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Abdollah Iravani - One of the best experts on this subject based on the ideXlab platform.
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Loracarbef versus Cefaclor in the treatment of urinary tract infections in women. Antimicrob AgentsChemother 1991;35:750-2. 41
2016Co-Authors: Abdollah IravaniAbstract:In a double-blind, prospective, randomized study, 108 college women with acute urinary tract infections were treated for 7 days with either loracarbef (LY163892) at 200 mg once daily (n = 53) or Cefaclor at 250 mg three times daily (n = 55). The cure rates at 5 to 9 days after treatment in the loracarbef and Cefaclor groups were 96 and 90%, respectively. Both loracarbef and Cefaclor are safe, well tolerated, and effective in the treatment of urinary tract infections in women. Loracarbef (LY163892) is a new beta-lactam antibiotic with in vitro activity similar to those of Cefaclor and amox-icillin-clavulanate potassium and superior to that of cepha-lexin (4, 11, 19). Loracarbef is absorbed well from the bowel, attaining high levels above the MICs for susceptible organ-isms in plasma; it is excreted mostly in the urine in the active form. Loracarbef is resistant to plasmid-mediated 1-lactam-ases and has greater biochemical stability than Cefaclor (3, 21, 22). These favorable characteristics make loracarbef a suitable antibiotic for once-a-day treatment of urinary trac
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comparison of cefprozil and Cefaclor for treatment of acute urinary tract infections in women
Antimicrobial Agents and Chemotherapy, 1991Co-Authors: Abdollah IravaniAbstract:A total of 108 college women with acute urinary tract infections were treated for 10 days with either 500 mg of cefprozil (BMY-28100-03-800) once a day (n = 72) or 250 mg of Cefaclor three times a day (n = 36). Clinical and bacterial cure rates at 1 week posttherapy were 94 and 93%, respectively, for the cefprozil group and 94 and 94%, respectively, for the Cefaclor group (P, not significant). Both cefprozil and Cefaclor were safe and effective.
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Loracarbef versus Cefaclor in the treatment of urinary tract infections in women.
Antimicrobial agents and chemotherapy, 1991Co-Authors: Abdollah IravaniAbstract:In a double-blind, prospective, randomized study, 108 college women with acute urinary tract infections were treated for 7 days with either loracarbef (LY163892) at 200 mg once daily (n = 53) or Cefaclor at 250 mg three times daily (n = 55). The cure rates at 5 to 9 days after treatment in the loracarbef and Cefaclor groups were 96 and 90%, respectively. Both loracarbef and Cefaclor are safe, well tolerated, and effective in the treatment of urinary tract infections in women.
Willard H Dere - One of the best experts on this subject based on the ideXlab platform.
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Loracarbef (LY163892) versus Cefaclor in the treatment of acute bacterial bronchitis.
Clinical therapeutics, 1992Co-Authors: Willard H Dere, D. Farlow, Gary E. RuoffAbstract:In this double-blind study, 319 patients (133 men, 186 women) with acute bronchitis were randomly assigned to receive 200 mg of loracarbef twice daily (n = 160; mean age, 42 years) or 250 mg of Cefaclor thrice daily (n = 159; mean age, 43 years) for seven days. Clinical and bacteriologic responses were assessed in 63 loracarbef-treated and 56 Cefaclor-treated patients in whom pretreatment positive cultures of pathogens susceptible to loracarbef and Cefaclor were found. Among these evaluable patients, a clinical cure was found in 68.3% of the loracarbef-treated patients and in 66.1% of the Cefaclor-treated patients and improvement in 27.0% and 28.6%, respectively; the pathogen was eliminated in 7.9% and 10.7% and presumed eliminated in 82.5% and 82.1%, respectively. Three in the loracarbef group discontinued treatment because of adverse events, two of which (nausea, nausea/diarrhea/vomiting) were presumably related to the drug. Headache was reported by 9.4% of the 160 patients in the loracarbef group and 6.9% of the 159 patients in the Cefaclor group; diarrhea by 5.6% and 6.9%, respectively; and dyspepsia/abdominal pain/gastrointestinal disorders by 5.6% and 4.4%, respectively. It is concluded that both loracarbef and Cefaclor are safe and effective in the treatment of acute bacterial bronchitis.
