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Tuesday 18th October, 2005
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Oral Zyvox® shows cost savings for outpatient treatment of skin and other
infections when compared to vancomycin.
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SAN FRANCISCO ? Oral ZYVOX? (linezolid) was associated with
significant savings to the health care system ? an average of $4,630 per
patient ? compared to vancomycin when used in an outpatient setting for
people with certain infections, according to data to be presented today
at the Infectious Diseases Society of America (IDSA) annual meeting.
In the study, patients taking oral ZYVOX had fewer physician office
visits, emergency room visits, hospitalizations, lab tests and other
health care services, as well as lower total costs, compared to patients
taking vancomycin.
The study retrospectively analyzed longitudinal claims data from more
than 80 health plans for patients treated with ZYVOX or vancomycin on an
outpatient basis for infections of which approximately half (48 percent)
were skin infections. The average total cost per patient, including drug
acquisition and administration as well as all related medical expenses,
was 34 percent less for patients who were treated with oral ZYVOX
compared with patients who were treated with vancomycin, which must be
taken intravenously. ZYVOX is available in interchangeable IV and oral
formulations.
"This new information broadens our understanding of the benefits of
oral linezolid," said Peggy S. McKinnon, PharmD, Clinical Pharmacist,
Transplant Infectious Diseases/Clinical Research at the Barnes-Jewish
Hospital in St. Louis, Mo. and lead investigator. "Using an oral agent
eliminates the risk of IV complications, such as line infections, as
well as the cost of IV administration. This study offers further
evidence of the cost savings of oral linezolid to the health care
system."
Study Background
McKinnon and other investigators conducted a retrospective study
using claims data from more than 80 health care plans to evaluate the
impact of outpatient treatment with oral ZYVOX versus IV vancomycin on
resource utilization and direct medical costs. The study analyzed 1,048
adult patients treated with ZYVOX and 1,048 adult patients treated with
vancomycin, matched by propensity score, between January 2002 and March
2004. Demographic, clinical and resource utilization data were collected
for 12 months prior and during the 35 day observation period, including
treatment duration. Demographic and clinical characteristics, such as
age, gender, plan type, comorbidities, infection-related events, and
total health care costs, were comparable between treatment groups for 12
months prior to treatment. Neither efficacy nor safety was evaluated in
this study.
Study Results
During the follow-up period, 35 days after treatment, patients who
received oral ZYVOX used significantly fewer health care resources in
the six areas studied, including physician office visits (4.1 vs. 8.4
visits per patient; p<0.0001), emergency room visits (0.13 vs. 0.17;
p=0.003), diagnostic claims (6.3 vs. 10.4; p<0.0001), other outpatient
claims (8.9 vs. 18.4; p<0.0001), pharmacy claims (7.3 vs. 13.6;
p<0.0001) and hospitalizations (0.19 vs. 0.23; p=0.024). The average
total cost of care per patient was $4,630 (34 percent) less for ZYVOX
patients compared with vancomycin patients ($8,922 vs. $13,552;
p<0.0001).
"In short, patients were able to recover at home with less medical
intervention than patients taking vancomycin," said Yehuda Carmeli, MD,
MPH, Beth Israel Deaconess Medical Center, Boston, Mass. and study
investigator. "As the medical community strives to provide the best
patient care while containing costs, these are important data for
physicians to take under consideration."
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About ZYVOX
ZYVOX was initially approved in the United States in April 2000 for
the treatment of complicated skin and skin structure infections (cSSSIs)
and nosocomial pneumonia, including those caused by methicillin-resistant
Staphylococcus aureus (MRSA), a serious bacteria linked to increased
morbidity, mortality and costs. ZYVOX is available in interchangeable IV
and oral formulations, and is the only oral medicine approved by the
U.S. Food and Drug Administration for the treatment of designated
infections due to MRSA. In December 2002, ZYVOX was approved for use in
pediatric patients and subsequently received approval for diabetic foot
infections in July 2003. Since its introduction, ZYVOX has proven to be
an important treatment option for designated infections known or
suspected to be caused by MRSA. To date, more than one million patients
worldwide have been treated with ZYVOX for its approved indications.
