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Some doctors are raising questions about the ethics of clinical trials that were used to show that the side effects of Jardiance, a new-generation diabetes drug, lowered the risk of heart attacks.
At issue is whether it is right to give patients suffering from type 2 diabetes a placebo pill when they should be getting medical treatment for a disease that can cause heart failure and other health problem, according to an editorial published on Monday in the medical journal Circulation.
The authors, Drs. Javed Butler and Stefan Anker, of Stony Brook University’s Cardiology Division, note that a number of randomized clinical trials have begun enrolling patients to assess further heart benefits of Jardiance and similar diabetes drugs, known as socium glucose cotransporter-2 (SGLT) inhibitors. The class also includes Invokana, Invokamet, Farxiga and Xigduo.
Attention was brought to the potential heart benefits of SGLT-2 inhibitors in August 2015, when Eli Lilly and Boehringer Ingelheim announced the findings of a clinical trial which appear to show that Jardiance (empagliflozin) use can reduce the risk of cardiovascular death, non-fatal heart attacks and strokes.
The FDA added the indication to the label, and since then, competing drug makers have put together clinical trials to hopefully show that their diabetes drug has the same benefits.
The problem now, according to the editorial, is that individuals participating in the study, who believe they are taking Jardiance or a similar drug as part of a clinical trial, may be just taking a placebo and not getting the other benefits of controlling their diabetes.
“While encouraging for the treatment of diabetes mellitus, these data have also raised concerns about whether patients with comorbid diabetes mellitus and heart failure, who may be perceived as fulfilling the new US Food and Drug Administration indication for the use of empagliflozin in patients with diabetes mellitus with established cardiovascular disease, can be ethically randomized to the placebo arm in future trials testing these agents in such patients,” they wrote. “The type of outcomes that improved in this trial included adverse events commonly seen in heart failure patients, ie, heart failure hospitalizations, heart failure death, and sudden cardiac death. Thus, randomizing such patients to the placebo arm with these existing data and the new US Food and Drug Administration indication has raised understandable concerns.”
Researchers noted that the trials and development of these drugs have too much life-saving potential to ignore, and determined that it is still ethically justified to conduct the clinical trials, but said trial subjects and all parties involved have to be better informed about the risks. The doctors called for new communications strategies that are more robust than typically used during a traditional phase III drug trial.
SGLT-2 Inhibitor Health Concerns
The editorial comes at a time when Jardiance, Invokana and similar drugs are also under much closer scrutiny due to concerns over diabetic ketoacidosis, kidney failure and amputation risk reports.
In December 2015, diabetic ketoacidosis warnings were added to Jardiance, Invokana and other SGLT2 inhibitors, indicating for the first time that users may face of risk of developing this serious condition.
Prior warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting, which is critical for avoiding serious complications from diabetic ketoacidosis.
Concerns about a potential link between SGLT-2 inhibitors and kidney failure have also emerged since the drug hit the market. In June 2016, the FDA required that new information be added to the drug label about the risk of acute kidney injury and other kidney issues.
In May 2017, FDA required a warning update about the Invokana amputation risks, placing information about the increased incidence of leg, foot and toe amputations in a prominent black box on the label, which is one of the strongest warnings the agency can require a prescription medication to carry.
A growing number of lawyers are now reviewing potential Jardiance lawsuits, as well as Invokana lawsuits, Farxiga lawsuits and claims involving other members of the class, for individuals hospitalized due to ketoacidosis.
Plaintiffs claim that the drug makers failed to adequately research the potential side effects before aggressively marketing the new generation diabetes treatments.