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George H. Talbot - One of the best experts on this subject based on the ideXlab platform.
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Sparfloxacin versus ciprofloxacin for the treatment of community acquired complicated skin and skin structure infections
Clinical Therapeutics, 1999Co-Authors: Benjamin A Lipsky, David Magner, Bruce Miller, Robert Schwartz, Dan C Henry, Thomas Nolan, Ann Mccabe, George H. TalbotAbstract:Fluoroquinolones have been shown to be effective in the treatment of complicated skin and skin-structure infections, in part because of their broad-spectrum antibacterial activity against causative pathogens that are resistant to older antimicrobial agents. We enrolled 603 adult patients (>58% male, >85% white) in a double-masked, double-dummy, randomized, multicenter trial to compare the efficacy and tolerability of Sparfloxacin (400-mg loading dose followed by 200 mg once daily) with those of ciprofloxacin (750 mg twice daily) for 10 days in the treatment of community-acquired, complicated skin and skin-structure infections. The primary efficacy variable was clinical response, based on assessment of signs and symptoms, in the clinically assessable population. Patients in the Sparfloxacin and ciprofloxacin groups were comparable with respect to demographic characteristics, underlying diseases, medical history, and laboratory test results. Wound infection was the most common diagnosis, and Staphylococcus aureus was the most frequently isolated pathogen. For the 475 clinically assessable patients, the clinical success rate (percentage of patients cured or improved) was 90.1% (210/233) with Sparfloxacin and 87.2% (211/242) with ciprofloxacin. In this analysis (95% confidence interval [CI], -2.8 to 8.6) and the intent-to-treat analyses (95% CI, -4.2 to 6.2), results with Sparfloxacin were statistically equivalent to those with ciprofloxacin (95% CI, -1 to 15.3). For bacteriologically assessable patients, eradication rates were 87.0% (141/162) with Sparfloxacin and 79.9% (123/154) with ciprofloxacin (95% CI, -1 to 15.3). Eradication rates of S. aureus and coagulase-negative staphylococcal infections were 90.2% (101/112) with Sparfloxacin and 77.9% (88/113) with ciprofloxacin. For patients with 2 or more pathogens at baseline (mixed infections), bacteriologic success was 87.6% for Sparfloxacin and 77.9% for ciprofloxacin. Pseudomonas aeruginosa infections were eradicated or presumed eradicated in 71.4% (10/14) of Sparfloxacin-treated patients and 87.5% (7/8) of ciprofloxacin-treated patients. Overall success rates in the bacteriologically assessable patients for Sparfloxacin (84.6% [137/162]) and ciprofloxacin (78.6% [121/154]) were statistically equivalent (95% CI, -2.5 to 14.5). Tolerability was assessed in all patients who received study medication. The overall frequency of treatment-related adverse events was comparable in the 2 treatment groups (26.5% Sparfloxacin, 23.3% ciprofloxacin). Drug-related adverse events involving the digestive system occurred in 7.1% of Sparfloxacin-treated patients and 19.0% of ciprofloxacin-treated patients; photosensitivity reactions were reported in 11.1% of patients in the Sparfloxacin group and 0.7% of patients in the ciprofloxacin group (P < 0.001). The mean change in QTc interval from baseline to the maximum on-treatment value was greater in the Sparfloxacin group (9 milliseconds) than in the ciprofloxacin group (3 milliseconds) (P = 0.005; 95% CI, 0.002 to 0.010). The efficacy of Sparfloxacin was comparable to that of ciprofloxacin in the treatment of community-acquired, complicated skin and skin-structure infections, including those caused by staphylococci, the most common pathogens. Sparfloxacin's once-daily regimen, high skin-tissue penetration, and improved activity against gram-positive cocci make it a therapeutic alternative to ciprofloxacin for patients who are not at risk for photosensitivity reactions or adverse events associated with prolongation of the QTc interval.
