pletal
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Synonyms
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Pletal (cilostazol) is a quinolinone derivative phosphodiesterase III inhibitor with vasodilatory and antiplatelet properties, prescribed primarily for symptomatic management of intermittent claudication in peripheral arterial disease. This selective PDE3 inhibitor increases cyclic adenosine monophosphate (cAMP) in platelets and vascular smooth muscle, producing dual antiplatelet and vasodilatory effects that improve walking distance in patients with reduced blood flow to extremities.
1. Introduction: What is Pletal? Its Role in Modern Medicine
Pletal represents a cornerstone in pharmacological management of intermittent claudication, a debilitating symptom of peripheral arterial disease affecting approximately 8-10 million Americans. Unlike simple pain relievers or basic vasodilators, Pletal addresses the underlying pathophysiology through targeted phosphodiesterase inhibition. When blood flow to leg muscles becomes compromised due to atherosclerotic narrowing of arteries, patients experience characteristic cramping, pain, and fatigue during walking that resolves with rest—the clinical hallmark of intermittent claudication.
The significance of Pletal in contemporary vascular medicine lies in its mechanism-based approach to a condition that substantially impairs quality of life and functional capacity. While exercise therapy and risk factor modification form the foundation of claudication management, Pletal provides pharmacological enhancement for patients who remain symptomatic despite conservative measures. Clinical evidence consistently demonstrates that Pletal increases pain-free and maximum walking distances by approximately 40-50% compared to placebo, making it one of the few FDA-approved medications specifically indicated for this challenging condition.
2. Key Components and Bioavailability Pletal
The active pharmaceutical ingredient in Pletal is cilostazol, a synthetic compound with the chemical name 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone. Each tablet contains precisely formulated cilostazol in either 50 mg or 100 mg strengths, with inactive components including corn starch, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose.
Pletal demonstrates favorable pharmacokinetic properties with absolute bioavailability of approximately 90% when administered orally. The medication undergoes extensive hepatic metabolism primarily via cytochrome P-450 enzymes, notably CYP3A4 and to a lesser extent CYP2C19, producing multiple active metabolites. The major metabolite, 3,4-dehydro-cilostazol, exhibits 4-7 times greater potency than the parent compound and accounts for approximately 50% of the pharmacologic activity.
Food significantly affects absorption kinetics—a high-fat meal increases peak plasma concentration (Cmax) by 90% and overall exposure (AUC) by 25%, though these alterations don’t appear clinically significant regarding efficacy or safety. The elimination half-life of cilostazol and its active metabolites approximates 11-13 hours, supporting the standard twice-daily dosing regimen that maintains therapeutic concentrations throughout waking hours when patients are most active.
3. Mechanism of Action Pletal: Scientific Substantiation
The therapeutic effects of Pletal stem from its selective inhibition of phosphodiesterase III (PDE3), an enzyme that degrades cyclic adenosine monophosphate (cAMP) in various tissues. By blocking PDE3, Pletal increases intracellular cAMP concentrations, triggering multiple downstream effects that collectively improve symptoms of intermittent claudication.
In vascular smooth muscle cells, elevated cAMP activates protein kinase A (PKA), which phosphorylates and inhibits myosin light chain kinase—the key enzyme responsible for smooth muscle contraction. This phosphorylation cascade results in vasodilation, particularly in arterial beds supplying skeletal muscle. The vasodilatory effect preferentially occurs in diseased vessels with compromised blood flow, helping redirect circulation to ischemic tissues.
Simultaneously, in platelets, increased cAMP levels suppress calcium mobilization and reduce expression of glycoprotein IIb/IIIa receptors, impairing platelet aggregation and adhesion. This antiplatelet activity helps prevent microvascular thrombosis in narrowed arteries, further improving tissue perfusion.
Beyond these primary mechanisms, Pletal demonstrates additional beneficial effects including inhibition of smooth muscle cell proliferation (potentially slowing atherosclerotic progression), reduced endothelial inflammation, and enhanced nitric oxide production. The medication may also improve erythrocyte deformability, facilitating capillary transit in the microcirculation.
4. Indications for Use: What is Pletal Effective For?
Pletal for Intermittent Claudication
The primary FDA-approved indication for Pletal is symptomatic improvement of intermittent claudication, supported by multiple randomized controlled trials. In these studies, patients receiving Pletal 100 mg twice daily demonstrated statistically significant improvements in both pain-free walking distance (increased by 28-100% from baseline) and maximum walking distance (increased by 28-50% from baseline) compared to placebo. The therapeutic effect typically emerges within 2-4 weeks and continues to improve over 12-24 weeks of treatment.
