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[Reduction of cardiovascular morbidity/mortality in arteriopathies treated ith PGE1 alpha-cyclodextrin]
G Belcaro1, M Bucci, M R Cesarone
1Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Insights
Cyclic treatment with prostaglandin E1 alpha-ciclodestrina (PGE1 alpha-ciclodestrina) significantly reduced cardiovascular morbidity and mortality in vascular patients. This therapy improved symptoms and decreased adverse cardiovascular events in patients with intermittent claudication and critical ischemia.
Area of Science:
- Vascular Medicine
- Cardiovascular Research
- Pharmacology
Background:
- Cardiovascular disease poses a significant threat to patients with vascular conditions.
- Evaluating the impact of prostaglandin E1 alpha-ciclodestrina (PGE1 alpha-ciclodestrina) on cardiovascular outcomes in vascular patients.
- Assessing long-term cardiovascular morbidity and mortality in patients undergoing treatment.
Purpose of the Study:
- To determine the efficacy of cyclic PGE1 alpha-ciclodestrina treatment in reducing cardiovascular events.
- To compare cardiovascular outcomes between patients treated with PGE1 alpha-ciclodestrina and a historical reference group.
- To investigate the impact of PGE1 alpha-ciclodestrina on symptoms and mortality in various vascular conditions.
Main Methods:
- A comparative study involving two groups of vascular patients: one treated with PGE1 alpha-ciclodestrina and a historical reference group.
- Patients in the treatment group received at least four short-term PGE1 alpha-ciclodestrina cycles annually.
- Follow-up duration was at least 24 months, with comparable sex and age distributions between groups.
Main Results:
- In intermittent claudication patients, yearly cardiovascular morbidity decreased from 15% to 10%, and mortality from 11% to 6% with PGE1 alpha-ciclodestrina.
- For critical ischemia patients (rest pain and gangrene), morbidity decreased from 24% to 19% and mortality from 16% to 11%.
- In gangrene patients, morbidity reduced from 35% to 27% (P < 0.025), and mortality decreased from 26% to 17% with PGE1 alpha-ciclodestrina treatment.
Conclusions:
- Cyclic treatment with PGE1 alpha-ciclodestrina demonstrates significant benefits beyond symptom improvement.
- The study highlights a notable reduction in cardiovascular morbidity and mortality, a previously unreported finding.
- PGE1 alpha-ciclodestrina offers a promising therapeutic strategy for managing vascular disease and its cardiovascular complications.
Background:
Cardiovascular morbidity and mortality were evaluated in two groups of vascular patients (one treated with PGE1 alpha-ciclodestrina according to the short term protocol and one reference group) with a follow up of at least 24 month.
Methods:
The former group included patients who had been treated with at least four PGE1 alpha-ciclodestrina, short-term treatment cycles per year while the latter was a historical reference group managed without prostaglandins. The two groups were comparable for sex and age distribution.
Results:
In the PGE1 alpha-ciclodestrina group 142 patients (mean age 64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia: 43 for rest pain, and 52 for localised gangrene). The historical reference group included 157 patients (mean age 65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia (49 rest pain, 55 gangrene). In claudicants yearly cardiovascular morbidity was reduced from the 15% observed in the reference group to 10% in patients treated with PGE1 alpha-ciclodestrina. Yearly mortality decreased from 11% in the reference group to 6% in the treated group. In rest pain patients morbidity decreased from 24% in the reference group to 19% in the treated group. Mortality also decreased (from 16% to 11%). In patients with gangrene the difference in morbidity between the reference group (35%) and the PGE1 alpha-ciclodestrina group (27%) was even more evident (P < 0.025). In this group the mortality per year was reduced from 26% in the reference group to 17% in the PGE1 alpha-ciclodestrina treated group.
Conclusion:
It appears that cyclic treatment with PGE1 alpha-ciclodestrina produces not only an improvement in signs and symptoms related to vascular disease but also an important decrease in cardiovascular morbidity and mortality which has not been previously reported.