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Advera Health Analytics, Inc.

An Analysis of Adverse Events Associated with Endothelin Receptor Antagonists (ERAs) using FAERS

November 10, 2017

Advera Health released a new functionality framework in Evidex this week called Custom Analytics. The goal of Custom Analytics is to provide Evidex users an easy way to perform complex queries across all of the clinical, spontaneous and other real-world data included in the Evidex platform and to return a filtered set of specific information. 

We have launched Custom Analytics with a Custom Drug-Adverse Event Analysis search function. With the Custom Drug-Adverse Event Analysis, users can easily filter case reports by specific drug combinations, demographic, and descriptive information, create customized MedDRA queries with multiple preferred terms, and calculate Reporting Odds Ratios (RORs).

The best part? It's simple to use.

Let's demonstrate the power of Custom Analytics through a case study, analyzing adverse events associated with endothelin receptor antagonists (ERAs) using the FDA Adverse Event Reporting System (FAERS) data. 

In this analysis we are looking to better understand the associated right heart failure and peripheral edema AEs that have been reported to FAERS in patients age 65 years or older, where an ERA is concomitant with a a PDE5 inhibitor.

In order to run this analysis, we need to first select the drugs. you can see that we have chosen to look at Letairis (ambrisentan) OR Tracleer (bosentan) OR Opsumit (macitentan) (the ERAs on market) when use with (AND) Adcirca (tadalafil) OR Revatio (sidenafil) OR Cialis (tadalafil) OR Levitra (vardenafil) OR Viagra (sildenafil) OR Staxyn (vardenafil) OR Stendra (avanafil).

ACA blog search form drug

 

 

We've selected several MedDRA Preferred Terms (PTs) that correspond with right heart failure and peripheral edema.

 

aca search form pt

 

 

and also chosen patients who were at least 65 year old at the time of the Adverse Event.

 

aca search form age

 

 

Now we can run our search. You can see the results in the screen shot below.

 

aca blog results

 

 

The search returned 2,577 distinct cases where: i) an ERA was used with a PDE5; ii) an adverse event related to right heart failure and peripheral edema was reported; and iii) the patient was over 65. The Evidex statistical engine calculated a ROR of 4.67, which suggests that reporting of these adverse events in this specific population is elevated. The individual cases are shown at the bottom, with literature references where available. A pooled meta-analysis from clinical trials results is also calculated via Evidex's statistical engine and displayed.

A treasure trove of information in minutes, with a few clicks of the mouse.

A logical next step in this analysis would be to now compare this cohort to say, one without the PDE5's. But, we don't want to deprive you of your own fun...

If you are a client, login today to test out the Custom Drug-AE Analysis, the first of many Custom Analytics.

Not a client? Request a demo using the form below.

Topics: FAERS, Clinical Evidence, Pharmacovigiance 2.0, Company News

By Jim Davis
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