Significant 30 Percent Increase in Relative Risk of Cardiovascular Events or Death

PfizerAn observational study of a large United Kingdom primary care database showed that switching patients from Pfizer's Lipitor® (atorvastatin calcium) Tablets to simvastatin was associated with a 30 percent increase in the relative risk of major cardiovascular events, including heart attacks, strokes and certain types of heart surgeries, or death compared to patients who remained on Lipitor therapy.

This analysis was presented today at the European Society of Cardiology Congress 2007 and is also in press at The British Journal of Cardiology.

The data, which included records from October 1997 to June 2005, were generated from a retrospective analysis of a medical database of anonymous patient records entered by general practitioners in the United Kingdom known as The Health Improvement Network (THIN). The analysis included 11,520 patients (2,511 patients who had taken Lipitor for six months or more and were switched to simvastatin vs. 9,009 patients who were taking Lipitor for six months or more and then remained on Lipitor therapy). Reasons for switching were not available from the database. Since patients were not randomly assigned to each group, the two treatment groups were matched based on certain risk factors and statistical adjustments were made to address any residual imbalances. As with all observational studies, the findings should be regarded as hypothesis generating.

"Today, many health care payors including governments and managed care companies are encouraging patients who are well-established on one therapy to switch to a different statin therapy," said Dr. Michael Berelowitz, senior vice president of Pfizer’s global medical division. "This study raises concerns about those policies. It suggests the potential for poorer cardiovascular outcomes associated with switching patients from established Lipitor therapy to simvastatin."

A secondary analysis of the same data showed that patients who were switched from Lipitor to simvastatin were more than twice as likely to discontinue their treatment compared to those who remained on Lipitor therapy (20.5 percent versus 7.62 percent, p<0.001). The reasons for discontinuation were not available from the database, though disruption in treatment has been associated with poor adherence in previous studies of statins and other medications.

"The results of this analysis complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor," said Dr. Berelowitz. "Observational studies help the medical community better appreciate what is really happening in doctors' offices, and are commonly used by healthcare payors to set medical practice guidelines. This analysis highlights the need to carefully consider individual patient circumstances and cardiovascular risk because indiscriminate switching may adversely affect some patients."

Additional Study Information The primary endpoint was time to a first major cardiovascular event, defined as heart attack, stroke, or coronary revascularization (a type of heart surgery), or all-cause death. There was a statistically significant 30 percent increase in the relative risk of the primary endpoint (p=0.03).

  • The individual components making up the primary endpoint were analyzed as secondary endpoints. Compared with patients who did not switch therapy, switching was associated with the following:
    • Significant 43 percent increase in the relative risk of major cardiovascular events (p=0.008)
    • No difference in all-cause death (p=0.369)
  • The two treatment groups were matched based on the following: gender, history of heart attack, diabetes, time since last statin exposure and general practitioner treatment center.
  • The following statistical adjustments were made to address any residual imbalances: age, gender, prior statin exposure, time since last statin exposure, diabetes, history of heart attack, and baseline cholesterol levels.
  • Relative risk is the ratio of the risk of major cardiovascular events or death occurring in the group who switched from Lipitor to simvastatin versus the risk in the group who remained on Lipitor.

About Lipitor
Lipitor is the only statin with all the following criteria most important for many physicians, patients and payors: significant and proven cardiovascular event reductions, impressive average LDL lowering of 39 percent to 60 percent, and a proven safety profile across a broad range of patients.

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 139 million patient-years of experience. It is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients. There have been more than ten cardiovascular outcomes trials with more then 50,000 patients.

For further information, please visit:
http://www.pfizer.com

Most Popular Now

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

Salvat Laboratories announces submission of New Dr…

Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsi...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

New insights on antibody responses to Omicron vari…

Knowing how well vaccination against one SARS-CoV-2 strain (with or without previous infection) counteracts infection with a different strain is a critical research quest...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

New drug shows promise for fighting both COVID-19 …

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot ...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...

Sanofi and GSK's next-generation COVID-19 booster …

After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by t...