title: Ezetimibe: Use, costs, and adverse events in Australia.
abstract: OBJECTIVE
  To analyze the subsidized use and reported adverse events of ezetimibe, used to lower cholesterol, in Australia over the 11 years following its inclusion on the Pharmaceutical Benefits Scheme (PBS) in 2004.
  
  
  METHODS
  Pharmacoepidemiological analysis of dispensed prescriptions from Medicare Australia. Adverse event data were obtained from the Therapeutic Goods Administration. Use was measured by the defined daily dose (DDD) per 1000 population per day for each calendar year. Adverse events were counted by organ class system.
  
  
  RESULTS
  Total ezetimibe use rose to 8.46 DDD/1000 population/d in the 11 years to 2015. Ezetimibe as a sole active ingredient was the most commonly dispensed formulation followed by the two combination products containing ezetimibe and 40 mg or 80 mg simvastatin. The average yearly increase in utilization was 19% with a 24% annual increase in costs to government (2006-2015) to $169.0 million in 2015. There were substantial differences in ezetimibe use between states, with no relationship to deaths from ischaemic heart disease (IHD) in each jurisdiction. The major reported adverse events were musculoskeletal and connective tissue disorders and gastrointestinal disorders.
  
  
  CONCLUSIONS
  Ezetimibe use has increased rapidly in Australia since receiving public subsidy. Although the indications for subsidy are very restricted, there appears to have been widespread use, not explained by differential geographical IHD death rates. Latest guidelines still question the value of ezetimibe, so further discussion about whether the public spending on this medication for any potential improvement in population health outcomes is justified.
authors.affiliation: School of Pharmacy, University of Queensland, Woolloongabba, QLD, Australia.
authors.forename: Samantha A
authors.identifier: http://orcid.org/0000-0002-5226-5663
authors.initials: SA
authors.lastname: Hollingworth
authors.affiliation: School of Pharmacy, University of Queensland, Woolloongabba, QLD, Australia.
authors.forename: Remo
authors.initials: R
authors.lastname: Ostino
authors.affiliation: School of Public Health, University of Queensland, Herston, QLD, Australia.
authors.forename: Michael C
authors.initials: MC
authors.lastname: David
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callahan, NSW, Australia.
authors.forename: Jennifer H
authors.initials: JH
authors.lastname: Martin
authors.affiliation: School of Pharmacy, University of Queensland, Woolloongabba, QLD, Australia.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Tett
mesh_terms: D000924:Anticholesteremic Agents / Q000009:adverse effects* / Q000191:economics*; D001315:Australia / Q000453:epidemiology; D016527:Drug Costs; D011307:Drug Prescriptions / Q000191:economics; D017723:Drug Utilization Review; D064420:Drug-Related Side Effects and Adverse Reactions / Q000191:economics / Q000453:epidemiology*; D000069438:Ezetimibe / Q000009:adverse effects* / Q000191:economics*; D000069499:Ezetimibe, Simvastatin Drug Combination / Q000009:adverse effects / Q000191:economics; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy* / Q000191:economics* / Q000453:epidemiology; D017891:Pharmacoepidemiology; D010818:Practice Patterns, Physicians' / Q000191:economics*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D000069499:Ezetimibe, Simvastatin Drug Combination; D000069438:Ezetimibe
keywords: Australia; anticholesteremic agents; drug-related side effects and adverse reactions; ezetimibe; pharmacoepidemiology; pharmacovigilance; simvastatin drug combination