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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: D 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.
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Antibiotic therapy for urinary tract infections
The American Journal of Medicine, 1992Co-Authors: Abdollah Iravani, Werner BischoffAbstract:Abstract Loracarbef, a member of the carbacephem class of β-lactam antibiotics, was tested in randomized, double-blind, parallel studies for the treatment of uncomplicated urinary tract infections (UTIs). In one study conducted in the United States, a 7-day course of once-daily doses of Loracarbef (200 mg) was compared with a 7-day course of multiple daily doses of cefaclor (250 mg three times a day). Analysis of data from a small, homogeneous patient population of 108 college-aged women showed that Loracarbef produced clinical and bacteriologic responses similar to those produced by cefaclor. At 5–9 days posttherapy, bacteriologic cure was observed in 96% of patients in the Loracarbef group and 90% of patients in the cefaclor group (p = 0.614); at 4–6 weeks posttherapy, the same cure rate (81%) was observed in both groups. Analysis of the larger (333 patients) and more heterogeneous study population containing several male and elderly female patients showed that Loracarbef again produced responses similar to those produced by cefaclor, with no statistical significant differences seen between the groups at 5–9 days or at 4–6 weeks posttherapy. The adverse events reported by the Loracarbef and cefaclor groups were also comparable in both the small and large patient populations analyzed. Similarly favorable results were seen when a 7-day regimen of Loracarbef (200 mg once a day) was compared with a 7-day regimen of norfloxacin (400 mg twice a day) in a large European study of approximately 300 patients with uncomplicated cystitis. These studies demonstrate that the safety and efficacy of once-daily Loracarbef are comparable to the safety and efficacy of multiple-dose/day therapy with other antimicrobial agents commonly used in the treatment of uncomplicated UTIs.
K. Wettich - One of the best experts on this subject based on the ideXlab platform.
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Loracarbef versus penicillin V in the treatment of streptococcal pharyngitis and tonsillitis
Infection, 1992Co-Authors: O. Muller, Z. Spirer, K. WettichAbstract:In einer 10tägigen, doppelblinden randomisierten Studie mit parallelen Behandlungsarmen wurden Loracarbef (200-mg-Kapsel zweimal täglich oder 15 mg/kg/Tag als orale Suspension in zwei Teildosen bis maximal 375 mg/Tag; n=169) und Penicillin V (250-mg-Kapsel viermal täglich oder 20 mg/kg/Tag als Suspension in vier Teildosen bis maximal 500 mg/Tag; n=175) bei der Behandlung von Pharyngitis und Tonsillitis durch β-hämolysierende Streptokokken der Gruppe A (GABHS) verglichen. Bei den auswertbaren Patienten war die klinische Erfolgsrate für beide Behandlungsgruppen ähnlich: 97,4% in der Loracarbef-Gruppe (101/115 Patienten geheilt und 11/115 gebessert) und 96,0% in der Penicillin-Gruppe (101/124 Patienten geheilt und 18/124 gebessert). Hinsichtlich der Eliminationsrate des Erregers ergab sich zwischen beiden Behandlungsgruppen ein statistisch signifikanter Unterschied: Bei 94,8% (109/115) der mit Loracarbef behandelten Patienten waren die posttherapeutischen Rachenkulturen GABHS-negativ im Vergleich zu 87,1% (108/124) der penicillinbehandelten Patienten (p=0,040). Bezüglich der Arzneimittelsicherheit waren Loracarbef und Penicillin V vergleichbar. Am häufigsten wurden unter der Therapie Kopfschmerzen und Übelkeit/Erbrechen berichtet (Übelkeit/Erbrechen traten in der Loracarbef-Gruppe geringfügig seltener auf). In jeder Gruppe brachen drei Patienten die Studie ab. Hautausschläge im Sinne arzneimittelbedingter Unverträglichkeitsreaktionen waren in der Loracarbefund Penicillin-Gruppe je einmal zu verzeichnen. Weitere Abbruchgründe waren in der Loracarbef-Gruppe ein Tonsillarabszeß am 1. Behandlungstag sowie die Verschlechterung eines bevorstehenden Kopfschmerzes. In der Penicillin-Gruppe brach ein Patient die Therapie ebenfalls wegen Kopfschmerz ab, ein weiterer wegen Erbrechens. Diese Daten untermauern den Schluß, daß die zweimal tägliche Gabe von Loracarbef und die hierdurch verbesserte Patienten-Compliance bei der Elimination von β-hämolysierenden Streptokokken