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Cefaclor AF in the treatment of streptococcal pharyngitis/tonsillitis
Postgraduate medical journal, 1992Co-Authors: M Derriennic, M Voi, L M Thoren, S A Black, Willard H DereAbstract:Two double-blind, double-dummy, randomized multicentre studies compared the safety and efficacy of 10-day regimens of Cefaclor advanced formulation (Cefaclor AF) (375 mg twice daily) with Cefaclor (250 mg three times daily) in the treatment of proven group A beta-haemolytic streptococcal pharyngitis/tonsillitis. Of the 1,138 patients enrolled, 764 (Cefaclor AF:392; Cefaclor: 372) were evaluated for efficacy. All patients enrolled in the studies (570 treated with Cefaclor AF and 568 treated with Cefaclor) were evaluated for safety. Clinical and bacteriological evaluations were performed on treatment days 4-6, and after completion of treatment within 3-5 days and 2-3 weeks. In evaluable patients, the post-therapy clinical success and bacteriological cure rates for Cefaclor AF were 96.7% and 93.6%, respectively; the rates were 98.1% and 94.1% for Cefaclor. Sixteen Cefaclor AF-treated patients and 14 Cefaclor-treated patients withdrew early from the trial because of adverse events. There were no significant differences between treatment groups in the overall number of adverse events reported. Diarrhoea was the most frequently reported adverse event (5.6%) in Cefaclor AF-treated patients, and headache/migraine was the most frequently reported adverse event (5.6%) in the Cefaclor-treated patients. Cefaclor AF (375 mg twice daily) is as effective and safe as Cefaclor capsules (250 mg three times daily) in the treatment of streptococcal pharyngitis/tonsillitis.
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Efficacy of Cefaclor AF in the treatment of skin and skin-structure infections.
Clinical therapeutics, 1992Co-Authors: Willard H DereAbstract:Cefaclor advanced formulation (Cefaclor AF) was compared with Cefaclor for the treatment of skin and skin-structure infections in a double-blind study at 28 centers in North America. Of the 563 patients originally randomized, 278 patients received Cefaclor AF (375 mg twice daily) and 285 patients received Cefaclor (250 mg three times daily). A total of 154 patients treated with Cefaclor AF and 157 patients treated with Cefaclor qualified for the efficacy analysis after completing 7 days of therapy. At the post-therapy visit, favorable clinical response rates for evaluable patients were 97.4% in the Cefaclor AF group and 94.9% in the Cefaclor group; favorable bacteriologic response rates were 85.7% and 84.1%, respectively. At the late post-therapy evaluation, 7 to 14 days after completion of therapy, favorable clinical response rates were 90.1% in the Cefaclor AF group versus 89.9% in the Cefaclor group, and favorable bacteriologic response rates were 88.7% and 86.9%, respectively. No significant difference was seen between the groups in clinical or bacteriologic efficacy at either evaluation or in the frequency of nature of side effects reported during the study.
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Comparative trials of Cefaclor AF in uncomplicated cystitis and asymptomatic bacteriuria.
Postgraduate medical journal, 1992Co-Authors: Iravani A, W Brumfitt, Willard H DereAbstract:Two different doses of Cefaclor advanced formulation (AF), a new sustained-release formulation of Cefaclor, were compared with the regular formulation of Cefaclor for efficacy and safety in the treatment of uncomplicated cystitis and asymptomatic bacteriuria. A 7-day course of treatment was used, and the trials were double-dummy and double-blind. In one trial, Cefaclor AF 500 mg once daily (at night) was compared with Cefaclor 250 mg three times a day. Satisfactory clinical and bacteriological responses were found in 179/189 (94.7%) and 160/191 (83.8%) patients, respectively, given Cefaclor AF and in 82/87 (94.3%) and 74/90 (82.2%) patients given Cefaclor, 5-9 days after the end of treatment. In the other trial, Cefaclor AF 375 mg twice daily was compared with Cefaclor 250 mg three times a day. Satisfactory clinical and bacteriological responses were obtained in 164/180 (91.1%) and 156/184 (84.8%) patients, respectively, given Cefaclor AF, and in 86/92 (93.5%) and 81/93 (87.1%) patients taking Cefaclor, 5-9 days after the end of treatment. Very similar results were found in both studies in those patients who were assessable 3-5 weeks later. Only 4.3% and 2.4% of patients treated with Cefaclor AF (375 mg and 500 mg, respectively) and 2.2% of Cefaclor patients discontinued therapy due to adverse events. The three most commonly reported events were vaginal moniliasis or vaginitis (8.6%), headache (5.0%) and nausea (4.8%). No significant differences were found between clinical efficacy and safety parameters in the different study groups, and it was concluded that Cefaclor AF in a twice-daily or once-daily dosage is as effective and as safe as the currently recommened three-times-a-day dosage of Cefaclor.
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A multicentre trial of Cefaclor advanced formulation versus Cefaclor in the treatment of acute bronchitis.
