The FDA recently approved three new drugs, meant to supplement diet and exercise modification as additional type-2 diabetes treatments. Designed to stabilize blood sugar, the drugs contain a new active ingredient called alogliptin, which spurs insulin release post-meal. According to the Journal of Diabetes Science and Technology, diabetes treatments became the lead source of increased prescription-drug spending in 2007.
All three were studied alone and also combined with type-2 therapies including insulin and sulfonylureas, and the FDA is mandating additional post-market studies. In 2008, the agency established more stringent cardio-safety standards for diabetes drugs after concerns surfaced about certain drugs, including Avandia, which was found to increase heart-attack risk, reported the AP. Alas, let’s compare.
*Demonstrated as safe and effective in 14 clinical trials involving about 8,500 type-2 diabetes patients
*Resulted in HbA1c reductions of 0.4 to 0.6 percent compared with placebo after 26 weeks
*FDA is requiring five post-marketing studies including a cardiovascular outcomes trial; monitoring of liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA)
*Most common side effects: stuffy or runny nose, headache, and upper respiratory tract infection
Kazano (alogliptin and metformin hydrochloride):
*Demonstrated as safe in four clinical trials involving more than 2,500 type-2 diabetes patients
*Resulted in additional HbA1c reductions of 1.1 percent over Nesina and 0.5 percent over Metformin after 26 weeks
* FDA is requiring two post-marketing studies including monitoring of liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study under PREA
**Carries a Boxed Warning for lactic acidosis, lactic acid build-up in the bloodstream
*Most common side effects: upper respiratory tract infection, stuffy or runny nose, sore throat, diarrhea, headache, high blood pressure, back pain, and urinary tract infection
Oseni (alogliptin and pioglitazone):
*Demonstrated as safe and effective in four clinical trials involving more than 1,500 type-2 diabetes patients
*Resulted in additional HbA1c reductions of 0.4 to 0.6 percent over Pioglitazone and 0.4 to 0.9 percent over Alogliptin
*FDA is requiring one post-marketing study: monitoring of liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions
**Carries a Boxed Warning for heart failure associated with Pioglitazone use
*Most common side effects include: stuffy or runny nose, sore throat, back pain, and upper respiratory infection
If you’re curious about how these drugs might affect current treatment, consult your doctor. Seeing as these are new-to-market, and still being studied post-approval regarding potential serious side effects, you might strongly consider waiting until a better understanding of long-term usage emerges before taking. Remember, Dears, exercise and diet changes are cost- and side-effect free, so attempt that route first.
Are you happy with Your diabetes drug?