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comparison of Sparfloxacin and clarithromycin in the treatment of acute bacterial maxillary sinusitis
Clinical Therapeutics, 1999Co-Authors: Dan C Henry, Hao Zhang, Daniel J Moller, Jeffrey Adelglass, Michael W Scheid, Carol K Jablonski, George H. TalbotAbstract:Abstract Five hundred four patients were enrolled in a randomized, double-masked, multicenter study comparing the efficacy and tolerability of a 10-day regimen of Sparfloxacin with a 14-day regimen of clarithromycin in the treatment of acute maxillary sinusitis. Two hundred fifty-two patients received Sparfloxacin as a single 400-mg dose on day 1 and 200 mg once daily for 9 additional days, and 252 patients received clarithromycin 500 mg twice daily for 14 days. In the all-treated population, clinical success was observed at 6 to 10 days after therapy in approximately 82% of the patients in each treatment group. A total of 430 patients met the inclusion criteria for clinical assessment. The success rates in these patients were also comparable, at 83.1% and 83.4% for the Sparfloxacin and clarithromycin groups, respectively. Sustained clinical success rates in the all-treated population 3 to 4 weeks after therapy were 71.6% for the Sparfloxacin group and 68.6% for the clarithromycin group. All treated patients were included in the tolerability analysis. The frequency of adverse events in the clarithromycin and Sparfloxacin groups was 57.9% and 48.4%, respectively. The most frequently noted adverse events were diarrhea, photosensitivity reaction, taste perversion, nausea, and abdominal pain; >96% of adverse events in the Sparfloxacin group and 94% of adverse events in the clarithromycin group were of mild or moderate severity. Among adverse events at least possibly related to study drug, photosensitivity reaction was more common in the Sparfloxacin group (9.5% vs 0.4%), whereas taste perversion (8.7% vs 0.8%) and abdominal pain (3.6% vs 1.6%) were more common in the clarithromycin group. Thus the Sparfloxacin's more convenient regimen was as effective as clarithromycin in the treatment of acute bacterial maxillary sinusitis, and the overall frequency of adverse events with Sparfloxacin was comparable to that with clarithromycin.
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Pharmacokinetic interaction of Sparfloxacin and digoxin
Clinical Therapeutics, 1999Co-Authors: Robert D. Johnson, Mary Beth Dorr, Thomas L. Hunt, Suzanne Conway, George H. TalbotAbstract:Abstract Sparfloxacin, a broad-spectrum, oral fluoroquinolone antimicrobial agent, has a long elimination half-life that permits once-daily administration. Antibiotics may increase the oral bioavailability of digoxin, leading to increases in its plasma concentration. Since patients treated with Sparfloxacin may be receiving concurrent treatment with digoxin, the possibility of an interaction between Sparfloxacin and digoxin was examined in a doublemasked, placebo-controlled, multipledose, two-way crossover study in 24 healthy male volunteers between 20 and 49 years of age. All subjects were given digoxin 0.3 mg once daily throughout the 20-day study. Sparfloxacin (or placebo) was given as a 400-mg loading dose on day 1, followed by single 200-mg daily doses for 9 days, with crossover to the alternate treatment on days 11 through 20. Plasma levels of digoxin were analyzed by validated radioimmunoassay, and plasma levels of Sparfloxacin were analyzed by validated high-performance liquid chromatography. Concomitant administration of Sparfloxacin and digoxin was generally well tolerated. Mean values for steady-state area under the concentration-time curve over 24 hours for the 2 treatments were virtually identical: 28.4 ng/h per mL −1 for digoxin administered with placebo and 28.9 ng/h per mL −1 for digoxin administered concomitantly with Sparfloxacin. Mean steady-state maximum plasma concentrations were 3.91 and 3.59 ng/mL for digoxin with placebo and digoxin with Sparfloxacin, respectively. Mean steady-state trough plasma digoxin concentrations for the 2 treatments were 0.87 and 0.89 ng/mL, respectively. Mean times to steady-state maximum plasma concentrations were identical at 0.89 hours for both treatments. Mean steady-state oral clearance was 10.6 L/h for digoxin alone and 10.4 L/h for digoxin with Sparfloxacin. Thus administration of Sparfloxacin in combination with digoxin did not alter the pharmacokinetics of digoxin in healthy male volunteers aged 20 to 49 years. Steady-state plasma Sparfloxacin concentrations were consistent with those obtained in other multiple-dose phase I studies, suggesting that digoxin does not alter the steady-state pharmacokinetics of Sparfloxacin.
