PubMed Health⌕ Search

Biomedical subjects

John Stewart

Publications and source records attributed to John Stewart.

At least 19 recordsLinked to original sources
PubMed2006

The feasibility of gene expression profiling generated in fine-needle aspiration specimens from patients with follicular lymphoma and diffuse large B-cell lymphoma.

Lymphoma of germinal center cell (GC) origin generally is an indolent malignancy that transforms progressively into a more aggressive disease. According to the World Health Organization classification, lymphomas of follicular center cell origin are classified as either large B-cell lymphoma (LBCL) or follicular lymphoma (FL). The authors tested the feasibility of performing gene expression profiling using amplified RNA from fine-needle aspirates (FNA) obtained from lymph nodes. Twenty-four samples from patients with a diagnosis of FL or LBCL were obtained after Institutional Review Board-approved informed consent was obtained. The diagnoses were confirmed by 2 pathologists and were classified into 2 groups (10 LBCL samples and 14 FL samples) by using conventional morphology and immunophenotyping. One hundred nanograms of total RNA were subjected to 2 cycles of standard, double-stranded complementary DNA synthesis and in vitro transcription for target amplification using a small-sample target-labeling protocol. The biotinylated cRNA from each sample was hybridized to gene chips. Gene expression profiling results were analyzed first by principal-component analysis (PCA) by using a list of 146 probe sets that represented 62 genes that are characteristic of an activated B-cell (ABC) signature or a GC signature. The analysis identified 5 LBCL samples with an ABC cell signature. Using a list of 207 probe sets that represented 113 genes involved in FL transformation, PCA analysis identified 2 overlapping clusters corresponding to FL and GC-diffuse LBCL. To improve this classification further, the authors generated a list of 72 genes that were expressed differentially between FL and GC-LBCL. Using this list of genes, PCA analysis demonstrated a clear separation between FL and GC-LBCL. However, five FL samples clustered as an intermediate group between FL and GC-DLBCL. These samples were characterized morphologically by a mixed cell pattern with relatively fewer large, noncleaved lymphocytes and more small, cleaved lymphocytes. The results support the feasibility of FNA-based transcription profiles in patients with FL or LBCL, which, in combination with morphology and immunophenotyping, can help in the subtyping of these entities.

Biopsy, Fine-Needle↗
PubMed2006

The acute intoxicating effects of ethanol are not dependent on the vasopressin 1a or 1b receptors.

Studies of the role of vasopressin (Avp) in mediating the effects of ethanol have focused on Avp's role in altering kidney function via its action through the vasopressin 2 receptor. However, alcohol consumption also has central effects that are poorly understood. There is evidence that Avp may mediate ethanol consumption as well as some of ethanol's behavioral effects. Centrally only two Avp receptor subtypes are expressed: the 1a receptor (Avpr1a) and the 1b receptor (Avpr1b). To determine the extent to which these receptors mediate the behavioral effects of alcohol, we used mice with targeted disruptions of either their Avpr1a or Avpr1b gene. We examined the effects of genotype on the acute intoxicating effects of ethanol as well as on voluntary ethanol consumption. Surprisingly, our findings indicate that there is no interaction between either the Avpr1a or Avpr1b and ethanol on motor coordination, hypothermia, mood, or voluntary ethanol consumption.

Alcohol Drinking↗
PubMed2006

Metastatic ductal adenocarcinoma of the prostate: cytologic features and clinical findings.

We retrospectively reviewed the cytologic features of metastatic prostatic ductal carcinoma (PDC) in 23 cases, clinical manifestations, and clinical outcomes. Cytologic smears typically showed tumor cells with abundant cytoplasm and oval nuclei arranged in papillary groups or flat and folded sheets, some of which showed peripheral nuclear palisading. However, these features could be focal, subtle, and even indistinguishable from those of acinar carcinoma, particularly when the ductal component was predominantly of a cribriform and solid pattern or coexisted with acinar carcinoma. A determination of a prostatic origin of a metastatic PDC, based on cytomorphologic features alone, could be difficult. Immunostaining for prostate-specific antigen and prostatic acid phosphatase proved helpful in determining a definitive diagnosis. The median followup of patients was 82 months, the median overall survival was 77 months, and the 5-year overall survival rate was 72%. Tumor growth pattern did not correlate with prognosis, but visceral metastasis conveyed a poor prognosis. The correlation with clinical and radiologic findings, a high index of suspicion, and the use of immunoperoxidase studies are important in making an accurate diagnosis.

