New data suggests that it would be effective and safe in the long term for non -alcoholic steatosis in patients with type 2 diabetes. The effect of other antidiabetics for this frequent comorbidity for which there is no specific therapy is investigated.
Non -alcoholic hepatic steatosis (EHNA) is a frequent comorbidity of type 2 diabetes that lacks specific treatment.Although previous studies had already pointed out that the antidiabetic Pioglitazona would have beneficial effects in the liver, now, a new essay, published at the end of June in Annals of Internal Medicine, reveals that it would be effective and safe in the long term.
Between 50 and 75 percent of type 2 diabetics would present Enha, points to CF José Javier Mediavilla, coordinator of the Diabetes Group of the Spanish Society of Primary Care Physicians (Semergen).It describes the ENHA as "the liver manifestation of metabolic syndrome", characterized by the high intrahepatic triglycerides that relates, in turn, with insulin resistance.
Along with the diet
Researchers at the Medical Center for Veterans Affairs in San Antonio (Texas, United States) recruited 101 patients to whom a hypocaloric diet was prescribed and divided into two groups to receive pioglitazone (45 mg/day) or a placebo.At 18 months, 58 percent of the active treatment group reached the primary objective (reduction of at least two points in the NAS of Steatosis without worsening of fibrosis) and in 51 the ENHA was resolved.In the 34 patients who continued the antidiabetic another 18 months (see table), the percentages were higher (68 and 59) and maintained for 36 months.
The therapy was associated with improvements in histological and metabolic markers, among others, the sensitivity to insulin and the liver content of triglycerides, but also with an increase in the weight of 2.5 kg.
The vice president of the Spanish Diabetes Society (SED), Antonio Pérez Pérez, highlights that although the results on efficacy were "predictable", they are "surprising in terms of the degree of efficacy" and could place the pioglitazone in the second line after metforminin patients with both comorbidities.
Mediavilla agrees that this study reinforces the indication of the pioglitazone as "drug and enha choice". This drug "acts by increasing insulin sensitivity and, both in people with diabetes and non -diabetics, improves levels oftransaminases, steatosis and steatohepatitis ”.
Although Juan Cavalía, CIBER Teaching Coordinator of Hepatic and Digestive Diseases (CIBEREHD), and researcher Ricardo García-Mayor, of the Galicia Sur Biomedical Foundation, highlight the interest of the study, indicate their limitations, such as the one that will be carried out in aUnique center or the number of participants.To this is added that the subjects of the essays are "most of the time, very different from those of daily practice," says García-Mayor.
In addition, alert, the increase in diabetic weight is not less.This medicine, which has been associated with heart failure and fractures, was again related to bladder cancer in March in a study appeared in The British Medical Journal, although other investigations have not found this link.
"Infrautilized drug"
For Pérez Pérez, this drug, approved fifteen years ago, "is clearly underutilized as a result of undervaluation of its effectiveness and the perception of excessive risk."He points out that together with these new data in ENHA, there are new evidence of their role in the prevention of cardiovascular events and stroke that they understand "will modify clinical practice as regards the selection of hypoglycemic treatment in patients with type 2 diabetes."
Thus, in FebruaryThey appeared in The New England Journal of Medicine (NEJM) results of the IRIS trial in secondary prevention in patients with insulin resistance but without frank diabetes that had suffered a stroke, which showed that it reduced the recurrence of cerebrovascular disease and the incidence of infarction ofMyocardium
As for a possible indication in non -diabetics, Cavalry states that the Pivens essay, published in Nejm in 2010, showed “a beneficial effect on reducing insulin resistance, in biochemical parameters and histological injuries”.The benefits were similar to those shown in the study of vitamin E and, again, the adverse "most remarkable" effect was weight gain.
Returning to diabetes, cavalry points out that it is investigated, in phase II and III tests, the effect on the ENHA of analogous antidiabetics of LPG-1 and DPP-4 inhibitors."The advisable pattern for the treatment of diabetes and EHNA will depend on these studies."