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

Novartis rises to second place in 2018 Access to M…

Novartis ranked second in the 2018 Access to Medicine Index (ATMi), up from 3rd place in 2016, in recognition of its long-standing efforts to improve worldwide access to ...

MSD is looking for a digital health solution to em…

MSD Lebanon is looking for an external partner to co-create a digital solution that helps oncologists to stay updated with relevant clinical content about cancer. The sol...

Lilly submits New Drug Application to the FDA for …

Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute...

FDA approves new treatment for patients with acute…

The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for t...

New study reveals probiotics do not help children …

Probiotics are a multibillion-dollar industry with marketing claims of being an effective treatment for a multitude of ailments, including diarrhea. However, findings fro...

Sanofi builds focus on rare blood disorders and ca…

Some of the most serious unmet patient needs today are in the field of hematology. Rare blood disorders and blood-related cancers continue to be a major focus of research...

Merck and Pfizer provide update on avelumab in pla…

Merck and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxor...

Bristol-Myers Squibb awards "Golden Tickets…

Bristol-Myers Squibb Company (NYSE: BMY) and LabCentral, an innovative, shared laboratory space designed as a launchpad for life-sciences and biotech startups, today anno...

U.S. FDA approves Larotrectinib, the first TRK inh…

The U.S. Food and Drug Administration (FDA) has approved larotrectinib, the first oral TRK inhibitor, under the brand name Vitrakvi®. The approval is for the treatment of...

Scorpion venom to shuttle drugs into the brain

The Peptides and Proteins lab at the Institute for Research in Biomedicine (IRB Barcelona) has published a paper in Chemical Communications describing the capacity of a s...

Abbott recommends rejection of below-market mini-T…

Abbott (NYSE: ABT) received notice of an unsolicited mini-tender offer by Baker Mills LLC (Baker Mills) to purchase up to 60,000 Abbott common shares, representing approx...

AstraZeneca to divest US Synagis rights to Sobi

AstraZeneca has agreed to sell US rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncyt...