Intervention: Bryostatin 1
Trial phase: Phase 4
SMILES: CCCC=CC=CC(=O)OC1C(=CC(=O)OC)CC2CC(C(C)O)OC(=O)CC(O)CC3CC(OC(C)=O)C(C)(C)C(O)(CC4CC(=CC(=O)OC)CC(C=CC(C)(C)C1(O)O2)O4)O3
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Statin medications

Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth.
Eligibility criteria:
Inclusion Criteria:

males and females 30-60 yrs old
experiencing muscle pain, weakness, numbness or cramping that they perceive to interfere with activities of daily living (ADLs), but 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
currently taking a statin (has been taking medications ≥ 80% of the time or at least 5 days/week)
≤ 15% probability of having a cardiovascular (CV) event in the next 10 years calculated using an online CV risk calculator (while on current statin) for the questionnaire portion; AND with a low or a moderate American College of Sports Medicine (ACSM) risk stratification for a cardiovascular event during a treadmill test for the full metabolic study
must agree to have a letter sent to inform the health care provider who prescribed the statin of study participation except for subjects referred by Metropolitan Hospital physicians

Exclusion Criteria:

concomitant treatment with other lipid-lowering agents
impaired liver or kidney function ( alanine aminotransferase (ALT) or asparate aminotransferase (AST) ≥ 3x upper limit of normal, creatinine ≥ 3x or creatine phosphokinase (CPK) ≥ 5x upper limit of normal)
untreated hypo or hyperthyroidism
current treatment with other medications known to increase risk of myopathy (e.g. cyclosporine, azithromycin, erythromycin and other macrolide antibiotics, azole antifungals, fusidic acid, digoxin)
documented history of muscle disorder or myopathy other than statin-associated myopathy
anemia (Hb< 110 g/dL)
cancer within 5 years of enrollment except basal or squamous cell carcinoma (CA) of the skin
diabetes
HIV-1 infection
Uncontrolled blood pressure ≥ 160/100
known coronary artery disease or peripheral vascular disease
chronic illnesses such as lupus, rheumatoid arthritis, psoriasis
any condition, that at the investigators' discretion would impact/ bias the study data
long term oral, nasal, or inhaler steroid use > 6 months
on Hormone Therapy except for thyroid replacement
alcohol consumption ≥ 40 g/day (3 glasses/day wine or beers or binge drinking ≥ 4 glasses/night)
engaged in significant amounts of sport or strenuous leisure activity (> 60 min four times per week)
surgery in the past 6 months except for minor excision/incision procedures,
12-L electrocardiogram demonstrating old/new myocardial infarction/ ischemia or other findings that, at the cardiologist's discretion, may put the subject at high risk
cognitive impairment that prevents comprehension of questionnaires
inability to read English (questionnaire language)

Exclusions for the metabolic study:

currently taking beta blockers
body mass index > 28 kg/m2
premenopausal females < 50 yrs (menopause defined as 12 consecutive months without menstruation (in order to avoid the confounding effect of the menstrual cycle phase on fuel selection)
physical disability or previous injury that prevents safe exercise testing
do not meet the magnetic resonance spectroscopy (MRS) prescreening criteria