Safety of once- daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice
Por:
Ross, S, Dzida, G, Ji, Q, Kaiser, M, Ligthelm, R, Meneghini, L, Nazeri, A, Orozco D, Pan, C, Svendsen, A and SOLVE Study Grp
Publicada:
1 may 2014
Categoría:
Endocrinology, Diabetes and Metabolism
Resumen:
BackgroundThe aim of the present study was to identify demographic and
treatment factors that were predictive of hypoglycemia in a large cohort
of type 2 diabetic patients initiating insulin detemir.
MethodsThe present 24-week observational study of insulin initiation
included 17374 participants from 10 countries. Severe hypoglycemia was
defined as an event requiring third party assistance; minor hypoglycemia
was defined as a daytime or nocturnal glucose measurement <3.1mmol/L.
ResultsPrior to initiating insulin therapy, 4.9% of the cohort reported
hypoglycemia (pre-insulin hypoglycemia), with most (94.2%) reporting
minor events and 9.6% reporting severe events. Compared with patients
without pre-insulin hypoglycemia, those with pre-insulin hypoglycemia
had a higher incidence of events of minor hypoglycemia (1.72 vs 4.46
events per patient-year [ppy], respectively), nocturnal hypoglycemia
(0.25 vs 1.09 events ppy, respectively), and severe hypoglycemia (<0.01
vs 0.04 events ppy, respectively) at final visit. Age (P<0.047), body
mass index (P<0.001), a prior history of microvascular disease
(P<0.001), pre-insulin hypoglycemia (P<0.001), increased number of oral
hypoglycemic agents (OHAs; P<0.001), OHA intensification (P<0.001), and
the use of glinides (P=0.004) were all found to be independently
associated with the occurrence of hypoglycemia during the study.
ConclusionsOnce-daily insulin detemir therapy was safe and effective,
and rates of hypoglycemia were low. Concerns about hypoglycemia should
not deter the initiation of basal insulin analogs.
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????????????????????????????2?????????????????????????????????
?????????24???????,??17374???10?????????????????????????????????????????
?????;??????????????????????? < 3.1 mmol/L?
????????????,????4.9%???????????(????????????????),???????(94.2%)?????
???????,?9.6%????????????????????????,????????????????????????,????????
????????????????????(???1.72?4.46???/??-?)????????(???0.25?1.09???/??-?)
?????????(???< 0.01?0.04???/???)?????????????????????????(P <
0.047)?????(P < 0.001)?????????(P < 0.001)?????????????????(P <
0.001)??????????(P < 0.001)??????????(P < 0.001)??????????(P =
0.004)?????????
????????????????????,????????????????????????????????
Filiaciones:
Ross, S:
Univ Calgary, Dept Med, Calgary, AB T2H 2G4, Canada
Dzida, G:
Med Univ Lublin, Dept Internal Dis, Lublin, Poland
Ji, Q:
Forth Mil Med Univ, Dept Endocrinol & Metab, Xijing Hosp, Xian, Peoples R China
Kaiser, M:
Practice Internal Med & Diabetol, Frankfurt, Germany
Ligthelm, R:
EHM Clin, Hoofddorp, Netherlands
Meneghini, L:
Univ Miami, Miller Sch Med, Miami, FL 33136 USA
Nazeri, A:
Novo Nordisk AS, Global Med Affairs, Soborg, Denmark
Orozco D:
Univ Miguel Hernandez, Dept Clin Med, Dept Med, Alicante, Spain
Pan, C:
Chinese Peoples Liberat Army Gen Hosp, Dept Endocrinol, Beijing, Peoples R China
Svendsen, A:
Novo Nordisk AS, Dept Biostat & Epidemiol, Soborg, Denmark
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