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With the launch of Actoplus met (Takeda Pharmaceuticals) on Oct. 24, it's going to be easier for patients to treat their Type 2 diabetes with just one tablet. Although Actos (pioglitazone) has been indicated for use in conjunction with metformin for some time, combination therapy has necessitated a prescription for each. As a pioglitazone/metformin combination, Actoplus met offers convenience, greater patient compliance, and perhaps an improvement in diabetes outcomes.
Most patients begin on monotherapy, but, as their disease progresses, they need additional medications to achieve adequate hemoglobin A1C (HgA1C) control. "We know that diabetic patients, three to five years after starting one diabetes medication, are on a second one." Often these patients are on other medications-for hypertension, dyslipidemia, and other conditions. "When you give patients multiple medications-say eight to 10 different types of medicines-their chances of taking them all is lower," noted Robert Spanheimer, M.D., director of diabetes & metabolism at Takeda.
The prevalence of patients taking a glitazone in combination with metformin is significant. In his practice setting at Wishard Memorial Hospital, Indianapolis, Craig Williams, Pharm.D., clinical associate professor at Purdue University's school of pharmacy, said, "I would conservatively say that 60%-70% of our patients on a glitazone are commonly on metformin ... and could get rid of at least a couple of pills a day [using the combination product]."
Combination therapy is generally used when primary therapy proves inadequate to glycemic control. However, the results of the PROspective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) study, presented at the recent European Association for the Study of Diabetes meeting in Athens, suggest that adding pioglitazone to "best care" tends to offer benefit beyond better glycemic control in very high risk patients. The patients treated with pioglitazone (plus "best care") demonstrated a 16% relative risk reduction in the time-to-first-occurrence of all-cause mortality, nonfatal myocardial infarction, and stroke, compared with "best care" without pioglitazone (p=0.027). The 5,000 patients evaluated over a four-year period had diabetes and had already experienced a cardiovascular event. Results from this study are consistent with evidence that shows that pioglitazone increases HDL levels, reduces triglycerides, and improves the LDL risk profile.
Used together, pioglitazone and metformin do not appear to have additive toxicities. However, each has its own precautions. Pioglitazone therapy should not be initiated in patients with serum transaminase levels exceeding 2.5 times the upper limits of normal. Metformin should not be initiated in patients with renal compromise (SrCr >1.5 mg/dL in men; >1.4 mg/dL in women; or abnormal creatinine clearance), nor in those older than 80 years old unless creatinine clearance is measured.
Actoplus met will be manufactured in two strengths: pioglitazone 15 mg/metformin 500 mg and pioglitazone 15 mg/metformin 850 mg.
THE AUTHOR is a medical writer based in Indiana.