)172
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 20C-lam 2.337Simvastatin 203961871/0
3.25 (0.13, 82.2)
yes5No
Davidson (2001) 185
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL)Lovastatin 10C-lam 3.850Lovastatin 102641700/0unclear4No
Fatal myocardial infarction
Sprecher (1994_1)52
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL), not on lipid- lowering medicationFluvastatin 10C-amine 8–1636Fluvastatin 1039242090/1
0.35 (0.01, 8.91)
unclear3No
Sprecher (1994_2)52
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL), not on lipid- lowering medicationFluvastatin 20C-amine 8–1637Fluvastatin 2038242090/0unclear3No
Serious adverse event(s)
Simons (1998)198
The Six Cities Study Pharm. fund
Participants with severe HC (LDL-c ≥190 mg/dL)Simvastatin 40C-amine 444Atorvastatin 8092303431/5
0.40 (0.05, 3.6)
unclear1No
Knapp (2001)172
North America Pharm. Fund Multicentre
Participants with moderate HC (LDL-c ≥160mg/dL), statin naïveSimvastatin 10–20C-lam 2.3–3.868Simvastatin 10–207461870/1
0.36 (0.01, 8.9)
yes5No

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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