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The effect of terfenadine on the cardiac pharmacodynamics of Sparfloxacin
Clinical Therapeutics, 1999Co-Authors: Joel Morganroth, Mary Beth Dorr, Thomas Hunt, David Magner, George H. TalbotAbstract:Abstract This double-masked, randomized, placebocontrolled study was conducted to assess the effect of concomitant administration of terfenadine and Sparfloxacin on the electrocardiographic (ECG) QT c interval in healthy volunteers, before the removal of terfenadine from the market. Eighty-eight men (aged 18 to 49 years, weighing 60.0 to 98.6 kg) with no clinically relevant ECG abnormalities received placebo, Sparfloxacin (400 mg on day 1, 200 mg daily on days 2–4), terfenadine (60 mg BID), or the combination of Sparfloxacin and terfenadine. After each dose, serial blood samples and ECG measurements were collected to determine Sparfloxacin pharmacokinetic and pharmacodynamic variables. The area under the concentration-time curve and maximum concentration for Sparfloxacin were ~16% less on day 4 compared with day 1, reflecting the higher plasma level after the 400-mg loading dose compared with that after the maintenance dose of 200 mg daily. Concomitant administration of terfenadine had no effect on these pharmacokinetic variables. When compared with the placeboadjusted increases in QT c interval in the Sparfloxacin (19 milliseconds on day 1 and 14 milliseconds on day 4) and terfenadine (2 milliseconds on day 1 and 7 milliseconds on day 4) treatment groups, the placeboadjusted increases in QT c interval in the volunteers treated with the combination of Sparfloxacin and terfenadine (18 milliseconds on day 1 and 22 milliseconds on day 4) were considered to be additive (no statistically significant interaction). Thus there are no apparent pharmacokinetic or dynamic QT c interactions between terfenadine and Sparfloxacin. However, Sparfloxacin should be administered with caution to patients receiving concomitant medications known to prolong the QT c interval.
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Sparfloxacin versus clarithromycin in the treatment of community-acquired pneumonia.
Clinical Therapeutics, 1999Co-Authors: Julio A. Ramirez, George H. Talbot, Joel Unowsky, Hao Zhang, Lloyd TownsendAbstract:Community-acquired pneumonia remains a significant health concern despite the availability of effective antibiotics. This randomized, double-masked, double-dummy, multicenter comparative trial was undertaken to compare the efficacy and safety of Sparfloxacin with those of clarithromycin in the treatment of community-acquired pneumonia. In 54 centers throughout the United States, 342 patients aged > or = 18 years with community-acquired pneumonia were enrolled in this trial. A total of 167 patients, 98 males and 69 females with a mean age of 51.0 years (range, 18-87), received a 400-mg loading dose of Sparfloxacin on the first day, followed by 200 mg once daily for a total of 10 days. A total of 175 patients, 85 males and 90 females with a mean age of 51.3 years (range, 18-91), received clarithromycin 250 mg twice daily for 10 days. In the intent-to-treat population, 133 (79.6%) patients in the Sparfloxacin group and 145 (82.9%) in the clarithromycin group were cured or improved (the 95% confidence interval [CI] for the differences in success rate between Sparfloxacin and clarithromycin was -11.5% to 5.1%). Success rates for the per-protocol patients were 88.7% (133/150) in the Sparfloxacin group and 88.9% (144/162) in the clarithromycin groups (95% CI, -7.2% to 6.8%). There were no significant differences in success rate between treatment groups based on age > or = 65 years. The overall bacteriologic response rates in the bacteriologically assessable population were 97.0% (64/66 isolates) in the Sparfloxacin group and 91.4% (74/81 isolates) in the clarithromycin group. Recurrence occurred in 6.0% of per-protocol patients in the Sparfloxacin group and 6.3% of patients in the clarithromycin group. The overall frequency of adverse events was 56.3% in the Sparfloxacin group and 65.1% in the clarithromycin group. Gastrointestinal disturbances were the most common adverse event in both groups. Abnormal taste related to study drug was reported by 17 patients (9.7%) treated with clarithromycin, versus 3 patients (1.8%) treated with Sparfloxacin (P = 0.002). Photosensitivity reactions were reported in 10 patients (6.0%) treated with Sparfloxacin, versus 1 patient (0.6%) treated with clarithromycin (P = 0.002). QT-interval prolongation was documented in 4 patients (2.4%) in the Sparfloxacin group and no patients in the clarithromycin group. Thus Sparfloxacin was as well tolerated and as effective as clarithromycin in the treatment of community-acquired pneumonia.
