Two existing drugs have recently been given FDA approval for new uses: One targets prostate enlargement, and the other is a combination diabetes and statin drug that is projected to prevent a wide range of complications commonly associated with diabetes, including cardiovascular disease (CVD).
The drug tadalafil (Lilly's Cialis), which is currently used to treat erectile dysfunction, has also gained FDA approval for the treatment of benign prostatic hyperplasia (BPH), a type of prostate enlargement. The agency's decision follows on the heels of two clinical trials that illustrated significant reductions in prostate enlargement symptoms among men who took 5 mg of tadalafil once daily.
Additionally, the FDA also approved a new combination drug for patients with type 2 diabetes. Called Juvisync, Merck's new combination therapy exploits the benefits of its previously approved blood sugar-lowering diabetes drug Januvia (sitagliptin) with simvastatin (Zocor), a statin long in use that helps lower levels of cholesterol, especially the "bad" LDL. This is the first drug to pair a diabetes treatment with a statin in one pill.
Considering that the American Diabetes Association recommends statin therapy for diabetics with a history of CVD, or for those who are over 40 years of age and show any CVD risk factors, Juvisync should reduce cardiovascular risks among diabetics. ACSH's Dr. Gilbert Ross is encouraged by the new combination therapy, adding, "While neither of these two drugs is new, the combination aimed at two different risk factors for CVD offers more convenience to diabetics, and thus should increase compliance. However, expense could be a negative factor. A Merck spokesperson asserted that nearly 40 percent of diabetics who should be taking statins are not, suggesting that increasing patients likelihood of taking this important preventive measure could provide significant benefits.