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Actos (Pioglitazone Hydrochloride) - Summary

 
 



WARNING: CONGESTIVE HEART FAILURE

  • Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of ACTOS, 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 ACTOS must be considered.
  • ACTOS is not recommended in patients with symptomatic heart failure. Initiation of ACTOS in patients with established NYHA Class III or IV heart failure is contraindicated (see CONTRAINDICATIONS and WARNINGS).
 

ACTOS SUMMARY

ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. ACTOS is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes). Pharmacological studies indicate that ACTOS improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. ACTOS improves glycemic control while reducing circulating insulin levels.

ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM). ACTOS is indicated for monotherapy. ACTOS is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent does not result in adequate 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.


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NEWS HIGHLIGHTS

Media Articles Related to Actos (Pioglitazone)

Lactose Tolerance Test
Source: MedicineNet Lactose Intolerance Specialty [2014.03.04]
Title: Lactose Tolerance Test
Category: Procedures and Tests
Created: 11/27/1998 5:08:00 PM
Last Editorial Review: 3/4/2014 12:00:00 AM

Lactose Intolerance
Source: MedicineNet Celiac Disease Specialty [2013.12.12]
Title: Lactose Intolerance
Category: Diseases and Conditions
Created: 12/14/1998 7:21:00 PM
Last Editorial Review: 12/12/2013 12:00:00 AM

FDA OKs Generic Actos for Type 2 Diabetes
Source: MedicineNet pioglitazone Specialty [2012.08.20]
Title: FDA OKs Generic Actos for Type 2 Diabetes
Category: Health News
Created: 8/18/2012 11:00:00 AM
Last Editorial Review: 8/20/2012 12:00:00 AM

Another Study Links Diabetes Drug Actos to Bladder Cancer
Source: MedicineNet pioglitazone Specialty [2012.07.05]
Title: Another Study Links Diabetes Drug Actos to Bladder Cancer
Category: Health News
Created: 7/3/2012 2:05:00 PM
Last Editorial Review: 7/5/2012 12:00:00 AM

Diabetes Drugs Avandia, Actos Linked to Vision Woes
Source: MedicineNet rosiglitazone Specialty [2012.06.12]
Title: Diabetes Drugs Avandia, Actos Linked to Vision Woes
Category: Health News
Created: 6/11/2012 6:06:00 PM
Last Editorial Review: 6/12/2012 12:00:00 AM

more news >>

Published Studies Related to Actos (Pioglitazone)

Clinical efficacy of pioglitazone: generic vs. original product. [2012]
CONCLUSION: These findings indicated that both formulations were bioequivalent as

Pioglitazone-mediated changes in lipoprotein particle composition are predicted by changes in adiponectin level in type 2 diabetes. [2012]
factors after an intervention that alters adiponectin levels... CONCLUSION: Increased adiponectin contributed to treatment-related benefit in

Rosiglitazone and pioglitazone for the treatment of Alzheimer's disease. [2011.11]
CONCLUSIONS: Results from clinical trials and current safety data suggest that rosiglitazone should not be used for the treatment of AD. Application of results from trials evaluating pioglitazone in the treatment of AD is limited because of major trial limitations; therefore, it should not be recommended at this time. Although these drugs are not commonly used in the treatment of AD, further pharmacoepidemiologic studies are warranted before their use can be recommended.

Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. [2011.11]
AIM: To assess the efficacy and safety of alogliptin added to pioglitazone versus pioglitazone monotherapy, in Japanese patients with type 2 diabetes who achieved inadequate glycaemic control on pioglitazone plus diet/exercise... CONCLUSIONS: Once-daily alogliptin was effective and generally well tolerated when given as add-on therapy to pioglitazone in Japanese patients with type 2 diabetes who achieved inadequate glycaemic control on pioglitazone plus lifestyle measures. Clinical benefits were maintained for 52 weeks. (c) 2011 Blackwell Publishing Ltd.

Pioglitazone delays proximal tubule dysfunction and improves cerebral vessel endothelial dysfunction in normoalbuminuric people with type 2 diabetes mellitus. [2011.10]
AIM: The renal and cerebral protective effects of pioglitazone were assessed in normoalbuminuric patients with type 2 diabetes mellitus (DM)... CONCLUSION: Proximal tubule (PT) dysfunction precedes albuminuria and is dissociated from endothelial dysfunction in patients with type 2 DM. Pioglitazone delays PT dysfunction and improves cerebral vessels endothelial dysfunction in normoalbuminuric patients with type 2 DM. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

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Clinical Trials Related to Actos (Pioglitazone)

A Portion-Controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS [Active, not recruiting]
We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fasting conditions.

Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fed conditions.

A Study to Evaluate SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone, or Pioglitazone HCl Alone for the Treatment of Type 2 Diabetes [Active, not recruiting]
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SYR-322 plus pioglitazone HCl, SYR-322 alone, or pioglitazone alone in subjects with type 2 diabetes.

Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation (PERISCOPE) [Completed]

more trials >>

Reports of Suspected Actos (Pioglitazone) Side Effects

Bladder Cancer (1096)Bladder Transitional Cell Carcinoma (104)Haematuria (70)Weight Increased (36)Blood Glucose Increased (34)Myocardial Infarction (33)Bladder Neoplasm (27)Cardiac Failure Congestive (26)Dyspnoea (26)Prostate Cancer (26)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Actos has an overall score of 7. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Actos review by 65 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   diabetes
Dosage & duration:   15 mg. taken one a day for the period of I have been taking it for 5 years
Other conditions:   NONE
Other drugs taken:   NONE
  
Reported Results
Benefits:   THE TREATMENT BENEFIT IS TO CONTROL THE GLUCOSE IN MY BLOOD, ALONG WITH A HEALTHY DIET AND AVOID SWEETS AND STARCHES.
Side effects:   NO SIDE EFFECTS SO FAR, BUT ALL PRESCRIPTION DRUGS HAVE SOME EFFECTS WITH THE YEARS. THAT'S WHY I TRY TO STAY AWAY FROM DRUGS.
Comments:   I TAKE ONE ACTOS 15 MG IN THE MORNING. HAVE BLOOD TESTS DONE EVERY 3 MONTHS TO CHECK MY KIDNEYS, GLUCOSE LEVEL, CHILESTEROL, ETC. ALSO HAVE MY EYES CHECK EVERY 12 MONTHS, AND MY FEET AS WELL.

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Page last updated: 2014-03-04

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