David Magner - One of the best experts on this subject based on the ideXlab platform.
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Sparfloxacin versus ciprofloxacin for the treatment of community acquired complicated skin and skin structure infections
Clinical Therapeutics, 1999Co-Authors: Benjamin A Lipsky, David Magner, Bruce Miller, Robert Schwartz, Dan C Henry, Thomas Nolan, Ann Mccabe, George H. TalbotAbstract:Fluoroquinolones have been shown to be effective in the treatment of complicated skin and skin-structure infections, in part because of their broad-spectrum antibacterial activity against causative pathogens that are resistant to older antimicrobial agents. We enrolled 603 adult patients (>58% male, >85% white) in a double-masked, double-dummy, randomized, multicenter trial to compare the efficacy and tolerability of Sparfloxacin (400-mg loading dose followed by 200 mg once daily) with those of ciprofloxacin (750 mg twice daily) for 10 days in the treatment of community-acquired, complicated skin and skin-structure infections. The primary efficacy variable was clinical response, based on assessment of signs and symptoms, in the clinically assessable population. Patients in the Sparfloxacin and ciprofloxacin groups were comparable with respect to demographic characteristics, underlying diseases, medical history, and laboratory test results. Wound infection was the most common diagnosis, and Staphylococcus aureus was the most frequently isolated pathogen. For the 475 clinically assessable patients, the clinical success rate (percentage of patients cured or improved) was 90.1% (210/233) with Sparfloxacin and 87.2% (211/242) with ciprofloxacin. In this analysis (95% confidence interval [CI], -2.8 to 8.6) and the intent-to-treat analyses (95% CI, -4.2 to 6.2), results with Sparfloxacin were statistically equivalent to those with ciprofloxacin (95% CI, -1 to 15.3). For bacteriologically assessable patients, eradication rates were 87.0% (141/162) with Sparfloxacin and 79.9% (123/154) with ciprofloxacin (95% CI, -1 to 15.3). Eradication rates of S. aureus and coagulase-negative staphylococcal infections were 90.2% (101/112) with Sparfloxacin and 77.9% (88/113) with ciprofloxacin. For patients with 2 or more pathogens at baseline (mixed infections), bacteriologic success was 87.6% for Sparfloxacin and 77.9% for ciprofloxacin. Pseudomonas aeruginosa infections were eradicated or presumed eradicated in 71.4% (10/14) of Sparfloxacin-treated patients and 87.5% (7/8) of ciprofloxacin-treated patients. Overall success rates in the bacteriologically assessable patients for Sparfloxacin (84.6% [137/162]) and ciprofloxacin (78.6% [121/154]) were statistically equivalent (95% CI, -2.5 to 14.5). Tolerability was assessed in all patients who received study medication. The overall frequency of treatment-related adverse events was comparable in the 2 treatment groups (26.5% Sparfloxacin, 23.3% ciprofloxacin). Drug-related adverse events involving the digestive system occurred in 7.1% of Sparfloxacin-treated patients and 19.0% of ciprofloxacin-treated patients; photosensitivity reactions were reported in 11.1% of patients in the Sparfloxacin group and 0.7% of patients in the ciprofloxacin group (P < 0.001). The mean change in QTc interval from baseline to the maximum on-treatment value was greater in the Sparfloxacin group (9 milliseconds) than in the ciprofloxacin group (3 milliseconds) (P = 0.005; 95% CI, 0.002 to 0.010). The efficacy of Sparfloxacin was comparable to that of ciprofloxacin in the treatment of community-acquired, complicated skin and skin-structure infections, including those caused by staphylococci, the most common pathogens. Sparfloxacin's once-daily regimen, high skin-tissue penetration, and improved activity against gram-positive cocci make it a therapeutic alternative to ciprofloxacin for patients who are not at risk for photosensitivity reactions or adverse events associated with prolongation of the QTc interval.
