Tags

Type your tag names separated by a space and hit enter

Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1).
Circulation. 2009 Jan 27; 119(3):452-8.Circ

Abstract

BACKGROUND

A potentially strong association exists between Chlamydia pneumoniae and atherosclerosis, but the clinical benefits of antibiotic therapy have not been demonstrated. Preliminary studies of antibiotic therapy in peripheral artery disease have shown a decreased need for revascularization and improved walking ability. The objective of this phase-III trial was to assess the effect of a potent anti-Chlamydial agent, rifalazil, on peak walking time in patients with symptomatic peripheral artery disease.

METHODS AND RESULTS

Patients with intermittent claudication secondary to peripheral artery disease who were seropositive for C pneumoniae were randomized to 25 mg rifalazil once weekly for 8 weeks or matching placebo. Two hundred ninety-seven patients were enrolled from 3 countries and were followed up for 1 year. The mean+/-SD ankle brachial index at baseline was 0.63+/-0.16. The primary end point, change from baseline in log peak walking time on a graded treadmill, was assessed 180 days after randomization. Secondary end points included changes in claudication onset time and quality of life, assessed with the Walking Impairment Questionnaire and the Short Form Medical Outcomes 36. No benefit of rifalazil therapy was found in the primary or any secondary end point among this cohort of patients with peripheral artery disease. The group treated with rifalazil improved their peak walking times by 23% (95% confidence interval, 15 to 31) from baseline to day 180, whereas the placebo group improved by 18% (95% confidence interval, 11 to 26; P=0.38). Peak walking time, claudication onset time, Walking Impairment Questionnaire, and Short Form Medical Outcomes 36 showed no treatment-by-time interaction during the 360-day study period. Thirty-two adjudicated cardiovascular events occurred, 16 in each treatment group.

CONCLUSIONS

Rifalazil did not improve exercise performance or quality of life in patients with intermittent claudication. No safety concerns were identified. Given the very small effect size, it is unlikely that larger studies would demonstrate a symptomatic benefit of this therapy in peripheral artery disease.

Authors+Show Affiliations

Vascular Center, Massachusetts General Hospital, Boston, MA 02114, USA. mjaff@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19139383

Citation

Jaff, Michael R., et al. "Anti-chlamydial Antibiotic Therapy for Symptom Improvement in Peripheral Artery Disease: Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Pneumoniae Seropositive Patients (PROVIDENCE-1)." Circulation, vol. 119, no. 3, 2009, pp. 452-8.
Jaff MR, Dale RA, Creager MA, et al. Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1). Circulation. 2009;119(3):452-8.
Jaff, M. R., Dale, R. A., Creager, M. A., Lipicky, R. J., Constant, J., Campbell, L. A., & Hiatt, W. R. (2009). Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1). Circulation, 119(3), 452-8. https://doi.org/10.1161/CIRCULATIONAHA.108.815308
Jaff MR, et al. Anti-chlamydial Antibiotic Therapy for Symptom Improvement in Peripheral Artery Disease: Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Pneumoniae Seropositive Patients (PROVIDENCE-1). Circulation. 2009 Jan 27;119(3):452-8. PubMed PMID: 19139383.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1). AU - Jaff,Michael R, AU - Dale,Rita A, AU - Creager,Mark A, AU - Lipicky,Raymond John, AU - Constant,John, AU - Campbell,Lee Ann, AU - Hiatt,William R, Y1 - 2009/01/12/ PY - 2009/1/14/entrez PY - 2009/1/14/pubmed PY - 2009/2/21/medline SP - 452 EP - 8 JF - Circulation JO - Circulation VL - 119 IS - 3 N2 - BACKGROUND: A potentially strong association exists between Chlamydia pneumoniae and atherosclerosis, but the clinical benefits of antibiotic therapy have not been demonstrated. Preliminary studies of antibiotic therapy in peripheral artery disease have shown a decreased need for revascularization and improved walking ability. The objective of this phase-III trial was to assess the effect of a potent anti-Chlamydial agent, rifalazil, on peak walking time in patients with symptomatic peripheral artery disease. METHODS AND RESULTS: Patients with intermittent claudication secondary to peripheral artery disease who were seropositive for C pneumoniae were randomized to 25 mg rifalazil once weekly for 8 weeks or matching placebo. Two hundred ninety-seven patients were enrolled from 3 countries and were followed up for 1 year. The mean+/-SD ankle brachial index at baseline was 0.63+/-0.16. The primary end point, change from baseline in log peak walking time on a graded treadmill, was assessed 180 days after randomization. Secondary end points included changes in claudication onset time and quality of life, assessed with the Walking Impairment Questionnaire and the Short Form Medical Outcomes 36. No benefit of rifalazil therapy was found in the primary or any secondary end point among this cohort of patients with peripheral artery disease. The group treated with rifalazil improved their peak walking times by 23% (95% confidence interval, 15 to 31) from baseline to day 180, whereas the placebo group improved by 18% (95% confidence interval, 11 to 26; P=0.38). Peak walking time, claudication onset time, Walking Impairment Questionnaire, and Short Form Medical Outcomes 36 showed no treatment-by-time interaction during the 360-day study period. Thirty-two adjudicated cardiovascular events occurred, 16 in each treatment group. CONCLUSIONS: Rifalazil did not improve exercise performance or quality of life in patients with intermittent claudication. No safety concerns were identified. Given the very small effect size, it is unlikely that larger studies would demonstrate a symptomatic benefit of this therapy in peripheral artery disease. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/19139383/Anti_chlamydial_antibiotic_therapy_for_symptom_improvement_in_peripheral_artery_disease:_prospective_evaluation_of_rifalazil_effect_on_vascular_symptoms_of_intermittent_claudication_and_other_endpoints_in_Chlamydia_pneumoniae_seropositive_patients__PROVIDENCE_1__ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.108.815308?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -