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We investigated the comparative efficacy and safety of dirithromycin and erythromycin in the treatment of skin and soft tissue infections in this double-blind, randomized, multicentre study, in which 439 patients were randomized to treatment with dirithromycin (500 mg daily for 5 days) or erythromycin (250 mg every 6 h for 7 days). All randomized patients were included in the termination analysis, which showed that 187 of 220 (85.0%) dirithromycin recipients and 177 of 219 (80.8%) erythromycin recipients were clinically cured or improved (95% confidence interval (CI) −3.0% to +11.4%). In the termination analysis of the 211 bacteriologically evaluable patients, clinical cure or improvement occurred in 83 of 100 (83%) dirithromycin recipients and in 89 of 111 (80.2%) erythromycin recipients (95% CI −7.8% to +13.4%), and bacteriological eradication occurred in 85 of 100 (85%) and 89 of 111 (80.2%), respectively. Adverse events were similar in incidence and nature between the two groups, except that there was less nausea with dirithromycin (3.6% versus 8.2%; P = 0.042). Ten of 220 (4.5%) dirithromycin recipients and 27 of 219 (12.3%) erythromycin recipients returned >20% of their prescribed medication (P = 0.033). In the treatment of skin and soft tissue infections, dirithromycin (500 mg daily for 5 days) was comparable in efficacy to, and caused significantly less nausea than, erythromycin (250 mg every 6 h for 7 days). Compliance with the dirithromycin regimen was superior to that with the erythromycin regimen. [ABSTRACT FROM PUBLISHER]

In a meta-analysis of two identically designed, well-controlled, randomized, double-blind clinical trials, we compared 5 days of dirithromycin with 7 days of erythromycin for acute exacerbations of chronic bronchitis. Five hundred and thirty-one patients were randomized to receive dirithromycin (500 mg od) for 5 days and 526 patients were randomized to receive erythromycin (250 mg qid) for 7 days. Clinical and bacteriological responses were assessed 3-5 days after therapy and at termination from the study. Adverse events were collected from both groups and compared with each other, and before and after treatment. Of the 690 patients clinically appraisable at the post-therapy visit, 298 (84.2%) dirithromycin-treated patients and 270 (80.4%) erythromycin-treated patients showed a favourable response. At termination, 273 (77.1%) dirithromycin-treated patients and 243 (72.3%) erythromycin-treated patients showed a favourable response. The microbiological cure was equivalent in the two groups (75% of dirithromycin-treated patients and 74.1% of erythromycin-treated patients showed a favourable response at termination). After therapy, dirithromycin was as effective as erythromycin in eradication Streptococcus penumoniae (77.8% vs 90.9%), Haemophilus influenzae (71.7% vs 72.2%), Moraxella catarrhalis (93.3% vs 88.9%) and Staphylococcus aureus (81.8% vs 82.1%). Although not statistically significant, fewer dirithromycin-treated patients reported adverse events than did erythromycin-treated patients. Nausea (6.8% vs 7.8%), headache (7.3% vs 8.2%) and diarrhoea (6.6% vs 9.5%) were the most frequently reported adverse events in both groups. In the treatment of acute exacerbations of chronic bronchitis, 5 days of dirithromycin is as effective as 7 days of erythromycin. [ABSTRACT FROM PUBLISHER]