Acid Phosphatase↗
PubMed2005

Ten year longitudinal study of neuropsychological functioning subsequent to a first episode of schizophrenia.

We previously reported relative stability in neuropsychological functions over a 4- to 5-year period after the onset of a first episode of schizophrenia, with patients demonstrating less improvement than controls on some functions [Hoff, A.L., Sakuma, M., Wieneke, M., Horon, R., Kushner, M., DeLisi, L.E., 1999. A longitudinal follow-up study of neuropsychological functioning subsequent to a first-episode of schizophrenia. American Journal of Psychiatry 156, 1336-1341.]. The current study was conducted to extend follow-up evaluations through 10 years of illness to determine whether neuropsychological functions remain stable or deteriorate over a longer time period. Twenty-one first episode patients and 8 controls were re-evaluated 10 years after an initial evaluation on neuropsychological and clinical measures. Repeated measures analyses demonstrated no differences between patients and controls in degree of change over this time period nor was change in symptoms reliably associated with improvement or deterioration in cognitive abilities. However, baseline level of cognitive functioning was correlated with the degree of change. Thus, when the baseline level of functioning was controlled for in the analyses, less or lack of improvement was seen in the patients compared with controls in verbal intellectual functioning, delayed verbal and nonverbal recall, and cognitive inhibition (Stroop Color Word Test). In no test did patients deteriorate significantly more than controls. We conclude that most first episode patients have had considerable cognitive decline by the time of their first hospitalization and that it remains relatively stable through at least 10 years of illness. Most cognitive change takes place early in this illness, prior to the first hospitalization, but its exact timing still remains unknown.

Adult↗
PubMed2005

The Australian Cancer Anaemia Survey: a snapshot of anaemia in adult patients with cancer.

OBJECTIVE: To evaluate the frequency and management of anaemia in Australian adults with solid and haematological malignancies. DESIGN: 6-month observational, prospective, multicentre study. PARTICIPANTS: 694 patients recruited from outpatient oncology clinics in 24 hospitals in five Australian states between 9 April 2001 and 31 July 2001. MAIN OUTCOME MEASURES: Frequency of anaemia (haemoglobin [Hb] level < 120 g/L) at enrolment and over ensuing 6 months, by tumour type, disease status and cancer treatment; anaemia treatment and "trigger" Hb level for this treatment. RESULTS: Participants had median age 60 years, and 61% were women. Prevalence of anaemia at enrolment was 35% (199/562), with 78% of these 199 having mild anaemia (Hb, 100-119 g/L). Frequency of anaemia (either present at enrolment or developing during the study) was 57% overall (323/566), and varied with tumour type, from 49% (lymphoma/myeloma) to 85% (urogenital cancer). Patients who received radiotherapy either in combination or concomitant with chemotherapy were more likely to have anaemia (73%) than those receiving chemotherapy alone (58%) (P = 0.004). Of all chemotherapy patients not anaemic at enrolment, 23% developed anaemia by the second monthly follow-up. Independent predictors for anaemia in chemotherapy patients were low baseline Hb level (odds ratio [OR], 5.4; 95% CI, 2.7-10.9) and use of platinum chemotherapeutic agents (OR, 4.8; 95% CI, 2.1-11.4) (P < 0.001). Anaemia was treated in 41% of patients with anaemia at enrolment--by transfusion (36%), iron (5%) and erythropoietic agents (2%). Frequency of anaemia treatment varied between tumour types, from 19% (breast cancer) to 60% (leukaemia). The mean "trigger Hb" for initiating transfusion was 95 g/L. CONCLUSIONS: Anaemia is prevalent among Australian patients with cancer managed in hospital oncology units. Its management varies between tumour types. Many patients do not receive treatment for their anaemia.

Adult↗
PubMed2005

Herceptin down-regulates HER-2/neu and vascular endothelial growth factor expression and enhances taxol-induced cytotoxicity of human Ewing's sarcoma cells in vitro and in vivo.

