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)

UCLA Researchers Reconstitute Enzyme That Synthesizes Cholesterol Drug Lovastatin
Source: Cholesterol News From Medical News Today [2009.11.05]
Researchers from the UCLA Henry Samueli School of Engineering and Applied Science have for the first time successfully reconstituted in the laboratory the enzyme responsible for producing the blockbuster cholesterol-lowering drug lovastatin. The research, published Oct. 23 in the journal Science, could potentially lead to the development of other compounds with similarly beneficial effects.

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Published Studies Related to Mevacor (Lovastatin)

Effect of folate supplementation on serum homocysteine and plasma total antioxidant capacity in hypercholesterolemic adults under lovastatin treatment: a double-blind randomized controlled clinical trial. [2009.07]
BACKGROUND AND AIMS: Hypercholesterolemia is one of the predisposing factors of cardiovascular diseases. A positive correlation of homocysteine (Hcy) concentration with total cholesterol is described. Lovastatin, one of the most administered agents in hypercholesterolemia, is not effective in lowering the level of serum Hcy and increasing serum total antioxidant capacity (TAC). This study was performed to evaluate the effects of folate supplementation on lowering Hcy level and changes of TAC in asymptomatic hypercholesterolemic adults under lovastatin treatment... CONCLUSIONS: Folate supplementation decreases the serum level of Hcy and increases TAC. It seems that a pharmacological dose of folate supplementation could potentially decrease the risk of cardiovascular diseases by reducing serum level of Hcy in adults with hypercholesterolemia.

Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study): a phase-II randomized clinical trial. [2009.06.18]
BACKGROUND: Highly active antiretroviral therapy produces a significant decrease in HIV-1 replication and allows an increase in the CD4 T-cell count, leading to a decrease in the incidence of opportunistic infections and mortality. However, the cost, side effects and complexity of antiretroviral regimens have underscored the immediate need for additional therapeutic approaches.

The comparative bioavailability of an extended-release niacin and lovastatin fixed dose combination tablet versus extended-release niacin tablet, lovastatin tablet and a combination of extended-release niacin tablet and lovastatin tablet. [2007.09]
Lovastatin and extended-release (ER) niacin in a fixed dose combination (Advicor) is approved for the treatment of dyslipidemia. Since both drugs are extensively metabolized, this study investigated the bioavailability and pharmacokinetics of their co-administration following single-dose administration...

Moderate alcohol consumption and safety of lovastatin and warfarin among men: the post-coronary artery bypass graft trial. [2006.05]
CONCLUSION: Moderate drinking did not adversely influence the safety of low-dose warfarin or even high-dose lovastatin among men in this randomized trial, as measured by INR and ALT levels.

Plasma clearance of lovastatin versus chinese red yeast rice in healthy volunteers. [2005.12]
Objectives: It is now accepted that inhibition of cholesterol biosynthesis is effective in the primary and secondary prevention of heart disease. However, the perceived side-effects on muscle and liver reduce the general acceptance of statin drug therapy as well as compliance over the long term, which is necessary for prevention efforts to be successful...

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Clinical Trials Related to Mevacor (Lovastatin)

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

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

Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication [Completed]
The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication.

At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study.

Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.

The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC [Completed]
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries.

At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study.

Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve “intermittent claudication” (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.

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

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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.