Postgraduate medical journal, 1992Co-Authors: Alfonso Alanis, K A Longest, J E Senetar, Willard H DereAbstract:Two prospective randomized, double-blind, parallel studies were carried out in Europe to compare Cefaclor advanced formulation (Cefaclor AF) with Cefaclor in the treatment of acute bronchitis caused by susceptible pathogens. A total of 1,321 patients suffering from acute bronchitis confirmed by clinical data and a negative chest X-ray were randomized for treatment in the two multicentre trials. Three doses of Cefaclor AF were tested: 375 mg twice daily and 500 mg twice daily were compared with Cefaclor 250 mg three times daily; and Cefaclor AF 750 mg twice daily was compared with Cefaclor 500 mg three times daily. Duration of therapy was seven days. Assessments (complete history, physical examination, sputum specimens for culture and Gram's stain, plus clinical and laboratory evaluations of safety) were carried out within 24 hours before the first dose, during therapy, within 72 hours after therapy completion and, in the 375 mg and 500 mg dose groups, 1-2 weeks after the end of therapy. There were no significant differences between the total evaluable Cefaclor AF population and the total evaluable Cefaclor population with regard to favourable post-therapy responses. Most favourable clinical and bacteriological response rates in the 375 and 500 mg doses were 80% or above. In the higher dose group, there was a favourable post-therapy symptomatic response in 100% of evaluable patients, with favourable bacteriological responses in 93.3% patients receiving Cefaclor AF and 96.8% receiving Cefaclor (no significant difference). Only one serious drug-related adverse event was reported (anaphylactic reaction). Adverse events related to the digestive system were reported by 4.7% of the Cefaclor AF-treated patients and 4.5% of the Cefaclor-treated patients during the entire study period. Cefaclor AF, at all three dose levels studies, was seen to be as safe as Cefaclor in the treatment of acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
Werner Bischoff - One of the best experts on this subject based on the ideXlab platform.
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Loracarbef (LY163892) versus Cefaclor and norfloxacin in the treatment of uncomplicated pyelonephritis.
The American journal of medicine, 1992Co-Authors: David L. Hyslop, Werner BischoffAbstract:Optimal therapy for pyelonephritis requires the immediate administration of an effective broad-spectrum antibiotic. Because conventional oral antibiotics such as the sulfonamides and the aminopenicillins are limited by the development of resistant bacteria associated with this common disease, the therapeutic effectiveness of a new oral carbacephem antibiotic was investigated. Two double-blind, randomized clinical trials of loracarbef (LY163892) were conducted. A total of 245 patients (greater than or equal to 18 years old) with uncomplicated pyelonephritis were enrolled in parallel studies. One study compared loracarbef with Cefaclor; the other compared loracarbef with norfloxacin. In the combined patient population, 119 patients were treated with loracarbef (400 mg twice daily), 43 with Cefaclor (500 mg three times daily), and 83 with norfloxacin (400 mg twice daily). All treatment regimens continued for greater than or equal to 14 days. A total of 68 patients in the loracarbef group, 25 in the Cefaclor group, and 43 in the norfloxacin group qualified for efficacy analysis. Escherichia coli was the causative pathogen in 85.0% of these patients. Successful posttherapy clinical and bacteriologic responses were similar for all three study drugs: 94.1 and 86.8%, 96.0 and 80.0%, 97.7 and 88.4% for loracarbef, Cefaclor, and norfloxacin, respectively. Late posttherapy clinical responses were 87.4, 83.3, and 91.7% for the loracarbef, Cefaclor, and norfloxacin groups, respectively. Bacteriologic responses for the three groups were 79.6, 60.0, and 88.9%. The most frequent adverse effects (headache, diarrhea, and nausea) were experienced by three patients (2.5%) in the loracarbef group; headaches were noted in two (4.7%) Cefaclor patients, diarrhea was noted in three (7.0%) patients in the Cefaclor group, and nausea was noted in four (9.3%). Gastrointestinal events were noted in four patients (4.8%) in the norfloxacin group. The data demonstrate that loracarbef is comparable in efficacy and safety to both Cefaclor and norfloxacin as oral therapy for uncomplicated pyelonephritis.
