Have you ever had a patient complain about experiencing side effects with their current statin? Or treated a patient who has switched their statins multiple times, with none of them seeming to be the right fit?
How about a patient who stopped their statin completely due to these challenges? According to a 2012 survey which was the largest cholesterol survey conducted in the U.S., at least 50 percent of people stop taking their prescribed statin within one year of starting it, despite the proven impact of statins on lowering cholesterol.1 That’s why it’s important for doctors to encourage open and honest conversations with patients about their individualized cholesterol treatment plan.
With several different statins on the market and more than 100 million U.S. adults living with high cholesterol, prescribing the right statin for each patient can be challenging. When patients complain about their statin, shouldn’t one switch be enough?
Tens of thousands of healthcare professionals trust LIVALO® (pitavastatin) as their go-to 2nd-line statin when patients have complaints with their initial statin. LIVALO is a statin medication that, along with a heart-healthy diet and regular exercise, can improve overall cholesterol levels while having a lower risk of certain unpredictable drug interactions compared to other statins.2
When patients require a statin switch, consider the benefits of LIVALO:
Demonstrated safety and tolerability: When tolerability issues require a switch to a different statin, consider LIVALO’s clinical safety and tolerability profile, which includes:
- ~3 percent of patients taking LIVALO 4 mg experienced myalgia (muscle pain) in pivotal trials
- Only 1 in 200 patients discontinued LIVALO
- < 4 percent discontinuation rates with LIVALO which were not dose dependent
Reduced potential for certain drug interactions: Unlike other commonly prescribed statins, minimal metabolism of LIVALO via the CYP450 system offers the reduced potential for certain drug interactions for patients already taking multiple medications.
Ease of prescribing: Coverage of LIVALO has greatly improved on a growing number of managed care plans, with 143 million patients covered under commercial and 23 million covered under Medicare Part D.
Specific patient considerations: Every patient is unique and one specific statin won’t fit all patients. LIVALO is a statin option that several different patient types may benefit from, including people with type 2 diabetes, people age 65 or older, people taking calcium channel blockers for high blood pressure, people with two or more risk factors for coronary heart disease (CHD), people taking warfarin, or people of Asian descent. Watch this video to learn more about these patient types.
High cholesterol that goes untreated can lead to serious health consequences, including heart disease. The good news? By helping your patients make healthy lifestyle choices, including maintaining a heart-healthy diet, getting regular exercise, and finding the right statin for them, they can effectively manage their high cholesterol. When patients complain about their statin, you can help ensure one switch is enough by making LIVALO your go-to 2nd line.
IMPORTANT SAFETY INFORMATION FOR LIVALO® (pitavastatin) tablets
INDICATIONS AND USAGE
Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.
PRIMARY HYPERLIPIDEMIA AND MIXED DYSLIPIDEMIA
LIVALO (pitavastatin) is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.
LIMITATIONS OF USE
- Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4-mg, once-daily dosing of LIVALO
- The effect of LIVALO on cardiovascular morbidity and mortality has not been determined
- LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias
IMPORTANT SAFETY INFORMATION FOR LIVALO® (pitavastatin) tablets
LIVALO is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in co-administration with cyclosporine.
WARNINGS AND PRECAUTIONS
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including LIVALO. These risks can occur at any dose level, but increase in a dose-dependent manner.
- LIVALO should be prescribed with caution in patients with predisposing factors for myopathy.
- The risk of skeletal muscle effects (e.g., myopathy and rhabdomyolysis) increases in a dose-dependent manner with advanced age (≥65 years), renal impairment, inadequately treated hypothyroidism, and in combination use with fibrates or lipid- modifying doses of niacin (≥1 g/day).
- LIVALO should be administered with caution in patients with impaired renal function, in elderly patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin.
- Concomitant administration of LIVALO with gemfibrozil should be avoided.
- LIVALO therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. LIVALO therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled seizures).
- Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and to discontinue LIVALO if these signs or symptoms appear.
- Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing LIVALO with colchicine
- There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. IMNM has not been reported with LIVALO therapy.
- Advise patients to promptly report if muscle signs and symptoms persist after discontinuing LIVALO as this may be a sign of IMNM requiring immediate medical attention.
Liver Enzyme Abnormalities
Increases in serum transaminases have been reported with HMG-CoA reductase inhibitors, including LIVALO.
- It is recommended that liver enzyme tests be performed before the initiation of LIVALO and if signs or symptoms of liver injury occur.
- There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pitavastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with LIVALO, promptly interrupt therapy. If an alternate etiology is not found do not restart LIVALO.
- LIVALO should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIVALO.
In short-term controlled studies, the most frequent adverse reactions reported by ≥2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and at a rate ≥ placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation (3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9% vs 1.9%), myalgia (1.9%, 2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). This is not a complete listing of all reported adverse events.
© Kowa Pharmaceuticals America, Inc. (2017) – LIV-RA-0107 PI V-11-2016
1 Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users. J. Clin Lipidol. 2012;6(3):208-215.
2 Wei et al. Journal of Clinical Lipidology (2013) 7, 472-483.