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Rogoz A1, Kucia K1, Skowron M1, Rys P1, Siejka S1, Palka I1, Gierczyński J2, Plisko R1, Wladysiuk M1 A study conducted by HTA Consulting
Health Care Decision Making in Europe: From Patients to Populations 1 – HTA Consulting, Poland, 2 – SanoÞ -Aventis, Poland
24-27 October 2009, Le Palais des Congrès de Paris, Paris, France Objective
The aim of this analysis was to compare efÞ cacy and safety of insulin Effi cacy
glargine (IGlar) when added to oral antidiabetic drugs (OADs) with pre-mixed human insulin alone in type 2 diabetes mellitus (T2DM).
HbA1c and FPG level
No statistically signiÞ cant differences were found in the percentage of patients experiencing any hypoglycaemic episodes: RR=0.90 [0.78; Pooled data for HbA1c demonstrated a lower level in the IGlar group 1.04]. The number of hypoglycemic episodes per patient per month than in the premixed insulin group (WMD = -0.33% [-0.50; -0.16]). In was signiÞ cantly lower in the IGlar group as compared with the premi- Introduction
addition meta-analysis for FPG level also revealed statistically signiÞ - xed insulin group (0.3 vs 0.8; p<0.001). The number of nocturnal hypo- cant differences in favour of IGlar (WMD = -0.87 mmol/l [-1,.21; -0.53]). glycemic episodes per patient per month was signiÞ cantly lower in the No statistically signiÞ cant heterogeneity between the studies was found Diabetes mellitus comprises a group of common metabolic disorders IGlar group as compared with the premixed insulin group (0.04 vs 0.09; characterized by elevated blood glucose level. Type 2 diabetes mellitus p=0.0449). Severe hypoglycaemia was investigated in one study but is a chronic condition in which insulin is produced but not utilized pro- perly. Without adequate control of blood glucose, the disease leads to vascular and non-vascular complications. The prevalence of all types Figure 1. Weighted mean difference in the HbA1c level
Figure 3. Relative risk of occurrence of a hypoglycaemic episode
of diabetes worldwide estimated by the WHO for the year 2000 was Summary meta-analysis plot [fixed effects] Relative risk meta-analysis plot (fixed effects) Insulin glargine (Lantus®) is a long-acting human insulin analogue, produced using recombinant DNA technology in E. coli K12 strain. In T2DM, when a combination of 2 or 3 OADs becomes ineffective, it is possible to introduce a basal + OADs treatment regimen or therapy with premixed insulin. In a basal + OADs regimen patients receive ba-sal insulin added to oral medications (except glitazones). Basal insulin is administered once daily (in the evening if morning hypoglycaemia is observed or in the morning in the case of normoglycaemia), while du-ring the day the patient receives oral medications.
Premixed insulin is a mixture of a rapid-acting insulin analogue with protamin suspension of this analogue or a mixture of a short-acting hu- man insulin with an intermediate-acting human isophane insulin. Usu- * difference (95% confidence interval) relative risk (95% confidence interval) ally mixtures are administered twice daily, although other dosage regi-mens are used.
Figure 2. Weighted mean difference in the FPG level
Table3. Summary of the results of comparison of effi cacy of insulin glargine
vs premixed insulin – continuous outcomes
Summary meta-analysis plot [fixed effects] Methodology
The comparison was based on randomized controlled trials (RCTs) identiÞ ed by means of a systematic review, carried out according to the Cochrane Collaboration and the Agency for Health Technology As-sessment in Poland guidelines. The most important medical databases (EMBASE, MEDLINE and CENTRAL) were searched in October 2008. Two reviewers independently selected trials, assessed their quality and extracted data. Meta-analysis of head-to-head trials was performed in order to compare IGlar added to OADs with premixed insulin alone (without OADs).
Table 1. Inclusion and exclusion criteria
* difference (95% confidence interval) Insulin glargine when added to oral antidiabetic agents Premixed human insulin alone (without OADs) Target HbA1c and FPG levels
More patients in the IGlar group achieved HbA1c ≤7%, although the Studies published in English, French or German difference was on the border of statistical signiÞ cance (RB=1.26 [1.00; 1.59]). The proportion of patients achieving a FPG level ≤ 5.6 mmol/l was higher in the IGlar group and the difference was statistically signiÞ - Studies, in which oral antidiabetic agents were not added cant (RB=2.11 [1.41; 3.17], NNT= 6.00 [3.97; 12.32]).
to insulin glargine or studies where OADs were admini- Weight gain
Weight gain was observed in both groups with no statistically signiÞ - cant differences between them (MD= -0.70 kg [-1.48; 0.08]).
Characeristics of clinical trials
The search in medical databases resulted in a total number of 2,289 Treatment satisfaction
identiÞ ed publications (including repeated titles). Finally 3 trials met the In one identiÞ ed study there was no statistically signiÞ cant difference inclusion criteria and were qualiÞ ed for further analysis. All included between treatment groups in the treatment satisfaction measured using studies had parallel design and their methodological credibility was as- Selection process according to QUOROM
Table 4. Abbreviations
Diabetes Treatment Satisfaction Questionnaire positions rejected after full text analysis • additional publication to included study – 5 Conclusions
Table 2. Qualifi ed trials
IGlar combined with OADs is associated with better gly- cemic control than premixed human insulin alone. The risk of hypoglycaemia or weight gain is comparable be-tween both arms.
We found only 3 studies which met the inclusion criteria. In all of them surrogate endpoints were assessed. There were no trials with clinically important endpoints, such as mortality or morbidity.



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