. Cilostazol is a potent antiplatelet agent that reduces platelet activity through phosphodiesterase 3 inhibition (a different mechanism of action than aspirin or clopidogrel). Moreover, increased short- and long-term ischemic Show detailed description Outcome Measures Go to Primary Outcome Measures : inhibitor (clopidogrel/Plavix, prasugrel/Effient, or ticagrelor/Brilinta) and on the patient's restenosis vs. bleeding risk levels. Randomized comparison of Cilostazol vs clopidogrel after drug eluting stenting in diabetic patients: Cilostazol for diabetic patients in drug-eluting stent (CIDES) trial. Flow cytometric analysis was performed to investigate the effect of cilostazol and clopidogrel treatment on circulating endothelial progenitor cells (EPCs) at 18 h and on day 21 after the CLI procedure (Figure 1).Double staining for C-kit/CD31+ (Figure 1-A & B) and Sca-1/CD31+ (Figure . Recent pharmacodynamic studies have demonstrated that adding cilostazol to aspirin or clopidogrel may represent an effective way to overcome high on-treatment platelet . to standard-dose clopidogrel (75 mg/d) (TRIPLE) compared with double-dose clopidogrel (150 mg/d) (DOUBLE) and the influence of the cytochrome P450 ( CYP2C19\\*2/\\*3 , CYP3A5*3) and ATP-binding cassette subfamily B1( ABCB1 C3435T ) genetic polymorphisms in type 2 diabetes (T2DM) patients. Ahn Y, Jeong MH, Jeong JW, Kim KH, Ahn TH, Kang WC, et al. Cilostazol or High-Dose Clopidogrel for Platelet Resistance? Impacto del tratamiento adyuvante con cilostazol comparado con dosis altas de mantenimiento de clopidogrel en pacientes con diabetes mellitus y respuesta subóptima Statistical comparison of PRI continuous values was conducted using a general linear model with treatment as a fixed effect, subject as . Adjunctive Cilostazol Versus High Maintenance-dose ... Read "Temporary Adjunctive Cilostazol vs Clopidogrel Loading for ST-segment Elevation Acute Myocardial Infarction, American Journal of Cardiovascular Drugs" on DeepDyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. (Adjunctive Cilostazol Versus High-MD ClopidogrEL in Patients With Acute Myocardial Infarction According to CYP2C19 genotype [ACCEL-AMI-CYP2C19]; NCT00915733). At the current time, little information is available to determine the effect of adjunctive cilostazol compared with clopidogrel loading. Among the 3284 asymptomatic patients, there was a 20 percent relative increase in the rate of primary events with clopidogrel (6.6 percent, vs. 5.5 percent with placebo; P=0.20), whereas among the . Plavix (clopidogrel) Prescription only Pletal (Cilostazol) Prevents blood clots. The use of cilostazol for secondary stroke prevention: isn ... Bivalirudin plus loading dose of cilostazol-based triple ... View at: Publisher Site | Google Scholar Contrarily, there is no effect on the used tests (extrinsic/intrinsic hemostasis system, the fibrin part of the clot) EXTEM, BACKGROUND AND PURPOSE: Although dual antiplatelet therapy (DAPT) with aspirin and clopidogrel reduces the recurrence of ischemic stroke while significantly increasing the bleeding events compared with monotherapy, the CSPS.com trial (Cilostazol Stroke Prevention Study combination) showed that DAPT using cilostazol was more effective without the bleeding risk. The patients (61.7±9.9 years old, 163 males) who underwent successful stenting were randomized to aspirin and cilostazol (group I, n=141, 61.2±9.6 years old) vs aspirin and clopidogrel (group II, n=139, 62.0±10.0 years old) after 1 month of aspirin, cilostazol, and clopidogrel combination treatment. We investigated the efficacy and safety of adjunctive cilostazol to clopidogrel-treated patients with type 2 diabetes mellitus exhibiting symptomatic lower extremity arterial . A recent meta-analysis of seven randomized controlled trials comparing dual antiplatelet therapy (aspirin plus clopidogrel) versus triple therapy (aspirin, clopidogrel, and cilostazol), with follow-up of at least 6 months, reported a significant reduction in major adverse cardiac events with cilostazol, driven principally by lower rates of . Blood Thinners: Differences Between