2,46 Mb - GuíaSalud

Slow-acting insulin analogues vs. NPH insulin
There are three SRs (151-153) and a report from a Canadian agency with an SR
and a meta-analysis (154) which have assessed the effectiveness and safety of the
different types of insulin. Three of them assess insulins glargine and detemir in
comparison to NPH insulin, while the third type (152), funded by the manufacturer,
aims to assess only the hypoglycaemia events of insulin glargine.
The studies included in the reviews compare single night insulin glargine
doses in contrast to one or two doses of NPH insulin, while the comparison of
insulin detemir in contrast to NPH insulin is with one or two doses of both. The
duration of the studies is limited in time (24-52 weeks), which makes it difficult to
detect differences in variables such as micro- and macroangiopathy. The variables
assessed are glycemic control measured as glycosylated haemoglobin values and
the hypoglycaemias as safety variables. The latter are assessed as total night and
severe hypoglycaemias without any standardization of their definition and their
recording. In some studies, these are referred by the patients themselves, without
masking of the treatment received.
There are no differences in glycemic control between insulin glargine or
detemir in contrast to NPH insulin. There are no differences either between the
number of severe hypoglycaemias, though there is in the total number of hypoglycaemias,
especially at the expense of night hypoglycaemias, which are less than
with analogues. The number of severe hypoglycaemias is seldom found in the
RCTs included in the SRs.
Appendix 3 describes the guidelines to begin the insulinization process and
the use of hypoglycaemic drugs. Appendix 4 records the hypoglycaemia treatment.
SR of RCT
1+
Evidence summary
1+ The combination of single night dose NPH insulin associated with an oral anti-diabetic
drug provides glycemic control comparable to monotherapy with insulin every 12 hours
or on a multiple schedule (144).
1+ In comparison with the insulin monotherapy, the combination of metformin with insulin
improves glycemic control (reduction of HbA 1
c) with less weight gain (145-147). The
results on the frequency of hypoglycaemias are contradictory (144-146; 148), though
a higher incidence has been proved as the treatment intensifies. There are no data on
morbimortality.
1+ The studies which compare the different insulins are not designed to show differences in
micro- and macrovascular complications and they do not provide data on quality of life
or patients’ preferences (151-154).
1+ There are no significant differences as regards glycemic control assessed by means of
glycosylated haemoglobin between the slow-acting insulin analogues and NPH insulin.
Slow acting insulin analogues are associated with a lower risk of hypoglycaemias at the
expense of the reduction of night hypoglycaemias (151-154).
72 CLINICAL PRACTICE GUIDELINES IN THE NHS