We have previously shown that high levels of HER-2/neu protein were overexpressed in human Ewing's sarcoma cells (TC71, SK-ES1) relative to normal human osteoblasts. The purpose of this study was to determine whether herceptin alone or in combination with chemotherapeutic agents could inhibit the growth of Ewing's sarcoma in vitro and in vivo. Western blot analysis showed that the protein levels of HER-2/neu were decreased following herceptin treatment. Cell growth was also inhibited by herceptin in a dose-dependent manner with an IC(50) of 4 mg/mL in TC71 and SK-ES1 cell line, whereas human immunoglobin had no effect. Northern blot and ELISA showed the RNA expression and protein levels of vascular endothelial growth factor were also inhibited by herceptin treatment with no alteration in HIF-1alpha protein and topoisomerase IIalpha expression. Furthermore, Ewing's sarcoma tumor growth was significantly delayed by 100 mg/kg herceptin treatment in our Ewing's sarcoma xenograft mouse model. Combining taxol with herceptin resulted in additive cytotoxicity, whereas herceptin-etoposide, doxorubicin, and 9-nitrocamptothecin combinations did not. Taxol-herceptin enhanced growth inhibition in TC71 cells in vitro compared with either agent alone. Ewing's sarcoma growth was also delayed in vivo and mean tumor size was significantly lower in mice treated with herceptin plus taxol than in those receiving taxol or herceptin alone. These data suggest that herceptin in combination with taxol may be a therapeutic option in the treatment of Ewing's sarcoma.

Antibodies, Monoclonal↗
PubMed2005

Pilot clinical trial of 18F-fluorodeoxyglucose positron-emission mammography in the surgical management of breast cancer.

BACKGROUND: High-resolution positron-emission mammography (PEM) is a new device, which allows the imaging of breast tissue. A prospective study was performed to assess the accuracy of PEM in newly diagnosed breast cancer patients. METHODS: In a prospective multicenter study, 44 women with confirmed breast cancers were imaged with a high-resolution PEM scanner (Naviscan PET Systems, Rockville, MD) with 18F-fluorodeoxyglucose. The images were blindly evaluated and were compared with final pathology. RESULTS: The majority of the index lesions were seen on PEM (89%, 39/44). PEM detected 4 of 5 incidental breast cancers, 3 of which were not seen by any other imaging modalities. Of 19 patients undergoing breast-conserving surgery, PEM correctly predicted 6 of 8 (75%) patients with positive margins and 100% (11/11) with negative margins. CONCLUSION: The current PEM device shows promise in detecting breast malignancies and may assist in the planning of adequate partial mastectomy procedures to better ensure negative margins.

Adult↗
PubMed2005

Triple therapy with glimepiride in patients with type 2 diabetes mellitus inadequately controlled by metformin and a thiazolidinedione: results of a 30-week, randomized, double-blind, placebo-controlled, parallel-group study.

OBJECTIVE: This study evaluated the efficacy and tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled with a combination of immediate- or extended-release metformin and a thiazolidinedione. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 2-arm study consisting of a 4-week stabilization and eligibility period and a 26-week treatment period. Patients with a diagnosis of type 2 diabetes for a minimum of 1 year received glimepiride (titrated sequentially from 2 to 4 to 8 mg/d over 6 weeks, followed by 20 weeks of maintenance therapy) or placebo in combination with an established regimen of immediate- or extended release metformin and rosiglitazone or pioglitazone. The primary efficacy outcome was the change in glycosylated hemoglobin (HbA(1c)) from baseline. The safety analysis was based on the incidence of hypo glycemia, adverse events, and laboratory abnormalities. Changes in lipid levels (high-density lipoprotein cholesterol, total cholesterol, low-density lipoprotein cholesterol, very low density lipoprotein cholesterol, and triglycerides) were evaluated, and health-related quality of life was assessed based on scores on the Diabetes Care Profile (DCP) and Health Utilities Index Mark 3 (HU13). RESULTS: Of 170 randomized patients, 159 were included in the efficacy analysis and 168 were included in the safety analysis. Demographic variables were similar at baseline between the glimepiride and placebo groups (mean age, 56.5 and 56.4 years, respectively; percent men/women, 61.0%/39.0% and 62.3%/37.7%; weight, 100.9 and 96.3 kg). HbA(1c) was significantly improved at end point with glimepiride combination therapy compared with placebo (mean [SE], -1.31% [0.08] vs -0.33% [0.08], respectively; P < 0.001). The majority of patients (62.2%) who received glimepiride achieved an HbA(1c) value of < or =7%, compared with 26.0% of patients receiving placebo (P < 0.001 between groups). At end point, the adjusted mean differences between treatments significantly favored the glimepiride combination in terms of fasting plasma glucose (-37.4 [4.0] mg/dL; P < 0.001), fasting insulin (4.06 [1.69] microIU/mL; P < 0.03), and C-peptide (124.5 [35.9] pmol/L; P < 0.001). The adjusted mean changes in body mass index from baseline to end point were 1.26 (0.16) kg/m(2) with glimepiride and 0.17 (0.16) kg/m(2) with placebo (P < 0.001). Similarly, the mean change in weight was greater with glimepiride than with placebo (3.76 [0.54] vs 0.45 [0.52] kg; P < 0.001). There were no significant differences in lipid levels between groups. Clinically significant adverse events, laboratory abnormalities, and rates of severe hypoglycemia were similar between treatment groups. The overall incidence of hypoglycemia, however, was 51.2% in the glimepiride group and 8.3% in the placebo group (P < 0.001). In general, there was no significant difference between treatment groups with respect to scores on the DCP or HUI3 over the study period. CONCLUSIONS: In these patients with type 2 diabetes that was not adequately controlled by dual combination therapy with metformin and a thiazolidinedione, the addition of glimepiride improved glycemic control compared with placebo with an acceptable tolerability profile. Although there were significantly more episodes of hypoglycemia with triple therapy than with dual therapy and placebo, the risk for severe hypoglycemia was low.