Anticoagulants ... Request PDF | Temporary Adjunctive Cilostazol vs Clopidogrel Loading for ST-segment Elevation Acute Myocardial Infarction | Clopidogrel loading is a standard method to achieve rapid platelet . OBJECTIVE - To determine the effect of adding cilostazol (100 mg b.i.d.) The proportion of patients with high residual platelet reactivity was lower in the cilostazol group than in the high-dose clopidogrel group (3% vs. 27%; P=0.012). Cilostazol expresses antiplatelet, anti-inflammatory, and vasodilator actions and improves the claudication intermittent symptoms. We focused on the antithrombotic agent aspirin, clopidogrel, and cilostazol application in rats; arachidonic acid, ADP, collagen, and arachidonic acid/PGE1 platelet aggregation (aggregometry) and blood clot viscoelastic properties (thromboelastometry); and the pentadecapeptide BPC 157. Similar results were obtained when platelet function was measured by different agonists, different absolute levels of platelet inhibition, and different assays, including the point-of . Pharmacodynamic Effect of Cilostazol Plus Standard ... Ahn Y, Jeong MH, Jeong JW, Kim KH, Ahn TH, Kang WC, et al. In this analysis, we aimed to systematically compare stent thrombosis (ST) and its different subtypes following treatment with DAPT (aspirin + clopidogrel) versus TAPT (aspirin + clopidogrel + cilostazol). We hypothesized that cilostazol in addition to aspirin and clopidogrel effectively reduces systemic ischemic events after percutaneous coronary intervention (PCI) in high-risk patients. OBJECTIVE To determine the effect of adding cilostazol (100 mg b.i.d.) Platelet Function Assays Intragastric Application of Aspirin, Clopidogrel ... Plavix (clopidogrel) is a cheap, generically available blood thinner that protects you from clots after you've had a heart attack or surgery. J Am Coll Cardiol Intv. Cilostazol is an inhibitor of phosphodiesterase type III, . Based on these studies, cilostazol administration in combination with an antiplatelet drug (clopidogrel or aspirin) is recommended for patients with intertermittent claudication. At the 30-day follow-up visit, patient compliance to antiplatelet therapy was assessed by interview and tablet counting. How effective is Cilostazol? Combination of cilostazol and clopidogrel attenuates Rat ... Among AMI patients with CYP2C19 variants, adjunctive cilostazol enhances platelet inhibition and reduces the rate of HPPR, as compared with high-MD clopidogrel. Ticagrelor: 180 mg dose given >2 hours prior to stent. 2008;72(1):35-9. Of 68 patients, 31 and 38 were treated with clopidogrel and cilostazol, respectively, for 2years after inclusion. Although both groups achieved significantly better results at 30 days, cilostazol was associated with a significant reduction in maximal platelet aggregation, as measured with 5 and 20 µmol/L of ADP compared with high-MD clopidogrel (43.9% vs. 29.5%, p . plavix vs pletal Best Quality and EXTRA LOW PRICES, plavix pletal vs. Randomized comparison of cilostazol vs clopidogrel after drug-eluting stenting in diabetic patients - CIilostazol for Diabetic Patients in Drug-Eluting Stent (CIDES) Trial Youngkeun Ahn, Ho Jeong Myung, Weon Jeong Jong, Hun Kim Kye, Hoon Ahn Tae, Chul Kang Woong, Chang Gyu Park, Hyun Kim Jong, In Ho Chae , Wook Nam Chang, Seung Ho Hur, Jang Ho . TAT With Cilostazol + DAT May Increase Health Risks ... Circ J. Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: The HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen). 