Statins
Also known by these names
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Key Points
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Authors
Nancy Hepp, MS, BCCT Project ManagerStatins are a class of cholesterol-lowering drugs being used off-label for cancer treatment by some integrative oncologists. Off-label use is a drug’s application for a disease or condition that has not yet received FDA approval. Every US state allows for drugs to be used off-label as long as there is enough evidence to support its use.
Statins are sub-classified as either more hydrophilic (tending to combine with or dissolve in water) or more lipophilic (tending to combine with or dissolve in lipids or fats).
The lipophilic statins are lovastatin, simvastatin, atorvastatin, fluvastatin and pitavastatin. The more hydrophilic statins are pravastatin and rosuvastatin. The more lipophilic statins especially have been associated with anticancer effects and cancer prevention.
BCCT sees statins as interesting and promising and is impressed with the early evidence to support re-purposing their use in cancer. At the same time, we are aware that statins can have serious side effects in some people. If you and your doctor are considering using these drugs off-label for your cancer, we urge you to weigh their potential benefits in treating your cancer against the risks.
Most reviewers suggest further study is needed before using statins in clinical practice as a cancer preventive or treatment.
Treating the Cancer
Working against cancer growth or spread, improving survival, or working with other treatments or therapies to improve their anticancer action
Clinical Evidence
General or Unspecified Cancers
Many studies of statins are observational, following people already taking statins to lower cholesterol and prevent heart disease. These patients tend to be older individuals with cardiovascular diseases or diabetes, who are more likely to be overweight and/or to smoke compared to patients who start taking statins only after a cancer diagnosis. These characteristics may explain why prediagnosis statin users have a poorer cancer prognosis.1 Observational studies in humans suggest the following effects of statins on cancer:
- Decreased risk of all-cause mortality compared with nonusers, with reduced cancer-specific mortality and improved progression-free survival, recurrence-free survival and disease-free survival who were taking statins before cancer diagnosis.2
- Postdiagnosis statin users gained significantly more recurrence-free survival benefit than prediagnosis statin users,3 and current users saw benefit, but not past users.4
- Improved survival among people with adenocarcinoma (may include breast, colorectal, lung, pancreatic and prostate cancers) with use at diagnosis. Post-diagnostic statin use was associated with prolonged survival in people, with greater benefit at higher doses.5
Breast Cancer
- Improved recurrence-free survival, cancer-specific survival, and/or overall survival6 including use after breast cancer diagnosis,7 although more uncertainty remains with post-diagnosis use8
- Lipophilic statins—particularly simvastatin—are especially associated with improved recurrence-free survival, overall survival, and cancer-specific survival in some reviews,9 but no difference was found in another10
- Improved three-year local recurrence-free survival in people with inflammatory breast cancer treated with postmastectomy radiation11
Antitumor properties:
- Clinical and epidemiological results show that statins may have anti-tumor potential.12
- Fluvastatin use reduced proliferation and increased cell death (apoptosis) in patients diagnosed with DCIS or stage 1 breast cancer with high grade (poorly differentiated) tumors.13
See Breast Cancer.
Colorectal Cancer
Improved survival or prognosis:
- Reduced all-cause and cancer-specific mortality with statin uses both before and after diagnosis in some reviews and meta-analyses14 and improved overall survival in a separate retrospective cohort review15 but no improvement in overall or progression-free survival in a randomized controlled trial16 or cohort study17
- Some studies and reviews found more benefit for specific people:
- However, other reviews concluded that most studies were unable to improve progression-free survival and overall survival,20 perhaps due to poor trial design21
- Similar survival outcomes to patients mean BMI 24-25 treated with lifestyle modifications22
- Improved prognosis in large-scale cohort studies23
Antitumor action:
- Higher rate of tumor downstaging (reduction in the cancer stage) with use during neoadjuvant therapy24
- Lower median regression grade and higher likelihood of a better response25
- Better prognosis of surgically resected colorectal cancer in one review,26 although another study found no differences in disease-free survival, recurrence-free survival or all-cause mortality in patients undergoing neoadjuvant chemoradiotherapy and resection for rectal cancer27
- Reduced proportion of late-stage (at diagnosis) colorectal cancer cases among users of lipophilic statins in a large retrospective study of women28 and a population-based case-control study29
- A combination regimen of simvastatin, cetuximab and irinotecan showed promising safety and efficacy in KRAS-mutated colorectal cancer patients for whom irinotecan and oxaliplatin had failed.30
See Colorectal Cancer.