The safety and efficacy of dirithromycin and clarithromycin were compared in a single-blind, multicentre study of patients with acute bacterial exacerbation of chronic bronchitis (AECB). Patients received either dirithromycin, 500 mg once daily for 5 days, or clarithromycin, 250 mg twice daily for 7 days. A total of 212 patients entered the study, of whom 191 qualified for efficacy analysis. Favourable post-therapy clinical and bacteriological response rates for qualified patients (95 dirithromycin and 96 clarithromycin) were similar: 89.5% and 68.8% for dirithromycin vs 94.8% and 71.9% for clarithromycin. At late post-therapy evaluation, favourable clinical and bacteriological response rates were achieved in 98.8% and 96.2% of dirithromycin patients and 95.3% and 93.3% of clarithromycin patients, respectively. These differences were neither statistically nor clinically significantly different. Both drugs had similar efficacy against Haemophilus influenzae and both were well tolerated. Dirithromycin, administered as a single daily dose for just 5 days resulted in complete compliance in all but four patients. In clarithromycin-treated patients, requiring a 7-day course of twice-daily treatment, compliance was less satisfactory, with 12 patients failing to comply, though the between-group difference was not statistically significant. It can be concluded that 5 days of dirithromycin, 500 mg once daily is as safe and effective as 7 days of clarithromycin, 250 mg, twice daily in the treatment of AECB. [ABSTRACT FROM AUTHOR]

Dirithromycin is a new macrolide antibiotic. A non-blinded, non-comparative study was performed in patients with mild, (Pugh and Childs Grade A) chronic, stable, impaired hepatic function (CSIHF) to determine the single- and multiple-dose pharmacokinetics and safety in such patients. Eight volunteers had disease affecting primarily the hepatic parenchyma, eight had primarily biliary system diseases and five healthy volunteers served as the control population. CSIHF patients and healthy volunteers all received a single dose of dirithromycin 500 mg po and 2 weeks later a 10-day course of dirithromycin 500 mg po once a day. Blood and urine samples were obtained with single dose administration and on days 1 and 10 of multiple-dose administration. The area under the serum concentration versus time curve (AUC) was higher with multiple-dose administration than with single-dose administration in all three treatment groups; however, the difference was not statistically significant between the treatment groups. With multiple-dose administration, peak serum concentrations (C) were 0.69 ± 0.74, 0.34 ± 0.15, and 0.78 ± 0.25 mg/L and the AUC were 6.45 ± 6.27, 4.05 ± 1.59, and 6.60 ± 2.89 mg.h/L in normal, paren-chymal, and biliary volunteers, respectively. Cmax and AUC were consistently lower in subjects with parenchymal disease than those with biliary disease or normal volunteers but the reason for this is unclear. Statistically significant differences in clearance, due to lower non-renal and renal clearances in the biliary volunteers with single- or multiple-dose administration were found between the groups but these differences were not thought to be clinically or pharmacokinetically relevant for short-term antibiotic administration. With dirithromycin administered for 14 days or less, no dosage adjustment should be necessary in patients with mild hepatic insufficiency. [ABSTRACT FROM PUBLISHER]

Dirithromycin is a recently developed oral antibiotic, and has been shown to be effective in the treatment of respiratory tract, skin and soft tissue infections. Dirithromycin is administered once daily which may contribute to patient compliance. In this paper we review the data from studies conducted in Europe, USA, Israel and South Africa over a six-year period to assess the safety and efficacy of dirithromycin in the treatment of a variety of acute infectious illnesses, and to compare it with structurally related antibiotics (erythromycin base, roxithromycin, and miocamycin) given orally. A total of 7437- patients have been enrolled from a total of 66 studies and trials, 4263 (57.3%) treated with dirithromycin and 3174 (42.7%) treated with a comparator antibiotic. Patients received either 500 mg dirithromycin (two tablets once daily), 1000 mg erythromycin base (250 mg qid), 300 mg roxithromycin (150 mg bid), or 1200 miocamycin (600 mg bid); the length of therapy ranged from 7 to 14 days. These studies have shown that dirithromycin has a safety profile similar to the comparator agents. The most frequently reported adverse events for both dirithromycin and comparator treatment groups were gastrointestinal in nature. The majority (99%) of adverse events reported from patients treated with dirithromycin were considered mild or moderate in severity. Early discontinuation of antibiotic therapy was infrequent (3–4%) in both treatment groups, and considered to be possibly drug-related in 2%3% of the population. The safety profile of dirithromycin in elderly patients was comparable to that recorded in the overall patient population. The incidence and nature of abnormal clinical laboratory evaluation were similar in dirithromycin and comparator groups. Notable alterations in laboratory tests of haematological or hepatic function were infrequent and were not associated with clinical manifestations. Routine monitoring of standard clinical laboratory tests in patients prescribed dirithromycin does not appear to be necessary. [ABSTRACT FROM PUBLISHER]

