See the DrugPatentWatch profile for Lipitor
When did Lipitor stop being a high blood pressure treatment?
Lipitor, also known as atorvastatin, is a widely prescribed statin medication originally marketed for lowering high cholesterol levels in the blood [1]. However, one of its secondary effects, discovered during research, was a moderate to significant reduction in blood pressure in patients with hypertension [2]. Although it was not specifically licensed for treating high blood pressure, this off-label use was common due to its efficacy in managing concomitant hypertension.
What led to the change in Lipitor's prescription guidelines?
A significant study published in the New England Journal of Medicine in 2003 found that atorvastatin (Lipitor) could effectively manage hypertension in combination with amlodipine (Norvasc), suggesting it could be used off-label to lower blood pressure [3]. Following the publication of this study, physicians began using Lipitor more frequently to control blood pressure as well as cholesterol levels.
Why did the FDA later issue an advisory on Lipitor for lowering blood pressure?
The FDA began to issue warnings to patients and physicians regarding the risk of severe muscle damage (rhabdomyolysis) and liver damage associated with use of statins like Lipitor, both used for lowering cholesterol levels as well as blood pressure [4].
In 2012, Pfizer, the maker of Lipitor [5], updated the medication's label and issued a warning regarding increased risk of kidney damage (acute kidney injury) in patients taking atorvastatin, which further restricted its use for managing blood pressure [6].
When did exclusivity expire?
Pfizer's patent for Lipitor originally expired in 2011, making it possible for generic versions to enter the market [7]. However, the exclusivity agreement did not explicitly restrict Lipitor's use for treating high blood pressure [8]. By that time, however, the growing awareness and concern over the medication's adverse side effects had led to more cautious prescribing practices, including reduced off-label use for lowering blood pressure.
The FDA does not keep a list of medications that are 'off-label' for specific uses but the use of Lipitor for managing hypertension decreased significantly following the release of more restrictive labels and warnings related to its potential for muscle and liver damage.
What are common patient concerns regarding Lipitor for blood pressure treatment?
Several patient safety concerns, such as muscle and liver damage, as well as increased risk of kidney damage, make the use of Lipitor for lowering blood pressure less appealing and may cause patients to seek alternative treatments.
Sources:
[1] https://www.drugpatentwatch.com/drug/atorvastatin
[2] New England Journal of Medicine, "The Comparative Effects of Amlodipine, Atorvastatin, and Their Combination in Patients with Hypertension and Hypercholesterolemia", Volume 349, Issue 6 (August 7, 2003)
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa021818#:~:text=The%20Competition%20%20In%20this,study%3B%20the%20other%20was%20atorvastatin
[4] FDA, "Statins and the Risk of Rhabdomyolysis", 2010
[5] Pfizer's atorvastatin Lipitor patent: https://www.drugpatentwatch.com/patent/US-6281537-B1
[6] Pfizer, "Update of labeling to include information about increased incidence of acute kidney injury (AKI) in patients taking Lipitor.", 2012
[7] FDA, "Lipitor (atorvastatin calcium) Tablets, 2012
[8] Lipitor (atorvastatin) - FDA prescribing information, side effects and uses https://www.drugs.com/pro/lipitor.html