(Statins) and Fixed-dose Combination Products Containing a Statin

Final Report Update 5 Drug Effectiveness Review Project
Key Question 5. Are there differences in the harms of statins or fixed-dose combination products
containing a statin and another lipid-lowering drug when used in the general population of adults? ...58
Summary of findings ......................................................................................................................58
Detailed assessment......................................................................................................................58
Key question 6. Are there differences in the harms of statins or fixed-dose combination products
containing a statin and another lipid-lowering drug when used in special populations or with other
medications (drug-drug interactions)? ...................................................................................................63
Summary of findings ......................................................................................................................63
Detailed assessment......................................................................................................................64
CHILDREN .................................................................................................................................72
Key Question 1. How do statins and fixed-dose combination products containing a statin and another
lipid-lowering drug compare in their ability to reduce low-density lipoprotein cholesterol? ...................72
Summary of findings ......................................................................................................................72
Key Question 1a. Are there doses for each statin or fixed-dose combination product containing a statin
and another lipid-lowering drug that produce similar percent reduction in low-density lipoprotein
cholesterol?............................................................................................................................................72
Key Question 1b. Do statins or fixed-dose combination product containing a statin and another lipidlowering
drug differ in the ability to achieve National Cholesterol Education Program goals? .............74
Key Question 2. How do statins and fixed-dose combination products containing a statin and another
lipid lowering drug compare in their ability to raise high-density lipoprotein cholesterol? .....................74
Summary of findings ......................................................................................................................74
Key Question 2b. Are there doses for each statin or fixed-dose combination product containing a statin
and another lipid lower drug that produce similar percent increase in high-density lipoprotein
cholesterol between statins? .................................................................................................................74
Key Question 3. How do statins and fixed-dose combination products containing a statin and another
lipid lowering drug compare in their ability to reduce the risk of nonfatal myocardial infarction, coronary
disease (angina), coronary heart disease mortality, all-cause mortality, stroke, hospitalization for
unstable angina, or need for revascularization (coronary artery bypass graft, angioplasty, or
stenting)? ...............................................................................................................................................76
Summary of findings ......................................................................................................................76
Detailed assessment......................................................................................................................76
Key Question 4. Are there differences in effectiveness of statins and fixed-dose combination products
containing a statin and another lipid lowering drug in different demographic groups or in patients with
comorbid conditions (e.g. diabetes, obesity)? .......................................................................................76
Summary of findings ......................................................................................................................76
Detailed assessment......................................................................................................................76
Key Question 5. Are there differences in the harms of statins or fixed-dose combination products
containing a statin and another lipid lowering drug when used in the general population of children?.77
Summary of findings ......................................................................................................................77
Detailed assessment......................................................................................................................77
Key Question 6. Are there differences in the harms of statins or fixed-dose combination products
containing a statin and another lipid lowering drug when used in special populations or with other
medications (drug-drug interactions)? ...................................................................................................78
Summary of findings ......................................................................................................................78
Detailed assessment......................................................................................................................78
SUMMARY .................................................................................................................................78
TABLES
Table 1. Included statins..........................................................................................................................8
Table 2. Included fixed-dose combination products ................................................................................9
Table 3. Percent reduction in low-density lipoprotein cholesterol with statins.......................................20
Table 4. Doses of statins that result in similar percent reductions in low-density lipoprotein
cholesterol a ............................................................................................................................................21
Statins Page 4 of 128