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The effect of terfenadine on the cardiac pharmacodynamics of Sparfloxacin
Clinical Therapeutics, 1999Co-Authors: Joel Morganroth, Mary Beth Dorr, Thomas Hunt, David Magner, George H. TalbotAbstract:Abstract This double-masked, randomized, placebocontrolled study was conducted to assess the effect of concomitant administration of terfenadine and Sparfloxacin on the electrocardiographic (ECG) QT c interval in healthy volunteers, before the removal of terfenadine from the market. Eighty-eight men (aged 18 to 49 years, weighing 60.0 to 98.6 kg) with no clinically relevant ECG abnormalities received placebo, Sparfloxacin (400 mg on day 1, 200 mg daily on days 2–4), terfenadine (60 mg BID), or the combination of Sparfloxacin and terfenadine. After each dose, serial blood samples and ECG measurements were collected to determine Sparfloxacin pharmacokinetic and pharmacodynamic variables. The area under the concentration-time curve and maximum concentration for Sparfloxacin were ~16% less on day 4 compared with day 1, reflecting the higher plasma level after the 400-mg loading dose compared with that after the maintenance dose of 200 mg daily. Concomitant administration of terfenadine had no effect on these pharmacokinetic variables. When compared with the placeboadjusted increases in QT c interval in the Sparfloxacin (19 milliseconds on day 1 and 14 milliseconds on day 4) and terfenadine (2 milliseconds on day 1 and 7 milliseconds on day 4) treatment groups, the placeboadjusted increases in QT c interval in the volunteers treated with the combination of Sparfloxacin and terfenadine (18 milliseconds on day 1 and 22 milliseconds on day 4) were considered to be additive (no statistically significant interaction). Thus there are no apparent pharmacokinetic or dynamic QT c interactions between terfenadine and Sparfloxacin. However, Sparfloxacin should be administered with caution to patients receiving concomitant medications known to prolong the QT c interval.
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safety profile of Sparfloxacin a new fluoroquinolone antibiotic
Clinical Therapeutics, 1999Co-Authors: Benjamin A Lipsky, Mary Beth Dorr, David Magner, George H. TalbotAbstract:Abstract The safety profile of Sparfloxacin, a newer fluoroquinolone antibiotic, was examined through an integrated analysis of safety data from 6 multicenter phase III trials. These consisted of 5 double-masked, randomized, comparative trials of Sparfloxacin (a 400-mg oral loading dose followed by 200 mg/d for 10 days) versus standard therapies (erythromycin, cefaclor, ofloxacin, clarithromycin, and ciprofloxacin) and 1 open-label trial (noncomparative) in patients with: community-acquired pneumonia (2 trials); acute bacterial exacerbations of chronic bronchitis ( 1 trial); acute maxillary sinusitis (2 trials, one of which was the noncomparative trial); and complicated skin and skin-structure infections (1 trial). Overall, 401 (25.3%) of 1585 patients treated with Sparfloxacin and 374 (28.1%) of 1331 receiving a comparator regimen experienced at least 1 adverse event considered to be related to the study medication. Photosensitivity reactions, usually of mild-to-moderate severity, were seen more frequently with Sparfloxacin (7.4%) than with comparator agents (0.5%), whereas gastrointestinal reactions (diarrhea, nausea, dyspepsia, abdominal pain, vomiting, and flatulence), insomnia, and taste perversion were more common in patients taking comparator drugs (22.3% vs 12.1%, 4.3% vs 1.5%, and 2.9% vs 1.2%, respectively). Analysis of electrocardiographic findings showed that the mean change from baseline in QT interval corrected for heart rate (QT c ) was significantly greater in Sparfloxacin-treated patients (10 msec) than in patients given comparator drugs (3 msec), but no associated ventricular arrhythmias were detected. Adverse events led to discontinuation of study medication in 104 (6.6%) patients receiving Sparfloxacin and 118 (8.9%) given comparator drags. Sparfloxacin may be considered an appropriate choice for the treatment of certain community-acquired infections for patients who are not at risk for photo-sensitivity reactions or adverse events associated with prolongation of the QT c interval.
