Mevacor (Lovastatin) - Summary

MEVACOR SUMMARY

MEVACOR (Lovastatin), is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding (beta)-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol.

MEVACOR is indicated for the following:

Therapy with MEVACOR should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. MEVACOR should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.

Primary Prevention of Coronary Heart Disease

In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, MEVACOR is indicated to reduce the risk of:

• Myocardial infarction
• Unstable angina
• Coronary revascularization procedures

(See CLINICAL PHARMACOLOGY, Clinical Studies.)

Coronary Heart Disease

MEVACOR is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels.

Hypercholesterolemia

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia. MEVACOR is indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb***), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate.

Adolescent Patients with Heterozygous Familial Hypercholesterolemia

MEVACOR is indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present:

1. LDL-C remains >189 mg/dL or
2. LDL-C remains >160 mg/dL and:
   • there is a positive family history of premature cardiovascular disease or
   • two or more other CVD risk factors are present in the adolescent patient

NEWS HIGHLIGHTS

Media Articles Related to Mevacor (Lovastatin)

Statin Drug Shows Promise For Fighting Malaria Effects
Source: Statins News From Medical News Today [2012.12.31]
Researchers have discovered that adding lovastatin, a widely used cholesterol-lowering drug, to traditional antimalarial treatment decreases neuroinflammation and protects against cognitive impairment in a mouse model of cerebral malaria...

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Published Studies Related to Mevacor (Lovastatin)

Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma. [2011.10]
The treatment of patients with multiple myeloma usually includes many drugs including thalidomide, lenalidomide and bortezomib.Our results suggest that the addition of lovastatin to the TD regimen may improve the response rate in patients with relapsed or refractory myeloma.

Influence of one-year treatment with lovastatin on myocardial remodeling and ischemia in patients with coronary artery disease. [2011.02]
OBJECTIVE: Emerging evidence assumes that statins have a benefit to influence the myocardial remodeling and ischemia in patients with coronary artery disease (CAD). Our aim was to investigate the possible and direct favorable effects of lovastatin on left ventricular (LV) systolic, diastolic function and myocardial ischemia in patients with CAD... CONCLUSION: Lipid-lowering therapy with lovastatin improved the LV systolic function and decreased myocardial ischemia.

Pharmacokinetic interaction between oral lovastatin and verapamil in healthy subjects: role of P-glycoprotein inhibition by lovastatin. [2010.03]
BACKGROUND: Lovastatin is an inhibitor of P-glycoprotein (P-gp) and is metabolized by the cytochrome P450 (CYP) 3A4 isoenzyme. Verapamil is a substrate of both P-gp and CYP3A4. It is therefore likely that lovastatin can alter the absorption and metabolism of verapamil... CONCLUSION: Lovastatin increased the absorption of verapamil by inhibiting P-gp and inhibited the first-pass metabolism of verapamil by inhibiting CYP3A4 in the intestine and/or liver in humans.

Effect of lovastatin on primary prevention of cardiovascular events in mild CKD and kidney function loss: a post hoc analysis of the Air Force/Texas Coronary Atherosclerosis Prevention Study. [2010.01]
BACKGROUND: Chronic kidney disease (CKD) is associated with an increased risk of incident cardiovascular disease (CVD); however, the role of statins for the primary prevention of acute cardiovascular events in patients with CKD and the effect of statins on kidney function loss in persons without prevalent CVD have not been studied... CONCLUSIONS: Lovastatin is effective for the primary prevention of CVD in patients with CKD, but is not effective in decreasing kidney function loss in persons with no CVD. Copyright 2009 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Effect of niacin ER/lovastatin on claudication symptoms in patients with peripheral artery disease. [2010]
In patients with peripheral artery disease (PAD), statins may improve the symptoms of claudication. The Intermittent Claudication Proof of Principle (ICPOP) study tested the hypothesis that the combination of extended release niacin plus lovastatin would improve exercise performance in patients with PAD and claudication compared with a diet intervention...

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Clinical Trials Related to Mevacor (Lovastatin)

Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets [Completed]

A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer [Recruiting]

Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1) [Recruiting]
Neurofibromatosis type I (NF1) is a genetic disorder that affects approximately 1 in 3500 individuals. Half of people with NF1 inherit the condition from a parent, and half have a new occurrence of the condition. The manifestation of NF1 is highly variable and multiple organ systems are typically affected. Some of the more common symptoms include benign neurofibromas, café au lait spots, Lisch nodules (tan spots on the iris of the eye). Some individuals with NF1 also exhibit more severe associated conditions, such as optic pathway tumors (gliomas) or bones bending or curving. Neurocognitive deficits and specific learning disabilities occur in approximately 30 to 50% of individuals with NF1 and are regarded by some observers and sufferers to be among the most troubling features of a disease. The most commonly reported findings are deficits in visuoperceptual ability, motor coordination, expressive and receptive language, and executive functioning, which requires intact short-term memory and attention. Patients with NF1 also show a slight depression in mean IQ scores compared to healthy adults without the disorder.