Kidney Cancer
See Kidney Cancer.
Leukemia
Liver Cancer
- Lower risk of death in those with chronic viral hepatitis compared to hydrophilic (water-soluble) statins or no statins with lipophilic (fat-soluble) statins, with the most benefit was seen in those taking moderate doses of the statin for at least two years.34
- Improved survival of patients with advanced hepatocellular carcinoma35 or liver cancer36 with pravastatin
See Liver Cancer.
Lung Cancer
Improved survival:
- Decreased lung cancer-specific mortality37 in cohort studies, but not in case-control studies or randomized controlled trials38 with pravastatin39
- Improved recurrence-free survival40 but not progression-free survival41
- Effects with specific groups or treatments:
- Improved progression-free survival in a subgroup of nonadenocarcinoma non-small cell lung cancer (NSCLC) patients prescribed simvastatin treated with gefitinib compared to patients prescribed gefitinib alone42
- Improved overall survival, cancer-specific survival and recurrence-free survival, especially with use after diagnosis or in stage IV lung cancer43
- No improved survival with postmenopausal women44
- Improved survival in patients undergoing surgery with lung adenocarcinoma with mutant p53, but worse prognosis of patients with wild type p5345
- No impact on survival, recurrence or recurrence-free survival following curative resection with use at least one month before surgery and continued after surgery46
- Improved 2-year loco-regional control but not survival among people with stage III NSCLC treated with definitive chemoradiation47
- No improved survival for people with small-cell lung cancer with use at diagnosis48
Chemotherapy enhancer:
- Potentially enhanced the effects of tyrosine kinase inhibitors and chemotherapy on the overall survival of patients with non-small-cell lung cancer, but did not increase overall response rate and toxicity49
See Lung Cancer.
Lymphoma
- Non-Hodgkin’s lymphoma: no improved survival.50
- Burkitt lymphoma: improved survival with use at the time of diagnosis51
- Diffuse large B-cell lymphoma: no meaningful impact on prognosis when treated with rituximab plus CHOP therapy52
See Lymphoma.
Melanoma
Multiple Myeloma
- Reduced all-cause and cancer-specific mortality54
- Improved progression-free survival, shortened response time for patients with relapsed or refractory multiple myeloma when lovastatin was added to treatment with thalidomide and dexamethasone55
- Reduced resistance to bortezomib and bendamustin with simvastatin,56 but did not reverse resistance to vincristine, adriamycin and dexamethasone (VAD)57
- No benefit, and possible harm regarding osteoclast activiry: no effect on bone turnover with high dose simvastatin for 7 days followed by a rest period of 21 days in two 4-week cycles, but transient stimulation of osteoclast activity58
See Multiple Myeloma.
Ovarian and Other Gynecologic Cancers
- Improved survival, especially with pre-diagnosis use59 but also with use after diagnosis60 among current users, but not past users61
- Effects with specific populations or treatments
- Improved survival among ovarian cancer patients who underwent surgical resection, for both serous and non-serous histologies62
- Improved survival with simvastatin among women with invasive epithelial ovarian cancer who were using statins before diagnosis63
- Improved survival, especially with atorvastatin or simvastatin, including in women who initiated lipophilic statins post-diagnosis64
See also Uterine Cancer below, plus handbooks on Cervical Cancer, Ovarian Cancer, Vaginal Cancer and Vulvar Cancer.
Pancreatic Cancer
- Improved overall and progression-free survival65
- Results with specific populations or treatments:
- Improved survival among patients with low-grade (I or II), but not high-grade (III or IV) pancreatic adenocarcinoma66
- Improved survival with both prior and active statin use, with a trend toward freedom from distant metastasis, in people with advanced-stage pancreatic adenocarcinoma67
- Improved long-term response and overall survival with a history of statin treatment among people with unresectable pancreatic cancer who received two or more cycles of gemcitabine-erlotinib combination therapy as first-line palliative chemotherapy68
- Improved survival among people newly diagnosed with pancreatic adenocarcinoma, especially with simvastatin or atorvastatin and patients with nonmetastatic pancreatic cancer69
- Improved survival among people with pancreatic ductal adenocarcinoma,70 especially with simvastatin or atorvastatin71
See Pancreatic Cancer.
