CardioExchange Archive

March 3rd, 2014

Pfizer Starts Testing for Over-the-Counter Atorvastatin

Larry Husten, PHD

Looking backward to improve its future, Pfizer will once again try to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reports in the Wall Street Journal that the company has started a clinical study to support the application for low-dose atorvastatin (10 mg). Over-the-counter statins have been unsuccessfully proposed in the past. Merck […]

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January 14th, 2014

All Lots of Liptruzet In U.S. Recalled Over Packaging Defect

Larry Husten, PHD

Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the U.S. The company said the recall was due to a packaging defect that could potentially allow air and moisture to affect the quality of the drug, although “the likelihood of the packaging defects decreasing the […]

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July 9th, 2013

Low Rate of Problems with Statins in Study of Quarter Million Patients

Larry Husten, PHD

A very large analysis of previously published studies finds that statins are generally safe and well tolerated, but helps confirm previous links to a small increased risk for diabetes and elevation of liver enzymes. Some statins were better tolerated than others, and lower-dose statins were better tolerated than high doses. In a paper published in Circulation: Cardiovascular […]

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April 16th, 2013

Blood Sample Mismatch Leads ‘Anguished’ Authors to Retract Three Lipitor Papers

Larry Husten, PHD

Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants. The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns. The […]

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January 3rd, 2013

Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path

Larry Husten, PHD

A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son […]

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November 29th, 2012

Following Earlier Recall, Ranbaxy Halts Manufacturing of Atorvastatin

Larry Husten, PHD

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012, the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the […]

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November 19th, 2012

Selections from Richard Lehman’s Literature Review: November 19th

Richard Lehman, BM, BCh, MRCGP

This week’s topics include multivitamins and cancer prevention in men, a comparison of atorvastatin with or without a PCSK9 Antibody in primary hypercholesterolemia, type-2 diabetes screening and population mortality over 10 years, and more.

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October 31st, 2012

PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect of Atorvastatin

Larry Husten, PHD

When added to low-dose atorvastatin, a much-discussed new monoclonal antibody to PCSK9 significantly lowers cholesterol more effectively than atorvastatin alone, according to a phase 2 study published in the New England Journal of Medicine. Earlier this year, in March, the findings of three phase 1 trials demonstrating the cholesterol-lowering effects of the drug in healthy […]

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May 10th, 2012

Atorvastatin Lifts Ranbaxy While Pfizer Abandons Its Lipitor Marketing Efforts

Larry Husten, PHD

Pfizer will no longer aggressively market Lipitor (atorvastatin), its former crown jewel and the most lucrative pharmaceutical product ever. At the same time, generic drug manufacturer Ranbaxy posted record revenue for the last business quarter, growth fueled largely by sales of generic atorvastatin in the United States. Pfizer told the Wall Street Journal that it was abandoning efforts […]

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November 30th, 2011

Generic Atorvastatin Hits the Market

Larry Husten, PHD

The first generic version of Lipitor (atorvastatin) became available today as the exclusive patent held by Pfizer finally expired. Lipitor was by far the most successful prescription drug in history. Watson Pharmaceuticals announced an authorized generic version. One other company, Ranbaxy, has been authorized to market atorvastatin, but has struggled to gain FDA approval of its manufacturing plant. The company has […]

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