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Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication

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Harvard

Tönnesen, KH, Albuquerque, P, Baitsch, G, Gomez Alonso, A, Ibanez, F, Kester, RC, Leveson, S & Poredos, P 1993, 'Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication', International Angiology, bind 12, nr. 4, s. 371-7.

APA

Tönnesen, K. H., Albuquerque, P., Baitsch, G., Gomez Alonso, A., Ibanez, F., Kester, R. C., Leveson, S., & Poredos, P. (1993). Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication. International Angiology, 12(4), 371-7.

CBE

Tönnesen KH, Albuquerque P, Baitsch G, Gomez Alonso A, Ibanez F, Kester RC, Leveson S, Poredos P. 1993. Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication. International Angiology. 12(4):371-7.

MLA

Vancouver

Author

Tönnesen, K H ; Albuquerque, P ; Baitsch, G ; Gomez Alonso, A ; Ibanez, F ; Kester, R C ; Leveson, S ; Poredos, P. / Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication. I: International Angiology. 1993 ; Bind 12, Nr. 4. s. 371-7.

Bibtex

@article{2b562a2555e847bebd6da86c0224a7fb,
title = "Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication",
abstract = "The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized treatment period. A total of 302 patients were allocated to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat analysis of the study population showed statistically significant superiority of indobufen over placebo after six months for both the initial (ICD) and absolute claudication distances (ACD). The ICD before treatment with indobufen or placebo averaged 137.9 +/- 68.2 and 136.6 +/- 63.2 m (mean +/- SD), respectively. After six months' treatment with active drug or placebo, this parameter reached 227.9 +/- 174.4 and 153.1 +/- 86.8 m (mean +/- SD), respectively (p <0.01). Similar results were obtained on ACD. The reduction of lower limb symptoms also suggested a greater clinical benefit in the indobufen-treated patients. There was no significant change in either group in the ankle/arm pressure ratio at the end of treatment. Adverse events of any type were reported by 18 patients (12.2%) in the indobufen group and by 11 patients (7.2%) in the placebo group. The mechanism whereby the drug is effective in this clinical condition could be related to both its antiplatelet and hemorheologic effects.",
keywords = "Double-Blind Method, Female, Follow-Up Studies, Humans, Intermittent Claudication, Isoindoles, Male, Middle Aged, Phenylbutyrates, Platelet Aggregation Inhibitors, Time Factors",
author = "T{\"o}nnesen, {K H} and P Albuquerque and G Baitsch and {Gomez Alonso}, A and F Ibanez and Kester, {R C} and S Leveson and P Poredos",
year = "1993",
month = dec,
language = "English",
volume = "12",
pages = "371--7",
journal = "International Angiology",
issn = "0392-9590",
publisher = "Edizioni/Minerva Medica",
number = "4",

}

RIS

TY - JOUR

T1 - Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication

AU - Tönnesen, K H

AU - Albuquerque, P

AU - Baitsch, G

AU - Gomez Alonso, A

AU - Ibanez, F

AU - Kester, R C

AU - Leveson, S

AU - Poredos, P

PY - 1993/12

Y1 - 1993/12

N2 - The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized treatment period. A total of 302 patients were allocated to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat analysis of the study population showed statistically significant superiority of indobufen over placebo after six months for both the initial (ICD) and absolute claudication distances (ACD). The ICD before treatment with indobufen or placebo averaged 137.9 +/- 68.2 and 136.6 +/- 63.2 m (mean +/- SD), respectively. After six months' treatment with active drug or placebo, this parameter reached 227.9 +/- 174.4 and 153.1 +/- 86.8 m (mean +/- SD), respectively (p <0.01). Similar results were obtained on ACD. The reduction of lower limb symptoms also suggested a greater clinical benefit in the indobufen-treated patients. There was no significant change in either group in the ankle/arm pressure ratio at the end of treatment. Adverse events of any type were reported by 18 patients (12.2%) in the indobufen group and by 11 patients (7.2%) in the placebo group. The mechanism whereby the drug is effective in this clinical condition could be related to both its antiplatelet and hemorheologic effects.

AB - The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized treatment period. A total of 302 patients were allocated to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat analysis of the study population showed statistically significant superiority of indobufen over placebo after six months for both the initial (ICD) and absolute claudication distances (ACD). The ICD before treatment with indobufen or placebo averaged 137.9 +/- 68.2 and 136.6 +/- 63.2 m (mean +/- SD), respectively. After six months' treatment with active drug or placebo, this parameter reached 227.9 +/- 174.4 and 153.1 +/- 86.8 m (mean +/- SD), respectively (p <0.01). Similar results were obtained on ACD. The reduction of lower limb symptoms also suggested a greater clinical benefit in the indobufen-treated patients. There was no significant change in either group in the ankle/arm pressure ratio at the end of treatment. Adverse events of any type were reported by 18 patients (12.2%) in the indobufen group and by 11 patients (7.2%) in the placebo group. The mechanism whereby the drug is effective in this clinical condition could be related to both its antiplatelet and hemorheologic effects.

KW - Double-Blind Method

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Intermittent Claudication

KW - Isoindoles

KW - Male

KW - Middle Aged

KW - Phenylbutyrates

KW - Platelet Aggregation Inhibitors

KW - Time Factors

M3 - Journal article

C2 - 8207316

VL - 12

SP - 371

EP - 377

JO - International Angiology

JF - International Angiology

SN - 0392-9590

IS - 4

ER -

ID: 39049544