Cilostazol improves walking distance in intermittent claudication: Study

20% of people above 70 years of age and 4-12% of people between 55-70 years of age suffer from blockages in the arteries of the legs, also called the 'peripheral arterial disease'. Intermittent claudication is a painful condition seen in 40% of people suffering from peripheral artery disease, which is triggered by severe exercise, which may cause muscle ischemia due to the obstruction of arterial flow. It more commonly affects the calf but the pain may also linger in the thighs and buttocks. These people are at an increased risk of death due to cardiovascular events as compared to their peers.

The best treatment modality for intermittent claudication is modifying lifestyle factors, like quitting smoking and exercising following a well-structured pattern. Further to lower the cardiovascular risk factors, blood pressure, diabetes, and cholesterol levels are regularly monitored. Despite this extensive treatment modality, the patients continue to suffer from the pain associated with intermittent claudication. However, drug therapies like cilostazol have been shown to considerably improve the symptoms.

A study was conducted by Forster B et. al to assess the evidence linked with the efficacy of cilostazol as compared to a placebo or other drugs in increasing the total and before calf pain walking distance as well as improving the quality of life of patients suffering from intermittent claudication.

The authors selected 3972 adults who had intermittent claudication secondary to peripheral artery disease, based on their search dated up to November 9, 2020, on which they conducted 16 double-bind, randomized controlled trials., out of which 5 studies compared the efficacy of cilostazol with pentoxifylline. The treatment lasted between 6-26 weeks, in which cilostazol dosage ranged from 100-300 mg and pentoxifylline dose ranged from 800-1200 mg.

The authors found the following:

Cilostazol versus placebo

• Those who took cilostazol for 3-6 months were able to walk 26 meters approx. (MD 26.49 metres; 95% CI 18.93 to 34.05; 1722 participants; six studies) before the initiation of calf pain and in total 40 approx. meters as compared to those on placebo (39.57 metres; 95% CI 21.80 to 57.33; 2360 participants; eight studies). However, for both the findings the certainty levels were very low.
• There was a possible indication of a better quality of life with participants who took cilostazol as compared to the placebo, however, the evidence certainty was low.
• Those who took cilostazol were also at three times the risk of experiencing headaches, with moderate evidence certainty.

Cilostazol versus pentoxifylline

• No difference seen between cilostazol and pentoxifylline for improving walking distance, both before the calf pain and the total distance, for both the findings the certainty levels, were low (MD 20.0 metres, 95% CI -2.57 to 42.57; 417 participants; one study; low-certainty evidence).
• No difference in the quality of life between cilostazol and pentoxifylline was noted, however the evidence certainty was low.
• Those who took cilostazol were also at three times the risk of experiencing headaches at 24 weeks, with low evidence certainty. (OR 2.20, 95% CI 1.16 to 4.17; 982 participants; two studies)

The authors concluded that although intake of cilostazol has demonstrated improvement in walking distance in people with intermittent claudication is associated with higher odds of experiencing headaches. Also, due to insufficient data, there was no difference noted between cilostazol and pentoxifylline for improving walking distance, hence no other conclusions on other outcomes could be made.

Reference:

A study titled, "Cilostazol for peripheral arterial disease" by Forster B et. al published in Cochrane Reviews.

https://www.cochrane.org/CD003748/PVD_cilostazol-peripheral-arterial-disease