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Dosing Recommendations (dosing + recommendation)

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Medical Sciences	100%

Selected Abstracts

Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups,

DIABETES OBESITY & METABOLISM, Issue 5 2006
M. Hompesch
Aim:, To evaluate the time-action profiles and the dose,response relationship of the long-acting insulin analogues insulin detemir (IDet) and NPH insulin (NPH) in type 2 diabetic patients belonging to different ethnic groups. Methods:, Forty-eight type 2 diabetic patients belonging to different ethnic groups (three groups of 16 African Americans (AA), 16 Hispanics/Latinos (HL) and 16 Caucasians) participated in this double-blind crossover trial. Each patient took part in six 16-h isoglycaemic glucose clamps (clamp target 7.2 mmol/l) and was randomly allocated to three doses (0.3, 0.6 and 1.2 (I)U/kg) of IDet and NPH, respectively. Results:, IDet and NPH showed comparable pharmacodynamic effects [the area under the glucose infusion rate curve (AUCGIR 0-16 h) (mg/kg)] in the investigated dose range: IDet, 0.3 U/kg, 207 AA, 535 HL, 285 Caucasians; 0.6 U/kg, 1203 AA, 824 HL and 1126 Caucasians; 1.2 U/kg, 1502 AA, 1977 HL and 2269 Caucasians; NPH, 0.3 IU/kg, 733 AA, 1148 HL and 1148 Caucasians; 0.6 IU/kg, 1395 AA, 1976 HL and 1077 Caucasians; 1.2 IU/kg, 2452 AA, 3296 HL and 2455 Caucasians. Both IDet and NPH showed a linear dose,response relationship in all three groups (p = 0.31), without any significant differences in slope (p = 0.71) or intercept (p = 0.51). Comparable results were obtained for pharmacokinetics. Conclusions:, These results confirm a linear dose,response relationship of IDet, without any relevant differences between ethnic groups. This suggests that similar dosing recommendation can be used for IDet in type 2 diabetic patients belonging to different ethnic group. [source]

FEIBA® safety profile in multiple modes of clinical and home-therapy application

HAEMOPHILIA, Issue 2004
H. Luu
Summary., The development of neutralizing antibodies to factor VIII or IX therapeutic concentrates remains the most serious and challenging complication in the management of patients with haemophilia A and B. FEIBA®, Anti-Inhibitor Coagulant Complex, is an activated prothrombin complex concentrate that has been used to treat patients with such complications for almost 30 years. The mechanism of action of FEIBA® has been proposed to involve simultaneous FVIII/FIX inhibitor bypassing action in the common, intrinsic and extrinsic coagulation pathways. FEIBA® is derived from human plasma that undergoes stringent viral screening followed by significant viral inactivation and removal. To date, there have been no confirmed reports of transmission of hepatitis A, B or C, or of human immunodeficiency viruses associated with the use of the current, vapour-heat-treated FEIBA® concentrate. The incidence of thrombotic adverse events recorded in the Baxter pharmacovigilance database for the 10-year postmarket period (1990,99) was approximately 4 : 100 000 infusions of FEIBA®. Almost all documented thrombotic events with FEIBA® occurred with doses that exceeded dosing recommendations, and known risk factors for cardiovascular disease were evident in more than 80% of the patients involved. Overall, clinical data have shown FEIBA® to be safe and well-tolerated for use in a wide variety of clinical settings, including treatment of bleeding episodes, management of surgical procedures, home therapy, long-term prophylaxis, and prophylaxis during immune tolerance induction, when used according to dosing guidelines. [source]

The relationship between dosing of alosetron and discontinuation patterns reported by patients participating in a follow-up programme

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2007
P. TENNIS
Summary Background Alosetron was reintroduced for treatment of irritable bowel syndrome with a risk management programme in November 2002. Recommended starting dosage was 1 mg/day for 4 weeks. If symptoms remained uncontrolled, dosage could be changed to 2 mg/day. Aim To describe alosetron dosages and associated patient characteristics from the Lotronex follow-up survey programme. Methods Patients reported dosages of alosetron at start and regular follow-up intervals. Analyses were limited to patients with the potential to have at least 1 year of follow-up (enrolled between 9 December 2002 and 31 December 2003). Results At baseline, 75% of 2817 respondents reported starting on 1 mg/day, 17% on 2 mg/day and 8% on other doses. Adherence to recommended starting dosage did not vary by status at end of follow-up, previous alosetron experience or age. At last reported dose, 50% of respondents were using 1 mg/day; 29% were using 2 mg/day. Discontinuation was not related to baseline doses. Longer times to discontinuation were associated with previous use, symptoms for more than 6 months and dose change throughout follow-up. Conclusions High adherence to recommended dosing at baseline and follow-up suggests that the risk management programme is encouraging safe use of alosetron, including adherence to dosing recommendations. [source]

Bioavailability of divalproex extended-release formulation relative to the divalproex delayed-release formulation

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 8 2004
Sandeep Dutta
Abstract Divalproex sodium extended-release tablet (divalproex-ER) is a novel formulation of the conventional divalproex sodium delayed-release tablet (divalproex). In five multiple-dose studies in healthy subjects (n=82) and epilepsy patients (n=86) the estimates of divalproex-ER/divalproex ratios for steady-state 24 h valproic acid area under the curve (AUC) central values, maximum concentration (Cmax) central values and minimum concentration (Cmin) means had ranges of 0.77,0.97, 0.71,0.87 and 0.78,1.03, respectively. These studies used different divalproex regimens (two, three or four times daily) and meal conditions (fasting, low, medium and high calorie meals). Divalproex-ER was administered once daily. A meta-analysis of divalproex-ER/divalproex relative bioavailability across five studies under different meal conditions and divalproex dosing frequencies was performed. This meta-estimate of relative bioavailability was used to provide dosing recommendations for conversion of patients from divalproex to divalproex-ER. The estimated AUC, Cmax and Cmin divalproex-ER/divalproex ratios (95% confidence interval) were 0.89 (0.85,0.94), 0.79 (0.74,0.84) and 0.96 (0.90,1.02), respectively. The food and divalproex regimen had no effect on the relative bioavailability. While switching from divalproex to divalproex-ER, the divalproex-ER daily dose may have to be increased by an average of 12% (calculated as 1.0/0.89) to achieve comparable plasma exposure. Since the divalproex-ER dosage strengths (250 and 500 mg) are not 12% higher than the divalproex dosage strengths (125, 250 and 500 mg), an 8% to 20% higher divalproex-ER daily dose should be considered for conversion from divalproex to divalproex-ER. Copyright © 2004 John Wiley & Sons, Ltd. [source]