Lipitor (Atorvastatin Calcium) - Summary

LIPITOR SUMMARY

Lipitor^® (atorvastatin calcium) is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age >/= 55 years, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, Lipitor is indicated to:

• Reduce the risk of myocardial infarction
• Reduce the risk for revascularization procedures and angina

Hypercholesterolemia

Lipitor is indicated:

1. as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb);
2. as an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV);
3. for the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet;
4. to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable;
5. as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
   
   1. LDL-C remains >/= 190 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 pediatric patient

See all Lipitor indications & dosage >>

LIPITOR NEWS HIGHLIGHTS

Media Articles Related to Lipitor (Atorvastatin)

Pre-PCI Reload Improves Outcomes for Statin Users (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2009.07.01]
LITTLE FALLS, N.J. (MedPage Today) -- Patients on chronic statin therapy who reloaded with high-dose atorvastatin (Lipitor) before percutaneous coronary intervention showed improved clinical outcomes in a randomized trial.

Statins Don't Lower Risk Of Pneumonia In Elderly
Source: Statins News From Medical News Today [2009.06.18]
Taking popular cholesterol-lowering statin drugs, such as Lipitor® (atorvastatin), does not lower the risk of pneumonia. That's the new finding from a study of more than 3,000 Group Health patients published online on June 16 in advance of the British Medical Journal's June 20 print issue.

Statins Do Not Help Prevent Alzheimer's Disease, Review Finds
Source: Statins News From Medical News Today [2009.04.15]
An increasing number of studies show that elevated serum cholesterol levels might be part of the cause of Alzheimer disease, but a new review of studies says that, even so, the most successful class of cholesterol-lowering medicines will not stave off the condition. Statins includes medications such as atorvastatin (Lipitor) and pravastatin (Pravachol), which are some of the best-selling drugs in the world.

Low Blood Pressure Levels May Increase Cardiovascular Risk Among Patients With Heart Disease Despite Substantial Lowering Of LDL-Cholesterol
Source: Cholesterol News From Medical News Today [2009.05.08]
Data from the Treating to New Targets (TNT) trial presented at the American Society of Hypertension's Twenty Fourth Annual Scientific Meeting (ASH 2009) show that low blood pressure levels may lead to increased risk of cardiovascular events, including heart attack and stroke. These data supplement previous findings from the TNT trial of atorvastatin showing aggressive LDL cholesterol-lowering reduced cardiovascular events.

more news >>

Published Studies Related to Lipitor (Atorvastatin)

Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. [2008.12.01]
The percentage of change from baseline in low-density lipoprotein (LDL) cholesterol after the addition of ezetimibe 10 mg to atorvastatin [generic for Lipitor] 40 mg was compared with uptitration to atorvastatin 80 mg. In this multicenter, double-blind, parallel-group study, adult hypercholesterolemic patients using atorvastatin 40 mg/day were randomly assigned to atorvastatin 40 mg plus ezetimibe 10 mg or uptitration to atorvastatin 80 mg...

Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. [2008.12.01]
The aim of this study was to evaluate the efficacy and safety of ezetimibe 10 mg added to atorvastatin [generic for Lipitor] 20 mg compared with doubling atorvastatin to 40 mg in patients with hypercholesterolemia at moderately high risk for coronary heart disease who did not reach low-density lipoprotein (LDL) cholesterol levels <100 mg/dl with atorvastatin 20 mg...

Superior benefit of aggressive lipid-lowering therapy for high- risk patients using statins: the SUBARU study--more hypercholesterolemic patients achieve Japan Atherosclerosis Society LDL-C goals with rosuvastatin therapy than with atorvastatin therapy. [2008.12]
AIM: There have been few comparisons between rosuvastatin and other statins in Japanese patients. This open-label, randomized, parallel-group comparative study was performed to compare the efficacy and safety of rosuvastatin (5 mg) and atorvastatin [generic for Lipitor] (10 mg) once daily in Japanese patients with hypercholesterolemia... CONCLUSION: Rosuvastatin (5 mg/day) is a useful treatment option for high-risk patients with hypercholesterolemia.

