New Diabetes Drug Expected This Week
How Invokana Works continued...
But, he says, he does not predict it will be the first drug doctors turn to when medication is needed to treat type 2 diabetes.
If lifestyle changes like diet, exercise, and weight loss don't control blood sugar enough, metformin is recommended first, says Richard Siegel, MD. That was spelled out in the 2012 American College of Physician treatment guidelines. Siegel is co-director of the Outpatient Diabetes Center at Tufts Medical Center and is an associate professor of medicine at the university's school of medicine in Boston.
Controlling blood sugar can lower the risk of complications such as heart disease, eye disease, and kidney and nerve problems.
What Studies Found: Invokana
In one of the Invokana studies, patients took the drug by itself. Other studies looked at results of the drug when used with other drugs, such as metformin.
A similar number of patients got their levels of A1c -- a test that measures blood sugar control -- down to the target of less than 7% whether they used Invokana alone or with metformin (45% and 46%, respectively, over a 26-week period). The same was true for how much weight they lost. People taking Invokana alone lost 8.5 pounds over 26 weeks, while those taking both drugs lost a little more than 9 pounds in the same time period.
Invokana worked better, the company says, in lowering weight and levels of A1c than the drugs sitagliptin (Januvia) or glimepiride (Amaryl).
Other side effects of Invokana include kidney problems, too much potassium in the blood, low blood sugar, and fainting.
Having more sugar in urine can be a problem, says Cypess, sometimes leading to urinary tract infections and yeast infections.
"It will make people go to the bathroom more often," McCall says. That could be a problem, he says, for men with an enlarged prostate (who already need to urinate frequently) or women with incontinence.
When the FDA approved Invokana, it asked Janssen to conduct post-marketing research on several areas, including any effects on the heart, pancreas, liver, and bones.
Last year, a similar drug, Forxiga (dapagliflozin), was turned down by the FDA. The agency cited concerns about breast and bladder cancer risk, among others. The drug was approved in Europe.
However, another benefit, possible weight loss, would be welcomed by many patients, McCall says. "You mention weight loss as a side effect of diabetes drugs and people perk up."