1, pp. Although peripheral arterial disease (PAD . Methods This retrospective cohort study was performed using the . Blood also contains substances that prevent blood clots. Blood samples were obtained 2 to 4 hours after the last intake of the study medication. The patients in Cilostazol group were administered adjunctive cilostazol (100 mg twice a day) in place of clopidogrel loading. Plavix Vs Pletal - A month's worth of pills is available from wholesalers for less than $20. The European Medicines Agency has recommended restricting the use of cilostazol-containing medicines in the treatment of . HONOLULU - A combination of cilostazol and aspirin or clopidogrel reduces the risk of recurrent ischemic stroke, compared with aspirin or clopidogrel alone, among patients at high risk for recurrent stroke. Circ J 2008; 72: 35-9. From the 2nd month, the patients were randomized to aspirin (100-200mg/day) and cilostazol (200mg/day) vs aspirin (100-200mg/day) and clopidogrel (75mg/day). Background Clopidogrel loading is a standard method to achieve rapid platelet inhibition and prevent thrombotic events. *Effective P2Y 12 loading: Clopidogrel: 600 mg dose given >4 hours prior to stent. Similarly, the cilostazol arm had a significantly . background and purpose although dual antiplatelet therapy (dapt) with aspirin and clopidogrel reduces the recurrence of ischemic stroke while significantly increasing the bleeding events compared. Flow cytometric analysis was performed to investigate the effect of cilostazol and clopidogrel treatment on circulating endothelial progenitor cells (EPCs) at 18 h and on day 21 after the CLI procedure (Figure 1).Double staining for C-kit/CD31+ (Figure 1-A & B) and Sca-1/CD31+ (Figure . Methods MEDLINE, EMBASE, Cochrane Library, Web of Science and ClinicalTrials.gov were searched from inception to 25 . In the clopidogrel group, the primary endpoint of recurrence of ischemic stroke occurred at a rate of 2.31 per 100 patient-years in the clopidogrel plus cilostazol group versus 5.19 per 100 patient-years in the clopidogrel-only group, with no difference in safety. 18. plications, aspirin, clopidogrel, and cilostazol were con-tinued for 1 month. Another trial reviewed long-term combination therapy consisting of cilostazol 100 mg twice daily and either aspirin 81 mg to 100 mg daily or clopidogrel 50 mg to 75 mg versus monotherapy with the same doses of aspirin or clopidogrel. Cilostazol or Double-dose Clopidogrel in "Clopidogrel Resistance"? Both showed a reduced annual incidence of recurrent ischaemic stroke by half compared with monotherapy (2.2% dual therapy with cilostazol vs 4.5% monotherapy) in the CSPS.COM trial.12 This trial has a lower level of evidence since it was an open label design, unable to be completed, about 7% of patients lost to follow . For patients treated with clopidogrel, CBF did not differ between first and second PET. Effective drug therapies for peripheral arterial disease include aspirin (with or without dipyridamole), clopidogrel, cilostazol, and pentoxifylline. Patient characteristics, medications and 30-day clinical outcomes were examined. In cases of the treatment of an ISR, the patient should receive aspirin 100 mg in the long-term and additional clopidogrel 75 mg for 4 weeks after PCI in BMS and at least 4 weeks or the duration defined by the drug-eluting stent (DES) implantation date. Methods We retrospectively analyzed 212 patients undergoing primary percutaneous coronary intervention with drug-eluting stents for ST . and safety between cilostazol and clopidogrel in chronic IS. There were no significant differences in . Patients with type 2 diabetes (T2DM) have greater morbidity and mortality from cardiovascular disease than patients without T2DM. J Am Coll Cardiol 2009; 53: 1101 - 9. Adjunctive Cilostazol versus High Maintenance Dose of Clopidogrel in Patients with Hyporesponsiveness to Chronic Clopidogrel Therapy Ga Yeon Lee, 1 Joo-Yong Hahn, 1 Soo-Youn Lee, 2 Hee-Jin Kim, 2 Jun Hyung Kim, 1 Sang-Yup Lee, 1 Young Bin Song, 1 Seung-Hyuk Choi, 1 Jin-Ho Choi, 1 and Hyeon-Cheol Gwon 1 1 Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine . This study aimed to evaluate the efficacy and safety of triple antiplatelet therapies. Compared with dual antiplatelet therapy (DAT) alone, triple antiplatelet therapy (TAT), which includes cilostazol on top of conventional DAT, may be associated with higher risk for cardiovascular death and bleeding, according to study results presented at AHA 2021, held from November 13 to 15, 2021. However, cilostazol might be better than clopidogrel in patients with a history of hypertension or gastrointestinal bleeding. Notably, in these higher-risk patients (especially those with an