Prostate Cancer
- Improved cancer-specific and all-cause survival with statin use.72 “If statin use is warranted for another indication, prolonged use, especially with a potent statin, may potentially decrease the risk of advanced prostate cancer or mortality associated with prostate cancer”,73 although one review suggests that use in treatment of prostate cancer is controversial74
- Reduced serum PSA in men when used for greater than 6 months, and especially when used for greater than 2 years75
- Results with specific populations or treatments:
- Improved prostate cancer-specific survival, especially in advanced cancer and/or with radiation therapy76
- Improved prostate cancer survival with use after diagnosis, especially in men managed with androgen deprivation therapy77
- Short-term treatment with atorvastatin reduced serum PSA level in a small prospective controlled clinical trial78
See Prostate Cancer.
Sarcoma
- Improved survival with bone/connective tissue cancer among current users, but not past users79
See Sarcoma.
Skin Cancer
- Improved survival in people with squamous-cell carcinoma patients with use following diagnosis, with greater benefit at higher doses80
See Skin Cancer.
Stomach (Gastric) Cancer
Improved survival among current users, but not past users81
See Stomach Cancer.
Uterine/Endometrial Cancer
- Improved overall survival,82 although no difference between statin users and nonusers in five-year recurrence-free survival, disease-specific survival or overall survival in a more recent study83
- Results with specific populations or treatments:
See Uterine Cancer.
Clinical Trials
A few clinical trials have been conducted or are in progress.
Several ongoing clinical trials are evaluating the effectiveness of statins as neoadjuvant therapy (therapy prior to a main therapy such as surgery) in postmenopausal breast cancer, prostate cancer and colorectal carcinoma. Encouraging clinical trial results suggest further study in these diseases:86
- Chronic lymphoblastic leukemia
- Multiple myeloma
- Pancreatic cancer
- Non small-cell lung cancer
- Small cell lung cancer
- Esophageal cancer
- Colorectal cancer
Modes of ActionMany observational and preclinical studies point to anticancer characteristics of statins:
All these processes play an important role in cancer causation, leading to oncologists’ interest in the role of statins in cancer prevention and treatment.87 Based on preclinical studies, researchers suggest that statins, through disturbing lipid metabolism, may influence pathways that signal cell growth and survival, thus leading to programmed cell death.88 The antineoplastic effect (inhibiting or preventing the growth and spread of tumors or malignant cells) of statins might also arise from a number of non-cholesterol-mediated mechanisms, such as immunoregulation, antioxidant activity and indirect anti-inflammatory properties.89 The anticancer effect of statins is a much more complex phenomenon and not only a result of their cholesterol-lowering effect.90 |
Lab and Animal Evidence
The following anticancer effects have been observed in preclinical studies:91
- Inhibition of cancer growth
- Inhibition of migration, invasion and metastasis formation
- Synergistic effects with other treatments
- Chemotherapy and immunotherapy: such as 5-FU, cisplatin, cetuximab, doxorubicin, celecoxib, carboplatin, imatinib
- Radiotherapy
- Cancer immune surveillance, the immune system's monitoring process to detect and destroy cancer cells in the body
According to Yao et al., only lipophilic statins are able to permeate the cell membrane and affect cellular functions. Their study demonstrated that all lipophilic statins tested (lovastatin, atorvastatin, fluvastatin, and simvastatin) but not a hydrophilic statin (pravastatin) significantly inhibited the cell proliferation of breast cancer cell lines.”92
Manthranvadi et al. note that the lipophilic statins in particular were associated with improved recurrence-free survival, overall survival and cancer-specific survival.93
Pisanti et al. state that statins’ anti-inflammatory properties and the subsequent alteration of the tumor microenvironment suggest that some patients with cancers characterized by chronic inflammation (such as lung cancer in smokers, esophageal cancer in Barrett’s patients, colorectal cancer and inflammatory breast cancer) may benefit from statins combined with other anti-inflammatory drugs.94
Findings in Specific Cancer Types
- Brain cancer: Anticancer effects have been seen on glioma cells in lab studies; however, whether these effects would be observed in animal and human trials remains uncertain.95
- Colorectal cancer:
- Anticancer proliferation effects in resistant colorectal cancer cells when used with chemotherapy drugs; interfered with insulin-like growth factor 1 receptor (IGF-1R) signaling, which is known to promote cancer cell survival and proliferation; and other anticancer effects96
- Only natural statins (simvastatin, mevastatin and lovastatin) suppressed NF-kB activation. NF-kB, a group of proteins that help control cell growth and survival, may be excessive or overactive in some types of cancer cells, which may lead to cancer cell growth.97
- Pretreatment with lovastatin significantly increased cell death (apoptosis) induced by 5-fluorouracil (5-FU) or cisplatin in colon cancer cell lines.98
- Hematologic (blood) malignancies: A 2015 review of preclinical and clinical studies of statins as adjuvant (supplemental) therapies in hematologic malignancies concluded that statins provide anticancer effects.99 The same review found statins may restore chemosensitivity.100
- Prostate cancer: A 2017 review found statins sensitize cancer cells to radiation and show other potential antitumor effects in prostate cancer. Statins may possibly increase prostate cancer-specific survival.101
- Thyroid cancer:102
- Statins have been associated with lower number and volume of thyroid nodules, greater cell death (apoptosis), and delayed metastasis, as well as potential protective effects on cancer progression.
