Home Treatment & Recovery Drugs to Treat Leg Pain - Cilostazol

Drugs to Treat Leg Pain - Cilostazol

What is cilostazol?

Cilostazol (sil-OS-tah-zol) is a medication used to treat peripheral artery disease (PAD) in women with leg pain during exercise that goes away with rest ( intermittent claudication). Cilostazol can relieve PAD symptoms and increase the distance you are able to walk without pain.

Cilostazol does not cure PAD or reduce your risk of complications. You will still need medication and lifestyle changes to reduce your risk of heart attack and stroke (see Overview of PAD Treatment to learn more). If your symptoms are not controlled by cilostazol or continue to get worse, you may benefit from a procedure to treat PAD, such as angioplasty or stent placement.

Although it is not known exactly how cilostazol works in patients with PAD, it has been shown to increase blood flow in the legs, make the blood less sticky so that it flows more easily, and raise HDL ("good") cholesterol and lower the levels of triglycerides (harmful fats in the blood).1

Cilostazol
Generic Names: cilostazol
Brand Names: Pletal®
How it is given: Oral (tablet)
What it is used for:
  • To relieve leg pain symptoms and improve walking ability in women and men with PAD
You should not be treated with it if:
  • You have heart failure
  • You have bleeding problems, such as a recent bleeding stroke, or a currently bleeding peptic (stomach or intestine) ulcer
  • You are allergic to cilostazol
Pregnancy / nursing: The safety of cilostazol during pregnancy is unknown. Cilostazol is found in breast milk, and your doctor may recommend that you either stop breastfeeding or stop taking this medication. If you are nursing, pregnant, or planning to become pregnant, talk to your doctor about the potential risks and benefits of this medication.

 

Who should receive cilostazol to treat PAD?

Most women with PAD who have leg pain during exercise that goes away with rest (intermittent claudication) should consider treatment with cilostazol to relieve symptoms and improve walking ability. The main exception is women with heart failure (see below).

Who should NOT take cilostazol?

Women with heart failure, a condition in which the heart is unable to pump enough blood to meet the body's needs, should not take cilostazol.2 Similar drugs have been shown to make heart failure worse and increase the risk of dying. Although cilostazol itself has not been proven harmful, the risks are thought to outweigh the benefits of treatment for patients with heart failure.

How is cilostazol given?

Cilostazol is given as a tablet that you swallow. The most common dose is 100 mg taken twice a day, but your doctor may choose a different dose based on your individual situation.

Cilostazol works best when taken on an empty stomach, so you should take each tablet at least 30 minutes before or two hours after a meal. Never stop taking cilostazol without first talking to your doctor.

How effective is cilostazol for treating PAD?

In women with PAD, cilostazol relieves leg pain symptoms, increases walking ability, and improves quality of life. You may start noticing an improvement within two to four weeks of starting cilostazol, although it may take up to 6 weeks for some women to notice a benefit.

After three to six months of treatment, women taking cilostazol may see improvements of 40% to 60% in the maximum distance they are able to walk.3-5 One study that looked at 2,702 patients (24% were women) with moderate to severe PAD found that cilostazol increased maximal walking distance by 50% and pain-free walking distance by 67%.4 The benefits were similar in women and men.

Cilostazol has also been shown to make walking easier,6 improve walking speed,7 and improve quality of life.3 Cilostazol lowers the levels of triglycerides (a harmful fat in the blood) and increases HDL (good) cholesterol levels.4 More than half of patients taking cilostazol report that they felt "better" or "much better" than they felt before the treatment.8

What are the potential side effects of this medication?

Cilostazol is safe and does not increase your risk of dying or developing heart problems.9,10 The most common side effect of cilostazol is headache, which causes about 3% of patients to stop taking the drug. Other common side effects include:7

  • A feeling of a rapid or irregular heartbeat ( palpitations)
  • Diarrhea
  • Dizziness
  • Upset stomach or stomach pain
  • Abnormal stools (bowel movements)
  • A runny nose, sore throat, or flu-like symptoms

These side effects are usually mild and typically go away after your body has adjusted to the medication (usually within 6 weeks after starting treatment).11 However, if any of these symptoms are severe, or if they do not go away or get worse, notify your doctor. A change in dose or switching to a different medication may be able to reduce the side effects.

Although rare, some women may have an allergic reaction to cilostazol that requires immediate medical attention. Call your doctor right away if you develop a rash, itching, swelling, dizziness, or trouble breathing while taking cilostazol.

Other rare but serious side effects may include:

  • Swelling of the hands, feet, or legs
  • Fainting
  • Vision changes
  • Weakness on one side of the body
  • Slurred speech
  • Chest pain
  • Easy bruising or bleeding
  • Black or bloody stools
  • A fever or sore throat that does not go away

If you notice any of these signs, call your doctor right away.

My doctor has prescribed cilostazol. What special precautions should I take?

Always make sure your doctor knows about all medications you are taking, including prescription drugs, over-the-counter medications, and any dietary supplements including vitamins, minerals, or herbal supplements. Common medications that may interact with cilostazol include:12

  • Blood-thinning drugs such as warfarin (Coumadin) or clopidogrel (Plavix)
  • Aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and other NSAIDs (non-steroidal anti-inflammatory drugs). If your doctor has prescribed daily aspirin to lower your risk of heart disease and stroke, you should keep taking it.
  • Calcium Channel Blockers such as diltiazem (Cardizem, Dilacor XR)
  • Drugs to treat acid reflux disease (GERD), especially omeprazole (Prilosec)
  • Certain antidepressants
  • Antibiotic or anti-fungal drugs

You should also tell your doctor if you use tobacco. Cigarette smoking may make cilostazol less effective.