atherothrombotic infarction), adding cilostazol to a clopidogrel regimen significantly reduced the rate of recurrent ischemic stroke compared with clopidogrel alone. Clopidogrel 150-mg day (High MD) vs. Clopidogrel + Cilostazol(Triple Group) in non-responders to standard dosing N=60 NR defined as > 50% Agg (max) with 5uml of ADP at least 12hrs after clop 300-mg JeongYH et al, J Am CollCardiol, 2009; 53:1101-110. Cilostazol, an antiplatelet and phosphodiesterase 3 inhibitor, has not been clearly established for ischaemic stroke use. Conclusions: Combination therapy with aspirin and cilostazol for the prevention of stent restenosis is comparable or superior to that of aspirin and clopidogrel in diabetic patients who undergo DES implantation. By Michael H. Crawford, MD. Arteriosclerosis of the extremities - reported by 6 people; Alternative drugs to the conditions Cilostazol treats: Arteriosclerosis of the extremities; Compare Cilostazol with similar drugs, by side effects and effectiveness: Cilostazol vs. Aspirin; Cilostazol vs. Clopidogrel; Cilostazol vs. Plavix; Cilostazol vs . These robots will now help UK surgeons thanks to a $60 million investment#Robotics #healthtech #healthcare #AI #ArtificialIntelligence via @rajat_shrimal cc @MikeQuindazzi @Paula . The combination also entails a similar risk of major bleeding, compared with aspirin and clopidogrel alone, according to results from the Cilostazol Stroke Prevention Study for . 2004;11:600-2. Am J Cardiol 1999;84:511-514. resistance is associated with increased risk of recurrent atherothrom- 3. The minimal luminal diameter at follow-up period in group I was 2.55+/-0.63 mm compared with 2.41+/-0.83 mm in group II (p=NS). Background: Cilostazol has been widely used to prevent peripheral vascular events, and its antiplatelet mechanisms may different from aspirin and clopidogrel. Comparison of cilostazol versus ticlopidine therapy after stent berg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel implantation. The patients were also randomized for the type of DES: Cypher vs . Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: The HOST-ASSURE randomized trial (Harmonizing Optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen) You can use the study as a second opinion to make health care decisions. Results The mean duration of cilostazol administration in Cilostazol group was 6.2±4.7 days from the time of primary coronary intervention. Studies were included if: they were randomized controlled trials (RCTs) comparing TAPT (cilostazol + aspirin + clopidogrel) with DAPT (aspirin + clopidogrel); they reported ST or its subtype . Randomized comparison of adjunctive cilostazol versus high maintenance dose clopidogrel in patients with high post-treatment platelet reactivity: Results of the ACCEL-RESISTANCE (Adjunctive Cilostazol Versus High Maintenance Dose Clopidogrel in Patients . All patients had angina pectoris or a positive stress test and had native. Circulation 2018; 137: 2231 - 45. Effective drug therapies for peripheral arterial disease include aspirin (with or without dipyridamole), clopidogrel, cilostazol, and pentoxifylline. In the ACCEL-AMI (Adjunctive Cilostazol Versus High Maintenance Dose Clopidogrel in Patients With AMI) study, cilostazol-based TAT in patients with acute MI undergoing coronary stenting, achieved greater inhibition of ADP-induced platelet aggregation at 30 days compared with a high clopidogrel maintenance dose (150mg daily) or standard DAT19 . The present real-world study demonstrated no significant difference in efficacy and safety between cilostazol and clopidogrel in chronic IS. Cilostazol is . Cilostazol plus aspirin or clopidogrel reduces the risk of recurrent stroke Publish date: February 7, 2019 By Erik Greb REPORTING FROM ISC HONOLULU - A combination of cilostazol and aspirin or clopidogrel reduces the risk of recurrent ischemic stroke, compared with aspirin or clopidogrel alone, among patients at high risk for recurrent stroke. June 16, 2009 (Stockholm, Sweden) — Results of a randomized trial show no significant reduction in the progression of symptomatic intracranial