Inpatient Insights
Pitavastatin shown to prevent CVD in patients with HIV
Patients with HIV infections have twice the risk of developing atherosclerotic CVD compared with others, making prevention strategies for this population critical. According to a new study published in NEJM on August 24, 2023, patients with HIV infections who received pitavastatin had a lower risk of a major adverse CV event than those who received placebo over a median follow-up of 5.1 years.
The REPRIEVE investigators conducted a Phase 3 trial in which almost 8,000 participants from research sites in the United States, Canada, Thailand, South Africa, Brazil, Peru, Haiti, Zimbabwe, Botswana, Uganda, and India were randomly assigned to receive 4 mg of pitavastatin calcium daily or a placebo. All patients had HIV infection with a low to moderate risk of CVD and were receiving antiretroviral therapy. The primary outcome was the occurrence of a major adverse CV event, which was defined as a composite of CV death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause.
The incidence of a major adverse CV event was 4.81 per 1,000 person-years in the pitava-statin group and 7.32 per 1,000 person-years in the placebo group, with muscle-related symptoms occurring in 2.3% of patients in the pitavastatin group and 1.4% of patients in the placebo group. The authors noted that other statins may have similar protective effects and that other strategies to lower LDL cholesterol may be useful in this population and should be compared with statin therapy with respect to efficacy, safety, and cost. ■
Can SGLT-2 inhibitors prevent gout flares?
SGLT-2 inhibitors are FDA-approved for managing adult patients with T2D to improve blood glucose control as an adjunct to diet and exercise. Because they are also known to decrease serum urate levels, it has been suggested that SGLT-2 inhibitors may also be useful in preventing recurrent flares of gout. Researchers from Massachusetts General Hospital and colleagues compared the number of gout flares and CV events among patients with gout taking SGLT-2 inhibitors versus patients taking DPP-4 inhibitors, another glucose-lowering medication not associated with serum urate levels or CV risk.
The study, a propensity score–matched, new-user cohort study, involved data from a general population database of patients with gout and T2D from January 1, 2014, to June 30, 2022. The primary outcome was recurrent gout flare counts from emergency department (ED), hospitalization, outpatient, and medication dispensing records. Secondary outcomes included myocardial infarction and stroke.
Results of the study, published in the August 2023 issue of Annals of Internal Medicine, showed that the flare rate was lower among patients who received SGLT-2 inhibitors than among those who received DPP-4 inhibitors (52.4 and 79.7 events per 1,000 person-years, respectively). Patients who received SGLT-2 inhibitors also had significantly fewer ED visits or hospitalizations and fewer myocardial infarctions. The question remains as to whether the same benefits would be seen in patients with gout but without T2D. ■
Coadministered pneumococcal conjugate vaccine may decrease immune response to hepatitis A vaccine
Hepatitis A vaccine (HepA) and pneumococcal conjugate vaccine (PCV) are increasingly used for pre-travel immunizations. Simultaneous administration of several vaccines prior to travel is a well-established practice, and providing 13-valent PCV (PCV13) together with HepA at pre-travel visits would be practical but data on coadministration of these two vaccines among adults have been lacking. A recent study in Clinical Microbiology and Infection, published on August 10, 2023, evaluated the safety and immunogenicity of coadministered PCV13 and HepA among over 300 adult volunteers at travel clinics at Helsinki University Hospital and Mälar Hospital in Eskilstuna, Sweden.
Patients were randomized into three groups receiving either PCV13, HepA only, or both. Antipneumococcal IgG concentrations, opsonophagocytic activity (OPA) titers, and total hepatitis A antibody concentrations were measured before vaccination and 28 ± 3 days after vaccination.
After vaccination, the mean concentration of hepatitis A antibodies was significantly lower in the PCV13 + HepA group than in the HepA group, with 83.5% of patients in the PCV13 + HepA group reaching a level of antibodies considered protective versus 96.2% of the patients in the HepA-only group. Increases in antipneumococcal IgG and OPA levels were comparable in the PCV13 + HepA and PCV13 groups, apart from a larger increase for serotype 3 in patients in the PCV13 + HepA group.
The authors concluded that while coadministration of HepA and PCV13 did not cause safety concerns or impact the patients’ response to PCV13, apart from serotype 3, it did significantly impair antibody responses to HepA. Thus, coadministration of the first HepA dose and PCV13 may not provide sufficient protection against hepatitis A for travelers. Ensuring early single-dose protection against hepatitis A may require that travelers opting for both HepA and PCV immunization not be given the vaccines together. ■
Naloxone requirements of patients with novel potent opioid overdose
Novel potent opioids (NPOs) such as brorphine, isotonitazene, metonitazene, and N-piperidinyl etonitazene are increasingly being detected in patients with illicit opioid overdose in the emergency department (ED), but the naloxone requirements and clinical needs of patients with NPO overdose are unclear. According to a recent study published in JAMA Network Open on August 29, 2023, in-hospital naloxone dosing was higher for patients who tested positive for NPOs than for patients who tested positive for fentanyl alone.
The authors conducted a subgroup analysis of data from the ongoing nationwide ToxIC Fentalog cohort study from 2020 to 2022 involving adults admitted to the ED who tested positive for NPOs. Patients were included in the analysis if their confirmatory testing was positive for an NPO analyte, including brorphine, isotonitazene, metonitazene, and/or N-piperidinyl etonitazene. The primary outcome was the total number of naloxone doses and total cumulative naloxone doses administered as part of routine clinical care following the overdose. Naloxone requirements and clinical sequelae of NPO-positive patients were compared with those testing positive for fentanyl only.
Findings of the analysis indicated that patients who tested positive for an NPO received a statistically significantly higher number of naloxone boluses in-hospital compared with patients who tested positive for fentanyl only. Patients who experienced metonitazene overdose were also more likely to suffer cardiac arrest and require cardiopulmonary resuscitation. The authors concluded that further study is warranted to confirm these preliminary results. ■