Pletal for Peripheral Arterial Disease
While Pletal specifically targets claudication symptoms, its effects on underlying peripheral arterial disease extend beyond symptomatic relief. The medication may slow disease progression through its antiproliferative effects on vascular smooth muscle cells and improved endothelial function. Some evidence suggests Pletal reduces cardiovascular events in PAD patients, though this remains an area of ongoing investigation.
Off-Label Applications
Emerging evidence supports potential benefits of Pletal in other vascular conditions, including cerebral infarction prevention (particularly in Asian populations where it’s approved for this indication), prevention of restenosis after peripheral angioplasty, and management of diabetic foot ulcers through improved microcirculation. However, these applications require further validation in diverse populations.
5. Instructions for Use: Dosage and Course of Administration
Proper administration of Pletal requires attention to timing, duration, and patient-specific factors. The standard therapeutic regimen follows these evidence-based guidelines:
| Indication | Recommended Dosage | Frequency | Administration Timing |
|---|---|---|---|
| Intermittent Claudication | 100 mg | Twice daily | 30 minutes before or 2 hours after breakfast and dinner |
| Initial Therapy or Dose Reduction | 50 mg | Twice daily | Same as above, for patients who develop adverse effects |
The medication should be taken consistently rather than on an “as-needed” basis, as therapeutic effects accumulate over weeks. Clinical response typically becomes apparent within 2-4 weeks, with maximal benefit observed after 12-24 weeks of continuous therapy. Treatment discontinuation generally results in return to baseline functional status within several weeks.
Dosage adjustments are necessary for patients taking concurrent CYP inhibitors or those with hepatic impairment. For patients receiving strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) or CYP2C19 inhibitors (omeprazole, lansoprazole), the Pletal dose should be reduced to 50 mg twice daily.
6. Contraindications and Drug Interactions Pletal
Pletal carries several important contraindications that warrant careful patient selection:
- Congestive heart failure of any severity: PDE3 inhibition has been associated with increased mortality in patients with heart failure
- Known hypersensitivity to cilostazol or any product components
- Hemorrhagic conditions such as active peptic ulcer disease, intracranial hemorrhage, or bleeding diatheses
- Severe hepatic impairment (Child-Pugh Class C)
- Pregnancy and breastfeeding due to insufficient safety data
Significant drug interactions require particular attention:
Antiplatelet/Anticoagulant Agents: Concurrent use with aspirin, clopidogrel, warfarin, or direct oral anticoagulants increases bleeding risk. While some studies support combination therapy in specific scenarios, careful benefit-risk assessment is essential.
CYP Enzyme Inhibitors: Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir) and CYP2C19 inhibitors (omeprazole, lansoprazole) increase cilostazol exposure, necessitating dose reduction to 50 mg twice daily.
CYP Enzyme Inducers: Medications like rifampin, carbamazepine, and St. John’s wort may decrease cilostazol concentrations, potentially reducing efficacy.
Antihypertensives: The vasodilatory effects of Pletal may potentiate blood pressure lowering, requiring monitoring and possible antihypertensive dose adjustment.
7. Clinical Studies and Evidence Base Pletal
The efficacy of Pletal for intermittent claudication rests on eight randomized, double-blind, placebo-controlled trials involving over 2,000 patients. The landmark study published in the American Journal of Medicine demonstrated that after 24 weeks, Pletal 100 mg twice daily increased maximal walking distance by 107 meters compared to 65 meters with placebo—a 64% greater improvement.
A meta-analysis in Vascular Medicine consolidated data from multiple trials, confirming that Pletal produces statistically significant improvements in both pain-free and maximal walking distances across diverse patient populations. The number needed to treat (NNT) for achieving clinically meaningful improvement (≥50% increase in walking distance) was approximately 5, comparing favorably with other symptomatic therapies.
Long-term extension studies suggest sustained benefit for up to 12 months, though gradual decline in walking performance occurs after treatment cessation, supporting the need for continuous therapy in responsive patients. The Cochrane Database systematic review concluded that Pletal provides modest but statistically significant improvement in walking ability with an acceptable safety profile.
Real-world evidence from post-marketing surveillance and registry data generally aligns with clinical trial findings, though absolute walking distance improvements in community practice tend to be somewhat lower, possibly reflecting broader patient inclusion and variable adherence.
8. Comparing Pletal with Similar Products and Choosing a Quality Product
When evaluating pharmacological options for intermittent claudication, Pletal occupies a distinct therapeutic niche compared to alternatives:
Pentoxifylline: The other FDA-approved medication for claudication works through different mechanisms (rheological effects on blood viscosity). Meta-analyses generally favor Pletal for walking distance improvement, though individual response varies. Many clinicians consider Pletal first-line based on superior evidence.
