NIRS to Diagnose SAMS
Statin Adverse Reaction, Skeletal Myopathy
About this trial
This is an interventional diagnostic trial for Statin Adverse Reaction
Eligibility Criteria
Inclusion Criteria:
- Subjects >40 years of age, equal numbers of age, with a prior history of statin-associated muscle symptoms (SAMS). Subjects will be considered to have had prior statin related complaints and recruited for participation in the study if the following occurred: 1) They developed new pain, cramps, or muscle aching during statin treatment; 2) The symptoms resolved within 4 weeks of stopping the statin; 3) The identical symptoms recurred during repeat statin exposure.
Exclusion Criteria:
Subjects who have had cancer within 5 years of entry, have hepatic disease (ALT > 2 times normal) or renal disease (creatinine > 2 mg/L) since these patients may require more careful monitoring during the study and would be best managed in a totally clinical setting
- Subjects presently treated with other medications known to alter statin metabolism;
- Subjects with hypo- or hyperthyroidism defined as a TSH > 5 or <0.01 IU/L since these conditions are known to be associated with statin intolerance and muscle weakness, respectively;1,2
- Subjects with hepatic dysfunction evidenced by a baseline alanine aminotransferase (ALT) level > 2 UNL;1,2
- Subjects with renal dysfunction defined as a baseline creatinine > 2mg/dl;
- Subjects with physical disabilities prohibiting the handgrip protocol;
- Women who are pregnant as determined by a urine pregnancy test using an Accutest Early Pregnancy Test Kit, or who are trying to become pregnant, and/or who have not been using a form of birth control for at least the last 3 months, since the impact of statins on pregnancy-related outcomes has not been well studied;1
- Subjects who regularly use corticosteroids or other drugs known to affect skeletal muscle metabolism or regularly have intramuscular injections that will affect CK levels.
Subjects who are unwilling to limit their alcohol intake to an average of two or less drinks daily.
Sites / Locations
- Hartford Hospital
- University of Connecticut
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
20 mg simvastatin
8 weeks treatment with placebo (or until muscle symptoms appear for at least 1 week or are unbearable)
8 weeks treatment with 20 mg simvastatin daily (or until muscle symptoms appear for at least 1 week or are unbearable)