The Acute Effects of Azithromycin Use on Cardiovascular Mortality, as Compared with Amoxicillin-Clavulanate in Veterans

Study identification

• EU PAS number:
  EUPAS17206
• Study ID:
  39503
• Official title and acronym:
  The Acute Effects of Azithromycin Use on Cardiovascular Mortality, as Compared with Amoxicillin-Clavulanate in Veterans
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this observational study is to examine the effects of azithromycin use on cardiovascular (CV) mortality. This observational study was preceded by four recently published retrospective cohort studies by Ray et al. (2012), Svanstrom et al. (2013), Rao et al. (2014), and Mortensen et al. (2014), which examined this, or a related research question. These studies have produced conflicting results, but taken together suggest a possible association between azithromycin use and acute CV risk, most notably in patients with pre existing CV risk at baseline. An additional observational study with sufficient power is required to further assess the potential CV signal. This observational study will be conducted in the Veterans Health Administration (VHA) database, as it closely resembles the study cohort in Ray et al. (2012), and will have sufficient power within high baseline CV risk subgroups, a population of particular interest for this research question.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:05/08/2016

Actual:05/08/2016

Study start date

Planned:31/03/2017

Actual:12/04/2017

Date of final study report

Planned:28/02/2020

Actual:19/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)