Almanya, Fransa ve Hindistan gibi ülkelerde tip II diyabet tedavisinde yasaklanan Piogliazone (Actos)’un Alman araştırmacılar tarafından uzun süre kullanımda Alzheimer riskini azalttığı ileri sürüldü. Daha önce Alzheimerde etkisiz olduğu gösterilen Actos’un yapılan gözlemsel çalışmada etkili olduğu ‘Alzheimer’s Association International Conference 2014’de tebliğ edildi (Abstract #P2-295). Alzheimer Derneği tıbbi direktörü Keith Fargo ise bu bulguların klinik araştırmalardan elde edilmediğini klinik çalışmalarda ilacın etkisiz olduğunun gösterildiğini ve konuda yeni bir klinil araştırmanın (TOMMORROW) çalışmasının yapılmakta olduğunu belirtti.
ACTOS’un ciddi yan etkileri: Mesane kanseri, kalp yetmezliği, karaciğer yetmezliği, gözde maküler dejenerasyon, kadınlarda kemik kırılması. Büyük ihtimalle hastalar bu yan etkiler sebebi ile Alzheimer olacak kadar yaşamamakta!
Orijinal prospektüsten:
WARNINGS AND PRECAUTIONS
• _Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. (5.1)
• _Hypoglycemia: When used with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. (5.2)
• _Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt ACTOS and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart ACTOS if liver injury is confirmed and no alternate etiology can be found. (5.3)
• _Bladder cancer: Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users. The observational data further suggest that the risk increases with duration of use. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer (5.4)
• _Edema: Dose-related edema may occur. (5.5)
• _Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. (5.6)
• _Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes. (5.7)
Pioglitazone Not Effective for Alzheimer's Disease
Pioglitazone, a medication designed to treat diabetes, is not effective in treating patients with Alzheimer's Disease (AD), a randomized pilot study suggests.
The study results "don't support the long-term development" of pioglitazone for symptomatic AD. Recent trials have shown "limited efficacy" for rosiglitazone as an AD treatment, possibly because of its "poor bioavailability to the central nervous system," pioglitazone has demonstrated blood–brain barrier penetration and activity on AD-related pathophysiology in laboratory mouse models.
Arch Neurol. Published online September 13, 2010.