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Biomedical subjects

R Lorber

Publications and source records attributed to R Lorber.

9 recordsLinked to original sources

The pharmacokinetics, electrocardiographic effects, and tolerability of loratadine syrup in children aged 2 to 5 years.

OBJECTIVE: We assessed the pharmacokinetics and tolerability of 5 mg loratadine syrup (1 mg/mL) in children aged 2 to 5 years. METHODS: Two studies were undertaken. A single-dose, open-label bioavailability study was performed to characterize the pharmacokinetic profiles of loratadine and its metabolite desloratadine. Plasma concentrations of loratadine and desloratadine were determined at 0, 1, 2, 4, 8, 12, 24, 48, and 72 hours after a single administration of 5 mg loratadine syrup to 18 healthy children (11 male, 7 female; 12 black, 5 white, 1 other; mean age +/- SD, 3.8 +/- 1.1 years; mean weight +/- SD, 17.4 +/- 4.4 kg). In addition, a randomized, double-blind, placebo-controlled, parallel-group study was performed to assess the tolerability of 5 mg loratadine syrup after multiple doses. Loratadine (n = 60) or placebo (n = 61) was given once daily for 15 days to children with a history of allergic rhinitis or chronic idiopathic urticaria. In the loratadine group, 27 boys and 33 girls (52 white, 8 black) were enrolled, with a mean age +/- SD of 3.67 +/- 1.13 years and a mean weight +/- SD of 17.2 +/- 3.8 kg. In the placebo group, 27 boys and 34 girls (53 white, 7 black, 1 Asian) were enrolled, with a mean age +/- SD of 3.52 +/- 1.12 years and a mean weight +/- SD of 17.3 +/- 2.9 kg. Tolerability was assessed based on electrocardiographic results, occurrence of adverse events, changes in vital signs, and results of laboratory tests and physical examinations. RESULTS: The peak plasma concentrations of loratadine and desloratadine were 7.78 and 5.09 ng/mL, respectively, observed 1.17 and 2.33 hours after administration of loratadine; the areas under the plasma concentration-time curve to the last quantifiable time point for loratadine and desloratadine were 16.7 and 87.2 ng x h/mL, respectively. Single and multiple doses were well tolerated, with no adverse events occurring with greater frequency after multiple doses of loratadine than after placebo. Electrocardiographic parameters were not altered by loratadine compared with placebo. There were no clinically meaningful changes in other tolerability assessments. CONCLUSION: Loratadine was well tolerated in this small, selected group of children aged 2 to 5 years at a dose providing exposure similar to that with the adult dose (ie, 10 mg once daily).

Anti-Allergic Agents↗

The go-no-go paradigm in attention deficit disorder.

We administered the go-no-go paradigm to 44 boys with attention deficit disorder (ADD) and 32 control subjects who did not have ADD. This task requires a subject to emit a simple motor response to one cue while inhibiting the response in the presence of another cue. Commission errors suggest impulsivity, and omission errors suggest inattention. ADD subjects made more total errors than did control subjects (p less than 0.03), and more ADD subjects made multiple errors (p less than 0.001). Within the ADD group, the nonhyperactive (ADDnoH) subjects were characterized by a high number of commission errors early, and significant improvement with practice (p less than 0.01). In contrast, the hyperactive ADD subjects (ADD/H) did not differ from control subjects in number of early commission errors, but differed from both control subjects and ADDnoH subjects in their failure to improve with practice. In addition, the incidence of omission errors was highest in the ADD/H group. This paradigm can be easily incorporated into the assessment of children with suspected ADD and provides an objective measure of inattention and impulsivity. Our data provide cognitive support for the empirical distinction between hyperactive and nonhyperactive children with ADD.

Adolescent↗

Pitfalls in the use of a continuous performance test as a diagnostic tool in attention deficit disorder.