der Gruppe A effektiver und hinsichtlich Sicherheit und klinischer Wirksamkeit der viermal täglichen Gabe von Penicillin V bei der Behandlung von durch GABHS verursachter Pharyngitis und Tonsillitis vergleichbar ist. Ten-day, double-blind, randomized, parallel treatment regimens of Loracarbef (200 mg capsule twice daily or 15 mg/kg/day oral suspension in two divided doses up to a maximum of 375 mg/day; n=169) and penicillin V (250 mg capsule four times daily or 20 mg/kg/day suspension in four divided doses up to a maximum of 500 mg/day; n=175) were compared in the treatment of group A β-haemolytic streptococcal (GABHS) pharyngitis and tonsillitis. Post-therapy clinical responses were similar for evaluable patients in both treatment groups: 97.4% of the Loracarbef group (101/115 patients cured and 11/115 improved) and 96.0% of the penicillin group (101/124 patients cured and 18/124 improved). A statistically significant difference in the pathogen elimination rate was noted between treatment groups: post-therapy throat cultures were negative for GABHS in 94.8% (109/115) of Loracarbef-treated patients compared with 87.1% (108/124) of penicillin-treated patients (p=0.040). Loracarbef and penicillin V were comparable in terms of safety. Headache and nausea/vomiting were the most common events reported during therapy (nausea/vomiting were slightly less common in the Loracarbef group). Three patients in each group were discontinued from the study due to drug-related adverse events; one due to rash in the Loracarbef group and one due to rash and one due to vomiting in the penicillin group. These data support the conclusion that Loracarbef twice daily is more effective in eradicating GABHS than penicillin V four times daily, and the two drugs are comparable in safety and clinical efficacy in the treatment of GABHS pharyngitis and tonsillitis.
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Comparison of Loracarbef (LY163892) versus amoxicillin in the treatment of bronchopneumonia and lobar pneumonia
Infection, 1992Co-Authors: O. Muller, K. WettichAbstract:Loracarbef, der erste Vertreter der neuen Substanzklasse der Carbacephem-Antibiotika, wurde in einer randomisierten doppelblinden Parallelgruppen-Studie bei 84 erwachsenen Patienten mit ambulant erworbener Broncho- bzw. Lobärpneumonie im Vergleich mit Amoxicillin auf seine Wirksamkeit und Sicherheit geprüft. Bei zweimal täglicher Gabe hatte Loracarbef dieselbe klinische und bakteriologische Wirksamkeit wie die dreimal tägliche Verabreichung von Amoxicillin. Die Nebenwirkungen waren in beiden Gruppen meist leichtgradig und passager. Die gute Wirksamkeit gegenüber den wichtigsten Erregern der ambulant erworbenen bakteriellen Pneumonie und die bessere Betalactamasestabilität sowie die längere Halbwertszeit im Vergleich zu Amoxicillin und die nur zweimal tägliche Verabreichung sind Vorteile von Loracarbef hinsichtlich der therapeutischen Sicherheit und der Patientenfreundlichkeit. Loracarbef (LY163892), a carbacephem, is the first of a new class of β-lactam compounds. A 14-day, double-blind, randomized, parallel treatment study compared Loracarbef (400 mg b.i.d.; n=169) and amoxicillin (500 mg t.i.d.; n=167) in the treatment of lobar pneumonia and bronchopneumonia. Forty-four patients in the Loracarbef group and 40 patients in the amoxicillin group were evaluable for efficacy analysis. Streptococcus pneumoniae and Haemophilus influenzae were isolated from pure or mixed cultures in 45.5% of the evaluable patients, with S. pneumoniae being isolated most frequently. Favourable clinical responses (cure or improvement) in the Loracarbef-treated group (42/44; 95.5%) were similar to those in the amoxicillin-treated group (38/40; 95%). A favourable bacteriological response was observed for 36/44 (81.8%) Loracarbef-treated patients compared with 28/40 (70%) amoxicillin-treated patients (p=0.2). Adverse events were similar in both groups. Withdrawal of treatment was required in three patients in each group due to gastrointestinal events or rash/allergic exanthema. These data support the conclusion that Loracarbef and amoxicillin have comparable efficacy and safety in the treatment of bronchopneumonia and lobar pneumonia caused by susceptible pathogens. However, Loracarbef can be administered twice daily, offering the advantage of improved patient compliance. It is also active against β-lactamse producing organisms.
