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An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.

Kauf TL, McKinnon P, Corey GR, Bedolla J, Riska PF, Sims M, Jauregui-Peredo L, Friedman B, Hoehns JD, Mercier RC, Garcia-Diaz J, Brenneman SK, Ng D, Lodise T - BMC Infect. Dis. (2015)

Bottom Line: Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs.Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3.This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes.

View Article: PubMed Central - PubMed

Affiliation: Health Economics and Outcomes Research, Merck & Co., Inc., 2000 Galloping Road, Kenilworth, NJ, 07033, USA. tkandrb@gmail.com.

ABSTRACT

Background: Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers.

Methods: The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge.

Results: No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95% confidence interval [CI], 0.249-0.997; P < 0.05).

Conclusion: This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.

Trial registration: ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).

No MeSH data available.


Related in: MedlinePlus

Mean inpatient costs by components. Drug cost calculation assumes waste of partial daptomycin vials. P = NS for all. Ward/unit cost was defined as the cost care in a particular unit or ward. Adjunctive procedures included incision/drainage, surgical debridement/excision, amputation, device removal/replacement, wound specialist services, and physical therapy. Radiology tests included radiography, medical resonance imaging, ultrasound, and computed tomography. WAC, wholesale acquisition cost
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Fig1: Mean inpatient costs by components. Drug cost calculation assumes waste of partial daptomycin vials. P = NS for all. Ward/unit cost was defined as the cost care in a particular unit or ward. Adjunctive procedures included incision/drainage, surgical debridement/excision, amputation, device removal/replacement, wound specialist services, and physical therapy. Radiology tests included radiography, medical resonance imaging, ultrasound, and computed tomography. WAC, wholesale acquisition cost

Mentions: In the sensitivity analysis, in which AWP was used and there was no assumed drug wasted, the mean total inpatient cost was $9409 for daptomycin and $9106 for vancomycin. Hospital LOS was the primary driver of cost in both treatment arms (Fig. 1). The drug cost for daptomycin was significantly greater than that of vancomycin. Conversely, daptomycin was associated with lower laboratory and radiologic test costs than vancomycin (P < 0.001 for both comparisons; Fig. 1). No statistically significant difference in IRLOS, LOS, and total inpatient cost between the daptomycin and vancomycin cohorts was seen when these parameters were analyzed by infection type or pathogen (Table 3).Fig. 1


An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.

Kauf TL, McKinnon P, Corey GR, Bedolla J, Riska PF, Sims M, Jauregui-Peredo L, Friedman B, Hoehns JD, Mercier RC, Garcia-Diaz J, Brenneman SK, Ng D, Lodise T - BMC Infect. Dis. (2015)

Mean inpatient costs by components. Drug cost calculation assumes waste of partial daptomycin vials. P = NS for all. Ward/unit cost was defined as the cost care in a particular unit or ward. Adjunctive procedures included incision/drainage, surgical debridement/excision, amputation, device removal/replacement, wound specialist services, and physical therapy. Radiology tests included radiography, medical resonance imaging, ultrasound, and computed tomography. WAC, wholesale acquisition cost
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4637139&req=5

Fig1: Mean inpatient costs by components. Drug cost calculation assumes waste of partial daptomycin vials. P = NS for all. Ward/unit cost was defined as the cost care in a particular unit or ward. Adjunctive procedures included incision/drainage, surgical debridement/excision, amputation, device removal/replacement, wound specialist services, and physical therapy. Radiology tests included radiography, medical resonance imaging, ultrasound, and computed tomography. WAC, wholesale acquisition cost
Mentions: In the sensitivity analysis, in which AWP was used and there was no assumed drug wasted, the mean total inpatient cost was $9409 for daptomycin and $9106 for vancomycin. Hospital LOS was the primary driver of cost in both treatment arms (Fig. 1). The drug cost for daptomycin was significantly greater than that of vancomycin. Conversely, daptomycin was associated with lower laboratory and radiologic test costs than vancomycin (P < 0.001 for both comparisons; Fig. 1). No statistically significant difference in IRLOS, LOS, and total inpatient cost between the daptomycin and vancomycin cohorts was seen when these parameters were analyzed by infection type or pathogen (Table 3).Fig. 1

Bottom Line: Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs.Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3.This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes.

View Article: PubMed Central - PubMed

Affiliation: Health Economics and Outcomes Research, Merck & Co., Inc., 2000 Galloping Road, Kenilworth, NJ, 07033, USA. tkandrb@gmail.com.

ABSTRACT

Background: Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers.

Methods: The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge.

Results: No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95% confidence interval [CI], 0.249-0.997; P < 0.05).

Conclusion: This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.

Trial registration: ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).

No MeSH data available.


Related in: MedlinePlus