Pirfenidone 53179-13-8 Raw Powder 99% Purity Quick Effect Quality Assurance

Basic Details

Result of Analysis

What is Pirfenidone ?

Pirfenidone is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep in the lungs. As time goes on, the scar tissue becomes thicker and becomes stiffer or thicker, which makes the work of the lungs more difficult. A decrease in lung function can make you breathless. When your brain, heart, and other organs don't get enough oxygen, other medical problems can occur.

Description

In the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) study, a randomized, double-blind, placebo-controlled trial, we aimed to confirm the effect of pirfenidone on disease progression in patients with idiopathic pulmonary fibrosis. Our design modifications with respect to the CAPACITY trial included the implementation of centralized procedures for diagnosis, spirometry, ,

Pirfenidone is an oral antifibrotic therapy that has been evaluated for the treatment of idiopathic pulmonary fibrosis in three phase 3, randomized, controlled trials. One of these trials was conducted in Japan and involved 275 patients. It was followed by two multinational studies, Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes, that were conducted in the United States, Europe, and Australia and involved 779 patients.7,8 In the Japanese trial, pirfenidone reduced the decline in vital capacity at week 52 and improved progression-free survival. In the multinational trials, the primary end point of change from baseline to week 72 in the percentage of the predicted forced vital capacitywas met in study 004 but not in study 006, prompting U.S. regulatory authorities to request an additional trial to support the approval of pirfenidone.

Applications

Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro systems and animal models of pulmonary fibrosis, although its precise mechanism of action remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokines such as transforming growth factor-β. It is also shown to slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor and platelet-derived growth factor.

Idiopathic pulmonary fibrosis is characterized by radiographically evident interstitial infiltrates predominantly affecting the lung bases and by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly shown to prolong survival. The current strict definition of idiopathic pulmonary fibrosis provides a new focus for basic and clinical research that will improve insight into the pathogenesis of this disorder and stimulate the development of novel therapies.

Pirfenidone Adverse effects

1. Gastrointestinal
Pirfenidone is frequently associated with gastrointestinal side effects such as dyspepsia, nausea, gastritis, gastroesophageal reflux disease (GERD) and vomiting.To reduce the severity of these reactions, pirfenidone is to be taken after meals.

2. Skin
Pirfenidone is known to cause photosensitivity reactions, rash, pruritus and dry skin. Patients are usually advised to avoid direct exposure to sunlight, including sun lamps, and to use protective clothing and sunscreening agents. Continuing photosensitivity reactions are usually managed by dose adjustment and temporary discontinuation of treatment if required, along with local symptomatic treatment.

3. Hepatic dysfunction
Pirfenidone can increase hepatic enzyme levels, especially those of aspartate transaminase (AST), alanine transaminase (ALT) and gamma-glutamyl transpeptidase (GGT); periodic monitoring of hepatic enzyme levels is required during therapy: once before the initiation of therapy, monthly monitoring until 6 months after initiation of therapy, and 3 monthly thereafter. Extra precaution is required while prescribing the drug in patients with hepatic impairment and in patients who are concomitantly

taking a CYP1A2 inhibitor. The drug is contraindicated in patients who have severe hepatic impairment.

4. Dizziness and fatigue
Dizziness and fatigue have been reported in patients undergoing pirfenidone treatment. Dizziness typically resolves, although patients should know how they react to pirfenidone before undertaking activities that need mental alertness or coordination. If severe, dose adjustment or treatment discontinuation may be required.

5. Weight loss
Weight loss has been reported in patients treated with pirfenidone. Doctors should monitor patients’ weight and encourage increased calorific intake if necessary.

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