- Statins may interact with other therapies. The combination of lovastatin with the chemotherapy drug paclitaxel reduced the cell-killing ability of paclitaxel and inhibited cell death.
Managing Side Effects and Promoting Wellness
Managing or relieving side effects or symptoms, reducing treatment toxicity, supporting quality of life or promoting general well-being
Clinical Evidence
Cardiovascular Effects
- Reduced anthracycline-induced cardiotoxicity:103
- Breast cancer patients receiving statins during anthracycline therapy had a lower risk of heart failure.
- Statins were at least equally potent as dexrazoxane, beta-blockers or angiotensin antagonists in preventing anthracycline-induced cardiotoxicity.
- Maintained left ventricular ejection fraction (LVEF) among patients receiving either high doses of atorvastatin or any statin during chemotherapy with doxorubicin or idarubicin for up to six months, while patients that did not receive the statin showed a significant decrease in LVEF.
- Reduced risk of stroke and combined risk of cardiovascular and cerebrovascular events from radiation to the chest, head or neck104
Other Side Effects
- Reduced anastomotic leaks (leaking where the colon segments were joined after removing the tumor) after elective colectomyIn colorectal cancer with use of statins near the time of surgery, but no difference in total complications or median hospital stay105
- Decreased risk of a skeletal-related event in people with multiple myeloma106
Lab and Animal Evidence
A 2017 review found that statins reduced anthracycline-induced cardiotoxicity in animals:107
- Lovastatin showed cardioprotective effects from doxorubicin in mice.
- Lovastatin reduced acute anthracycline-induced cardiotoxicity and protected from doxorubicin-induced sub-acute cardiac damage and liver damage in mice.
- Rosuvastatin protected rats from doxorubicin-induced delayed cardiotoxicity, increased blood pressure and other cardiovascular markers.
- Atorvastatin protected mouse hearts and testes from doxorubicin-induced DNA damage.
- Pitavastatin reduced doxorubicin-induced cardiotoxicity in mice.
Another review concluded that statins reduced cardiotoxicity from the use of anthracycline therapy in preclinical studies.108
Reducing Risk
Reducing the risk of developing cancer or the risk of recurrence
Statins may be useful in reducing risk of several types of cancer. In most of the human observational studies, statins were already being used by patients to lower cholesterol and to prevent heart disease:109
- Modest decrease in the risk of developing colorectal cancer
- Lower risk of advanced/aggressive prostate cancer
- Larger risk reductions for certain cancer types (such as gastric, oesophageal or hepatocellular) associated with statin use.
- Meta-analyses failed to show any difference in cancer risk between hydrophilic and lipophilic statins.
Some analyses conclude that the data are most convincing for simvastatin, with use for several years (greater than three years or greater than five years depending on the study) and in modest doses (up to 40 mg simvastatin, for example). The effect may be greater when combined with aspirin or other nonsteroidal anti-inflammatory drugs.110
Other reviews found no convincing evidence of any impact of statin use on cancer incidence, neither decreasing nor increasing risk.111
Blood Cancers
(as a group)
- Reduced risk of blood cancers in observational studies, but not randomized control trials112 .
See also Leukemia, Lymphoma and Myeloma below
Brain Cancer
- Reduced risk of glioma113
Breast Cancer
Meta-analyses, reviews and case control studies:
- Reduced incidence of breast cancer in several investigations114 but not all115
- Decreased five-year breast cancer recurrence rates with initiatiion of statins less than three years after diagnosis of early stage breast cancer with lipophilic statins but not hydrophilic statins116
See Breast Cancer.
