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

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NEWS HIGHLIGHTS

Media Articles Related to Lipitor (Atorvastatin)

Pfizer Submits New Pediatric Data For Lipitor(R) (Atorvastatin) To The European Medicines Agency (EMEA)
Source: Cholesterol News From Medical News Today [2009.11.18]
Pfizer Inc (NYSE:PFE) announced it has submitted pediatric data for Lipitor® (atorvastatin) to the European Medicines Agency (EMEA). Pfizer has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5 mg dose, which is part of this submission.

Ezetimibe Makes Atorvastatin More Efficient In Lowering Lipids In Men And Women Age 65 And Older
Source: Cholesterol News From Medical News Today [2009.10.29]
Adding ezetimibe to atorvastatin significantly boosted the attainment of lipid targets as specified by both Canadian and European guidelines in elderly patients aged 65 and older and the combination produced superior results than simply increasing the dose of atorvastatin alone, Dr. Christian Constance told the Canadian Cardiovascular Congress 2009, co-hosted by the Heart and Stroke Foundation and the Canadian Cardiovascular Society.

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Published Studies Related to Lipitor (Atorvastatin)

Effect of Preoperative Atorvastatin Therapy on Atrial Fibrillation Following Off-Pump Coronary Artery Bypass Grafting. [2009.10.13]
Background: Atrial fibrillation (AF) after coronary artery bypass grafting (CABG) is still the most common postoperative arrhythmic complication. Previous studies report that patients undergoing preoperative statin therapy had a lower incidence of postoperative AF... Conclusions: Administration of atorvastatin 20 mg/day, initiated 1 week before elective off-pump CABG and continued in the postoperative period, significantly decreases postoperative AF.

Atorvastatin increases the number of endothelial progenitor cells after cardiac surgery: a randomized control study. [2009.10.09]
Endothelial Progenitor Cells(EPCs) are a subtype of haematopoietic stem cells which contribute to the repair of injured endothelium. Treatment with atorvastatin has been shown to increase EPC count in patients with coronary artery disease, therefore we investigated whether atorvastatin augments the number of EPCs after cardiopulmonary bypass(CPB) surgery.Randomized, double-blind, placebo-controlled two way cross-over trial in 50 patients undergoing elective coronary surgery...

Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. [2009.09.01]
Both randomized and observational studies have suggested that pretreatment with statins may reduce the incidence of periprocedural myocardial infarction (PMI) in patients with stable angina during elective percutaneous coronary intervention (PCI)... In conclusion, in the present study 2-day pre-PCI therapy with atorvastatin did not reduce the occurrence of PMI in patients with stable angina pectoris undergoing elective PCI.

Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. [2009.09]
The impact of gastric bypass on atorvastatin pharmacokinetics was investigated in 12 morbidly obese patients being treated with 20-80 mg atorvastatin each morning. Eight-hour pharmacokinetic investigations were performed the day before the surgery and at a median of 5 weeks (range 3-6 weeks) after the surgery...

Effects of atorvastatin on serum soluble receptors for advanced glycation end-products in type 2 diabetes. [2009.08.21]
OBJECTIVE: The receptor for advanced glycation end-products (RAGE) plays an important role in the pathogenesis of diabetic complications and atherosclerosis. Interfering with the activation of RAGE by using a soluble form of the receptor (sRAGE) ameliorates the vascular complications of diabetes in animal models. We have investigated whether statin can influence the expression of sRAGE and esRAGE (a splice variant of sRAGE) in vitro and in vivo... CONCLUSIONS: Statins are known to have pleiotropic effects and we have shown that atorvastatin can increase circulating esRAGE levels in type 2 diabetic patients.

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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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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 67 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		cholesterol
Dosage & duration:		20mg taken 1 a day for the period of 6 months
Other conditions:		muscle problems, liver and kidney problesm
Other drugs taken:		synthroid
		Reported Results
Benefits:		No. They were harmful to me.
Side effects:		Yes. All kinds of side effects and several trips to Quest for blood work to find out what was happening to my body. On 10/31/07 these were my readings My AST was 384 instead of 10-35, My Alt was 655 instead of 6-40, By 5/1/08 after I stopped taking it for 7 months my readings were AST 37 and ALT 76 a big improvement
Comments:		I couldn't walk because of muscle problems. Then it attacked my kidney and bladder. Drs thought I had cancer. Reduced dosage from 20 mg to 10mg. Had to get off it and through away about $200.00 worth of pills.