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Loracarbef (LY163892) versus Cefaclor and norfloxacin in the treatment of uncomplicated pyelonephritis
The American Journal of Medicine, 1992Co-Authors: David L. Hyslop, Werner BischoffAbstract:Abstract Optimal therapy for pyelonephritis requires the immediate administration of an effective broad-spectrum antibiotic. Because conventional oral antibiotics such as the sulfonamides and the aminopenicillins are limited by the development of resistant bacteria associated with this common disease, the therapeutic effectiveness of a new oral carbacephem antibiotic was investigated. Two double-blind, randomized clinical trials of loracarbef (LY163892) were conducted. A total of 245 patients (≥18 years old) with uncomplicated pyelonephritis were enrolled in parallel studies. One study compared loracarbef with Cefaclor; the other compared loracarbef with norfloxacin. In the combined patient population, 119 patients were treated with loracarbef (400 mg twice daily), 43 with Cefaclor (500 mg three times daily), and 83 with norfloxacin (400 mg twice daily). All treatment regimens continued for ≥14 days. A total of 68 patients in the loracarbef group, 25 in the Cefaclor group, and 43 in the norfloxacin group qualified for efficacy analysis. Escherichia coli was the causative pathogen in 85.0% of these patients. Successful posttherapy clinical and bacteriologic responses were similar for all three study drugs: 94.1% and 86.8%, 96.0 and 80.0%, 97.7 and 88.4% for loracarbef, Cefaclor, and norfloxacin, respectively. Late posttherapy clinical responses were 87.4, 83.3, and 91.7% for the loracarbef, Cefaclor, and norfloxacin groups, respectively. Bacteriologic responses for the three groups were 79.6, 60.0, and 88.9%. The most frequent adverse effects (headache, diarrhea, and nausea) were experienced by three patients (2.5%) in the loracarbef group; headaches were noted in two (4.7%) Cefaclor patients, diarrhea was noted in three (7.0%) patients in the Cefaclor group, and nausea was noted in four (9.3%). Gastrointestinal events were noted in four patients (4.8%) in the norfloxacin group. The data demonstrate that loracarbef is comparable in efficacy and safety to both Cefaclor and norfloxacin as oral therapy for uncomplicated pyelonephritis.
Gregory L. Kearns - One of the best experts on this subject based on the ideXlab platform.
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serum sickness like reaction to Cefaclor lack of in vitro cross reactivity with loracarbef
Clinical Pharmacology & Therapeutics, 1998Co-Authors: Gregory L. Kearns, Michael J. Rieder, Gary J Wheeler, Joanne ReidAbstract:Objectives A lymphocyte-based in vitro rechallenge technique was used to examine the potential for cross-reactivity between loracarbef and Cefaclor in children who had had adverse reactions to Cefaclor. Study design The study cohort included 10 patients (2.2 ± 1.1 years old) with a serum sickness-like reaction to Cefaclor, five patients (4.1 ± 4.6 years old) with immediate-type hypersensitivity reactions to the drug, and five patients (1.5 ± 0.9 years old) who had a delayed hypersensitivity reaction to Cefaclor without joint involvement (i.e., not a serum sickness-like reaction). Peripheral blood mononuclear cells were isolated from each patient and were exposed to Cefaclor, loracarbef, and the metabolites of each generated with phenobarbital-induced murine hepatic microsomes. Results Among patients with Cefaclor-associated serum sickness-like reactions, lymphocyte killing (expressed as percentage cell kill above baseline) in the presence of Cefaclor metabolites (83.6% ± 42.2%) was significantly (p < 0.02) higher than that observed among the patients with either immediate-type (1.1% ± 2.4%) or delayed hypersensitivity (0%) reactions. In contrast, loracarbef did not produce significant in vitro cytotoxicity among any of the patient subgroups. Our in vitro evidence was supported at therapeutic rechallenge with loracarbef among three children with Cefaclor-associated serum sickness-like reactions who tolerated a full course of therapy without adverse reactions. Conclusion The metabolite-mediated cytotoxicity associated with Cefaclor among patients who had had serum sickness-like reactions after therapeutic administration of the drug was not shared with loracarbef. The extent to which the apparent lack of in vitro cross-reactivity between Cefaclor and loracarbef may be predictive of clinical cross-reactivity is not known. Clinical Pharmacology & Therapeutics (1998) 63, 686–693; doi:
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Serum sickness—like reaction to Cefaclor: Lack of in vitro cross‐reactivity with loracarbef
