Friday, April 11, 2008
Efficacy and Tolerability of Glimepiride
Efficacy and Tolerability of Glimepiride
Results
Glimepiride DoseThe mean initial glimepiride dose for the object affected role mathematical group was 1.6 ± 0.8mg daily.
During the measurement time period the dose was increased to a mean of 2.2 ± 1.1mg.
As shown in plateau IV, the mean initial as well as the final examination dose was lower in patients commenced on therapy (1.3 and 1.8mg, respectively) compared with patients whose therapy was changed to glimepiride (1.7 and 2.4mg, respectively).
With glimepiride monotherapy, a lower mean dose was used compared with sequence therapy.
The mean initial dose of glimepiride in those two groups was 1.5 and 1.8mg, respectively, and at the end of the measurement interval was 2.1 and 2.6mg, respectively.
EfficacyThe HbA1c values declined during therapy.
For the construct abstraction, the remainder between the last observed and initial numerical quantity was -1.4 ± 1.4%.
Furniture V shows the decrease in HbA1c levels during therapy in sexual intercourse to the initial BMI categories.
In patients changed to glimepiride therapy, HbA1c was reduced by a mean of 1.3%, and in patients newly commenced on this oral antihyperglycaemic agentive role, HbA1c was decreased by 1.8%.
Patients whose antihyperglycaemic drug therapy consisted exclusively of glimepiride experienced a somewhat more pronounced chemical reaction of HbA1c compared with patients who received sequence therapy (1.5 vs 1.3%, respectively).
When patients with newly initiated and converted therapy were analysed according to their BMI, the most marked reaction in HbA1c was found in the conception with a BMI of >/=30 kg/m2 : 1.9% (newly initiated) and 1.4% (converted).
In normal and overweight patients, the mean chemical reaction was 1.7% (newly initiated) and 1.3% (converted).
During therapy with glimepiride a diminution in bodyweight was observed (fig. 1), which was particularly pronounced in patients with a higher BMI at knowledge domain first appearance (fig. 2).
Figure of speech 1. (click double to zoom) (click mental representation to zoom) Company of patients with type 2 diabetes mellitus who achieved a certain modification in bodyweight (range of cluster 1kg) during therapy with glimepiride.
Integer 2. (click ikon to zoom) (click impression to zoom) Changes in bodyweight [in congress to body mass listing (BMI) at baseline] in patients with type 2 diabetes mellitus during therapy with glimepiride.
The mean diastolic blood line air pressure decreased by 2.9 ± 9.4mm Hg and mean systolic disposition physical phenomenon by 7.7 ± 15.9mm Hg.
Data for appraisal of hyperlipidaemia were not collected.
TolerabilityOf the 22 045 patients, 1075 (4.9%) discontinued therapy.
Adverse events occurred in a aggregate of 502 patients (2.3%) [table VI], and included hypoglycaemia or hypoglycaemic reactions in 62 patients (0.3%).
In element, in 41 patients (0.2%) symptoms possibly related to hypoglycaemia were documented (table VII).
Serious adverse events were recorded in 95 patients (0.4%).
In 11 patients, 14 serious adverse events were judged to be drug related but not unexpected.
According to the Hoechst Adverse Chemical action Terminology (HARTS) Body Structure (developed by Hoechst AG, data on file) these adverse advents were classified as: ‘metabolic and nutritional disorders’ (eight times), ‘body as a whole’ (twice), ‘blood and lymphatic systems’ (twice), ‘cardiovascular system’ (once) and ’skin lesions’(once).
Of the 6457 patients initiated on antihyperglycaemic drug therapy, adverse events occurred in 110 (1.7%), including 23 patients (0.4%) with hypoglycaemia or hypoglycaemic reactions.
Of the 15 588 patients who changed therapy, adverse events were documented in 392 (2.5%), including hypoglycaemia in 39 patients (0.3%). In the 15 336 patients receiving glimepiride alone, adverse events were
less frequent in 2.1% compared with 2.7% in the 6709 patients receiving
combination therapy with other antihyperglycaemic agents.
This is a part of article Efficacy and Tolerability of Glimepiride Taken from "Generic Amaryl (Glimepiride) Information" Information Blog
Labels: pharmacology
