title: Therapeutic effectiveness of a generic versus original meropenem in serious infections.
abstract: BACKGROUND
  Meropenem plays a significant role in the current antimicrobial treatment of serious infections. Recently, generic meropenems have become widely available in Thailand.
  
  
  OBJECTIVE
  Compare the effectiveness and safety ofa generic meropenem (Mapenem) with the original meropenem (Meronem) in clinical practice.
  
  
  METHODS
  A retrospective cohort study was conducted in hospitalized patients with serious infections that had been treated with either the generic or the original meropenem in nine secondary- and tertiary-care hospitals nationwide. The treatment outcomes at days 3, 7, and 14 after the use ofmeropenem between the two groups were compared.
  
  
  RESULTS
  Three hundred ninety seven patients with a mean (SD) age of 66.4 +/- 16.9 years were included. There were 228 (57.4%) males and 169 (42.6%) females. Two hundred and seven (52.1%) and 190 (47.9%) cases fell into the generic and original groups respectively. There were no significant differences regarding age, gender history of underlying disease, body weight, and ward of admission between the two groups. The majority ofpatients had presented with the respiratory tract (48.6%) and bloodstream infections (29.5%). The three most common causative bacteria were Pseudomonas aeruginosa, Acinetobacter baumannii, and extended-spectrum beta-lactamase (ESBL) producing Escherichia coli. The distribution ofthe sites of infection, causative microorganisms, the dosage ofmeropenem, and duration oftreatment were similar between the two groups. The distribution of patients with complete resolution, improvement, stable, worse, diedfrom infection, and died from other causes were similar between the two groups at day 3, 7, and 14 ofmeropenem use (p > 0.05). The drugs were well-tolerated, and less than 2% of patients in both groups discontinued meropenem due to the adverse drug effects.
  
  
  CONCLUSIONS
  The generic meropenem has a similar effectiveness in the treatment of serious bacterial infections when compared with original meropenem. Both formulations are well tolerated among patients with substantial comorbidities. Adverse drug effects that lead to drug discontinuation are uncommon.
authors.affiliation: Buddhachinnaraj Hospital, Phitsanulok, Thailand.
authors.forename: Somboon
authors.initials: S
authors.lastname: Tansuphasawadikul
authors.forename: Songchai
authors.initials: S
authors.lastname: Simaroj
authors.forename: Somchai
authors.initials: S
authors.lastname: Chantarothorn
authors.forename: Nontakan
authors.initials: N
authors.lastname: Nuntachit
authors.forename: Kamonwan
authors.initials: K
authors.lastname: Jutivorakool
authors.forename: Warangkana
authors.initials: W
authors.lastname: Munsakul
authors.forename: Kanittha
authors.initials: K
authors.lastname: Yomtem
authors.forename: Thitirat
authors.initials: T
authors.lastname: Tangkosakul
authors.forename: Suppaleark
authors.initials: S
authors.lastname: Wannasunthornchai
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects* / Q000302:isolation & purification; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D015331:Cohort Studies; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006785:Hospitals, University; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D008297:Male; D000077731:Meropenem; D008875:Middle Aged; D012189:Retrospective Studies; D013785:Thailand; D013845:Thienamycins / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D013845:Thienamycins; D000077731:Meropenem