WARNING: CONGESTIVE HEART FAILURE
- Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS MET, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Pioglitazone hydrochloride). After initiation of ACTOPLUS MET, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS MET must be considered.
- ACTOPLUS MET is not recommended in patients with symptomatic heart failure. Initiation of ACTOPLUS MET in patients with established NYHA Class III or IV heart failure is contraindicated (see CONTRAINDICATIONS and WARNINGS, Pioglitazone hydrochloride).
|
| |
ACTOPLUS MET SUMMARY
WARNING: CONGESTIVE HEART FAILURE
ACTOPLUS MET® (pioglitazone hydrochloride and metformin hydrochloride) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone hydrochloride and metformin hydrochloride. The concomitant use of pioglitazone and metformin has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on metformin. Additional efficacy and safety information about pioglitazone and metformin monotherapies may be found in the prescribing information for each individual drug.
Pioglitazone hydrochloride is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.
Metformin hydrochloride (N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents.
ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control.
Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug therapy.
|
NEWS HIGHLIGHTS
Published Studies Related to Actoplus MET (Pioglitazone / Metformin)
Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. [2009.10.14]
Abstract Background: Studies have shown that many patients with type 2 diabetes do not achieve optimal glycemic control, and progression of diabetes over time requires more than one pharmacotherapy to achieve glycemic goal. Objective: To examine the efficacy and safety of the fixed-dose combination (FDC) of pioglitazone 15 mg and metformin 850 mg versus its individual components in a twice-daily regimen over 24 weeks of treatment in type 2 diabetes patients who were currently not receiving antidiabetes therapy...
Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions. [2009.06]
BACKGROUND: In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone... CONCLUSIONS: These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions.
Monitoring the safety of pioglitazone : results of a prescription-event monitoring study of 12,772 patients in England. [2008]
BACKGROUND: Pioglitazone is an antidiabetic drug that targets insulin resistance in patients with type 2 diabetes mellitus by stimulating the peroxisome proliferator-activated receptor (PPAR)-gamma. Pioglitazone belongs to a class of drugs called thiazolidinediones (TZDs) and was launched in the UK in November 2000. OBJECTIVE: To monitor, using prescription-event monitoring, the post-marketing safety of pioglitazone, which is prescribed in primary care in England... CONCLUSION: Pioglitazone was considered to be a reasonably well tolerated drug, with the main reasons for discontinuing being related to the drug not being effective. The frequency of individual ADRs reported in this study did not exceed the frequency in the summary of product characteristics (SPC) for pioglitazone. However, amongst the frequently reported suspected ADRs, 'nausea/vomiting' and 'diarrhoea' are not listed in the SPC. Further research is required to assess whether the risk of myocardial infarction and deaths due to cardiovascular causes is a class effect of the thiazolidinediones. Results from this study should be taken into account with other clinical and pharmacoepidemiological studies.
A fixed-dose combination of pioglitazone and metformin: A promising alternative in metabolic control. [2006]
CONCLUSION: The co-formulation of pioglitazone and metformin is a rational approach that maximizes the established, complimentary benefits of these agents, while potentially improving compliance.
Pioglitazone/metformin. [2006]
A fixed-dose pioglitazone/metformin tablet is approved in the US and the EU for the treatment of adult patients with type 2 diabetes mellitus who currently have inadequate glycaemic control with metformin monotherapy. In the US, the combination tablet is also approved for the treatment of adult patients with type 2 diabetes who currently have inadequate glycaemic control with pioglitazone monotherapy and for those already receiving a combination of pioglitazone and metformin...
Clinical Trials Related to Actoplus MET (Pioglitazone / Metformin)
Efficacy and Safety Study of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes. [Recruiting]
This is a safety and efficacy study of pioglitazone 15 mg and metformin 850 mg combination
therapy compared to pioglitazone 15 mg by itself and metformin 850 mg by itself in treating
subjects with type 2 diabetes.
|
|
|
|
Page last updated: 2009-10-20
|