Do not drink grapefruit juice while taking cilostazol. Grapefruit juice interacts with many medications, and may increase the levels of cilostazol in your blood so that you get a higher dose than your doctor intends.

Are there any alternatives to cilostazol to treat leg pain caused by PAD?

The main alternative to cilostazol to treat claudication pain in women with PAD is pentoxifylline (pen-tak-SIF-uh-leen). This drug works by thinning the blood and allowing it to flow more easily, especially in the small vessels in your hands and feet.

Pentoxifylline can relieve leg pain caused by PAD and improve walking ability. It is less effective than cilostazol, but has fewer side effects.7 This medication can increase walking distance by 20% to 30%, compared with 40% to 60% for cilostazol.13,14 Pentoxifylline is typically used only if you cannot tolerate the side effects of cilostazol, or if you are taking other medications that cannot be combined with cilostazol.2

Common side effects of pentoxifylline include sore throat, upset stomach, nausea, diarrhea, dizziness, and headache. Talk to your doctor if these symptoms do not go away or get worse, and call your doctor immediately if you experience chest pain or a fast heartbeat when taking this drug.15

Pentoxifylline
Generic Names: pentoxifylline
Brand Names: Trental®, Pentoxil®
How it is given: Oral (tablet). Usually 400 mg three times a day with meals.
What it is used for:
  • To relieve leg pain symptoms and improve walking ability in women and men with PAD.
  • May be used to treat other conditions including leg ulcers, stroke, eye and ear disorders, and diabetic nerve pain.
You should not be treated with it if:
  • You have recently had a stroke or other bleeding problems
  • You are allergic to this drug, caffeine, theophylline (used to treat asthma and lung disease), or theobromine
Pregnancy / nursing: The safety of pentoxifylline during pregnancy is unknown. Pentoxifylline is found in breast milk, but safety for the infant is not known.16 If you are nursing, pregnant, or planning to become pregnant, talk to your doctor about the risks and benefits of this medication.

 

References

  1. Elam MB, Heckman J, Crouse JR, et al. Effect of the novel antiplatelet agent cilostazol on plasma lipoproteins in patients with intermittent claudication. Arterioscler Thromb Vasc Biol. Dec 1998;18(12):1942-1947.
  2. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. Mar 21 2006;113(11):e463-654.
  3. Regensteiner JG, Ware JE, Jr., McCarthy WJ, et al. Effect of cilostazol on treadmill walking, community-based walking ability, and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials. J Am Geriatr Soc. Dec 2002;50(12):1939-1946.
  4. Thompson PD, Zimet R, Forbes WP, Zhang P. Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication. Am J Cardiol. Dec 15 2002;90(12):1314-1319.
  5. Pande RL, Hiatt WR, Zhang P, Hittel N, Creager MA, McDermott M. A pooled analysis of the durability and predictors of treatment response of cilostazol in patients with intermittent claudication. Vasc Med. Jun;15(3):181-188.
  6. Money SR, Herd JA, Isaacsohn JL, et al. Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease. J Vasc Surg. Feb 1998;27(2):267-274; discussion 274-265.
  7. Dawson DL, Cutler BS, Hiatt WR, et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. Nov 2000;109(7):523-530.
  8. Beebe HG, Dawson DL, Cutler BS, et al. A new pharmacological treatment for intermittent claudication: results of a randomized, multicenter trial. Arch Intern Med. Sep 27 1999;159(17):2041-2050.
  9. Robless P, Mikhailidis DP, Stansby GP. Cilostazol for peripheral arterial disease. Cochrane Database Syst Rev. 2008(1):CD003748.
  10. Allison MA, Hiatt WR, Hirsch AT, Coll JR, Criqui MH. A high ankle-brachial index is associated with increased cardiovascular disease morbidity and lower quality of life. J Am Coll Cardiol. Apr 1 2008;51(13):1292-1298.
  11. O'Donnell ME, Badger SA, Sharif MA, Young IS, Lee B, Soong CV. The vascular and biochemical effects of cilostazol in patients with peripheral arterial disease. J Vasc Surg. May 2009;49(5):1226-1234.
  12. Cilostazol: Medline Plus Drug Information. Medline Plus Drug Information [9/1/2008; http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601038.html. Accessed July 29, 2010.
  13. Porter JM, Cutler BS, Lee BY, et al. Pentoxifylline efficacy in the treatment of intermittent claudication: multicenter controlled double-blind trial with objective assessment of chronic occlusive arterial disease patients. Am Heart J. Jul 1982;104(1):66-72.
  14. Lindgarde F, Jelnes R, Bjorkman H, et al. Conservative drug treatment in patients with moderately severe chronic occlusive peripheral arterial disease. Scandinavian Study Group. Circulation. Dec 1989;80(6):1549-1556.
  15. PubMedHealth - Pentoxifylline. September 1, 2008; http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000846. Accessed July 28, 2010.
  16. Hale TW. Medications and Mothers' Milk. 13 ed; 2008.

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