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treatment of community acquired acute uncomplicated urinary tract infection with Sparfloxacin versus ofloxacin
Antimicrobial Agents and Chemotherapy, 1998Co-Authors: Dan C Henry, Mary Beth Dorr, David Magner, W Ellison, J Sullivan, D L Mansfield, George H. TalbotAbstract:The efficacy and safety of a 3-day regimen of Sparfloxacin were compared with those of a 3-day regimen of ofloxacin for the treatment of community-acquired acute uncomplicated urinary tract infections. Four hundred nineteen women were enrolled in a randomized, open-label, observer-blinded, multicenter study; 204 received Sparfloxacin as a 400-mg loading dose on the first day and 200 mg once daily thereafter, and 215 received ofloxacin as 200 mg twice daily. A total of 383 patients met the criteria for clinical evaluability, and 174 were also bacteriologically evaluable; all treated patients were included in the safety analysis. Escherichia coli (86%) and Staphylococcus saprophyticus (4.6%) were the organisms most commonly isolated. Positive clinical responses were obtained 5 to 9 days after therapy in more than 92% of the patients in each group; sustained clinical cure rates 4 to 6 weeks after therapy were 78.3 and 76.9% in the Sparfloxacin and ofloxacin groups, respectively. A positive bacteriologic response was observed in 98% of the bacteriologically evaluable patients in each treatment group at 5 to 9 days posttherapy and in 88.2 and 92.6% of the patients in the Sparfloxacin and ofloxacin groups, respectively, 4 to 6 weeks after therapy. Almost 90% of all adverse events were of mild or moderate severity; the most frequent events at least possibly related to drug treatment were those common to the fluoroquinolones, namely, nausea, diarrhea, headache, insomnia, and photosensitivity. Photosensitivity was more frequent in the Sparfloxacin group (6.9% versus 0.5% in the ofloxacin group); insomnia was more frequent in the ofloxacin group (3.7% versus 1.0% in the Sparfloxacin group). These data suggest that a once-daily, 3-day regimen of Sparfloxacin is effective and generally well tolerated in the treatment of acute uncomplicated urinary tract infections.
Benjamin A Lipsky - One of the best experts on this subject based on the ideXlab platform.
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Sparfloxacin versus ciprofloxacin for the treatment of community acquired complicated skin and skin structure infections
Clinical Therapeutics, 1999Co-Authors: Benjamin A Lipsky, David Magner, Bruce Miller, Robert Schwartz, Dan C Henry, Thomas Nolan, Ann Mccabe, George H. TalbotAbstract:Fluoroquinolones have been shown to be effective in the treatment of complicated skin and skin-structure infections, in part because of their broad-spectrum antibacterial activity against causative pathogens that are resistant to older antimicrobial agents. We enrolled 603 adult patients (>58% male, >85% white) in a double-masked, double-dummy, randomized, multicenter trial to compare the efficacy and tolerability of Sparfloxacin (400-mg loading dose followed by 200 mg once daily) with those of ciprofloxacin (750 mg twice daily) for 10 days in the treatment of community-acquired, complicated skin and skin-structure infections. The primary efficacy variable was clinical response, based on assessment of signs and symptoms, in the clinically assessable population. Patients in the Sparfloxacin and ciprofloxacin groups were comparable with respect to demographic characteristics, underlying diseases, medical history, and laboratory test results. Wound infection was the most common diagnosis, and Staphylococcus aureus was the most frequently isolated pathogen. For the 475 clinically assessable patients, the clinical success rate (percentage of patients cured or improved) was 90.1% (210/233) with Sparfloxacin and 87.2% (211/242) with ciprofloxacin. In this analysis (95% confidence interval [CI], -2.8 to 8.6) and the intent-to-treat analyses (95% CI, -4.2 to 6.2), results with Sparfloxacin were statistically equivalent to those with ciprofloxacin (95% CI, -1 to 15.3). For bacteriologically assessable patients, eradication rates were 87.0% (141/162) with Sparfloxacin and 79.9% (123/154) with