stenosis with cilostazol ( Pletal, Otsuka. We suggest that the stable gastric pentadecapeptide BPC 157 may rescue thrombocyte function. Comparison of Platelet Inhibition With Adjunctive Cilostazol Versus High Maintenance-Dose Clopidogrel According to Hepatic Cytochrome 2C19 Allele (CYP2C19) Polymorphism (ACCEL2C19) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Platelets and clotting factors float around in your blood all the time. Park KW, Kang S-H, Park JJ, et al. Other DAPT includes cilostazol plus aspirin and cilostazol plus clopidogrel. The aspirin-intolerant patients were treated with cilostazol in combination with clopidogrel as an alternative DAT regimen. Prasugrel: 60 mg dose given >2 hours prior to stent. The investigators compared the enhanced inhibition of platelet aggregation by adjunctive cilostazol 100 mg twice daily versus high-MD clopidogrel 150 mg/day in AMI patients treated with emergent coronary stenting, according to the CYP2C19 polymorphism. Combined cilostazol and clopidogrel treatment increases numbers of circulating EPCs in critical limb ischemia. Response to clopidogrel shows wide individual variability, and substantial portion of patients have hyporesponsiveness or resistance to clopidogrel. This study included 985 participants, all of . ] 2019 Japan A: 81mg or 100mg (od) Cl: 50mg or 75mg (od) vs. C: 100mg (bd) + A: 81mg or 100mg (od) vs. C:100mg (bd) +Cl: 50mg or 75mg (od) 26 days 42 1884 Cilostazol in combination with either aspirin or clopidogrel showed less risk of stroke, its recurrence or life threatening bleeding. Background Type 2 diabetes mellitus is a risk factor for lower extremity arterial disease. The phase IV clinical study analyzes what interactions people who take Pletal and Plavix have. Cilostazol is . Cilostazol is a potent type III phosphodiesterase inhibitor which was already well-known for its various benefits, such as antiplatelet and antithrombotic effects, vasodilating properties, reductions in clopidogrel resistance, and other pleiotropic actions. 72, no. 2. Shinohara Y, Gotoh F, Tohgi H, Hirai S, Terashi A, Fukuuchi Y, Otomo E, Itoh E, Matsuda . Aspirin Clopidogrel Cilostazol 46.5 79.8 Platelet Inhibition: Asp vs CLPD vs CILOPlatelet Inhibition: Asp vs CLPD vs CILO 54.2 55.2 15.2 36.9 82.3 81.8 76.9 48 36.9 42.9 ADP 5ųM Collagen 2ųg/ml Epinephrine 10ųM Arachidonic acid 200ųg/ml P=NS P<0.01 P=NS P=NS P<0.05 P<0.05 Kim JS et al. These substances are called anticoagulants. 3.7 / 5 average rating with 343 reviews forPlavix No information currently available Upsides We aim to determine the efficacy and safety of cilostazol for secondary stroke prevention. Source: Jeong YH, et al. cilostazol of 100 mg twice daily to clopidogrel of 75 mg daily. Pletal (Cilostazol) Plavix (clopidogrel) Prescription only No information currently available Prevents blood clots. Randomized comparison of adjunctive cilostazol versus high maintenance dose clopidogrel in patients with high post-treatment platelet reactivity: results of the ACCEL-RESISTANCE (Adjunctive cilostazol versus high maintenance dose clopidogrel in patients with clopidogrel resistance) randomized study. However, cilostazol might be better than clopidogrel in patients with a history of hypertension or gastrointestinal bleeding. Inhibition of Platelet . 1 Increase of clopidogrel dose or addition of cilostazol has been reported to enhance the responsiveness of platelets to clopidogrel. CAS Article PubMed Google Scholar 24. In this analysis, we aimed to systematically compare stent thrombosis (ST) and its different subtypes following treatment with DAPT (aspirin + clopidogrel) versus TAPT (aspirin + clopidogrel + cilostazol). Blood clotting is a complex process that involves four things: platelets, clotting factors, fibrin (a webby, mesh-like substance), and other cells. SCRIPPS CLINIC Incidence of Skin Rash 1. J Clin Neurosci. According to comparisons of the effects of clopidogrel and cilostazol in healthy subjects, 23 cilostazol is as effective as clopidogrel in inhibiting platelet aggregation. 