new YORK (Reuters Health) – type 2 diabetics
they could not control their levels of glucose with high doses
insulin improved levels of HbA1c and loss
sustained weight once they added dapagliflozina in one
recent proof.
however, the researchers reported in the journal
Annals of Internal Medicine patients had more
episodes of minor hypoglycemia.
The dapagliflozina selectively inhibits the cotransportador
proteins type 2, for increase urinary excretion of
glucose, according to Dr. John p. H. Wilding and his colleagues of the
University hospital Aintree in Liverpool, Great Britain.
808 Patients in 24 weeks testing had high
levels of glucose in the blood despite taking at least 30
Or daily insulin. The research team assigned to the
random 2.5, 5 or 10 mg of dapagliflozina once a day, or a
placebo.
After 24 weeks, the average HbA1c level fell
up 0.96% in groups of dapagliflozina in
comparison with a 0.39 percent fall in the Group of
placebo.
Specifically, differences in the changes of the HbA1c
among placebo patients and patients with 2.5, 5 and 10
mg/d of dapagliflozina was – 0.40 percent, – 0.49 by
percent, and – 0.57 percent respectively, the report said.
Body weight decreased with the dapagliflozina and increased
with placebo, with respective differences in changes of
weight in the three groups with dapagliflozina-1.35 kg, – 1.42
kg and – 2.04 kg compared with placebo groups.
In addition, the average daily dose of insulin decreased from
0.63 to 1.95 U with dapagliflozina, but increased in 5.65 or with the
placebo.
After a further 24 weeks of evidence,
the researchers found that these effects were maintained
48 weeks.
On the downside, the rate of hypoglycemia episodes
it was from 56.6 per cent in dapagliflozina groups
compared to a 51.8 percent in the placebo group, according to
the report.
In addition, the corresponding rates of probability of
urinary tract infection were 9.7 per cent
versus a 5.1 per cent, probably related to the increase
of treatment of dapagliflozina glycosuria.
“is reassuring to observe that these facts responded to
“
conventional therapy and rarely led to the withdrawal of the
“
studies”, commented Dr. Wilding and his colleagues.
The authors conclude that “these data suggest that the
“
dapagliflozina can offer a new treatment option
for patients undergoing treatment with insulin and
“
those with type 2 diabetes who are not checked adequately”.
In January, the food and Drug Administration (FDA
for its acronym in English) told AstraZeneca and Bristol-Myers
Squibb who wanted more data before approving the dapagliflozina.
At that time the manufacturers said that they remain committed
with the development of the drug.
This report also indicates that a test more of
52 weeks of extension is underway.
Source: Ann Intern Med online 19 March 2012