Adult↗
PubMed2005

Factors influencing reported rates of treated end-stage renal disease.

Rates of treated end-stage renal disease have risen relentlessly throughout the Western world over the past 30 years, with little indication of a slowing in the rate. This increase has a number of causes, such as important trends in disease prevalence, changing population structure, and changing treatment patterns. A number of biases also affect measured rates of renal replacement therapy. These biases include lead-time and length bias, as well as classification bias. A further important effect will be changes in competing risks, in particular, changing mortality from cardiovascular disease. We examine the effects of these factors by analyzing data from the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry. Rates of treated ESRD have risen steadily over the past 30 years, which appears to be the result of several factors. Rates among older people have increased particularly, as have rates among Australian and New Zealand indigenous peoples. Higher rates are also seen among some immigrant groups. Accentuating the effect of these changing rates are changes in the structure of the population and the tendency to commence treatment earlier. The increase in rates of ESRD treatment is often ascribed to an explosion of kidney disease. Although a major contribution comes from increasing disease prevalence, understanding the implications of this increase requires comprehension of a number of other factors.

Australia↗
PubMed2005

Fas expression in lung metastasis from osteosarcoma patients.

The authors' animal studies have shown that the metastatic potential of osteosarcoma (OS) cells correlates inversely with Fas expression-that is, Fas-negative cells metastasize but Fas-positive cells do not. One reason for this in the context of OS lung metastases may be that Fas-positive cells are eliminated by engagement with the Fas ligand (FasL) constitutively expressed on the surface of pneumocytes, whereas Fas-negative tumor cells are not. The purpose of this study was to determine the status of Fas expression in OS lung metastases from patients. Specifically, archived paraffin-embedded specimens of lung metastases from 38 patients with OS were analyzed by immunohistochemistry. Lung nodules from 23 of the 38 patients (60%) were Fas negative, those from 12 patients (32%) were weakly positive, and that from only 1 patient (3%) was strongly positive. Findings in the samples from the remaining two patients (5%) could not be interpreted because of extensive necrosis. Most patients with the weakly positive tumors and the single patient with the strongly positive tumor received chemotherapy prior to lung resection. There was a significant correlation between Fas expression and the administration of preoperative salvage chemotherapy (P = 0.0013). These data indicate that loss of Fas may be one mechanism by which OS cells evade host resistance in the lung. Chemotherapy may induce regression by upregulating Fas.

Adolescent↗
PubMed2004

Increased Fas expression reduces the metastatic potential of human osteosarcoma cells.

PURPOSE: The process of metastasis requires the single tumor cell that seeds the metastatic clone to complete a complex series of steps. Identifying factors responsible for these steps is essential in developing and improving targeted therapy for metastasis. Resistance to receptor-mediated cell death, such as the Fas/Fas ligand pathway, is one mechanism commonly exploited by metastatic cell populations. EXPERIMENTAL DESIGN AND RESULTS: LM7, a subline of the SAOS human osteosarcoma cell line with low Fas expression, was selected for its high metastatic potential in an experimental nude mouse model. When transfected with the full-length Fas gene (LM7-Fas), these cells expressed higher levels of Fas than the parental LM7 cells or LM7-neo control-transfected cells. These cells were also more sensitive to Fas-induced cell death than controls. When injected intravenously into nude mice, the LM7-Fas cell line produced a significantly lower incidence of tumor nodules than control cell lines. Lung weight and tumor nodule size were also decreased in those mice injected with LM7-Fas. Levels of Fas were quantified in osteosarcoma lung nodules from 17 patients. Eight samples were Fas negative, whereas the remaining 9 were only weakly positive compared with normal human liver (positive control). CONCLUSIONS: Our results demonstrate that altering Fas expression can impact the metastatic potential of osteosarcoma cells. We conclude that the increase of Fas on the surface of the LM7 osteosarcoma cells increased their sensitivity to Fas-induced cell death in the microenvironment of the lung, where Fas ligand is constitutively expressed. Thus, loss of Fas expression is one mechanism by which osteosarcoma cells may evade host resistance mechanisms in the lung, increasing metastatic potential. Fas may therefore be a new therapeutic target for osteosarcoma.