Colorectal Cancer
- Reduced risk of colorectal cancer in large epidemiological studies, but not always in randomized controlled studies, case control and cohort studies, perhaps because of shorter timeframes and confounding conditions, or perhaps because of publication bias in epidemiological studies117
- Mixed evidence regarding reduced risk of recurrent, multiple or advanced adenomas or adenomatous polyps118
- Results with specific populations or treatments:
- Reduced risk for patients with diabetes or irritable bowel disease (IBD) with long-term use119
- Lower risk of postcolonoscopy colorectal cancer, particularly for cancer in the lower colon120
Esophageal Cancer
- Some epidemiological evidence of prevention of adenocarcinoma of esophagus in patients with Barrett’s esophagus was found in a 2014 study. However, the authors conclude that sufficient clinical data is lacking, and thus “their use is justified only in patients with cardiovascular disease.”121
- Preliminary evidence of prevention of esophageal carcinoma is cited in a 2014 review.122
See Esophageal Cancer.
Gynecologic Cancer (Endometrial and Ovarian)
- Lab and animal studies suggest a chemopreventive role of statins.123
See Ovarian Cancer and Uterine Cancer.
Head and Neck Cancers
- Reduced incidence of head and neck cancers124
Kidney Cancer
- A preventive effect against kidney cancer in one 2014 review125 but not in a separate 2014 review and meta-analysis126
Leukemia
- Reduced risk of leukemia127
Liver Cancer
- Reviews have found preliminary and promising evidence of statins’ role in prevention,128 especially with simvastatin, lovastatin and atorvastatin.129
- Results with specific populations or treatments:
- Preventive effect among patients with diabetes.130
- Lower risk of developing liver cancer among people with with chronic viral hepatitis with use of lipophilic (fat-soluble) statins than use of hydrophilic (water-soluble) statins or no statins at all; for those taking lipophilic statins, the most benefit was seen in those taking moderate doses of the statin for at least two years.131
Lung Cancer
- Reduced lung cancer incidence with statin use132 irrespective of the presence of diabetes, smoking or alcohol use;133 however, a 2014 review concluded that recent studies fail to confirm a beneficial effect.134
Lymphoma
Melanoma
Myeloma
Pancreatic Cancer
- Reduced risk of pancreatic cancer, although data are conflicting, possibly indicating a differential effect by sex, with prevention seen mainly in males.141
Prostate Cancer
- Some conclude that evidence of reduced risk of prostate cancer is inconclusive142 and use in prevention of prostate cancer is controversial.143 But others find reduced risk144145 and conclude that if statin use is warranted for another indication, prolonged use, especially with a potent statin, may potentially decrease the risk of advanced prostate cancer.”146
- Decreased risk of advanced or aggressive prostate cancer.147
- Decreased risk of recurrence after radiation therapy, although evidence of benefit in reducing recurrence is still limited148 but not radical prostatectomy, and only among men undergoing androgen deprivation therapy149
See Prostate Cancer.
Skin Cancer (Non-Melanoma)
Reduced skin cancer incidence with statin use150
Stomach (Gastric) Cancer
- Some evidence indicates statins may reduce the risk of gastric cancer both generally151 and specifically in diabetic patients.152
See Stomach Cancer.
Uterine Cancer
- Reduced risk of non-endometrioid endometrial cancer in women with type 2 diabetes153
Preclinical Evidence:
- Reduced colorectal cancer development in mice154
Optimizing Your Terrain
Creating an environment within your body that does not support cancer development, growth or spread
- Changes in gene expression following two weeks of use before breast cancer surgery155 specifically with high-dose atorvastatin156
- Anti-inflammatory effects influencing the tumor microenvironment and host inflammatory response157
Access
Statins oral form are available with a prescription at pharmacies. The dose and formulation varies by the specific statin prescribed. Some, such as lovastatin, are available in extended-release formulation.
Cautions
Some evidence indicates that statins may increase cancer risk in elderly patients, especially in association with hydrophilic statin use.158 A 2014 review concluded that “recent meta-analysis, however, showed no evidence of cancer increment in statin-treated elderly participants.”159 Some evidence indicates they may induce resistance to chemotherapy.160
Grade 3 or higher nausea and anorexia were noted slightly more often in patients with metastatic colorectal cancer in the simvastatin arm compared with with the placebo arm during treatment with XELIRI/FOLFIRI.161 Gastrointestinal side effects were also noted with high-dose simvastatin for people with multiple myeloma.162
Common Side Effects/Adverse Events
Side effects in conventional dosing to lower cholesterol:163
- Headache
- Difficulty sleeping
- Flushing of the skin
- Muscle aches, tenderness, or weakness (myalgia)
- Drowsiness
- Dizziness
- Nausea or vomiting
- Abdominal cramping or pain
- Bloating or gas
- Diarrhea
- Constipation
- Rash
Statins also carry warnings of the following possible side effects:164
- Memory loss
- Mental confusion
- High blood sugar
- Type 2 diabetes
Rare, but potentially serious side effects:165
- Myositis (inflammation of the muscles), the risk of muscle injury increases when certain other medications are taken with statins.