Effect of omega-3-acid ethyl esters on steady-state plasma pharmacokinetics of atorvastatin in healthy adults. [2008.12]
BACKGROUND: Prescription omega-3-acid ethyl esters (P-OM3) have been used as adjunctive therapy to statin drugs in patients with mixed hyperlipidemia. OBJECTIVE: To assess the effect of concomitant administration of 4 g P-OM3 on the steady-state pharmacokinetics of the maximum recommended daily dose of atorvastatin [generic for Lipitor] (80 mg) in healthy volunteers... CONCLUSIONS: After 14 days of dosing, the rate and extent of exposure (AUCtau, C(max,ss)) to atorvastatin and its active metabolites were similar with both treatments, indicating that administration of P-OM3 did not affect the steady-state bioavailability of orally administered atorvastatin.

Effect of atorvastatin on inflammation and outcome in patients with type 2 diabetes mellitus on hemodialysis. [2008.12]
Statins have multiple effects, including anti-inflammatory actions, lowering C-reactive protein levels, and reducing coronary events. We performed a post hoc analysis of the randomized placebo-controlled 4D Study that had evaluated the efficacy and safety of atorvastatin [generic for Lipitor] in 1255 patients with type 2 diabetes mellitus who were on maintenance hemodialysis.

more studies >>

Clinical Trials Related to Lipitor (Atorvastatin)

Switching to Rosuvastain Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708) [Terminated]
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of <2. 5 mmol/L. Treatment phase is 6 weeks.

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg. [Active, not recruiting]

Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434) [Completed]
This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg [Completed]

Atorvastatin (Lipitor) to Prevent Bone Pain [Completed]
In the proposed randomized double blind cross-over placebo controlled study, the researchers intend to investigate if Atorvastatin (FDA approved statin for children) can be used to alleviate the symptom of bone pain (acute phase reaction) that is commonly associated with initial doses of pamidronate or zoledronic acid, and also the mechanism that underlies this proposed beneficial effect of Atorvastatin. The primary outcome studied will be alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale in children treated with pamidronate or zoledronic acid. The secondary outcome investigated will be changes in blood count and γδT cell count, C-reactive protein (CRP) and cytokine levels of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and gamma interferon (γ-IFN) following treatment with Atorvastatin compared to placebo.

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LIPITOR PATIENT REVIEWS / RATINGS / COMMENTS

Lipitor review by 44 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		incontinence
Dosage & duration:		4mg taken daily for the period of 3 years - ongoing
Other conditions:		continual lack of control over bladder due to chemical imbalance
Other drugs taken:		none
		Reported Results
Benefits:		regulated bladder control to allow patient (me) to return to a regular life and not have to modify all movements by where the nearest bathroon is located.
Side effects:		none
Comments:		Single capsule taken in morning.

Lipitor review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		high cholesterol
Dosage & duration:		20mg taken daily for the period of 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		lower cholesterol
Side effects:		none
Comments:		daily with water at nite. and every three month blood test for liver issues.

Lipitor review by 71 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Cholesterol slightly elevated
Dosage & duration:		20 mg taken daily for the period of 2 weeks
Other conditions:		Recent mitral valve replacement, mild congestive heart failure, high blood pressure
Other drugs taken:		clindamycin hcl, diovan, furosemide, metoprolol succinae, potassium chloride
		Reported Results
Benefits:		I didn't take the product long enough to evaluate the benefits. I quit because of side effects.
Side effects:		Very painful muscles, it took a while to even get them going in the morning.
Comments:		When my cholesterol was found to be slightly elevated, my cardiologist put me on Lipitor. The first week was fine. The beginning of the second week I began to have sore muscles all over. By the end of the second week this was so bad I could hardly get out of bed in the morning. So I quit the Lipitor (did not consult the doctor on this); in the AARP magazine (or else newsletter, not sure which) there was a question for the medical doctor about possible natural replacements for the statin medications and he recommended Red Yeast Rice. I found a product with that and a few other cholesterol-lowering supplements (primarily CoQ-10) ad have been taking that with no side effects. I am due for another blood test in a couple of weeks, so we will see how well it has been working.