Clinical pharmacology and therapeutics, 1998Co-Authors: Gregory L. Kearns, J. Gary Wheeler, Michael J. Rieder, Joanne ReidAbstract:Objectives A lymphocyte-based in vitro rechallenge technique was used to examine the potential for cross-reactivity between loracarbef and Cefaclor in children who had had adverse reactions to Cefaclor. Study design The study cohort included 10 patients (2.2 ± 1.1 years old) with a serum sickness-like reaction to Cefaclor, five patients (4.1 ± 4.6 years old) with immediate-type hypersensitivity reactions to the drug, and five patients (1.5 ± 0.9 years old) who had a delayed hypersensitivity reaction to Cefaclor without joint involvement (i.e., not a serum sickness-like reaction). Peripheral blood mononuclear cells were isolated from each patient and were exposed to Cefaclor, loracarbef, and the metabolites of each generated with phenobarbital-induced murine hepatic microsomes. Results Among patients with Cefaclor-associated serum sickness-like reactions, lymphocyte killing (expressed as percentage cell kill above baseline) in the presence of Cefaclor metabolites (83.6% ± 42.2%) was significantly (p < 0.02) higher than that observed among the patients with either immediate-type (1.1% ± 2.4%) or delayed hypersensitivity (0%) reactions. In contrast, loracarbef did not produce significant in vitro cytotoxicity among any of the patient subgroups. Our in vitro evidence was supported at therapeutic rechallenge with loracarbef among three children with Cefaclor-associated serum sickness-like reactions who tolerated a full course of therapy without adverse reactions. Conclusion The metabolite-mediated cytotoxicity associated with Cefaclor among patients who had had serum sickness-like reactions after therapeutic administration of the drug was not shared with loracarbef. The extent to which the apparent lack of in vitro cross-reactivity between Cefaclor and loracarbef may be predictive of clinical cross-reactivity is not known. Clinical Pharmacology & Therapeutics (1998) 63, 686–693; doi:
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serum sickness like reactions to Cefaclor role of hepatic metabolism and individual susceptibility
The Journal of Pediatrics, 1994Co-Authors: Gregory L. Kearns, Gary J Wheeler, Sherry H Childress, Lynda LetzigAbstract:Abstract In an effort to explain the increased incidence of serum sickness-like reactions (SSLR) in patients receiving Cefaclor, we used an in vitro murine microsomal system as a surrogate for in vivo hepatic drug biotransformation. Lymphocytes from three groups of subjects were exposed to a nonselective mixture of Cefaclor metabolites. After an 18-hour incubation of lymphocytes with these metabolites, cells were examined for viability by trypan blue exclusion. The subject groups consisted of patients with a previous history of SSLR after Cefaclor therapy (n = 19), patients who experienced adverse reactions to Cefaclor suggestive of immediate hypersensitivity (n = 11), and control subjects who had previously tolerated at least two courses of Cefaclor therapy without adverse effect (n = 9). Additionally, immediate family members of six subjects with Cefaclor-associated SSLR were studied. Lymphocyte killing was 100% greater than baseline (i.e., a non-drug-containing control) in subjects with SSLR compared with those with immediate hypersensitivity reactions (4% cell death above baseline; p EDIATR 1994;125:805-11)
K D Jacobson - One of the best experts on this subject based on the ideXlab platform.
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Loracarbef (LY163892) versus Cefaclor in the treatment of bacterial skin and skin-structure infections in an adult population.
The American journal of medicine, 1992Co-Authors: J Mccarty, Gary E. Ruoff, K D JacobsonAbstract:Loracarbef (LY163892), a member of the class of beta-lactam antibiotics known as carbacephems, is characterized by a high level of chemical stability and a broad spectrum of antibacterial activity that persists in the presence of beta-lactamase. The efficacy and safety of loracarbef, 200 mg (twice daily), and Cefaclor, 250 mg (three times daily) (one patient received 178 mg of Cefaclor suspension, three times daily), were compared in a randomized, double-blind, multicenter trial conducted in adults with skin and skin-structure infections due predominantly to Staphylococcus aureus. Examination within 72 hours after the completion of therapy indicated a favorable clinical response in 84 (93.3%) of the 90 loracarbef-treated patients evaluable for efficacy and in 79 (95.2%) of the 83 evaluable patients treated with Cefaclor. Pathogens were eradicated in 83 (92.2%) of the patients in the loracarbef group and 74 (89.2%) of those in the Cefaclor group. Only four adverse events--headache/migraine, diarrhea, abdominal pain, and nausea--occurred in greater than 2% of the total study population. The overall incidence of adverse events in the 201 loracarbef-treated and 192 Cefaclor-treated patients evaluated for safety was 19.9% and 24.5%, respectively. Adverse events that required hospitalization or discontinuation of treatment occurred in four patients in the Cefaclor group but in none of those treated with loracarbef. There were no statistically significant differences in the clinical or bacteriologic response or the incidence of side effects between the two treatment groups. These findings indicate that loracarbef given twice daily is comparable in safety and efficacy to Cefaclor given three times daily in the treatment of adults with skin and skin-structure infections.