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Short-Course Induction Treatment with Intrathecal Amphotericin B Lipid Emulsion for HIV Infected Patients with Cryptococcal Meningitis.

Alvarez-Uria G, Midde M, Pakam R, Yalla PS, Naik PK, Reddy R - J Trop Med (2015)

Bottom Line: After adjustment for baseline characteristics (gender, age, altered mental status or seizures at presentation, CD4 cell count, white blood cells, cerebrospinal fluid white cells, and haemoglobin), the use of Regimen II was associated with a significant relative risk reduction in mortality (adjusted hazard ratio 0.4, 95% confidence interval, 0.22-0.76) and 26.7% absolute risk reduction (95% confidence interval, 9.9-43.5) at 12 weeks.The use of Regimen II resulted in lower costs of drugs and hospital admission days.Since the study is observational in nature, we should be cautious about our results.

View Article: PubMed Central - PubMed

Affiliation: Department of Infectious Diseases, RDT Bathalapalli Hospital, Kadiri Road, Bathalapalli 515661, India.

ABSTRACT
Cryptococcal meningitis (CM) is a common cause of death among HIV infected patients in developing countries, especially in sub-Saharan Africa. In this observational HIV cohort study in a resource-limited setting in India, we compared the standard two-week intravenous amphotericin B deoxycholate (AmBd) (Regimen I) with one week of intravenous AmBd along with daily therapeutic lumbar punctures and intrathecal AmB lipid emulsion (Regimen II) during the intensive phase of CM treatment. 78 patients received Regimen I and 45 patients received Regimen II. After adjustment for baseline characteristics (gender, age, altered mental status or seizures at presentation, CD4 cell count, white blood cells, cerebrospinal fluid white cells, and haemoglobin), the use of Regimen II was associated with a significant relative risk reduction in mortality (adjusted hazard ratio 0.4, 95% confidence interval, 0.22-0.76) and 26.7% absolute risk reduction (95% confidence interval, 9.9-43.5) at 12 weeks. The use of Regimen II resulted in lower costs of drugs and hospital admission days. Since the study is observational in nature, we should be cautious about our results. However, the good tolerability of intrathecal administration of AmB lipid emulsion and the clinically important mortality reduction observed with the short-course induction treatment warrant further research, ideally through a randomized clinical trial.

No MeSH data available.


Related in: MedlinePlus

Adjusted risk difference and number needed to treat using flexible parametric survival methods. NNT: number needed to treat.
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fig2: Adjusted risk difference and number needed to treat using flexible parametric survival methods. NNT: number needed to treat.

Mentions: Sixty patients died during the study period, 45 in standard AmB group, and 15 in the short-intrathecal group. Kaplan-Meier survival estimates by treatment group are shown in Figure 1. Compared with patients who received the standard AmB regimen, patients in the short-intrathecal AmB regimen group had significant lower mortality (P = 0.0165). Univariate and multivariate analyses of factors associated with mortality are described in Table 2. Compared with the standard AmB regimen, patients who received the short-intrathecal AmB regimen had a significant lower risk of death in univariate (hazard ratio (HR) 0.5, 95% confidence interval [CI], 0.28–0.89, P = 0.019) and multivariate analyses (adjusted HR 0.4, 95% CI, 0.22–0.76, P = 0.005). We also performed a multivariate analysis using flexible parametric survival methods, showing similar results (adjusted HR 0.4, 95% CI, 0.21–0.75, P = 0.004). Adjusted risk differences and numbers needed to treat are shown in Figure 2. The use of the short-intrathecal AmB regimen was associated with a 26.7% absolute risk reduction (95% CI, 9.9–43.5) in mortality at 12 weeks.


Short-Course Induction Treatment with Intrathecal Amphotericin B Lipid Emulsion for HIV Infected Patients with Cryptococcal Meningitis.

Alvarez-Uria G, Midde M, Pakam R, Yalla PS, Naik PK, Reddy R - J Trop Med (2015)

Adjusted risk difference and number needed to treat using flexible parametric survival methods. NNT: number needed to treat.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4581562&req=5

fig2: Adjusted risk difference and number needed to treat using flexible parametric survival methods. NNT: number needed to treat.
Mentions: Sixty patients died during the study period, 45 in standard AmB group, and 15 in the short-intrathecal group. Kaplan-Meier survival estimates by treatment group are shown in Figure 1. Compared with patients who received the standard AmB regimen, patients in the short-intrathecal AmB regimen group had significant lower mortality (P = 0.0165). Univariate and multivariate analyses of factors associated with mortality are described in Table 2. Compared with the standard AmB regimen, patients who received the short-intrathecal AmB regimen had a significant lower risk of death in univariate (hazard ratio (HR) 0.5, 95% confidence interval [CI], 0.28–0.89, P = 0.019) and multivariate analyses (adjusted HR 0.4, 95% CI, 0.22–0.76, P = 0.005). We also performed a multivariate analysis using flexible parametric survival methods, showing similar results (adjusted HR 0.4, 95% CI, 0.21–0.75, P = 0.004). Adjusted risk differences and numbers needed to treat are shown in Figure 2. The use of the short-intrathecal AmB regimen was associated with a 26.7% absolute risk reduction (95% CI, 9.9–43.5) in mortality at 12 weeks.

Bottom Line: After adjustment for baseline characteristics (gender, age, altered mental status or seizures at presentation, CD4 cell count, white blood cells, cerebrospinal fluid white cells, and haemoglobin), the use of Regimen II was associated with a significant relative risk reduction in mortality (adjusted hazard ratio 0.4, 95% confidence interval, 0.22-0.76) and 26.7% absolute risk reduction (95% confidence interval, 9.9-43.5) at 12 weeks.The use of Regimen II resulted in lower costs of drugs and hospital admission days.Since the study is observational in nature, we should be cautious about our results.

View Article: PubMed Central - PubMed

Affiliation: Department of Infectious Diseases, RDT Bathalapalli Hospital, Kadiri Road, Bathalapalli 515661, India.

ABSTRACT
Cryptococcal meningitis (CM) is a common cause of death among HIV infected patients in developing countries, especially in sub-Saharan Africa. In this observational HIV cohort study in a resource-limited setting in India, we compared the standard two-week intravenous amphotericin B deoxycholate (AmBd) (Regimen I) with one week of intravenous AmBd along with daily therapeutic lumbar punctures and intrathecal AmB lipid emulsion (Regimen II) during the intensive phase of CM treatment. 78 patients received Regimen I and 45 patients received Regimen II. After adjustment for baseline characteristics (gender, age, altered mental status or seizures at presentation, CD4 cell count, white blood cells, cerebrospinal fluid white cells, and haemoglobin), the use of Regimen II was associated with a significant relative risk reduction in mortality (adjusted hazard ratio 0.4, 95% confidence interval, 0.22-0.76) and 26.7% absolute risk reduction (95% confidence interval, 9.9-43.5) at 12 weeks. The use of Regimen II resulted in lower costs of drugs and hospital admission days. Since the study is observational in nature, we should be cautious about our results. However, the good tolerability of intrathecal administration of AmB lipid emulsion and the clinically important mortality reduction observed with the short-course induction treatment warrant further research, ideally through a randomized clinical trial.

No MeSH data available.


Related in: MedlinePlus