While cognitive deficits are now a widely-recognized feature of Neurofibromatosis Type 1 (NF1), the precise cause of these deficits still remain to be determined. Dr. Alcino Silva, a co- investigator on this study, has developed an animal model of NF1 in which mice have a specific mutation of the *NF1* gene. These mice are physically normal but show specific learning impairments. Dr. Silva's lab found that treatment with a medication called lovastatin, a drug typically used for high cholesterol, reversed some of the spatial deficits seen in these animals. Lovastatin is a medication commonly used to treat high cholesterol and has been proven to be relatively safe and tolerable in humans.

The investigators are now conducting a randomized, double-blinded, placebo- controlled, trial of lovastatin in patients with NF1. Participants will be randomly assigned to lovastatin or placebo and treated for approximately 14 weeks with baseline and follow-up assessments to evaluate safety and any effects on neurocognitive test performance.

Pre-Prostatectomy Lovastatin on Prostate Cancer [Recruiting]
To determine the dose of continuous daily oral lovastatin needed to achieve MYC [v-myc myelocytomatosis viral oncogene homolog (avian)] down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.

Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis [Recruiting]

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Reports of Suspected Mevacor (Lovastatin) Side Effects

Drug Ineffective (5),  Abdominal Pain Upper (4),  Muscle Spasms (4),  Malaise (3),  Completed Suicide (3),  Myocardial Infarction (3),  Pain in Extremity (3),  Toxicity TO Various Agents (3),  Abasia (2),  Influenza Like Illness (2), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Mevacor review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		originally brain lesions then lower cholesterol
Dosage & duration:		10 mg increased to 20mg taken nightly for the period of 3 years
Other conditions:		multiple schlerosis
Other drugs taken:		imipramine & wellbutrin
		Reported Results
Benefits:		I believe the treatment at the lower 10 mg dose was effective in reducing the serverity of my brain lesions. I also believe I was thinking more clearly afterwards than I was prior to starting on lovastatin. A brain MRI taken a year after starting on Lovastatin indicated the lesions had reduced a bit, but that was not confirmed by my doctor as my previous MRI had been lost when I changed doctors.
Side effects:		After increasing the dosage to 20 mgs to also reduce my cholesterol levels, I started to experience extreme pain in my arm muscles.
Comments:		Originally I started taking it to see if it would have any positive effect on the number and size of brain lesions I had. I had experienced an increasing inability to handle job stress, was losing my concentration abilities and was becoming increasingly forgetful. I believe it did have some positive effect in reducing the size and number of brain lesions, but not to the effect of improving my cognitive thinking ability to the extent I could return to work. Two years later, my doctor wanted me to increase the dosage to reduce my cholesterol levels. Shortly after increasing my dosage, I started to experience chronic pain in my arms. I finally did some research and discovered muscle pain to be a "side effect" when taking statin drugs. When I stopped taking Lovastatin, the pain went away after a few months.

Mevacor review by 51 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		high cholesterol
Dosage & duration:		60 mg taken once a day for the period of month
Other conditions:		high blood pressure
Other drugs taken:		vasotec
		Reported Results
Benefits:		NONE!!!!!
Side effects:		I began having very irregular heart rhythm within about 2 1/2 weeks of taking this medicine. Feeling like I was going to pass out or maybe my heart would even stop beating.
Comments:		I began having very irregular heart rhythm within about 2 1/2 weeks of taking this medicine. I began feeling like I was going to pass out or maybe my heart would stop beating & I would just keel over & die if I didn't immediately start moving around. I could be sitting or laying down in bed & these "spells" would come on out of the blue & very regularly. I spent one night up all night laying on the couch because it was so bad that I was afraid that if I fell asleep I might not wake up. I tried to pretend it would go way at first but then made an appointment with my Dr. first & then a cardiologist, it was just too scary. My Dr. didn't believe that it was the medicine. By the time I could get in to see the cardiologist & have the heart monitor holster, echocardiogram etc. done I had been off the medicine for 2 weeks & the symptoms had lessened & of course did not appear while I was being tested. The Dr. thought I was crazy & that there was no way it was the medicine & that maybe I was having panic attacks. I have never had a panic attack in my life & I have had similar heart rhythm symptoms with other meds that quit when I stopped taking them & I know my own body. It WAS the lovastatin. It took a year & a half before I started feeling normal again & didn't have these attacks come on sometimes. I truly believe the lovastatin had an affect on my heart that took that long to get better. I will NEVER take another cholesterol med again that has the possible side affects of affecting muscles. The heart is a muscle. I also found that other people have had this same experience while taking statins while I was researching this on the internet. Neither Dr. would even look at the article I printed out about it & it was even written by another Dr. who was researching statin side affects.