ciprofloxacin (95% CI, -1 to 15.3). Eradication rates of S. aureus and coagulase-negative staphylococcal infections were 90.2% (101/112) with Sparfloxacin and 77.9% (88/113) with ciprofloxacin. For patients with 2 or more pathogens at baseline (mixed infections), bacteriologic success was 87.6% for Sparfloxacin and 77.9% for ciprofloxacin. Pseudomonas aeruginosa infections were eradicated or presumed eradicated in 71.4% (10/14) of Sparfloxacin-treated patients and 87.5% (7/8) of ciprofloxacin-treated patients. Overall success rates in the bacteriologically assessable patients for Sparfloxacin (84.6% [137/162]) and ciprofloxacin (78.6% [121/154]) were statistically equivalent (95% CI, -2.5 to 14.5). Tolerability was assessed in all patients who received study medication. The overall frequency of treatment-related adverse events was comparable in the 2 treatment groups (26.5% Sparfloxacin, 23.3% ciprofloxacin). Drug-related adverse events involving the digestive system occurred in 7.1% of Sparfloxacin-treated patients and 19.0% of ciprofloxacin-treated patients; photosensitivity reactions were reported in 11.1% of patients in the Sparfloxacin group and 0.7% of patients in the ciprofloxacin group (P < 0.001). The mean change in QTc interval from baseline to the maximum on-treatment value was greater in the Sparfloxacin group (9 milliseconds) than in the ciprofloxacin group (3 milliseconds) (P = 0.005; 95% CI, 0.002 to 0.010). The efficacy of Sparfloxacin was comparable to that of ciprofloxacin in the treatment of community-acquired, complicated skin and skin-structure infections, including those caused by staphylococci, the most common pathogens. Sparfloxacin's once-daily regimen, high skin-tissue penetration, and improved activity against gram-positive cocci make it a therapeutic alternative to ciprofloxacin for patients who are not at risk for photosensitivity reactions or adverse events associated with prolongation of the QTc interval.
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safety profile of Sparfloxacin a new fluoroquinolone antibiotic
Clinical Therapeutics, 1999Co-Authors: Benjamin A Lipsky, Mary Beth Dorr, David Magner, George H. TalbotAbstract:Abstract The safety profile of Sparfloxacin, a newer fluoroquinolone antibiotic, was examined through an integrated analysis of safety data from 6 multicenter phase III trials. These consisted of 5 double-masked, randomized, comparative trials of Sparfloxacin (a 400-mg oral loading dose followed by 200 mg/d for 10 days) versus standard therapies (erythromycin, cefaclor, ofloxacin, clarithromycin, and ciprofloxacin) and 1 open-label trial (noncomparative) in patients with: community-acquired pneumonia (2 trials); acute bacterial exacerbations of chronic bronchitis ( 1 trial); acute maxillary sinusitis (2 trials, one of which was the noncomparative trial); and complicated skin and skin-structure infections (1 trial). Overall, 401 (25.3%) of 1585 patients treated with Sparfloxacin and 374 (28.1%) of 1331 receiving a comparator regimen experienced at least 1 adverse event considered to be related to the study medication. Photosensitivity reactions, usually of mild-to-moderate severity, were seen more frequently with Sparfloxacin (7.4%) than with comparator agents (0.5%), whereas gastrointestinal reactions (diarrhea, nausea, dyspepsia, abdominal pain, vomiting, and flatulence), insomnia, and taste perversion were more common in patients taking comparator drugs (22.3% vs 12.1%, 4.3% vs 1.5%, and 2.9% vs 1.2%, respectively). Analysis of electrocardiographic findings showed that the mean change from baseline in QT interval corrected for heart rate (QT c ) was significantly greater in Sparfloxacin-treated patients (10 msec) than in patients given comparator drugs (3 msec), but no associated ventricular arrhythmias were detected. Adverse events led to discontinuation of study medication in 104 (6.6%) patients receiving Sparfloxacin and 118 (8.9%) given comparator drags. Sparfloxacin may be considered an appropriate choice for the treatment of certain community-acquired infections for patients who are not at risk for photo-sensitivity reactions or adverse events associated with prolongation of the QT c interval.