- Elevated levels of CPK (creatine kinase), a muscle enzyme that when elevated, can cause muscle pain, mild inflammation, and muscle weakness. This condition, though uncommon, can take a long time to resolve.
- Rhabdomyolysis (extreme muscle inflammation and damage). With this condition, muscles all over the body become painful and weak. The severely damaged muscles release proteins into the blood that collect in the kidneys. The kidneys can become damaged trying to eliminate a large amount of muscle breakdown caused by statin use. This can ultimately lead to kidney failure or even death. Fortunately, rhabdomyolysis is extremely rare.
"Statins should always be accompanied by CoQ-10 or ubiquinol" according to integrative oncologist and BCCT advisor Dwight McKee, MD.166 Integrative oncologist and BCCT advisor Keith Block, MD, concurs: “Because statins deplete coenzyme Q10 especially from your muscle cells, particularly your heart, I advise patients on statins to take at least 30 mg of coQ10 per day, and 200 mg or considerably more if they are taking any heart-damaging medications such as Adriamycin or Herceptin."167 See further discussion in the Commentary section below.
In 2019, the FDA added statins to its list of drugs requiring evaluation for the need for regulatory action. The side effect in question is immune-mediated necrotising myopathy, characterized by “signs of necrosis, or cell death, in the muscles, which causes weakness and fatigue.”168 BCCT asked retired integrative oncologist and BCCT advisor Dwight McKee, MD, about the implications of this FDA evaluation and if people with autoimmune conditions were at increased risk for this side effect. See his reply in Commentary below.
“Although they have been observed, such side effects as insomnia and decrease in cognitive function are still questionable. It is very important for a pharmacist to suggest a less lipophilic member of the statin group when dealing with patients who have an existing or potential condition of insomnia or decreased cognitive function.”169
Thus a trade-off exists: the more lipophilic statins are considered to have greater anticancer potential but also greater risks for cognitive function. Therefore, potential benefits of statin use solely for anticancer purposes need to be carefully weighed for those with insomnia or at risk of decreased cognitive function.
Statins and Drug or Food Interactions
Statins may interact with drugs, causing potentially serious side effects including these:170
- Over-the-counter vitamins and dietary and herbal supplements
- Cholesterol lowering medications such as fibrates or nicotinic acid
- Certain antibiotics
- Birth control medications
- Warfarin (Coumadin), a blood thinner (the combination of statins and warfarin may cause blood to become too thin)
- Medications to treat HIV/AIDS
- Medications used to suppress the immune system.
- Grapefruit juice may decrease the ability of the liver to metabolize some statins, such as atorvastatin (Lipitor), simvastatin (Zocor), and lovastatin (Mevacor, Altocor); thus grapefruit juice should not be consumed at the same time as the statin medication is taken. Some doctors recommend avoiding any grapefruit juice.
- Pomegranate Juice: "Pomegranate juice may increase the risk of rhabdomyolysis for patients on statin therapy, possibly due to the inhibition of CYP 450 enzymes."171
- Baicalin, an active constituent of skullcap, can decrease the blood level of statin drugs.172
Interactions increasing the risk of rhabdomyolysis (breakdown of muscle tissue that releases a damaging protein into the blood): “Rhabdomyolysis is probably the most serious statin side effect. Risk is increased when statins are co-administered with medications that inhibit their elimination. Due to differences among statins in elimination pathways, not all statins pose the same risk of drug interactions. Lovastatin, simvastatin, and to a lesser extent atorvastatin, have the most drug interactions.”173
Interaction with chemotherapy:
- One study found that use of lovastatin at the same time as paclitaxel interfered with paclitaxel’s cell-killing ability as well as cell death (apoptosis).174
- Because statins may interact with chemotherapy and other drugs, make sure your oncologist and primary care doctor know you are taking statins.
Checking for drug interactions:
- Clinicians can use the chart in the Canadian Pharmacist’s Letter to tailor medication choices to minimize risk.
- Patients can use the WebMD Interaction Checker to check for drug interactions.
