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Therapeutic effectiveness of a generic versus original meropenem in serious infections
Somboon Tansuphasawadikul1, Songchai Simaroj, Somchai Chantarothorn
1Buddhachinnaraj Hospital, Phitsanulok, Thailand.
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.
Material And Method:
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.
Conclusion:
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.
Insights
Generic meropenem (Mapenem) demonstrated comparable effectiveness and safety to original meropenem (Meronem) in treating serious bacterial infections. Both formulations were well-tolerated, with rare adverse events leading to discontinuation.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Pharmacy
Background:
- Meropenem is a critical antibiotic for severe infections.
- Generic meropenem formulations are increasingly available in Thailand.
Purpose of the Study:
- To compare the clinical effectiveness and safety of generic meropenem (Mapenem) against original meropenem (Meronem).
Main Methods:
- Retrospective cohort study in nine Thai hospitals.
- Compared outcomes at 3, 7, and 14 days in patients treated with generic or original meropenem.
- Included patients with serious bacterial infections.
Main Results:
- No significant differences in effectiveness or safety between generic and original meropenem.
- Common infections included respiratory tract and bloodstream infections.
- Adverse drug effects leading to discontinuation were uncommon (<2%) in both groups.
Conclusions:
- Generic meropenem is as effective as the original formulation for serious bacterial infections.
- Both meropenem formulations are well-tolerated, even in patients with comorbidities.
- Discontinuation due to adverse drug effects is rare for both generic and original meropenem.
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