G Talbot - One of the best experts on this subject based on the ideXlab platform.
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Overview of electrocardiographic and cardiovascular safety data for Sparfloxacin
Journal of Antimicrobial Chemotherapy, 1996Co-Authors: Philippe Jaillon, I. Brumpt, Joel Morganroth, G TalbotAbstract:During the preclinical development of Sparfloxacin, prolongation of the electrocardiographic QT interval was observed in dogs. Subsequently, the effect of Sparfloxacin on the QTc interval in man was studied in Phase I studies in healthy volunteers. An independent Safety Board was established to evaluate the electrocardiograms, provide an assessment of the clinical consequences of prolongation of the QT interval, and advise on the design of current and future studies. Results of Phase I and Phase III studies have been consistent and indicate that the increase in QTc interval associated with Sparfloxacin is moderate (3% on average) and that patients with renal or hepatic impairment are not at increased risk. Few serious adverse cardiovascular events have been reported during post-marketing surveillance of Sparfloxacin and all have occurred in patients with an underlying cardiac condition.
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Overview of electrocardiographic and cardiovascular safety data for Sparfloxacin. Sparfloxacin Safety Group.
The Journal of antimicrobial chemotherapy, 1996Co-Authors: Philippe Jaillon, I. Brumpt, Joel Morganroth, G TalbotAbstract:During the preclinical development of Sparfloxacin, prolongation of the electrocardiographic QT interval was observed in dogs. Subsequently, the effect of Sparfloxacin on the QTc interval in man was studied in Phase I studies in healthy volunteers. An independent Safety Board was established to evaluate the electrocardiograms, provide an assessment of the clinical consequences of prolongation of the QT interval, and advise on the design of current and future studies. Results of Phase I and Phase III studies have been consistent and indicate that the increase in QTc interval associated with Sparfloxacin is moderate (3% on average) and that patients with renal or hepatic impairment are not at increased risk. Few serious adverse cardiovascular events have been reported during post-marketing surveillance of Sparfloxacin and all have occurred in patients with an underlying cardiac condition.
Philippe Jaillon - One of the best experts on this subject based on the ideXlab platform.
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Overview of electrocardiographic and cardiovascular safety data for Sparfloxacin
Journal of Antimicrobial Chemotherapy, 1996Co-Authors: Philippe Jaillon, I. Brumpt, Joel Morganroth, G TalbotAbstract:During the preclinical development of Sparfloxacin, prolongation of the electrocardiographic QT interval was observed in dogs. Subsequently, the effect of Sparfloxacin on the QTc interval in man was studied in Phase I studies in healthy volunteers. An independent Safety Board was established to evaluate the electrocardiograms, provide an assessment of the clinical consequences of prolongation of the QT interval, and advise on the design of current and future studies. Results of Phase I and Phase III studies have been consistent and indicate that the increase in QTc interval associated with Sparfloxacin is moderate (3% on average) and that patients with renal or hepatic impairment are not at increased risk. Few serious adverse cardiovascular events have been reported during post-marketing surveillance of Sparfloxacin and all have occurred in patients with an underlying cardiac condition.
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Overview of electrocardiographic and cardiovascular safety data for Sparfloxacin. Sparfloxacin Safety Group.
The Journal of antimicrobial chemotherapy, 1996Co-Authors: Philippe Jaillon, I. Brumpt, Joel Morganroth, G TalbotAbstract:During the preclinical development of Sparfloxacin, prolongation of the electrocardiographic QT interval was observed in dogs. Subsequently, the effect of Sparfloxacin on the QTc interval in man was studied in Phase I studies in healthy volunteers. An independent Safety Board was established to evaluate the electrocardiograms, provide an assessment of the clinical consequences of prolongation of the QT interval, and advise on the design of current and future studies. Results of Phase I and Phase III studies have been consistent and indicate that the increase in QTc interval associated with Sparfloxacin is moderate (3% on average) and that patients with renal or hepatic impairment are not at increased risk. Few serious adverse cardiovascular events have been reported during post-marketing surveillance of Sparfloxacin and all have occurred in patients with an underlying cardiac condition.
