Telemedicine improved diabetic management.

Effective control of diabetes is known to delay or prevent the end-organ complications of this disease. Can telemedicine improve a patient's ability to self-manage diabetes? Twenty-eight patients entered a study comparing home telemedicine consultation with standard outpatient care. A nurse case manager contacted the telemedicine group once a week under the direction of a primary care physician, who contacted the telemedicine group once a month. Laboratory studies and total body weight were measured at the beginning and at the end of the 3-month study. The hemoglobin A1c (HbA1c) and total body weight improved significantly in the intervention (telemedicine) group, as shown by a 16% reduction in mean HbA1c level (from 9.5 to 8.2%) and a 4% mean weight reduction (from 214.3 to 206.7 pounds). Based on our experience, we present a functionally based telemedicine classification system to improve the application of electronic medicine in future studies.

Tolerability and pharmacokinetics of single and multiple doses of azelastine hydrochloride in elderly volunteers.

The tolerability and pharmacokinetics of azelastine hydrochloride (CAS 73907-93-0, A-05610) after single and multiple dosing (4.4 mg as tablet, tau = 12 h) were investigated in 14 volunteers (6 female, 8 male) older than 65 years (70 +/- 5 years, mean +/- SD). The medication was administered as tablets in the morning of days 1 and 11, and b.i.d. on days 4 to 10 in a randomized, open-labelled, uncontrolled study. Tolerance proved to be very good. Reported number of adverse events was independent from height of plasma levels measured, which showed pronounced inter- and intraindividual variation. When comparing pharmacokinetic parameters from plasma levels (determined with a radioimmunoassay (RIA)) of the elderly with those of young volunteers (26 +/- 5 years), there is a difference in half lives (t1/2 elderly vs young: single dose: 38.5 +/- 15.3 h vs 25.0 +/- 5.2 h; multiple dose: 35.5 +/- 16.3 h vs 55.4 +/- 24.9 h), and also after a single dose AUC and after multiple dosing AUCss tau, tssmax, Cssmax, Cssmin (pre dose levels), and the ratios of accumulation Rmax and Rmin (calculated from Cssmax/Cmax and Cssmin/Cmin) are approximately twice as high in elderly as those in young volunteers. The RIA co-detects besides azelastine the pharmacodynamically active metabolite N-demethyl-azelastine and thus, the parameters describe the pharmacokinetic behaviour as a resultant from both compounds, i.e. the "active principle". N-Demethylated metabolites are known to have longer half-lives usually than their parent compounds and thus, accumulate in a higher degree during multiple dosing.(ABSTRACT TRUNCATED AT 250 WORDS)

Tolerability, pharmacokinetics and dose linearity of azelastine hydrochloride in healthy subjects.

In a double-blind, randomized, 4-period crossover study, single oral doses of azelastine hydrochloride tablets (A-05610, Allergodil, Radethazin, Azeptin, CAS 79307-93-0) were ingested by 12 healthy volunteers (6 males, 6 females, mean age 25.2 +/- 3.5 years). Dose linearity was demonstrated for 2.2, 4.4, 8.8 and 17.6 mg of azelastine hydrochloride. The values of AUC0-infinity and Cmax increased linear to the dose (means of AUC0-infinity: 47.3, 93.7, 208.0 and 405.90 ng-eq h/ml; means of Cmax: 1.5, 3.3, 6.0 and 12.5 ng-eq/ml), whereas tmax and the terminal half-life of elimination (t1/2 beta) were obviously not influenced by the dose. Mean values over all doses and subjects amounted to 4.6 h (tmax) and 25.5 h (t1/2 beta). Plasma levels showed relatively high inter- and somewhat less intraindividual variations. This is most likely due to a varying degree of enterohepatic circulation resulting from alimentary factors. As for the co-detection of azelastine and the pharmacodynamically active metabolite N-desmethyl-azelastine by the radio-immuno-assay (RIA) used, the parameters describe the pharmacokinetic behaviour as a resultant from both compounds and thus the active principle of the drug. Independently of the dosages administered the overall tolerance proved to be very good. According to this trial the therapeutic range is wide enough to recommend 4.4 mg b.i.d. or single doses of 8.8 mg of azelastine hydrochloride per day for therapy in adult patients.