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Symptomatic thromboembolic events in patients treated with intravenous-immunoglobulins: Results from a retrospective cohort study
Authors:Elena Ramí  rez,José   A. Romero-Garrido,Eduardo Ló  pez-Granados,Alberto M. Borobia,Tamara Pé  rez,Nicolá  s Medrano,Cristina Rueda,Hoi Y. Tong,Alicia Herrero,Jesú  s Frí  as
Affiliation:1. Department of Clinical Pharmacology, Hospital Universitario La Paz, IdiPAZ, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain;2. Department of Pharmacy, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain;3. Department of Immunology, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain
Abstract:

Aims

To estimate the incidence and predictors of symptomatic arterial and venous thromboembolic events (TEE) from intravenous immunoglobulin (IVIg) therapy according to its indications.

Methods

We performed a retrospective cohort study of patients seen at our institution and treated with IVIg over a 36-month period. Indications, comorbility and comedication associated with TEE were identified by a stepwise logistic regression analysis.

Results

Of 303 patients included with at least one infusion of IVIg over three years, TEE were identified in a total of 50 patients treated with IVIg, for an incidence of 16.9% (CI 95%: 13.0–21.6); 27 (54%) arterial (9.1%;CI 95%: 6.3–13.0%) and 23 (46%) venous TEE (7.8%; CI95%: 5.2–11.4%), overall mortality was 32%. Per indication there were more patients with autoimmune conditions, secondary immunodeficiency, dysimmune neuropathies, acute rejection of solid organ transplantation and sepsis. Patients with TEE were significantly older, were more likely to be men, they had more comorbid conditions; the doses of IVIg were high (589.4 mg/kg/day vs 387.0 mg/kg/day, p < 0.001) and differences in comedication were found. The stepwise logistic regression analysis retained high doses of IVIg (OR 3.03; CI 95%: 1.49–5.67) and diuretics therapy (OR 1.69; CI 95%: 1.06–3.97) when combined with the usual comorbid confounders.

Conclusions

The incidence of TEE from IVIg therapy remains high at one in six patients treated. The most remediable factor is a high daily IVIg load. Decreasing the daily IVIg dose together with carefully weighing diuretics therapy and comorbid risk factors may be the keys to saving lives.
Keywords:Thromboembolism   Immunoglobulin therapy   Pharmacoepidemiology   Incidence studies   Comorbidity
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