The efficacy and safety of seven days treatment with oral dirithromycin 500 mg given once daily was compared with oral crythromydn 250 mg qid in patients with acute bacterial exacerbations of chronic bronchitis. A total of 393 patients received dirithromycin and 409 erythromycin. Of 101 dirithromycin-treated patients analysed for efficacy, 87 (86%) had favourable clinical responses compared with 72/81 (89%) of those treated with erythromycin. Proven or presumed pathogen elimination was noted in 85/101 (84%) dirithromycin-treated patients and 66/81 (82%) erythromycin treated patients. Late post-therapy responses were also similar between treatment groups. Favourable clinical responses were noted in 89% of patients treated with dirithromycin and 91% of those receiving erythromycin. A favourable bacteriological response was noted in 87-5% and 89-6% of the dirithromycin- and erythro-mycin-treated groups, respectively.Adverse events were also similar between treatment groups. Gastrointestinal events were the most common events in both groups of patients; erythromycin was associated with a significantly higher incidence of diarrhoea (P=0.003). Dirithromycin was associated with a higher incidence of lung events (P=0.043).It is concluded that dirithromycin given once a day is comparable in efficacy and safety to four-times-daily erythromycin in the treatment of acute bacterial exacerbations of chronic bronchitis. [ABSTRACT FROM PUBLISHER]

Preventing bovine respiratory disease (BRD) among incoming calves is a challenge for feedlot or backgrounding systems. The objective of this study was to determine the effect of Excede® at arrival or at revaccination on morbidity, mortality, and gain in both feedlot and pasture receiving systems. A total of 2,264 steer calves from 3 buyers were assigned randomly to pens receiving one of three treatments with 12 replications per treatment. Seven reps were in a feedlot receiving system (20 steers/pen; 36 m2/steer) and 5 reps were on cool-season pastures (88-152 steers/1.6-10.1 ha pasture). All calves received modified-live viral vaccine and Haemophilus somnus bacterin at initial processing and reprocessing. All calves received injectable anthelmintic at initial processing and 7-way Clostridium spp. bacterin-toxoid at reprocessing (median 18 d; d 16-27). Treatments included no antibiotic at arrival (CON), Excede (6.6 mg/kg BW) at arrival (ARR), or Excede (6.6 mg/kg BW) at revaccination (REVAC). Respiratory disease incidence and BW data were analyzed accounting for correlated observations of steer within pen. No differences (P < 0.05) of initial or final BW, or ADG were observed due to treatment. Initial BW, treatment, receiving system (pasture or feedlot), and buyer explained the cumulative incidence of respiratory disease for the study period (P < 0.01) in a generalized estimating equations logistic regression model. Cumulative incidence of BRD was 4.7 ± 1.1%, 11.0 ± 1.9%, and 13.8 ± 2.1% for ARR, CON, and REVAC, respectively. The ARR model-adjusted incidence of BRD was less than CON (P < 0.01). The model-adjusted incidence of BRD among REVAC steers was not significantly different from CON. Cumulative incidence of BRD was less (P = 0.02) for pasture receiving than feedlot receiving, 7.4 ± 1.1% and 11.0 ± 2.1% respectively. Most incidents of BRD occurred during the first 14 days of arrival and before the REVAC medication was administered. The ARR medication effectively improved animal health status by reducing BRD incidence. [ABSTRACT FROM AUTHOR]

Discusses the abstract of the study 'Evaluation of initial implants on performance and carcass quality in feedlot heifers,' presented at the American Society of Animal Science's Midwestern Branch conference on March 17-19, 2003, in Des Moines, Iowa.