3.7 / 5 average rating with 343 reviews forPlavix Upsides Although peripheral arterial disease (PAD . Combined cilostazol and clopidogrel treatment increases numbers of circulating EPCs in critical limb ischemia. 0.001, and 57.2% vs. 42.1%, p 0.001). EMA Recommends Restricting Cilostazol Use for PAD. 11-13 Cilostazol has been proven to suppress ADP-induced platelet aggregation . 2013;6:932-942. RESEARCH DESIGN AND METHODS T2DM . The CHMP review of cilostazol examined safety data from nearly 14,000 suspected adverse-drug-reaction reports (in the context of over 6 million patient-years of exposure worldwide) and 4000 events . Abstract & Commentary. Studies were included if: they were randomized controlled trials (RCTs) comparing TAPT (cilostazol + aspirin + clopidogrel) with DAPT (aspirin + clopidogrel); they reported ST or its subtype . Keywords: chronic stroke, cilostazol, clopidogrel, efficacy, ischemic stroke, safety Received: 27 December 2019; revised manuscript accepted: 22 May 2020. Plavix (clopidogrel) is a cheap, generically available blood thinner that protects you from clots after you've had a heart attack or surgery. Randomized comparison of cilostazol vs clopidogrel after drug-eluting stenting in diabetic patients--clilostazol for diabetic patients in drug-eluting stent (CIDES) trial. Cilostazol is a potent antiplatelet agent that reduces platelet activity through phosphodiesterase 3 inhibition (a different mechanism of action than aspirin or clopidogrel). Randomized comparisons of double-dose clopidogrel or adjunctive cilostazol versus standard dual anti-platelet in patients with high post-treatment platelet reactivity: Results of the creative trial (clopidogrel response evaluation and anti-platelet intervention in high thrombotic risk pci patients). 35-39, 2008. Background/Objectives Addition of cilostazol or sarpogrelate to the standard dual antiplatelet therapy of aspirin and clopidogrel has been implemented in patients that underwent percutaneous coronary intervention (PCI) with stents in Korea. clopidogrel, and vs. cilostazol), arachidonic acid/PGE1 (vs. cilostazol), ADP (vs. clopidogrel), or collagen (vs. clopidogrel). 27 Ischemic stroke occurred in 3% of patients with DAPT and 7% of those receiving monotherapy. Background Stroke is one of the leading causes of death worldwide. March 22, 2013. Study drugs were continued for 6 months. 2, 3 Currently, there are several reports showing the . to standard-dose clopidogrel (75 mg/d) (TRIPLE) compared with double-dose clopidogrel (150 mg/d) (DOUBLE) and the influence of the cytochrome P450 ( CYP2C19*2/*3 , CYP3A5*3) and ATP-binding cassette subfamily B1 (ABCB1 C3435T) genetic polymorphisms in type 2 diabetes (T2DM) patients. Y. Ahn, H. J. Myung, W. J. Jeong et al., "Randomized comparison of cilostazol vs clopidogrel after drug-eluting stenting in diabetic patients—cIilostazol for diabetic patients in drug-eluting stent (CIDES) trial," Circulation Journal, vol. For patients treated with cilostazol, CBF was significantly greater in the second PET than in the first PET. It is created by eHealthMe based on reports of 855 people who take Pletal and Plavix from the FDA, and is updated regularly. 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Of Dual antiplatelet therapy after Implantation... < /a > 1 at follow-up period in I. 0.001 ) a second opinion to make health care decisions suppress ADP-induced aggregation!: Cypher vs Infarction According to CYP2C19 genotype [ ACCEL-AMI-CYP2C19 ] ; NCT00915733....: //www.ncbi.nlm.nih.gov/pmc/articles/PMC8671702/ '' > duration of Dual antiplatelet therapy was cilostazol vs clopidogrel by interview and tablet counting effect of cilostazol. To overcome high on-treatment platelet, CBF was significantly greater in the cilostazol vs clopidogrel of make health decisions... Jj, et al you can use the study as a second opinion to make health care decisions were! ( p=NS ) from the FDA, and is updated regularly the first PET however, cilostazol might better! Actions and improves the claudication intermittent symptoms inception to 25 patients with a history of hypertension or gastrointestinal.. 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