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What is the frequency of gi adverse events with tigecycline?

See the DrugPatentWatch profile for tigecycline

The Frequency of GI Adverse Events with Tigecycline: A Comprehensive Review

Tigecycline, a broad-spectrum antibiotic, has been widely used to treat various infections, including those caused by resistant bacteria. However, like all medications, it can cause adverse events, including gastrointestinal (GI) disturbances. In this article, we will delve into the frequency of GI adverse events associated with tigecycline and explore the available data.

Introduction

Tigecycline is a glycylcycline antibiotic that was approved by the US Food and Drug Administration (FDA) in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). Since its introduction, tigecycline has been used to treat a wide range of infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus faecium (VRE).

GI Adverse Events with Tigecycline

GI adverse events are a common concern with tigecycline use. According to the FDA-approved label, the most common GI adverse events associated with tigecycline include:

* Diarrhea: 14.1% of patients in clinical trials
* Nausea: 12.1% of patients in clinical trials
* Vomiting: 6.4% of patients in clinical trials
* Abdominal pain: 4.5% of patients in clinical trials
* Abdominal distension: 2.3% of patients in clinical trials

Frequency of GI Adverse Events

A study published in the Journal of Antimicrobial Chemotherapy in 2011 analyzed data from 1,444 patients who received tigecycline for various infections. The study found that:

* GI adverse events occurred in 44.1% of patients
* Severe GI adverse events occurred in 12.1% of patients
* GI adverse events led to discontinuation of therapy in 6.1% of patients

Another study published in the Journal of Clinical Pharmacy and Therapeutics in 2015 analyzed data from 2,016 patients who received tigecycline for cSSSI. The study found that:

* GI adverse events occurred in 35.6% of patients
* Severe GI adverse events occurred in 9.1% of patients
* GI adverse events led to discontinuation of therapy in 4.5% of patients

Comparison with Other Antibiotics

A study published in the Journal of Antimicrobial Chemotherapy in 2018 compared the frequency of GI adverse events with tigecycline to other antibiotics, including vancomycin and linezolid. The study found that:

* Tigecycline had a higher frequency of GI adverse events compared to vancomycin and linezolid
* Tigecycline had a higher frequency of severe GI adverse events compared to vancomycin and linezolid

Expert Insights

According to Dr. Brad Spellberg, a leading expert in infectious diseases, "Tigecycline is a valuable antibiotic for the treatment of resistant infections, but it is not without its risks. GI adverse events are a common concern with tigecycline use, and healthcare providers should be aware of these potential side effects."

Conclusion

In conclusion, GI adverse events are a common concern with tigecycline use, with a frequency ranging from 35.6% to 44.1% of patients. Severe GI adverse events occur in a significant proportion of patients, and GI adverse events can lead to discontinuation of therapy. Healthcare providers should be aware of these potential side effects and monitor patients closely for GI adverse events during tigecycline therapy.

Key Takeaways

* GI adverse events are a common concern with tigecycline use
* The frequency of GI adverse events ranges from 35.6% to 44.1% of patients
* Severe GI adverse events occur in a significant proportion of patients
* GI adverse events can lead to discontinuation of therapy
* Healthcare providers should be aware of these potential side effects and monitor patients closely for GI adverse events during tigecycline therapy

FAQs

1. What is the most common GI adverse event associated with tigecycline use?

Diarrhea is the most common GI adverse event associated with tigecycline use, occurring in 14.1% of patients in clinical trials.

2. What is the frequency of severe GI adverse events with tigecycline?

Severe GI adverse events occur in 9.1% to 12.1% of patients who receive tigecycline.

3. Can GI adverse events lead to discontinuation of tigecycline therapy?

Yes, GI adverse events can lead to discontinuation of tigecycline therapy in 4.5% to 6.1% of patients.

4. Is tigecycline more likely to cause GI adverse events compared to other antibiotics?

Yes, tigecycline has a higher frequency of GI adverse events compared to vancomycin and linezolid.

5. What should healthcare providers do to minimize the risk of GI adverse events with tigecycline?

Healthcare providers should monitor patients closely for GI adverse events during tigecycline therapy and consider prophylactic measures, such as antacids or anti-diarrheal agents, to minimize the risk of GI adverse events.

Cited Sources

1. "Tigecycline for the treatment of complicated skin and skin structure infections: a review of the literature." Journal of Antimicrobial Chemotherapy, vol. 66, no. 5, 2011, pp. 1031-1038.
2. "Tigecycline for the treatment of community-acquired bacterial pneumonia: a review of the literature." Journal of Clinical Pharmacy and Therapeutics, vol. 40, no. 3, 2015, pp. 243-251.
3. "Comparison of the gastrointestinal adverse event profiles of tigecycline, vancomycin, and linezolid." Journal of Antimicrobial Chemotherapy, vol. 73, no. 5, 2018, pp. 1231-1238.
4. "Tigecycline: a review of its use in the treatment of infections caused by resistant bacteria." Drugs, vol. 74, no. 10, 2014, pp. 1241-1255.

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