Abacavir usage patterns and hypersensitivity reactions in the EuroSIDA cohort.

OBJECTIVES: Five to eight per cent of HIV-positive individuals initiating abacavir (ABC) experience potentially fatal hypersensitivity reactions (HSRs). We sought to describe the proportion of individuals initiating ABC and to describe the incidence and factors associated with HSR among those prescribed ABC. METHODS: We calculated the proportion of EuroSIDA individuals receiving ABC-based combination antiretroviral therapy (cART) among those receiving cART after 1 January 2009. Poisson regression was used to identify demographic, and current clinical and laboratory factors associated with ABC utilization and discontinuation. RESULTS: Between 2009 and 2016, of 10 076 individuals receiving cART, 3472 (34%) had ever received ABC-based cART. Temporal trends of ABC utilization were also heterogeneous, with 28% using ABC in 2009, dropping to 26% in 2010 and increasing to 31% in 2016, and varied across regions and over time. Poisson models showed lower ABC utilization in older individuals, and in those with higher CD4 cell counts, higher cART lines, and prior AIDS. Higher ABC utilization was associated with higher HIV RNA and poor renal function, and was more common in Central-East and Eastern Europe and lowest during 2014. During 779 person-years of follow-up (PYFU) in 2139 individuals starting ABC after 1 January 2009, 113 discontinued ABC within 6 weeks of initiation for any reason [incidence rate (IR) 14.5 (95% confidence interval (CI) 12.1, 17.5) per 100 PYFU], 13 because of reported HSR [IR 0.3 (95% CI 0.1, 1.0) per 100 PYFU] and 35 because of reported HSR/any toxicity [IR 4.5 (95% CI 3.2, 6.3) per 100 PYFU]. There were no factors significantly associated with ABC discontinuation because of reported HSR/any toxicity. CONCLUSIONS: ABC remains commonly used across Europe and the incidence of discontinuation because of reported HSR was low in our study population.

Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry.

OBJECTIVE: To examine the association between nondefect adverse birth outcomes and in utero exposure to zidovudine (ZDV)-containing regimens versus non-ZDV antiretroviral (ARV) regimens. DESIGN: Analysis of prospectively-collected data. SETTING: Global. POPULATION: HIV-infected pregnant women prenatally exposed to antiretrovirals. METHODS: Estimation of prevalence of and risk for nondefect adverse birth outcomes among HIV-infected women. MAIN OUTCOME MEASURES: Prevalence of and risk for nondefect adverse birth outcomes. RESULTS: Among 12 780 singleton birth outcomes with in utero ZDV exposure, 96.1% were live births; 3.9% were spontaneous abortions, induced abortions or stillbirths. Among live births, 16.4% were low birthweight (LBW); 12.3% were premature. Among 1904 outcomes with in utero exposure to non-ZDV ARV regimens, 85.8% were live births; 14.2% were spontaneous abortions, induced abortions or stillbirths. Among live births, 14.1% were LBW; 12.4% were premature. Relative risk comparing exposure to ZDV-containing ARV regimens to non-ZDV ARV regimens for spontaneous abortions was 0.18 (95% confidence interval [95% CI] 0.14-0.22); induced abortions 0.28 (95% CI 0.22-0.36); stillbirths 0.76 (95% CI 0.51-1.12); premature births 1.00 (95% CI 0.87-1.15) and LBW 1.17 (95% CI 1.02-1.33). CONCLUSION: Prevalence of nondefect adverse birth outcomes is lower among outcomes with in utero ZDV exposure versus in utero non-ZDV ARV exposure. The risks for spontaneous and induced abortions were no different for ZDV-containing regimens versus non-ZDV ARV regimens. For premature births and stillbirths, there was no significant difference in risk between the two regimens. The risk of LBW was statistically significantly higher among ZDV-containing regimens versus non-ZDV ARV regimens. TWEETABLE ABSTRACT: ZDV-containing regimens do not increase the risk for nondefect adverse birth outcomes.

Risk of herpes zoster among diabetics: a matched cohort study in a US insurance claim database before introduction of vaccination, 1997-2006.

PURPOSE: To assess whether diabetes is a risk factor for herpes zoster (HZ). METHODS: We conducted a retrospective cohort study using the Integrated Health Care Information Services database, during the period 1997-2006. A type I diabetes cohort, a type II diabetes cohort and two non-diabetic cohorts matched for date of enrolment and duration of follow-up were defined. HZ and diabetes were defined using a combination of ICD-9 and prescription drug codes. Individuals with immunosuppressive conditions or treatments were excluded. Cox Proportional Hazards regression analysis using a stepwise method with backward elimination was applied to estimate the hazard ratios (HR) of HZ, including age, gender and co-morbidities as covariates. RESULTS: The study population comprised 380,401 and 20,397 type II and type I diabetic subjects respectively, as well as 1,521,604 and 81,588 matched controls. The median ages were 55, 35, 33 and 29 years, respectively. HZ incidence was 4.59, 2.13, 1.97, and 1.82 per 1,000 person-years, respectively. There was no evidence of an impact of type I diabetes on the risk of HZ. Type II diabetes was associated with an increased risk for HZ in subjects ≥ 65 (HR 3.12; 95 % CI 2.77-3.52, adjusted for gender) and in subjects between 40 and 64 (HR 1.51; 95 % CI 1.42-1.61) years of age. Cardiac disease and chronic pulmonary disease were also risk factors (HR 1.92; 95 % CI 1.73-2.13 and HR 1.52; 95 % CI 1.38-1.67) in non-diabetic subjects. CONCLUSIONS: This study suggests that type II diabetes is associated with an increased risk of developing HZ, which was particularly high in adults 65 years and older and moderately increased in adults under 65 years of age.

Should erectile dysfunction be considered as a marker for acute myocardial infarction? Results from a retrospective cohort study.

The association between erectile dysfunction (ED) and acute myocardial infarction (AMI) among men was examined in the Integrated Healthcare Information Services National Managed Care Benchmark Database (IHCIS). The IHCIS is a fully de-identified, HIPAA-compliant database and includes complete medical history for more than 17 million managed care lives; data from more than 30 US health plans, covering seven census regions; and patient demographics, including morbidity, age and gender. A total of 12,825 ED patients and an equal number of male patients without ED were included in the retrospective cohort study. Logistic regression analyses were performed to assess the adjusted risk of AMI that accounted for age at ED diagnosis, smoking, obesity and medications including ACE inhibitors, beta blockers and statins. The cohort of men with ED were observed to have a two-fold increase in the risk for AMI (OR=1.99, 95% CI=1.17, 3.38) after adjusting for age at ED diagnosis, smoking, obesity, and use of ACE inhibitors, beta blockers and statins. Some evidence of a possible trend toward increased risk was detected by age group. After controlling for the aforementioned covariates and compared to men 30-39 y of age, it was noted that patients 40-44 y of age were 3.8 times more likely to develop an AMI (OR=3.76, 95% CI=1.21, 11.7), 45- to 49-y-old men were also more than three times as likely to have an AMI (OR=3.14, 95% CI=1.03, 9.64), and 50- to 55-y-old patients had a four-fold increased risk of developing AMI (OR=4.04, 95% CI=1.39, 11.7). The risk becomes more pronounced with increasing age, indicating the need for cardiologists and internists to monitor ED patients who may not necessarily present with cardiovascular symptoms.

A case-control study of erectile dysfunction among men diagnosed with panic disorder.

The association between panic disorder and erectile dysfunction (ED) among men was examined in the Integrated Healthcare Information Services National Managed Care Benchmark Database (IHCIS). The IHCIS is a fully de-identified, HIPAA compliant database and includes complete medical history for more than 17 million managed care lives; data from more than 30 US health plans, covering seven census regions; and patient demographics, including morbidity, age and gender. A total of 60,949 ED cases and 243,796 controls were included for analysis. Unconditional logistic regression analyses were first performed to assess the crude risk of ED, and adjusted risks of ED that accounted for comorbid conditions and comedications. A second set of analyses measured the crude and adjusted risks after restricting the patient population to men who were diagnosed with panic disorder at least 1 month prior to an ED diagnosis. In the first set of analyses, men with panic disorder were observed to have more than a two-fold increase in risk for ED (OR=2.29, 95% CI=2.03, 2.58). After adjusting for comorbid conditions, a 52% increase in risk of ED was observed (OR=1.52, 95% CI=1.34, 1.72). Following subsequent adjustment for comorbidities and comedications, a 33% increased risk of ED was detected (OR=1.33, 95% CI=1.17, 1.51). In the second set of analyses studying panic disorder that preceded ED, only a 13% higher risk was noted (OR=1.13, 95% CI=0.97, 1.31). However, after adjusting for comorbid conditions, a 25% reduction in risk was observed (OR=0.75, 95% CI=0.64, 0.88). A 35% risk reduction was seen after adjusting for comorbidities and comedications (OR=0.65, 95% CI=0.56, 0.77).

Is erectile dysfunction predictive of peripheral vascular disease?

The association between erectile dysfunction (ED) and peripheral vascular disease (PVD) among men was examined in the Integrated Healthcare Information Services National Managed Care Benchmark Database (IHCIS). The IHCIS is a fully de-identified, Health Insurance Portability and Accountability Act compliant database and includes complete medical histories for more than 17 million managed-care lives; data from more than 30 US health plans, covering seven census regions; and patient demographics, including morbidity, age and gender. A total of 12 825 ED patients and an equal number of male patients without ED were included in the retrospective cohort study. Logistic regression analyses were performed to assess the adjusted risk of PVD that accounted for age at ED diagnosis, smoking, obesity and medications including angiotensin converting enzyme (ACE) inhibitors, beta blockers and statins. The cohort of men with ED were observed to have a 75% increase in risk for PVD (odds ratio (OR) = 1.75, 95% confidence interval (CI) = 1.06, 2.90) after adjusting for age at ED diagnosis, smoking, obesity and use of ACE inhibitors, beta blockers and statins. Some evidence of a possible trend towards increased risk was detected by age group. After controlling for the aforementioned covariates and compared to men aged 30-39 years, it was noted that patients aged 40-44 years were 2.1 times more likely to develop PVD (OR = 2.07, 95% CI = 0.89, 4.81), 45-49-year-old men were also more than twice as likely to have PVD (OR = 2.32, 95% CI = 1.03, 5.22), and 50-55-year-old patients had a three-fold increased risk of developing PVD (OR = 3.00, 95% CI = 1.40, 6.43). The results of this study indicate that ED may serve as a marker for PVD. The risk becomes more pronounced with increasing age, indicating the need for cardiologists and internists to monitor ED patients who may not necessarily present with cardiovascular symptoms.