New ARB evidence leaves experts in a pickle
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| Kaitlyn Dmyterko, Staff Writer |
Outlined this week by two different sources—the FDA and Lancet Oncology—the new evidence questions the use of these drugs after both showed that use of certain ARBs may up the ante on CV deaths among diabetics and cause cancer.
The meta-analysis in Lancet Oncology found that use of telmasartan (Micardis), losartan (Cozaar) and candesartan (Atacand) may modestly increase the rate of cancer in patients and significantly increase the risk of lung cancer by 25 percent.
Lead author of the analysis, Dr. Ilke Sipahi, said that while the risk of cancer increased, the rates of mortality and MI were no different. “These rates were completely equal to the dummy pill or active comparators. These findings could be an inconvenient truth,” said Sipahi, adding that an FDA review of the drugs is urgently needed.
However, on the other side of the argument, Dr. William B. White, president-elect of the American Society of Hypertension (ASH) said, “My practice is not going to change one bit because of this analysis.”
White said that because the absolute increase in cancer risk was not statistically meaningful, he does not think that this analysis “has proven by any means an increase in cancer,” and having patients stop ARBs because of this research would be unfortunate at the present time.
Additionally, the FDA announced that it is evaluating whether data from two long-term clinical trials—ROADMAP and ORIENT—have depicted a link between CV deaths and the use of olmesartan (Benicar) when administered to diabetics.
In response to the ongoing investigation, White said that it's too early to make assumptions about the findings, but called them “surprising.”
He said that ARBs and ACE inhibitors are popular treatments for diabetics as well as those with hypertension because they have been proven to prevent the need for dialysis or kidney transplant in patients who have kidney involvement.
In addition, he said these findings were “unexpected” because prior studies looking at the same class of drugs including losartan (RENAAL trial) and telmasartan (DETAIL trial) have shown that CV event rates were lower or similar to the control arm.
“The FDA needs to figure out if there was something different by chance between the patients who got the ARB and placebo or if there was something different about this ARB than other ARBs that led to increased CV events,” White concluded.
"Any doctor will admit that any drug can have side effects, and that writing a prescription involves weighing the potential benefits against the risks," said Sen. Mark Udall, D-Colo.
While the FDA has not yet issued any recommendations or warnings about stopping the usage of these ARBs, investigations to evaluate whether their benefits outweigh their harms are sure to cause debate in the clinical sense.
On these topics or others, please feel free to contact me.
Kaitlyn Dmyterko
Kdmyterko@cardiovascularbusiness.com