Antiplatelet Agents: While aspirin and clopidogrel reduce cardiovascular events in PAD patients, they provide minimal symptomatic relief for claudication.
Statins: Beyond lipid-lowering, some statins demonstrate modest benefits for walking distance, though substantially less than Pletal.
Cilostazol vs. Generic Equivalents: Bioequivalence studies confirm therapeutic equivalence between brand-name Pletal and generic cilostazol, making cost often the determining factor.
When selecting a quality product, verification of FDA approval and manufacturing under current Good Manufacturing Practices (cGMP) provides assurance of consistent potency and purity. Patients should look for products with clear labeling of strength (50 mg or 100 mg) and proper packaging to maintain stability.
9. Frequently Asked Questions (FAQ) about Pletal
How long does it take for Pletal to start working?
Most patients notice initial improvement in walking distance within 2-4 weeks, with maximal benefit typically occurring after 3-6 months of continuous therapy.
Can Pletal be taken with food?
Yes, though taking Pletal 30 minutes before or 2 hours after meals may minimize potential gastrointestinal side effects. Consistent timing relative to meals helps maintain stable blood levels.
What are the most common side effects of Pletal?
Headache (25-34%), diarrhea (12-19%), abnormal stools (12-15%), palpitations (9-14%), and dizziness (9-12%) occur most frequently. These often diminish with continued treatment.
Is Pletal safe for patients with diabetes?
Yes, Pletal is generally safe in diabetes and may offer particular benefits for diabetic foot complications through improved microcirculation. However, careful monitoring is advised in those with diabetic gastroparesis or cardiovascular autonomic neuropathy.
Can Pletal be combined with blood thinners?
Concomitant use requires careful supervision due to increased bleeding risk. The combination may be appropriate in selected patients with high thrombotic risk, but requires individualized benefit-risk assessment.
What should I do if I miss a dose of Pletal?
Take the missed dose as soon as remembered unless it’s nearly time for the next dose. Never double doses. Consistent twice-daily administration maintains therapeutic levels.
10. Conclusion: Validity of Pletal Use in Clinical Practice
Pletal represents an evidence-based therapeutic option for patients with disabling intermittent claudication who have not achieved adequate symptom control with exercise and risk factor modification alone. The medication’s dual mechanism—combining vasodilation with antiplatelet effects—addresses key pathophysiological elements in symptomatic peripheral arterial disease.
The risk-benefit profile favors Pletal in appropriately selected patients without heart failure or significant bleeding risk. While side effects like headache and palpitations occur relatively frequently, they often diminish over time and rarely necessitate discontinuation. The clinically meaningful improvements in walking distance demonstrated across multiple randomized trials translate to real-world functional benefits that enhance quality of life.
Based on current evidence, Pletal deserves consideration as first-line pharmacotherapy for symptomatic claudication when conservative measures prove insufficient. Ongoing research continues to elucidate potential expanded applications in cerebrovascular and cardiovascular diseases, possibly broadening its role in comprehensive vascular protection.
I remember when we first started using cilostazol back in the early 2000s—we were skeptical about yet another “claudication drug” after pentoxifylline had shown such modest results. The pharmaceutical rep kept emphasizing the dual mechanism, but honestly, half the attendings in our vascular clinic dismissed it as marketing hype.
Then I started seeing results in practice that made me reconsider. Not every patient responded, but when they did, the improvement was sometimes dramatic. One that stands out was Robert, a 68-year-old retired mail carrier who could barely make it from his car to our clinic entrance without stopping. After three months on Pletal, he walked three blocks to his granddaughter’s school play—his wife called us crying with gratitude. Those are the cases that stick with you.
We had our share of treatment failures too. Probably 30-40% of patients either didn’t respond or couldn’t tolerate the side effects. The headaches were particularly problematic initially—we learned to start at 50 mg BID and titrate up after a couple weeks, which helped considerably. The cardiology department fought us on using it in any patient with even remote history of heart failure, which created some tension in our combined cases.
What surprised me most was discovering that some of our best responders were diabetic patients with microvascular disease—something not emphasized in the initial trials. We started tracking A1c levels and found better responses in well-controlled diabetics, though I’m not sure if that’s been formally studied.
Five years later, we’ve followed over 200 patients on Pletal with generally positive outcomes. About 65% maintain meaningful improvement at one year, though some require dose adjustments. The key seems to be setting realistic expectations—this isn’t a cure, but for selected patients, it provides that extra 100-200 feet that makes the difference between house confinement and community engagement.
Sarah, now 72, told me last month that Pletal let her resume her grocery shopping independently after two years relying on delivery services. “It’s not just the walking,” she said, “it’s my life back.” That’s the part that never shows up in the clinical trials but matters most in practice.