Although automated continuous performance tests (CPT) are gaining popularity as aids to the diagnosis of attention deficit disorder (ADD), little is known of their validity in this context. Our preliminary experience with a commercially available visual CPT indicated that as many as a third of children meeting the DMS-III criteria for ADD may score well enough on this measure to escape detection. We therefore analyzed the results of neuropsychological testing as well as CPT performance in 14 ADD children and six non-ADD children in an effort to determine whether CPT performance might reflect higher level cognitive variables other than attention and/or impulsivity. We found that those ADD children classified as "abnormal" on the basis of the CPT scored significantly below those classified as "normal" on measures of abstract reasoning and logical problem solving, simple verbal reasoning, nonverbal problem solving, and simple arithmetic skills. The non-ADD group contained a high proportion (83%) of subjects with CPT performance outside of the normal range. These data suggest that CPT may yield both false negative and false positive results when used as screening tools for ADD, and we recommend therefore that caution be used in their interpretation.

Adolescent↗

Netilmicin versus tobramycin in multi-centre studies.

In two prospective, randomized studies conducted in West Germany and involving 80 patients, netilmicin-ticarcillin was compared to tobramycin-ticarcillin in the treatment of serious systemic infections. Both regimens were essentially identical with respect to the clinical and bacteriological results they produced. The netilmicin group developed significantly less nephrotoxicity than the tobramycin group (0% versus 15%, P = 0.03). Ototoxicity also occurred less frequently in the netilmicin-treated patients (3% versus 10%, P = 0.4). In a large collaborative study involving 15 centres, 254 patients were enrolled. Clinical and bacteriological responses were excellent, with netilmicin and tobramycin equally effective, but the incidences of nephrotoxicity and ototoxicity were lower in patients treated with netilmicin than those receiving tobramycin.

Acute Kidney Injury↗

Comparative clinical trial of sisomicin and gentamicin in serious systemic gram-negative infections.

One hundred one hospitalized patients with serious gram-negative infections were treated with either sisomicin, 1.0 mg/kg every eight hours, or gentamicin, 1.5 mg/kg every eight hours, in a multicenter study conducted at ten separate locations in the United States. Since the drugs were administered at different dosages, a blinded investigator was employed to assess treatment response, while an unblinded investigator was responsible for making dosage adjustments based on each patient's renal function and clinical response. Sixty of the patients (sisomicin, 29; gentamicin, 31) were treated for a sufficient period (average seven to ten days) to be valid for inclusion in the assessment of treatment efficacy; 81 were included in the safety analysis. Sisomicin was found to be superior to gentamicin in bacteriological response and slightly better than gentamicin in producing favorable clinical responses. Elimination of pathogens or a significant reduction in pathogen population was observed in 93% of the sisomicin-treated patients, compared with 67% in the gentamicin group (P = 0.06). The incidence of adverse effects in both treatment groups was low, with no significant differences in adverse reaction patterns.

Bacterial Infections↗

Visual acuity following binocular deprivation in the cat.

Threshold visual acuity for three cats which were reared from birth to 4--12 months of age with bilateral lid closure was measured and compared to visual acuity in three cats which had the use of a non-deprived eye. The results indicate that binocular deprivation (BD) results in significant deficits in visual acuity which are proportional to the duration of deprivation. Threshold visual acuities were 3.7 cycles/deg. following 4 months of BD, 3.25 cycles/deg. following 7 months of BD and 2.55 cycles/deg. following 12 months of BD compared to acuities of 6.0, 6.5 and 6.8 cycles/deg9 for cats using a non-deprived eye. All BD cats had recovered from the initial visuomotor deficits, seen in these cats and reported in the literature, following lid-parting. The implication of such deficits in visual acuity on visual discrimination learning in BD cats is discussed.

Animals↗

Onset of action of loratadine and placebo and other efficacy variables in patients with seasonal allergic rhinitis.

In a double-blind study, 185 patients with seasonal allergic rhinitis were randomly assigned to receive 10 mg of loratadine or placebo once daily for three days. On day 1 of treatment, the onset of relief of symptoms within 30 minutes of drug administration was reported by 13% of the loratadine-treated patients and by 4% of the placebo patients (P less than 0.05). At two hours after drug administration, 65% of the loratadine-treated patients and 48% of the placebo patients reported symptom relief. On day 3, the loratadine-treated patients reported a significantly greater relief of symptoms, and according to both physician and patient evaluations, the treatment response was significantly superior in the loratadine-treated than in the placebo patients. The incidence of sedation was 2% in the loratadine group and 1% in the placebo group.

Adolescent↗