February 8, 2023

I’m peggy peck medpage today reporting from the american heart association scientific sessions in new orleans rosiglitazone a controversial type 2 diabetes drug failed to meet the primary endpoint in the long awaited approach ivis results as we hear hear thiazolidinediones of tz ds rosiglitazone and pioglitazone do things that one might think could affect the

Progression of coronary artery disease these include that they do improve glycemic control they they lower blood pressure a small degree usually two to three millimeters in most trials they are powerful anti-inflammatory drugs notably they produce a decrease in crp on the average of twenty to forty percent even on maximal statin therapies they have variable

Effects on the lipid profile there are small differences between the drugs mostly associated such that they they both raise hdl and lower triglycerides they both been shown to improve endothelial function and both of them in different trials of different sizes have been shown to reduce the progression of carotid imt in patients with and without diabetes tz ds may

Therefore reduce the progression of coronary atherosclerosis compared to other antidiabetic drugs this study was designed to assess the effect of rosiglitazone an insulin sensitizer versus clip aside an insulin secrete agog on intravascular ultrasound assessment of atherosclerosis and native coronary arteries the primary endpoint was a intravascular ultrasound

Endpoint and this was the change in percent atheroma volume there were two other major secondary endpoints of the to change in normalized total atheroma volume and also change in atheroma volume in the most disease 10 millimeter segments within the 40 millimeter segment that was analyzed in the non intervene vessel here is the primary endpoint it was obtained

In 462 of the patients are representing sixty-nine percent of the toe cohort for those patients having a clinical event such that they could not have the 18-month ivis those patients were assigned a percent after room of volume using a worse sensitivity worst ranked sensitivity analysis that is a conservative way to to assign a value in a patient that did not

Have the final ibis as you can see in the glipizide treatment arm there was an increase in percent atheroma volume from baseline of 0 point 10 point 4 3 this was not a statistically significant increase compared to baseline for those patients allocated to rosiglitazone there was a decrease in percent after oma volume of 0 point to one once again not statistically

Significant compared to baseline the treatment difference also was not statistically significant with a p-value of 0.12 with an overall delta difference in pa v of 0 point six four percent the approach trial leads to inevitable comparisons with a similar trial called periscope reported at the acc which i also was a co-investigator these trials have includes similar

Patients with diabetes there are some baseline differences in the two the trial design is very similar 18 month apart coronary ivis assessments the comparator drug treatment are both s use whether or not there’s difference between those two s as those two drugs as it relates to ivis measured progression is unclear nevertheless i presented the results on the left with

Approach and on just just to remind you in periscope there was an increase of point 73 in the blue member id treatment arm a decrease of 0.16 and he piled with his own arm and there was a statistically significant difference between the two so in summary compared to glipizide allocation of rosiglitazone led to a non significant reduction of the primary endpoint a

Percent atheroma fine that was not statistically significant there was a significant reduction in the secondary outcome of normalized total atheroma volume there was no statistically significant duction compared to glipizide in the secondary outcome of atheroma volume in the worst ten millimeter segment there was no significant differences in major cardiovascular

Events hypoglycemia was more frequent with glipizide and a decrease of hemoglobin of at least three grams per deciliter was greater in patients randomized to rosiglitazone in conclusion this study supports but does not prove the hypothesis that rosiglitazone has a greater anti-frizz karateka effect than glipizide in these patients pre-specified subgroup analyses

Which i’ll presented the abstract raised a hypothesis there rosiglitazone we have a graver greater anti a thorough sporadic effect in patients with more advanced diabetes ongoing analyses will evaluate which factors relate to changes in atherosclerosis as measured by ibis and discussion matrix rodriguez had this cautionary take the findings of this study need to be

Interpreted with caution these findings did suggest that rosiglitazone may be associated with a reduction in the total at the roma volume but again we need to be cautious with this interpretation there was a recent consensus statement on the management of type 2 diabetes from the american diabetes association and the european association for the study of diabetes

That was very recently published in diabetes care which indicated that although those previous meta analysis and research findings showing an increased risk of am i were not conclusive given that their various other options available for the treatment of type 2 diabetes this group advise against the use of rosiglitazone at this time until more with more research

Is conducted so to sum up these results are essentially the flip side of the periscope results but they don’t really advance the argument of which drug to use i’m peggy peck medpage today you

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AHA: Rosiglitazone Fails to Slow Plaque Progression By MedPage Today