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Comparison of Loracarbef (LY163892) versus amoxicillin in the treatment of bronchopneumonia and lobar pneumonia.
Infection, 1992Co-Authors: O. Muller, K. WettichAbstract:Loracarbef (LY163892), a carbacephem, is the first of a new class of β-lactam compounds. A 14-day, double-blind, randomized, parallel treatment study compared Loracarbef (400 mg b.i.d.; n=169) and amoxicillin (500 mg t.i.d.; n=167) in the treatment of lobar pneumonia and bronchopneumonia. Forty-four patients in the Loracarbef group and 40 patients in the amoxicillin group were evaluable for efficacy analysis.Streptococcus pneumoniae andHaemophilus influenzae were isolated from pure or mixed cultures in 45.5% of the evaluable patients, withS. pneumoniae being isolated most frequently. Favourable clinical responses (cure or improvement) in the Loracarbef-treated group (42/44; 95.5%) were similar to those in the amoxicillin-treated group (38/40; 95%). A favourable bacteriological response was observed for 36/44 (81.8%) Loracarbef-treated patients compared with 28/40 (70%) amoxicillin-treated patients (p=0.2). Adverse events were similar in both groups. Withdrawal of treatment was required in three patients in each group due to gastrointestinal events or rash/allergic exanthema. These data support the conclusion that Loracarbef and amoxicillin have comparable efficacy and safety in the treatment of bronchopneumonia and lobar pneumonia caused by susceptible pathogens. However, Loracarbef can be administered twice daily, offering the advantage of improved patient compliance. It is also active against β-lactamse producing organisms.
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Comparison of Loracarbef (LY163892) versus amoxicillin in the treatment of bronchopneumonia and lobar pneumonia.
Infection, 1992Co-Authors: O. Muller, K. WettichAbstract:Loracarbef (LY163892), a carbacephem, is the first of a new class of beta-lactam compounds. A 14-day, double-blind, randomized, parallel treatment study compared Loracarbef (400 mg b.i.d.; n = 169) and amoxicillin (500 mg t.i.d.; n = 167) in the treatment of lobar pneumonia and bronchopneumonia. Forty-four patients in the Loracarbef group and 40 patients in the amoxicillin group were evaluable for efficacy analysis. Streptococcus pneumoniae and Haemophilus influenzae were isolated from pure or mixed cultures in 45.5% of the evaluable patients, with S. pneumoniae being isolated most frequently. Favourable clinical responses (cure or improvement) in the Loracarbef-treated group (42/44; 95.5%) were similar to those in the amoxicillin-treated group (38/40; 95%). A favourable bacteriological response was observed for 36/44 (81.8%) Loracarbef-treated patients compared with 28/40 (70%) amoxicillin-treated patients (p = 0.2). Adverse events were similar in both groups. Withdrawal of treatment was required in three patients in each group due to gastrointestinal events or rash/allergic exanthema. These data support the conclusion that Loracarbef and amoxicillin have comparable efficacy and safety in the treatment of bronchopneumonia and lobar pneumonia caused by susceptible pathogens. However, Loracarbef can be administered twice daily, offering the advantage of improved patient compliance. It is also active against beta-lactamase producing organisms.
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Loracarbef versus penicillin V in the treatment of streptococcal pharyngitis and tonsillitis.
