Dabigatran and Simvastatin Tablets

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Simvastatin may increase the blood levels of dabigatran in some patients. This may increase the risk of bleeding complications. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. You should seek immediate medical attention if you experience any unusual bleeding or bruising, or have other signs and symptoms of bleeding such as dizziness; lightheadedness; red or black, tarry stools; coughing up or vomiting fresh or dried blood that looks like coffee grounds; severe headache; and weakness. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

GENERALLY AVOID: Data from a population-based, nested case-control study suggest that coadministration with lovastatin or simvastatin may increase the risk of bleeding associated with the use of dabigatran. The potential mechanism of interaction is unclear. Increased bioavailability of dabigatran due to inhibition of intestinal P-glycoprotein (P-gp)-mediated efflux has been proposed by investigators, although pharmacokinetic data are lacking. While some in vitro data seem to support this mechanistic explanation, in vivo studies with various P-gp substrates including digoxin have largely failed to establish lovastatin and simvastatin as clinically relevant P-gp inhibitors. Moreover, not all P-gp inhibitors that have been studied with dabigatran have demonstrated a significant interaction. Using records from Ontario, Canada's administrative health databases, investigators identified a cohort of patients aged 66 years or older who started dabigatran between May 1, 2012 and March 31, 2014. Case patients (n=1117) were those with a hospital admission or emergency department visit for a hemorrhagic event during a period of continuous dabigatran therapy within 60 days of receiving a prescription for a statin, and they were matched with controls (n=4465) who also received a statin 60 days preceding the index date but did not experience hemorrhage. After multivariable adjustment, users of lovastatin (n=27) and simvastatin (n=502) had a greater than 40% higher relative risk of major hemorrhage compared to users of other statins (atorvastatin n=2778; fluvastatin n=26; pravastatin n=190; rosuvastatin n=2059). Additional studies are needed to validate these observations.

MANAGEMENT: Until more information is available, concomitant use of dabigatran with lovastatin, simvastatin, or red yeast rice (which contains lovastatin) should preferably be avoided. It is not known whether separating the dosing times can mitigate the effect of this potential interaction.

Dabigatran

Generic Name: dabigatran

Brand name: Pradaxa

Synonyms: Dabigatran Etexilate

What is Dabigatran?

Simvastatin Tablets

Generic Name: simvastatin

Brand name: Zocor, Flolipid

Synonyms: Simvastatin

What is Simvastatin Tablets?