Animals↗
PubMed2004

Establishment and characterization of a new mantle cell lymphoma cell line M-1.

A new mantle cell lymphoma cell line, M-1, was established from peripheral blood mononuclear cells of a patient with a diagnosis of blastoid variant of mantle cell lymphoma in leukemic phase. This cell line showed cell surface antigens identical to the original tumor and demonstrated the profile of a mature B-cell phenotype typical of mantle cell lymphoma: positive for CD5, CD19, CD20, sIgM and FMC7, and negative for CD3, CD10 and CD23. Cytogenetically, the M-1 cell line showed chromosomal alterations similar to the initial clinical specimen, among which a translocation t(11;14) (q13;q32) resulting in the overexpression of cyclin D1 as well as additional abnormalities involving chromosomes 3, 9 and 10. This cell line was used as a model to investigate the activity of the three drugs doxorubicin, cyclophosphamide and vincristine, commonly used in the treatment of mantle cell lymphoma patients. The effect of the drugs was evaluated by a 24 h cytotoxicity test and a 7-days anti-proliferation test using a microculture tetrazolium-based assay (MTT). Both assays indicated a higher sensitivity of the cell line to vincristine when compared to doxorubicin and cyclophosphamide. The characterization of a new mantle cell lymphoma cell line is a unique tool for studying the biology of this subtype of lymphoma for which only a few cell lines have been established.

Antigens, Surface↗
PubMed2004

Lipopolysaccharides of Bacteroides fragilis, Chlamydia trachomatis and Pseudomonas aeruginosa signal via toll-like receptor 2.

Recognition of bacterial lipopolysaccharide (LPS) is critical in the host defence against Gram-negative infection. While enterobacterial LPS signals via Toll-like receptor 4 (TLR4), it has recently been reported that the LPS of Leptospira interrogans, Legionella pneumophila, Rhizobium species Sin-1 and at least one strain of Porphyromonas gingivalis are capable of signalling via TLR2. Using a TLR transfection assay and measurement of an NF-kappaB-sensitive promoter region, the results show that the LPS of Bacteroides fragilis NCTC-9343, Chlamydia trachomatis LGV-1 and Pseudomonas aeruginosa PAC-611 also signal via TLR2 and it is pointed out that all TLR2-signalling LPS discovered to date demonstrate relatively weak endotoxicity in some models and structural features distinct from those LPS shown to signal via TLR4.

Adaptation, Physiological↗
PubMed2004

The distribution of, and antibody response to, the core lipopolysaccharide region of Escherichia coli isolated from the faeces of healthy humans and cattle.

There are five different core types of Escherichia coli lipopolysaccharide (LPS), and enterohaemorrhagic E. coli tend to have the R3 core type. It has been hypothesized that increased carriage of bacteria with a specific core type will induce higher levels of antibodies and protect against disease caused by bacteria carrying that specific LPS core. Approximately 320 isolates of E. coli, half from healthy human faeces and half from healthy bovine faeces have been core typed both by core-specific monoclonal antibodies, and by PCR for genes encoding the enzymes responsible for the biosynthesis of the specific core structures. Results showed that E. coli possessing R1 core LPS were most frequently detected in both human and cattle populations (63 and 49%, respectively). Compared to the human isolates a significantly higher level of bacteria with R3 core LPS was detected among the bovine commensal E. coli (11% compared to 4%; P < 0.05). Antibody levels to each of the specific core types were measured in serum samples from healthy humans (n = 91) and healthy cattle (n = 39). In each population the highest level of antibody detected was reactive to the R4 core. In cattle the level of anti-R3 core antibody was significantly higher than the level of anti-R1, -R2 and -K12 antibodies (P < 0.01). In summary there was a greater proportion of E. coli with R3 core type in cattle, together with a corresponding higher anti-R3 antibody level. This suggests that cattle may have greater immunity to E. coli strains with an LPS of R3 core type.

