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Use of Azithromycin and Death from Cardiovascular Causes

Use of Azithromycin and Death from Cardiovascular Causes. Whitney Shirley University of Georgia Pharm.D . Candidate 2014. Azithromycin: Background Information. Macrolide antibiotic Treats Lower and upper respiratory infections Skin and soft-tissue infections Sexually transmitted diseases

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Use of Azithromycin and Death from Cardiovascular Causes

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  1. Use of Azithromycin and Death from Cardiovascular Causes Whitney Shirley University of Georgia Pharm.D. Candidate 2014

  2. Azithromycin: Background Information • Macrolide antibiotic • Treats • Lower and upper respiratory infections • Skin and soft-tissue infections • Sexually transmitted diseases • Adverse events • Increased risk of death from cardiovascular causes seen in patients who are at a high baseline risk

  3. Objectives • Investigate the potential pro-arrhythmic effect of Azithromycin • Rational: • Other macrolide antibiotics are known to prolong the QT interval • Primary outcome • Cardiovascular death • Secondary outcome • Death from other causes

  4. Methods • Inclusion Criteria • 18-64 years old • Denmark resident for the past 2 years • Exclusion Criteria • hospitalizations/antibiotic use within the past 30 days • No prescription filled within 1 year before the index date • Received another antibiotic on index date

  5. Methods • Prospective study • 1997-2010 • Azithromycin vs antibiotic use • N=2,204,100 • 1:1 ratio • Azithromycin vs Penicillin use • N=1,102,419 (azithromycin) • N=7,364,292 (Penicillin) • Current use: 1-5 days • Recent use: 6-10 days • Past use: 11-35 days

  6. Results • Primary outcomes • Significant increase in the risk of death from cardiovascular causes with current use of Azithromycin versus no antibiotic use • Rate ratio: 2.85 • 95% confidence interval 1.13 to 7.24 • NO increased risk of cardiovascular death was seen in Azithromycin use over Penicillin • Rate ratio: 0.93 • 95% confidence interval 0.56 to 1.55

  7. Results • Secondary outcomes • Azithromycin versus no antibiotic use • Rate ratio: 1.60 • 95% confidence interval 1.00 to 2.54 • Azithromycin versus Penicillin use • 46 deaths during current use of Azithromycin • Incidence rate: 3.1 per 1,000 person-years • 410 deaths during current use of Penicillin • Incidence rate: 4.1 per 1,000 person-years

  8. Results HenrikSvanström, M.Sc., Björn Pasternak, M.D., Ph.D., and Anders Hviid, Dr.Med.Sci. N Engl J Med 2013; 368:1704-1712 May2,2013 DOI: 10.1056/NEJMoa1300799

  9. Sensitivity Analysis HenrikSvanström, M.Sc., Björn Pasternak, M.D., Ph.D., and Anders Hviid, Dr.Med.Sci. N Engl J Med 2013; 368:1704-1712 May2,2013 DOI: 10.1056/NEJMoa1300799

  10. Conclusions • Significant increased risk of cardiovascular death was seen in Azithromycin use versus no antibiotic use, but was not seen when comparing Azithromycin use versus Penicillin use • The increased risk seen in the first group is contributed to the risk of death associated with acute infection rather than Azithromycin use • NO association between azithromycin use and increased risk of death from cardiovascular causes in young and middle-aged adults

  11. Seminarian’s Conclusions • Azithromycin is a safe and effective antibiotic when used in the general population • Caution should be taken when prescribing azithromycin in elderly patients or in those patients who have extensive health care problems

  12. References • Svanströmet al. Use of Azithromycin and Death from Cardiovascular Causese. N Engl J Med 2013; 368:1704-1712 May2,2013 DOI: 10.1056/NEJMoa1300799 • Ray et al. Azithromycin and the Risk of Cardiovascular Death. N Engl J Med 2012; 366:1881-1890May 17, 2012DOI: 10.1056/NEJMoa1003833

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