Efficacy and safety of simvastatin in Asian and non-Asian coronary heart disease patients: a comparison of the GOALLS and STATT studies.
BACKGROUND
Asians are thought to be more responsive to the lipid-lowering effects of statins than non-Asians although there are no head-to-head trials that examine this perception.


OBJECTIVE
To compare the results of the GOALLS and STATT studies that used similar titrate-to-goal protocols with 20 mg up to 80 mg simvastatin in Asian and non-Asian coronary heart disease (CHD) patients.


METHODS
GOALLS (N = 198; included non-Asians and Asians) and STATT (N = 133; included Asians only) were both multi-center, open-label 14-week studies in CHD patients with serum low density lipoprotein cholesterol (LDL-C) levels 115 mg/dL-180 mg/dL and triglycerides (TG) levels < or = 400 mg/dL. Simvastatin was titrated from 20 mg/day up to 80 mg/day in order to achieve the National Cholesterol Education Program (NCEP) LDL-C target < or = 100 mg/dL. The primary efficacy variable was the percentage of patients attaining the NCEP LDL-C target at Week 14. Secondary endpoints included proportion of patients achieving the European Society of Cardiology/European Atherosclerosis Society/European Society of Hypertension (European) LDL-C target < or = 115 mg/dL at Week 14 and percentage change in lipid parameters. Safety and tolerability were assessed by monitoring adverse experiences and safety laboratory tests. Fifteen Asian patients were part of the GOALLS cohort and their data were compared separately with results of non-Asians from GOALLS and Asians from the STATT study.


RESULTS
After 14 weeks of simvastatin treatment, 87.1% of GOALLS non-Asians, 85.7% of GOALLS Asians, and 78.2% of STATT patients attained the NCEP LDL-C target. At Week 14, 94.4%, 92.9%, and 91.7% of the GOALLS non-Asians, GOALLS Asians, and STATT patients achieved the European LDL-C target, respectively. The average treatment doses to attain NCEP and European targets were comparable among groups. The percentage reductions in lipid parameters from baseline to week 14 were similar among groups except, changes in high density lipoprotein cholesterol and apolipoprotein A-I favored Asian subjects. There was also a greater reduction in TG in the STATT study, but this was not consistent with TG reductions experienced by Asians in the GOALLS study. In both studies, simvastatin was generally well tolerated by all patients across the dosage range of 20 mg-80 mg. No cases of rhabdomyolysis or myopathy were reported in either study.


CONCLUSIONS
A great majority of CHD patients is able to achieve LDL-C treatment goals (up to 90%) on simvastatin regardless of racial background. Simvastatin treatment at doses of 20 mg-80 mg is well-tolerated in Asian and non-Asian CHD patients. This side-by-side comparison provides evidence that Asian and non-Asian CHD populations respond similarly to comparable doses of simvastatin.
Manila Doctor's Hospital, Manila, Philippines. ddmclinic@edsamail.com.ph
Dante
D
Morales
Namsik
N
Chung
Jun-Ren
JR
Zhu
Somkiat
S
Sangwatanaroj
Wei-Hsien
WH
Yin
Kathy
K
Lee
Michael J
MJ
Davies
Arvind
A
Shah
Tom
T
Loeys
David
D
Bilheimer
D001208:Asia / Q000208:ethnology; D002986:Clinical Trials as Topic; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008875:Middle Aged; D019821:Simvastatin / Q000627:therapeutic use*; D016896:Treatment Outcome
D000960:Hypolipidemic Agents; D019821:Simvastatin