Top Papers Of The Month

Top Papers in Nephrology: Research You May Have Missed in May 2021

AUTHOR:
James Matera, DO
Practicing Nephrologist, Senior Vice President for Medical Affairs, and Chief Medical Officer
CentraState Medical Center, Freehold, New Jersey

CITATION:
Matera J. Top papers in nephrology: research you may have missed in May 2021. Consultant360. Published online July 22, 2021.

 

Several interesting and timely articles have been published in the last few months which are summarized here, including research on the effects of apabetalone on major cardiovascular events in patients with diabetes and chronic kidney disease, pharmacy-led mobile health interventions and transplant medication safety, and intensive management blood pressure.

Effect of Apabetalone on Cardiovascular Events in Dialysis, CKD, and Recent Acute Coronary Syndromes1

Results from the Bromodomain and Extraterminal on Major Adverse Cardiovascular Events (BETonMACE) placebo-controlled, randomized control trial from the University of California, Irvine, were published in June. This phase 3 trial was designed to compare the effects of apabetalone (a selective modulator of bromodomain and extraterminal transcription system) on major cardiovascular events in patients with diabetes and chronic kidney disease (CKD). The endpoint was time to first major cardiovascular event.

A total of 2425 patients with type 2 diabetes and a recent acute coronary event were studied. In this cohort, 288 had defined CKD with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min. This trial was carried out for 27 months with a follow-up period of 27 months.

Patients with CKD in the placebo group had developed more incidents of MACE compared with those without CKD (35 events in 164 patients [21%] vs 114 events in 1041 patients [11%]). The secondary endpoint was hospitalization for congestive heart failure, results for which also showed that patients in the placebo group had a higher number of hospitalizations (14 hospitalizations in 164 patients [9%] compared with 34 of 1041 patients [3%]).

Adverse effects were also similar between the placebo and treatment arms. With MACE being a large cause of morbidity and mortality in patients with CKD with diabetes, this trial is the first to study the BET protein manipulation as a potential to reduce risk. More studies may prove beneficial.

Pharmacy-Led Mobile Health Interventions and Transplant Medication Safety: A Randomized Controlled Trial2

Medication errors are a global problem in the entire field of medicine. In transplant medicine, they can lead to adverse events including increased hospitalization and even allograft loss or dysfunction. Medication education is geared to help alleviate some of these problems, and pharmacy-led initiatives bring the pharmacist as a medication expert into the forefront role in the health care team. A study from South Carolina analyzed post-transplant patients and randomly assigned them into 1 of 2 arms:

  1. Intervention arm where they had pharmacist-driven medication monitoring using a mobile health application, televisits, and patient integration using home blood pressure and glucose monitoring. The application included their medication regimen, reminders on dosing times, and assessment of any adverse effects.
  2. Control arm where they did not use this application.

Patients in both the control and intervention arms received usual care, including serial laboratory monitoring and regular clinic visits. The outcomes studied focused on the incidence and severity of medication errors and adverse events. Although it was a small study group, 68 patients were enrolled in each arm. The average age was 51 years. A total 57% of the participants were men and 64% of the participants were Black.

In the intervention arm, a 61% reduction in the risk rate was reported, and a significantly lower incidence risk of severe adverse events was seen (1.97 adverse events/y in the control arm and 1.18 adverse events/y in the intervention arm). A secondary outcome of hospitalizations was also studied, results of which also showed improvement in the intervention arm (44 vs 74).

While this study that showed pharmacist-led mobile intervention can lead to a reduction in adverse events, medical errors, and even hospitalizations, whether this truly impacts the overall graft survival rates in transplant patients has yet to be studied.

Final Report of a Trial of Intensive or Standard Blood Pressure Control3

The SPRINT research group tried to answer an age-old question: “What blood pressure approach is best?” More than 9000 patients who did not have diabetes and without prior cerebrovascular disease were assigned to either an intensive blood pressure control group, defined as a systolic blood pressure target of less than 120 mm Hg, or a standard blood pressure control group, defined as a systolic blood pressure target of less than 140 mm Hg. Primary outcomes reviewed were myocardial infarction, acute coronary syndromes, stroke, acute decompensated heart failure, or death from cardiovascular causes.

After an average 3.3-year follow-up, measurements of the primary outcomes during the trial were significantly lower in the intensive-treatment group than in the standard group (1.77%/y vs 2.40%/y). All-cause mortality was also lower in the intensive group vs in the standard arm (1.06%/y vs 1.41%/y).

One of the issues that always faced the intensive control group focused on serious adverse events, which limited the effectiveness of goals. Again, this study showed that hypotension, AKI, and syncope were seen more frequently in the intensive arm. There was also a trend toward higher rates of heart failure in the intensive group. Good clinical judgement is needed to weigh the risks of adverse events vs cardiovascular benefits of intensive control.

References

  1. Kalantar-Zadeh K, Schwartz GG, Nicholls SJ, et al; BETonMACE Investigators. Effect of apabetalone on cardiovascular events in diabetes, CKD, and recent acute coronary syndrome: results from the BETonMACE randomized controlled trial. Clin J Am Soc Nephrol. 2021;16(5):705-716. https://doi.org/10.2215/cjn.16751020
  2. Gonzales HM, Fleming JN, Gebregziabher M, et al. Pharmacist-led mobile health intervention and transplant medication safety: a randomized controlled clinical trial. Clin J Am Soc Nephrol. 2021;16(5):776-784. https://doi.org/10.2215/cjn.15911020
  3. SPRINT Research Group, Lewis CE, Fine LJ, et al. Final report of a trial of intensive versus standard blood-pressure control. N Engl J Med. 2021;384(20):1921-1930. https://doi.org/10.1056/nejmoa1901281