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Statins are a class of drugs given to lower cholesterol. Although statins are considered to be generally safe, some studies show that about 10% of people on statins develop muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a lifethreatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms may greatly affect their daily activities. One consideration why symptoms develop in only some patients is that they may have an underlying problem in the way their muscles use fats to produce energy. In these patients, the muscles are not able to fully utilize fats and so they become tired more easily. Fat within the muscle can also affect how your body uses a hormone called insulin, which affects your blood sugar levels. The investigators are specifically interested in previous statin users and determine if the muscle symptoms are related to changes in energy and sugar use. We propose to enroll patients who have developed muscle side effects on previous statin treatment and have since discontinued statin treatment.
Our aim is to compare the metabolic parameters in these patients to age and gender-matched normal individuals.
Enrollment
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Inclusion criteria
SAM Group
Males and females 40-65 yrs old; females must be post-menopause (>12 months since last menstrual period)
Developed statin-associated myopathy, defined as:
Able to ambulate independently (in order to perform exercise tests)
Muscle symptoms started/ occurred within one year of starting statin treatment or within one year of changing statin brand or dose adjustment
Discontinued statins at least 2 months from study inclusion date
20% probability of having a cardiovascular (CV) event in the next 10 years calculated using an online CV risk calculator AND with a low or a moderate American College of Sports Medicine (ACSM) risk stratification for a cardiovascular event during a treadmill test
Normal Control Group
Exclusion criteria
Applies to both groups of subjects
23 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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