Infection, 1992Co-Authors: O. Muller, Z. Spirer, K. WettichAbstract:Ten-day, double-blind, randomized, parallel treatment regimens of Loracarbef (200 mg capsule twice daily or 15 mg/kg/day oral suspension in two divided doses up to a maximum of 375 mg/day; n=169) and penicillin V (250 mg capsule four times daily or 20 mg/kg/day suspension in four divided doses up to a maximum of 500 mg/day; n=175) were compared in the treatment of group A β-haemolytic streptococcal (GABHS) pharyngitis and tonsillitis. Post-therapy clinical responses were similar for evaluable patients in both treatment groups: 97.4% of the Loracarbef group (101/115 patients cured and 11/115 improved) and 96.0% of the penicillin group (101/124 patients cured and 18/124 improved). A statistically significant difference in the pathogen elimination rate was noted between treatment groups: post-therapy throat cultures were negative for GABHS in 94.8% (109/115) of Loracarbef-treated patients compared with 87.1% (108/124) of penicillin-treated patients (p=0.040). Loracarbef and penicillin V were comparable in terms of safety. Headache and nausea/vomiting were the most common events reported during therapy (nausea/vomiting were slightly less common in the Loracarbef group). Three patients in each group were discontinued from the study due to drug-related adverse events; one due to rash in the Loracarbef group and one due to rash and one due to vomiting in the penicillin group. These data support the conclusion that Loracarbef twice daily is more effective in eradicating GABHS than penicillin V four times daily, and the two drugs are comparable in safety and clinical efficacy in the treatment of GABHS pharyngitis and tonsillitis.
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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Antibiotic therapy for urinary tract infections
The American Journal of Medicine, 1992Co-Authors: Abdollah Iravani, Werner BischoffAbstract:Abstract Loracarbef, a member of the carbacephem class of β-lactam antibiotics, was tested in randomized, double-blind, parallel studies for the treatment of uncomplicated urinary tract infections (UTIs). In one study conducted in the United States, a 7-day course of once-daily doses of Loracarbef (200 mg) was compared with a 7-day course of multiple daily doses of cefaclor (250 mg three times a day). Analysis of data from a small, homogeneous patient population of 108 college-aged women showed that Loracarbef produced clinical and bacteriologic responses similar to those produced by cefaclor. At 5–9 days posttherapy, bacteriologic cure was observed in 96% of patients in the Loracarbef group and 90% of patients in the cefaclor group (p = 0.614); at 4–6 weeks posttherapy, the same cure rate (81%) was observed in both groups. Analysis of the larger (333 patients) and more heterogeneous study population containing several male and elderly female patients showed that Loracarbef again produced responses similar to those produced by cefaclor, with no statistical significant differences seen between the groups at 5–9 days or at 4–6 weeks posttherapy. The adverse events reported by the Loracarbef and cefaclor groups were also comparable in both the small and large patient populations analyzed. Similarly favorable results were seen when a 7-day regimen of Loracarbef (200 mg once a day) was compared with a 7-day regimen of norfloxacin (400 mg twice a day) in a large European study of approximately 300 patients with uncomplicated cystitis. These studies demonstrate that the safety and efficacy of once-daily Loracarbef are comparable to the safety and efficacy of multiple-dose/day therapy with other antimicrobial agents commonly used in the treatment of uncomplicated UTIs.
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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.
James Mccarty - One of the best experts on this subject based on the ideXlab platform.
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Loracarbef versus penicillin VK in the treatment of streptococcal pharyngitis and tonsillitis in an adult population.
The American Journal of Medicine, 1992Co-Authors: James MccartyAbstract:Abstract Loracarbef, a member of the carbacephem class of β-lactam antibiotics, is a potent antibacterial agent. In a double-blind, randomized clinical trial to assess the efficacy and safety of Loracarbef in the treatment of streptococcal pharyngitis and tonsillitis, 107 adult patients were treated with Loracarbef (200 mg capsules twice a day or 15 mg/kg/day suspension) and 111 patients were treated with penicillin VK (250 mg capsules four times a day or 20 mg/kg/day suspension) for 10 days. In the Loracarbef treatment group, 96.6% of the evaluable patients had a favorable clinical response 3–5 days after therapy, a result that compared favorably with the 93.9% response rate achieved in the penicillin group. The clinical failure/relapse rates were 3.4% for Loracarbef-treated patients and 6.1% for patients receiving penicillin. Bacteriologic response data approximated the clinical results, with a successful response in 89.9% of the Loracarbef-treated patients and 91.5% of the penicillin recipients. Two (1.9%) Loracarbef-treated patients with rash and one (0.9%) penicillin-treated patient with diarrhea discontinued the study early because of these adverse events. The incidence of adverse events was comparable in the two treatment groups except for increased cough, which was reported by 3.7% of the Loracarbef-treated patients and none of the penicillin recipients. These data support the conclusion that Loracarbef is comparable to penicillin VK in the treatment of streptococcal pharyngitis and tonsillitis in adults.
