Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

Anidulafungin

Droga: anidulafungin

A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.

Otros nombres:

• ECALTA, ERAXIS

Percentage of Participants With Favorable Outcome

Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Percentage of Participants With Unfavorable Outcome

Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.

Percentage of Participants Who Died Due to All Causes

Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.

Percentage of Participants With Death Attributable to Fungal Infection

Percentage of Participants With Death Unrelated to Fungal Infection

Percentage of Participants With Favorable Clinical Response

Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Percentage of Participants With Lack of Clinical Response

Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Percentage of Participants Requiring Change or Additional Antifungal Therapy

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Percentage of Participants With Oral Antifungal Started to Complete Therapy

Percentage of Participants With Documented Eradication of Infecting Species

Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.

Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results

An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results

A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy

Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).

Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy

Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.

Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy

Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.

Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy

Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)

Duration of Stay at Liver Intensive Therapy Unit (LITU)

Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).

Percentage of Participants With Concomitant Bacterial or Viral Infection

Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).

Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Dose Changes for Immunosuppressant Drugs

Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy

Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).

Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Number of Participants With Infection Sites as Per Microbiological Analysis

Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.

Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan

Infecting Organisms by Species

Percentage of Participants With Prior Colonization With Candida by Species

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Percentage of Participants With Prior Colonization With Candida by Colonization Index

Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index

Number of Participants Who Received Water-based and Ethanol-based Formulation

Percentage of Participants Who Received Water-based and Ethanol-based Formulation

Percentage of Participants Who Received 200 mg Loading Dose

Percentage of Participants Who Received 100 mg Dose on Day 2

Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses

Number of Participants With Other Dosing Patterns

The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.

Duration of Anidulafungin Therapy

Number of Serious Adverse Events (SAEs)

Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)

Number of Participants With Different Types of Drug-related Serious Adverse Events