Contraindications
Individuals with these situations should not use statins:175
- Allergic to statins or their ingredients
- Pregnant or planning a pregnancy
- Breastfeeding
- Active liver disease
- Drink excessive amounts of alcohol or are an alcoholic
- History of myopathy (a type of muscle disease)
- Renal failure due to rhabdomyolysis
Dosing
BCCT does not recommend therapies or doses, but only provides information for patients and providers to consider as part of a complete treatment plan. Patients should discuss therapies with their physicians, as contraindications, interactions and side effects must be evaluated.
Dosing of statins in conventional use varies depending on the particular statin prescribed.
The most effective dosing of statins for use in cancer treatment has not yet been established by randomized control clinical trials. At this time, no single statin agent and dose has been recommended for cancer prevention in the general population.176
Since most human studies have been observational of people already on statins for lowering cholesterol and other conditions, conventional doses were used. Some lab and animal studies suggest that higher doses may be needed for anticancer effects.177
The following reviews discuss doses of specific statin drugs used in cancer prevention and/or treatment studies:
- A 2014 review of therapeutic use of statins in several cancers178
- A 2001 trial of prevastatin in hepatocellular carcinoma179
- A 2016 review of DCIS or stage 1 breast cancer180
- Fluvastatin dosing in invasive breast cancer181
Integrative Programs, Protocols and Medical Systems
| For more information about programs and protocols, see our Integrative Programs and Protocols page. |
- Programs and protocols
- Block program182 for inflammation
- Chang strategies183
- Liver cancer use as an adjuvant treatment
- In cocktail treatment for both primary and secondary cancer prevention (preventing cancer occurrence as well as recurrence), especially for breast, colon, lung and prostate cancer
Commentary
Regarding concern for cognitive dysfunction with statin use, Gary Oberlender, MD, a geriatrician and consultant in geriatric care states: “Though the connection between statins and cognitive dysfunction has not been ‘proven’, that does not prove a lack of connection. The studies published have been too short and not well performed, in my view. However, there is abundant anecdotal evidence, including my own [clinical] experience, that strongly suggests that some, but certainly not all, people who take statins experience brain fog or other ill-defined cognitive symptoms. I think it has to do with too low LDL levels. In any event, I routinely recommend stopping statin drugs in persons experiencing cognitive symptoms, but only after a discussion with their primary care provider. I am not aware of evidence linking statin use with improved cognitive performance, though statins may reduce the risk of vascular dementia.”184
Retired integrative oncologist and BCCT advisor Dwight McKee, MD: It’s been known for a long time that statins can cause muscle inflammation, pain and weakness. In 2013 it was found that there is a subset of these side effects that are autoimmune mediated—that is, the person’s immune system reacts against the same enzyme target as the statins.[185 This happens in about 2-3 per 100,000 statin users, so it’s pretty rare. I think it probably should be added to the list, with that proviso that the incidence appears to be about 2-3 persons per 100,000 statin users.
I doubt there are any data, but the precautionary principle would certainly dictate that people with autoimmune disease avoid statins. When I was in practice, I used red yeast rice (RYR) that had adequate monokolin K content (which is identical to lovastatin. The pharmaceutical chemist who 'invented' lovastatin appears to have copied it from the yeast and knew of its long use in Chinese medicine for 'excessive blood thickness'.) Several clinical studies in Asia have shown similar results in cancer control with RYR as with pharmaceutical statins.
I've never seen any of the typical statin side effects from red yeast rice, and it’s been shown to have similar anticancer effects as do statins. One problem however, is that in the US the FDA forbids RYR that contains monocolin K, since that's a known 'drug' (lovastatin). In the European Union, the regulation is the opposite—manufacturers can't make any health claims about red yeast rice UNLESS they have an adequate content of monocolin K.
The nutraceutical company that I formulate for (Life Plus International) has its major markets in Europe, where we sell a monocolin K rich RYR (took a while to find one with very low levels of citrinin, a mycotoxin that can develop during production--and high levels of citrinin often accompany low levels of monocolin K. Citrinin is nephrotoxic in animals, not tested in humans). I formulated it with 50 mg of Co-q-10 in each capsule. We can only sell it in the EU, however, where it’s required to have minimum 10 mg monocolin K per capsule to make the allowed health claims for red yeast rice.