Animals↗
PubMed2004

Autopoiesis and cognition.

This article revisits the concept of autopoiesis and examines its relation to cognition and life. We present a mathematical model of a 3D tesselation automaton, considered as a minimal example of autopoiesis. This leads us to a thesis T1: "An autopoietic system can be described as a random dynamical system, which is defined only within its organized autopoietic domain." We propose a modified definition of autopoiesis: "An autopoietic system is a network of processes that produces the components that reproduce the network, and that also regulates the boundary conditions necessary for its ongoing existence as a network." We also propose a definition of cognition: "A system is cognitive if and only if sensory inputs serve to trigger actions in a specific way, so as to satisfy a viability constraint." It follows from these definitions that the concepts of autopoiesis and cognition, although deeply related in their connection with the regulation of the boundary conditions of the system, are not immediately identical: a system can be autopoietic without being cognitive, and cognitive without being autopoietic. Finally, we propose a thesis T2: "A system that is both autopoietic and cognitive is a living system."

Automation↗
PubMed2004

The affirmation of self: a new perspective on the immune system.

The fundamental concepts of autopoiesis, which emphasize the circular organization underlying both living organisms and cognition, have been criticized on the grounds that since they are conceived as a tight logical chain of definitions and implications, it is often not clear whether they are indeed a scientific theory or rather just a potential scientific vocabulary of doubtful utility to working scientists. This article presents the deployment of the concepts of autopoiesis in the field of immunology, a discipline where working biologists themselves spontaneously have long had recourse to "cognitive" metaphors: "recognition"; a "repertoire" of recognized molecular shapes; "learning" and "memory"; and, most striking of all, a "self versus non-self" distinction. It is shown that in immunology, the concepts of autopoiesis can be employed to generate clear novel hypotheses, models demonstrating these ideas, testable predictions, and novel therapeutic procedures. Epistemologically, it is shown that the self-non-self distinction, while quite real, is misleadingly named. When a real mechanism for generating this distinction is identified, it appears that the actual operational distinction is between (a) a sufficiently numerous set of initial antigens, present from the start of ontogeny, in conditions that allow for their participation in the construction of the system's organization and operation, and (b) single antigens that are first presented to the system after two successive phases of maturation. To call this a self-non-self distinction obscures the issue by presupposing what it ought to be the job of scientific investigation to explain.

Artificial Intelligence↗
PubMed2004

Comparison of hospitalization rates in patients with community-acquired pneumonia treated with 10 days of telithromycin or clarithromycin.

AIMS: To compare the impact on hospitalization rates and the clinical efficacy of oral telithromycin and clarithromycin treatment in patients with community-acquired pneumonia (CAP). PATIENTS AND METHODS: Outpatients aged >or= 18 years (n = 448) with CAP were enrolled in a randomized, double-blind, multinational study and received telithromycin 800 mg once daily (n = 224) or clarithromycin 500 mg twice daily (n = 224) for 10 days. The primary outcome measure was clinical efficacy at post-therapy/test of cure (Days 17-24) in the per-protocol population. Frequency of CAP-related hospitalizations, physician visits/tests/procedures, and additional respiratory tract infection-related antibacterial use were compared by treatment group (intent to treat population) up to the late post-therapy visit (Days 31-36). Study investigators who were blinded to the treatment arm assessed whether hospital admissions were CAP related or not. Hospitalization costs (USdollars) associated with telithromycin and clarithromycin treatment were compared. RESULTS: Per-protocol clinical cure rates for telithromycin and clarithromycin were statistically reduced number of hospitalizations/days required equivalent (88.3% [143/162] vs 88.5% [138/156] - difference: -0.2%; 95% CI: -7.8, 7.5). There were four CAP-related hospitalizations (1.8 events/100 patients) among patients treated with telithromycin vs eight (3.6 events/100 patients) among clarithromycin patients (p = 0.281). Total CAP-related hospitalization costs for telithromycin and clarithromycin patients were $25 360 vs $70 567, respectively (difference: -20 182 per 100 patients; 95% CI: -49 531; 9168) [corrected]. CONCLUSIONS: This study demonstrates that telithromycin is an effective therapy for outpatients with CAP. There were no significant differences in hospitalization rates between treatments; however, a tendency towards a numerically in hospital among telithromycin patients was observed. This could potentially translate into reduced hospitalization costs for telithromycin vs clarithromycin in the treatment of CAP.

Administration, Oral↗