Actos® (pioglitazone) has been approved by the US FDA for therapy of
Type 2 diabetes.
Although it is unlikely that it will cause liver problems (see troglitazone),
there are statements about the
cardiovascular risks associated with the use of thiazolidinediones.
Actos (pioglitazone maleate)
- Class: thiazolidinedione
- For: Type 2 diabetes,
for use as monotherapy (that is, with no other diabetes medications) or in combination therapy with
metformin
or sulfonylurea
pills
or insulin.
- Route of Administration: oral
- Action: Insulin sensitizer
- Marketed by:
Takeda Pharmaceuticals America, Inc.
and
Eli Lilly and Company
- Status:
Approved in USA.
- Dose: 15-30 mg daily; if no improvement, can
increase to 45 mg daily.
- Available as: 15 mg, 30 mg, and 45 mg tablets.
- What it does: improves the action of the liver,
muscles, and fat tissues (functions as an "insulin sensitizer")
- Side Effects: Fluid retention, possible liver disease, increased risk of fractures in women.
- Other drugs in same class:
rosiglitazone,
troglitazone (now withdrawn from the market because of liver problems)
In August, 2007, the FDA announced the manufacturers of
Actos and
Avandia
have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning - FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
See Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure.
In March, 2007, Takeda
announced
that a study found an increased risk of broken bones in women taking
Actos, less than three weeks after rival GlaxoSmithKline Plc
issued a similar precaution for Avandia (rosiglitazone).
In July 2004, the following changes were added to the WARNINGS section of the labeling of Actos, under
Cardiac Failure and Other Cardiac Effects, In Type 2 Diabetes and Congestive Heart Failure (Systolic Dysfunction):
A 24-week post-marketing safety study was performed to compare Actos (n=262) to glyburide (n=256) in uncontrolled diabetic patients (mean HbA1C 8.8% at baseline) with NYHA Class II and III heart failure and ejection fraction less than 40% (mean EF 30% at baseline). Over the course of the study, overnight hospitalization for congestive heart failure was reported in 9.9% of patients on Actos compared to 4.7% of patients on glyburide with a treatment difference observed from 6 weeks. This adverse event associated with Actos was more marked in patients using insulin at baseline and in patients over 64 years of age. No difference in cardiovascular mortality between the treatment groups was observed.
Actos should be initiated at the lowest approved dose if it is prescribed for patients with type 2 diabetes and systolic heart failure (NYHA Class II). If subsequent dose escalation is necessary, the dose should be increased gradually only after several months of treatment with careful monitoring for weight gain, edema, or signs and symptoms of CHF exacerbation.
Also see
Actos
from the manufacturer,
Takeda Pharmaceuticals America, Inc., and Eli Lilly and Company
To read the complete MedWatch 2002 Safety Alert
about the
cardiovascular risks associated with the use of thiazolidinediones as
monotherapy and in combination with other antidiabetic agents, particularly
insulin,
including links to "dear
healthcare professional" letters and the revised labeling, go to:
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#Thiazo.
Takeda's letter about the risk of fractures may be found at
the
FDA website:
Observation of an Increased Incidence of Fractures in Female Patients
Who Received Long-Term Treatment with ACTOS® (pioglitazone HCL) Tablets for Type 2 Diabetes Mellitus
[PDF file].
Pioglitazone HCl (marketed as Actos and Duetact) Information (from the FDA).
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