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Loracarbef versus penicillin VK in the treatment of streptococcal pharyngitis and tonsillitis in an adult population.
The American journal of medicine, 1992Co-Authors: James MccartyAbstract:Loracarbef, a member of the carbacephem class of beta-lactam antibiotics, is a potent anti-bacterial agent. In a double-blind, randomized clinical trial to assess the efficacy and safety of Loracarbef in the treatment of streptococcal pharyngitis and tonsillitis, 107 adult patients were treated with Loracarbef (200 mg capsules twice a day or 15 mg/kg/day suspension) and 111 patients were treated with penicillin VK (250 mg capsules four times a day or 20 mg/kg/day suspension) for 10 days. In the Loracarbef treatment group, 96.6% of the evaluable patients had a favorable clinical response 3-5 days after therapy, a result that compared favorably with the 93.9% response rate achieved in the penicillin group. The clinical failure/relapse rates were 3.4% for Loracarbef-treated patients and 6.1% for patients receiving penicillin. Bacteriologic response data approximated the clinical results, with a successful response in 89.9% of the Loracarbef-treated patients and 91.5% of the penicillin recipients. Two (1.9%) Loracarbef-treated patients with rash and one (0.9%) penicillin-treated patient with diarrhea discontinued the study early because of these adverse events. The incidence of adverse events was comparable in the two treatment groups except for increased cough, which was reported by 3.7% of the Loracarbef-treated patients and none of the penicillin recipients. These data support the conclusion that Loracarbef is comparable to penicillin VK in the treatment of streptococcal pharyngitis and tonsillitis in adults.
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Loracarbef versus penicillin VK in the treatment of streptococcal pharyngitis and tonsillitis in adults.
Clinical therapeutics, 1992Co-Authors: James Mccarty, Y. Hernon, Lawrence S. Linn, D. G. Therasse, A. Molina, N. BleileAbstract:Loracarbef, a member of a unique class of beta-lactam compounds (carbacephems), has excellent chemical and beta-lactamase stability, as well as documented clinical effectiveness against a broad spectrum of bacteria. Ten-day treatment regimens of Loracarbef (200-mg capsule BID or 15 mg/kg/day suspension) and penicillin VK (250-mg capsule QID or 20 mg/kg/day suspension) were compared in the treatment of group A beta-hemolytic streptococcal (GABHS) pharyngitis and tonsillitis. Adults (greater than or equal to 12 years of age) were administered Loracarbef (n = 58) or penicillin (n = 58) in a double-blind, randomized, parallel study of clinical and bacteriologic response to treatment. Favorable clinical responses among qualified (evaluable) patients in the Loracarbef-treated group (46/47; 97.9%) were similar to those for evaluable patients in the penicillin-treated group (43/43; 100%). Forty-one of 47 (87.2%) of the evaluable Loracarbef-treated patients and 100% (43/43) of the evaluable penicillin-treated patients had negative posttherapy throat cultures for GABHS. Thirty-nine evaluable patients in each treatment group were assessed 28 to 35 days after completion of therapy: 2.6% of patients in each group experienced relapse of symptoms; and 7.7% of Loracarbef-treated patients had positive cultures, compared to 12.8% of penicillin-treated patients. Two (1.9%) Loracarbef-treated patients with rashes and one (0.9%) penicillin-treated patient with diarrhea withdrew from the study due to these adverse events. Diarrhea, the most frequently occurring adverse event during therapy in the Loracarbef group, was reported by 8.6% of the Loracarbef group and by 5.2% of the penicillin group. These data support the conclusion that Loracarbef is comparable in safety and efficacy to penicillin VK for the treatment of streptococcal pharyngitis and tonsillitis in adults.
Joanne Reid - 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:
