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Pharmacoepidemiology and Drug Safety 2010-May

Increased risk of abdominal wall hernia associated with combination anti-retroviral therapy in HIV-infected patients-results from a Swedish cohort-study.

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Anders Sundström
Orjan Mortimer
Börje Akerlund
Anders Karlsson
Leo Flamholc
Camilla Håkangård
Helena Granholm
Ingemar Persson
Linda Morfeldt

Słowa kluczowe

Abstrakcyjny

OBJECTIVE

To determine if anti-retroviral therapy (ART) in HIV-infected patients is associated with an increased risk for development of abdominal wall hernia.

METHODS

A cohort study of 1072 HIV-infected patients in Sweden. Information was collected by questionnaires to patients and treating physicians, chart reviews by study physicians and regular blood tests for metabolic disorders. Adjusted relative risks were estimated by Cox proportional hazards models.

RESULTS

Sixty-three patients (5.9%) developed abdominal wall hernia during the study period, 34 inguinal and 29 midline. Compared to the male general population, inguinal hernia was twice as common in the male study population, standardized incidence ratio (SIR) 2.0 (95% confidence interval (CI) 1.4-2.8). An increased incidence rate of abdominal wall hernia was found in patients exposed to ART, 11.3 per 1000 person-years (PY) compared with therapy naïves, 2.1 per 1000 PY. When adjusting for confounding risk-factors, ART containing protease inhibitors (PIs) during the 2nd and 3rd year of treatment was associated with the development of midline hernia with a hazard ratio (HR) of 10.7 (95%CI 1.3-85.7), and of inguinal hernia with an HR of 4.4 (95%CI 1.1-16.6). Other independent risk factors were age and diabetes/impaired fasting glucose for midline hernia, and age and a previous diagnosis of AIDS for inguinal hernia.

CONCLUSIONS

We found an increased risk of developing abdominal wall hernia associated with PI-containing ART. The size of the study-population did not permit any conclusions regarding non-PI-containing ART.

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