INTRODUCTION: Concerns about the effects of HMG-CoA reductase inhibitors ('statins') on health-related quality of life may contribute to their underuse in older adults with and at risk for cardiovascular disease. These concerns also may prevent clinicians from enrolling older patients in clinical trials assessing the efficacy of statins as a preventive therapy for Alzheimer's disease. OBJECTIVE: To determine the effects of pravastatin and tocopherol (vitamin E), alone and in combination, on health-related quality of life in older adults. STUDY DESIGN: Double-blind, randomised, placebo-controlled, crossover study. PARTICIPANTS: Forty-one community-dwelling men and women aged > or = 70 years with low-density lipoprotein-cholesterol (LDL-C) > or = 3.62 mmol/L (140 mg/dl) participated. METHODS: Subjects received pravastatin for 6 months then pravastatin plus tocopherol for an additional 6 months (group 1), or tocopherol for 6 months then pravastatin plus tocopherol for an additional 6 months (group 2). Dosages were pravastatin 20 mg daily and tocopherol 400 IU daily. MAIN OUTCOME MEASURES: The following health-related quality-of-life measures were assessed at baseline, after 6 months and after 1 year: health perception, depression, physical function, cognitive function and sleep behaviour. In addition, data on adverse effects and laboratory abnormalities were obtained. RESULTS:Pravastatin reduced levels of total cholesterol (-21%, p < 0.001) and LDL-C (-29%, p < 0.001). Health-related quality-of-life scores, physical adverse effects, muscle enzyme levels and liver function tests did not change after 12 months of therapy with pravastatin, tocopherol or their combination. CONCLUSION: Both pravastatin and tocopherol have a good safety profile, are well tolerated and do not adversely affect health-related quality of life in older patients with hypercholesterolaemia. Given the significant beneficial cardiovascular effects of statin therapy in older adults and the potential role of statins in prevention of Alzheimer's disease, concerns about adverse effects on quality of life should not deter use of these medications in this population.
RCT Entities:
INTRODUCTION: Concerns about the effects of HMG-CoA reductase inhibitors ('statins') on health-related quality of life may contribute to their underuse in older adults with and at risk for cardiovascular disease. These concerns also may prevent clinicians from enrolling older patients in clinical trials assessing the efficacy of statins as a preventive therapy for Alzheimer's disease. OBJECTIVE: To determine the effects of pravastatin and tocopherol (vitamin E), alone and in combination, on health-related quality of life in older adults. STUDY DESIGN: Double-blind, randomised, placebo-controlled, crossover study. PARTICIPANTS: Forty-one community-dwelling men and women aged > or = 70 years with low-density lipoprotein-cholesterol (LDL-C) > or = 3.62 mmol/L (140 mg/dl) participated. METHODS: Subjects received pravastatin for 6 months then pravastatin plus tocopherol for an additional 6 months (group 1), or tocopherol for 6 months then pravastatin plus tocopherol for an additional 6 months (group 2). Dosages were pravastatin 20 mg daily and tocopherol 400 IU daily. MAIN OUTCOME MEASURES: The following health-related quality-of-life measures were assessed at baseline, after 6 months and after 1 year: health perception, depression, physical function, cognitive function and sleep behaviour. In addition, data on adverse effects and laboratory abnormalities were obtained. RESULTS:Pravastatin reduced levels of total cholesterol (-21%, p < 0.001) and LDL-C (-29%, p < 0.001). Health-related quality-of-life scores, physical adverse effects, muscle enzyme levels and liver function tests did not change after 12 months of therapy with pravastatin, tocopherol or their combination. CONCLUSION: Both pravastatin and tocopherol have a good safety profile, are well tolerated and do not adversely affect health-related quality of life in older patients with hypercholesterolaemia. Given the significant beneficial cardiovascular effects of statin therapy in older adults and the potential role of statins in prevention of Alzheimer's disease, concerns about adverse effects on quality of life should not deter use of these medications in this population.
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