ZYVOX is indicated in the treatment of the following infections
caused by susceptible strains of the designated microorganisms:
Complicated skin and skin structure infections, including diabetic
foot infections, without concomitant osteomyelitis, caused by
Staphylococcus aureus (methicillin-susceptible and -resistant strains),
Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOX has not been
studied in the treatment of decubitus ulcers. Combination therapy may be
clinically indicated if the documented or presumptive pathogens include
Gram-negative organisms.Nosocomial pneumonia caused by Staphylococcus
aureus (methicillin-susceptible and-resistant strains) or Streptococcus
pneumoniae (including multidrug-resistant strains [MDRSP]*). Combination
therapy may be clinically indicated if the documented or presumptive
pathogens include Gram-negative organisms.
ZYVOX formulations are contraindicated for use in patients who have
known hypersensitivity to linezolid or any of the other product
components.
Myelosuppression (including anemia, leukopenia, pancytopenia, and
thrombocytopenia) has been reported in patients receiving linezolid. In
cases where the outcome is known, when linezolid was discontinued, the
affected hematologic parameters have risen toward pretreatment levels.
Complete blood counts should be monitored weekly in patients who receive
linezolid, particularly in those who receive linezolid for longer than 2
weeks, those with preexisting myelosuppression, those receiving
concomitant drugs that produce bone marrow suppression, or those with a
chronic infection who have received previous or concomitant antibiotic
therapy. Discontinuation of therapy with linezolid should be considered
in patients who develop or have worsening myelosuppression.
Lactic acidosis has been reported with the use of ZYVOX. In reported
cases, patients experienced repeated episodes of nausea and vomiting.
Patients who develop recurrent nausea or vomiting, unexplained acidosis,
or a low bicarbonate level while receiving ZYVOX should receive
immediate medical evaluation.
Spontaneous reports of serotonin syndrome associated with
co-administration of ZYVOX and serotonergic agents, including
antidepressants such as selective serotonin reuptake inhibitors (SSRIs),
have been reported. Patients who are treated with ZYVOX and concomitant
serotonergic agents should be closely observed for signs and symptoms of
serotonin syndrome (e.g., cognitive dysfunction, hyperpyrexia,
hyperreflexia, incoordination). If any signs or symptoms occur
physicians should consider discontinuation of either one or both agents
(ZYVOX or concomitant serotonergic agents).
Peripheral and optic neuropathy have been reported in patients
treated with ZYVOX, primarily those patients treated for longer than the
maximum recommended duration of 28 days. In cases of optic neuropathy
that progressed to loss of vision, patients were treated for extended
periods beyond the maximum recommended duration. Visual blurring has
been reported in some patients treated with ZYVOX for less than 28 days.
If patients experience symptoms of visual impairment, such as changes
in visual acuity, changes in color vision, blurred vision, or visual
field defect, prompt ophthalmic evaluation is recommended. Visual
function should be monitored in all patients taking ZYVOX for extended
periods (=3 months) and in all patients reporting new visual symptoms
regardless of length of therapy with ZYVOX. If peripheral or optic
neuropathy occurs, the continued use of ZYVOX in these patients should
be weighed against the potential risks.
The most commonly reported adverse events in adults across clinical
trials were nausea, headache, and diarrhea.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. When culture and
susceptibility information are available, they should be considered in
selecting or modifying antibacterial therapy. In the absence of such
data, local epidemiology and susceptibility patterns may contribute to
the empiric selection of therapy.
As with nearly all antibacterial agents, pseudomembranous colitis has
been reported with ZYVOX. Therefore, it is important to consider this
diagnosis in patients who present with diarrhea subsequent to the
administration of ZYVOX.
*MDRSP refers to isolates resistant to 2 or more of the following
antibiotics: penicillin, second-generation cephalosporins, macrolides,
tetracycline, and trimethoprim/sulfamethoxazole.
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