A royal-inspired event gathered specialists in diabetes, cardiology and endocrinology in witnessing the recent grand unveiling of “CASTLE,” an acronym for Cilostazol: A Study in Long-Term Effects.
The results of this latest study provided added data on cilostazol’s safety in the long-term management of peripheral arterial disease (PAD), which has been reported to be prevalent among Filipinos with risk factors such as diabetes, cholesterol problems, hypertension and smoking.
An estimated 20 percent of adult Filipinos suffer from PAD whose common symptoms include pain in the lower extremities when walking, relieved by rest. In more severe cases, it can lead to leg gangrene and amputation.
The CASTLE results showed that in almost 1,500 patients with intermittent claudication secondary to PAD, there was no increased risk of all-cause or cardiovascular deaths and PAD-related disability.
The study also demonstrated no increased risk of bleeding with cilostazol as compared to placebo, either alone or with concomitant antiplatelet therapy.
Dr. Augusto Litonjua, acknowledged as the father of Philippine endocrinology, discussed the results of CASTLE during a recent presentation for the Philippine medical community held at the Crowne Plaza Hotel in Quezon City.
“It (CASTLE) is a study that shows the durability, efficacy of cilostazol and its safety over a period of time,” he said.
In terms of safety, the drug poses no serious adverse effects. “The CASTLE (study) reconfirms the safety of the long-term treatment of intermittent claudication patients with cilostazol,” he said.
The CASTLE was conducted to investigate the long-term effect of cilostazol in patients with intermittent claudication secondary to PAD. Its primary aim was to evaluate the rate of deaths from all causes, while the secondary aims were to assess both the cardiovascular deaths and the tolerability to cilostazol over a three-year period of continuous drug intake.
This phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel arm study involved almost 1,500 males and females with intermittent claudication secondary to PAD who were followed up for a period of three and a half years over a two-year enrollment period.
It also included patients aged 17 and above who were already on aspirin, clopidogrel, pentoxifylline and other anticoagulants (blood thinning agents) in the management of PAD.
In CASTLE, 37.8 percent of patients with diabetes took cilostazol, while 33.7 percent were placed on placebo. In patients with other conditions (heart attack, stroke and congestive heart failure), 44.3 percent took cilostazol while 44.4 percent took placebo.
These patients underwent a 30-day single run-in phase before the start of the study. The study had a relatively big number of dropouts (lost to follow-up), but this did not stall the study.
“So, what they did was anyone who was exposed to either placebo or the drug (cilostazol) was observed for an additional one month,” Litonjua said.
Most of the specialists who attended the presentation agreed that the overall outcome of the CASTLE study strengthened the evidence of the use of cilostazol among patients with PAD.
Diabetes mellitus is a disease with multi-systemic involvement particularly of the vascular system. It is highly prevalent with 500 new cases of diabetes diagnosed in the Philippines every day, according to Dr. Ricardo Fernando, founder of the Institute for Studies on Diabetes Foundation, Inc.
With the prevalence of diabetes, it is alarming to note that there may be an impending increase of PAD incidence in the country for it is one of diabetes’ many deadly complications.
Diabetes is only one of lifestyle-related diseases that contribute to PAD. Others are smoking, chronic obstructive pulmonary disease (COPD), collagen vascular disease (connective tissue disease) and heart disease.
PAD is usually associated with significant long-term illness, disability and death, hence, it should be managed during the early stages of the disease. It can pose a serious threat to life and limb if left untreated.
Despite the grim complications PAD is associated with, experts contend that it remains a manageable disease. The CASTLE study proves that cilostazol is an effective prescription medicine for improving the prognosis or outlook of patients with PAD.
For more information on PAD and its treatment, call the i-PAD hotline at 811-4723 for Greater Manila Area or 1-800-1-888-4723 for outside GMA.