In the US, there are a number of the professional line supplement companies that have intact monocolin K, despite the FDA rule. Thorne Research and several of the other professional supplement lines (used primarily by health care professionals) make red yeast rice (RYR) without removing the monocolin K, which is required for the cholesterol lowering effect. Other companies such as Metagenics and Designs for Health also do. Since these supplements are not FDA-approved drugs they don't require a prescription. But the fact that doctors recommend these particular products seems to give them a bit more insulation from FDA than non-professional-line supplements. I would advise against buying RYR in a drug store or health food store, as FDA does not regulate for citrinin content. Consumer lab.com, a private company that analyzes and publishes their findings on many RYR products, found low levels of monocolin K, and substantial levels of the mycotoxin citirinin in many OTC brands of RYR.
I think it’s always a good idea to take Co Q10 (or the reduced form, ubiquinol) with RYR, since inhibition of the enzyme HMG COA reductase (the target of statins, and also the target of the autoimmune response that can be triggered by taking statins), also prevents the body's ability to produce Co Q10.
Uses of Statins Off-Label for Cancer
What some researchers and clinicians are saying:
Integrative oncologist and BCCT advisor Keith Block, MD, wrote in his 2009 book: “A 2007 trial suggested that a statin may overcome drug resistance in multiple myeloma. So if a patient has multiple myeloma and is out of options, I would certainly consider as one option prescribing a statin for her alongside her drug protocol, in hopes of overcoming resistance and initiating a response.”186
Raymond Chang, MD, FACP, medical director of the Meridian Medical Group, writes: “Based on the large volume of research, the benefits of statin use appear to outweigh the potential risks. Still, patients should discuss statin use with a healthcare professional and take the drug only as directed.“187
Pon et al. in a 2015 review: “If statin use is warranted for another indication, prolonged use, especially with a potent statin, may potentially decrease the risk of advanced prostate cancer or mortality associated with prostate cancer.”188
Henninger and Fritz: “Off-label use of statins or novel Rac1 inhibitors might represent a promising pharmacological approach to gain control over chronic cardiotoxicity by interfering with key mechanisms of anthracycline-induced cardiomyocyte cell death.”189
Wang et al.: “Studies seem to suggest that statins may be protective and are not likely to be harmful in the setting of cancer, suggesting that cancer patients who already take statins should not have this medication discontinued.”190
Non-cancer Uses of StatinsStatins are a class of drugs that lower the level of cholesterol in the blood by reducing the production of cholesterol by the liver. Statins block the enzyme in the liver that is responsible for making cholesterol. They are also used to prevent and treat atherosclerosis.191 Statins are one of the most commonly prescribed drugs in the US to reduce the risk of strokes, heart attacks and cholesterol levels. In addition to cancer, statins use is also being researched in these conditions:192
BCCT has not reviewed the effectiveness of this therapy for non-cancer uses. |
Integrative oncologist and BCCT advisor Dwight McKee, MD, among others, concludes that “because most of the statins have patents that are expired or near expiration, there is a lack of incentive on the part of drug companies to conduct large scale clinical trials using these agents against cancer, so it is not clear that we will gain much more useful clinical insight in the near future, but strong reasons to consider adding statins to most cancer preventative or treatment cocktails unless side-effects are an issue in an individual patient.
“Notwithstanding occasional contradictory reports of statins increasing the risk of cancer, given the safety (simvastatin is available as an OTC in the U.K.) and low cost of statins, plus the wide array of studies and accumulating data showing a protective effect of statins against cancer development and recurrence, statins should be seriously considered as part of a cocktailed approach for primary and secondary cancer prevention (especially for colon, breast, lung and prostate—where the data are strongest).
“Statins should also be seriously considered as a cornerstone ingredient to combine synergistically with other compounds such as gamma tocotrienols, cox-2 inhibitors, bisphosphonates etc for added effects in cancer treatment. Not all statins are the same however, and some (e.g. lipophilic statins such as simvastatin) may work better against certain cancers than others (e.g. hydrophilic statins such as pravastatin). Dosage may be important as well.”193
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More Information
- Chang R. Beyond the Magic Bullet: The Anti-Cancer Cocktail. New York: Square One Publishers. 2012. p. 104-105.
- Block KI. Life Over Cancer. New York: Bantam Dell. 2009. p. 522.
- Clinical trial using statins for cancer are listed at clinicaltrials.gov.
- Healthline: Red Yeast Rice: Benefits, Side Effects and Dosage
- Moss Reports podcast: Repurposed Drugs for Cancer with Raymond Chang, MD
- LifeExtension Nutritional Support: Cancer Adjuvant Therapy: Repurposing Common Drugs as Adjuvant Cancer Therapies
- Block KI, Block PB, Gyllenhaal C: Integrative Treatment for Colorectal Cancer
- Dwight McKee, MD, editor: Clinical Pearls
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