Some people will not take "yes" for an answer....
The results of the RECORD study would seem to vindicate the use of Avandia as a treatment option for diabetes patients seeking to maintain glycemic control and reduce the risk of death from cardiovascular disease....
RECORD: No overall increase in CV risk with rosiglitazone
American Diabetes Association's 69th Scientific Sessions
Rosiglitazone was not associated with an increased risk for overall cardiovascular morbidity or mortality compared with standard glucose-lowering therapies, according to the final analysis data of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study.
At 5.5 years, the primary outcome – first occurrence of CV death or hospitalization – was equivalent (14.5%) in patients assigned to rosiglitazone (Avandia, GlaxoSmithKline) or metformin and sulfonylurea, according to Philip D. Home, DM, DPhil, chairman of the RECORD Steering Committee and professor of diabetes medicine at Newcastle University, UK. The researchers reported 321 events among patients assigned rosiglitazone as add-on therapy and 323 events among patients assigned metformin or sulfonylurea only (HR=0.99; 95% CI, 0.85-1.16).
“Overall, in CV terms, the drug is safe. Would rosiglitazone meet current FDA criteria as a safe drug in diabetes? The answer to that is yes,” Home said during a press conference on Friday.
The RECORD study was designed to evaluate the long-term effect of rosiglitazone on CV outcomes and blood glucose control compared with metformin and sulfonylureas. The open-label study was conducted at 338 centers in 23 countries in Europe, Australia and New Zealand. The researchers randomly assigned 4,447 patients with type 2 diabetes who were already on metformin or sulfonylurea monotherapy to either add-on rosiglitazone (n=2,220) or a combination of metformin and sulfonylurea (n=2,227). All doses were progressively increased toward achieving and maintaining a target HbA1c of <7%. If HbA1c rose to 8.5% or more, either a third oral glucose-lowering drug was added (for rosiglitazone group) or insulin was started (for active control group).
Click here to read the full article.
So How do we explain this headline?
RECORD results: rosiglitazone doubles risk of heart failure, fractures
The much-anticipated results of the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial seem destined to become yet another element in the agent’s controversial history.
Although rosiglitazone did not increase overall cardiovascular hospitalizations or deaths compared with metformin and sulfonylurea, the risk of heart failure doubled among patients taking rosiglitazone, and there were increased heart failure deaths, reports Philip D. Home, DM, chairman of the RECORD steering committee and Professor of Diabetes Medicine, Newcastle University, UK (pictured above).
And another point. Steve Nissen admitted, in the face of the RECORD evidence, that his initial meta-analysis might be inaccurate…
There were too few incidences of myocardial infarction and MI death among RECORD patients to detect a significant association with rosiglitazone. "I agree with the authors," says Steven Nissen, MD, chairman, Department of Cardiovascular Medicine, Cleveland Clinic. "The results of RECORD are inconclusive with respect to the effects of the drug on the risk of heart attack."
Dr. Nissen points out, however, that in the subgroup of RECORD patients with preexisting heart disease, there was a 26% increase (p=0.055) in MI.
Click here to read the full article.
I should point out, however, that Nissen’s meta-analysis swept everyone who used Avandia into his data pool to get his increase of risk (43 percent). Of course 26 percent is less than 43 percent.
Meanwhile, what havoc and public health impact was caused by the fearmongering…?
The results of the RECORD study would seem to vindicate the use of Avandia as a treatment option for diabetes patients seeking to maintain glycemic control and reduce the risk of death from cardiovascular disease....
RECORD: No overall increase in CV risk with rosiglitazone
Adverse findings include increased risk for fracture in women, heart failure
Posted on June 6, 2009
American Diabetes Association's 69th Scientific SessionsRosiglitazone was not associated with an increased risk for overall cardiovascular morbidity or mortality compared with standard glucose-lowering therapies, according to the final analysis data of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study.
At 5.5 years, the primary outcome – first occurrence of CV death or hospitalization – was equivalent (14.5%) in patients assigned to rosiglitazone (Avandia, GlaxoSmithKline) or metformin and sulfonylurea, according to Philip D. Home, DM, DPhil, chairman of the RECORD Steering Committee and professor of diabetes medicine at Newcastle University, UK. The researchers reported 321 events among patients assigned rosiglitazone as add-on therapy and 323 events among patients assigned metformin or sulfonylurea only (HR=0.99; 95% CI, 0.85-1.16).
“Overall, in CV terms, the drug is safe. Would rosiglitazone meet current FDA criteria as a safe drug in diabetes? The answer to that is yes,” Home said during a press conference on Friday.
The RECORD study was designed to evaluate the long-term effect of rosiglitazone on CV outcomes and blood glucose control compared with metformin and sulfonylureas. The open-label study was conducted at 338 centers in 23 countries in Europe, Australia and New Zealand. The researchers randomly assigned 4,447 patients with type 2 diabetes who were already on metformin or sulfonylurea monotherapy to either add-on rosiglitazone (n=2,220) or a combination of metformin and sulfonylurea (n=2,227). All doses were progressively increased toward achieving and maintaining a target HbA1c of <7%. If HbA1c rose to 8.5% or more, either a third oral glucose-lowering drug was added (for rosiglitazone group) or insulin was started (for active control group).
Click here to read the full article.
So How do we explain this headline?
RECORD results: rosiglitazone doubles risk of heart failure, fractures
Publish date: Jun 6, 2009
By: Maude L. Campbell, Clinical Managing Editor
The much-anticipated results of the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial seem destined to become yet another element in the agent’s controversial history.Although rosiglitazone did not increase overall cardiovascular hospitalizations or deaths compared with metformin and sulfonylurea, the risk of heart failure doubled among patients taking rosiglitazone, and there were increased heart failure deaths, reports Philip D. Home, DM, chairman of the RECORD steering committee and Professor of Diabetes Medicine, Newcastle University, UK (pictured above).And another point. Steve Nissen admitted, in the face of the RECORD evidence, that his initial meta-analysis might be inaccurate…
There were too few incidences of myocardial infarction and MI death among RECORD patients to detect a significant association with rosiglitazone. "I agree with the authors," says Steven Nissen, MD, chairman, Department of Cardiovascular Medicine, Cleveland Clinic. "The results of RECORD are inconclusive with respect to the effects of the drug on the risk of heart attack."
Dr. Nissen points out, however, that in the subgroup of RECORD patients with preexisting heart disease, there was a 26% increase (p=0.055) in MI.
Click here to read the full article.
I should point out, however, that Nissen’s meta-analysis swept everyone who used Avandia into his data pool to get his increase of risk (43 percent). Of course 26 percent is less than 43 percent.
Meanwhile, what havoc and public health impact was caused by the fearmongering…?
