作者: Kalantar-Zadeh, Kamyar ; Molnar, Miklos Z ; Thomas, Fridtjof ; Kovesdy, Csaba P ; Streja, Elani ; Potukuchi, Praveen K ; Obi, Yoshitsugu ; Dashputre, Ankur A ; Sumida, Keiichi ; Akbilgic, Oguz ; Gatwood, Justin

BACKGROUND: Patients with advanced chronic kidney disease (CKD) are at high risk for dyskalemias, which may induce arrhythmias that require immediate emergent or hospital care. The association of dyskalemias with short-term hospital/emergency room (ER) visits in advanced CKD is understudied. OBJECTIVE: To assess the association of dyskalemias with short-term hospital/ER visits in an advanced CKD population. METHODS: From among 102,477 US veterans transitioning to dialysis from 2007 to 2015, we identified 21,366 patients with 2 predialysis outpatient eGFR < 30 ml/min/1.73m² 90-365 days apart (with the second eGFR serving as the index date) and at least 1 potassium (K) in the baseline period (1 year before index) and 1 outpatient K (oK) in the follow-up (1 year after the index but before dialysis initiation). We examined the association of time-varying hypokalemia (K < 3.5 mEq/L) and hyperkalemia (K > 5.5 mEq/L) vs referent (3.5-5.5 mEq/L) with separate hospital and ER visits within 2 calendar days following each oK value over the 1-year follow-up period from the index. We used generalized estimating equations with binary distribution and logit link to model the exposure-outcome relationship adjusted for various confounders. We conducted various subgroup and sensitivity analyses to test the robustness of our results. RESULTS: Over the 1-year follow-up, 125,266 oK measurements were observed, of which 6.8% and 3.7% were classified as hyper- and hypokalemia, respectively. In the multivariable-adjusted model, hyperkalemia (adjusted odds ratio [aOR] = 2.04; 95% CI = 1.88-2.21) and hypokalemia (aOR = 1.66; 95% CI = 1.48-1.86) were associated with significantly higher odds of hospital visits. Similarly, hyperkalemia (aOR = 1.83; 95% CI = 1.65-2.03) and hypokalemia (aOR = 1.24; 95% CI = 1.07-1.44) were associated with significantly higher odds of ER visits. Results were robust to subgroups and sensitivity analyses. CONCLUSIONS: In patients with advanced CKD, dyskalemias are associated with higher risk of hospital/ER visits. Interventions targeted at lowering the risk of dyskalemias might help in reducing the health care utilization and associated economic burden among patients with advanced CKD experiencing dyskalemias. DISCLOSURES: This study was supported by grant 5U01DK102163 from the National Institute of Health (NIH) to Kamyar Kalantar-Zadeh and Csaba P. Kovesdy and by resources from the US Department of Veterans Affairs. The data reported here have been supplied in part by the United States Renal Data System (USRDS). Support for VA/CMS data were provided by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development, VA Information Resource Center (project numbers SDR 02-237 and 98-004). Opinions expressed in this article are those of the authors and do not necessarily represent the opinion of the Department of Veterans Affairs or the funding institution. Kovesdy has received honoraria from Akebia, Ardelyx, Astra Zeneca, Bayer, Boehringer-Ingelheim, Cara Therapeutics, Reata, and Tricida unrelated to this study. Kalantar-Zadeh has received honoraria and/or support from Abbott, Abbvie, ACI Clinical (Cara Therapeutics), Akebia, Alexion, Amgen, American Society of Nephrology, Astra-Zeneca, Aveo, BBraun, Chugai, Cytokinetics, Daiichi, DaVita, Fresenius, Genentech, Haymarket Media, Hofstra Medical School, International Federation of Kidney Foundations, International Society of Hemodialysis, International Society of Renal Nutrition & Metabolism, Japanese Society of Dialysis Therapy, Hospira, Kabi, Keryx, Kissei, Novartis, OPKO, National Institutes of Health, National Kidney Foundations, Pfizer, Regulus, Relypsa, Resverlogix, Dr Schaer, Sandoz, Sanofi, Shire, Veterans Affairs, Vifor, UpToDate, and ZS-Pharma, unrelated to this study. Gatwood has received research support from AstraZeneca, Merck & Co., and GlaxoSmithKline unrelated to this study. Obi has received research support from Relypsa/Vifor Pharma Inc. The remaining authors declare that they have no relevant financial interests.

2019-10-01·The Lancet1区 · 医学

Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial

1区 · 医学

Article

作者: Ma, Jia ; Warren, Suzette ; Romero, Alain ; Rossignol, Patrick ; Agarwal, Rajiv ; Williams, Bryan ; Garza, Dahlia ; Mayo, Martha R ; White, William B

BACKGROUNDSpironolactone is effective at reducing blood pressure in patients with uncontrolled resistant hypertension. However, the use of spironolactone in patients with chronic kidney disease can be restricted by hyperkalaemia. We evaluated use of the potassium binder patiromer to allow more persistent use of spironolactone in patients with chronic kidney disease and resistant hypertension.METHODSIn this phase 2 multicentre, randomised, double-blind, placebo-controlled study, we enrolled participants aged 18 years and older with chronic kidney disease (estimated glomerular filtration rate 25 to ≤45 mL/min per 1·73 m²) and uncontrolled resistant hypertension from 62 outpatient centres in ten countries (Bulgaria, Croatia, Georgia, Hungary, Ukraine, France, Germany, South Africa, the UK, and the USA). Patients meeting all eligibility criteria at the final screening visit were stratified by local serum potassium measurement (4·3 to <4·7 mmol/L vs 4·7 to 5·1 mmol/L) and history of diabetes. Participants were randomly assigned (1:1) with an interactive web response system to receive either placebo or patiromer (8·4 g once daily), in addition to open-label spironolactone (starting at 25 mg once daily) and their baseline blood pressure medications. Participants, the study team that administered treatments and measured blood pressure, and the investigators were masked to assigned treatment groups. Dose titrations were permitted after 1 week (patiromer) and 3 weeks (spironolactone). The primary endpoint was the between-group difference at week 12 in the proportion of patients on spironolactone. Efficacy endpoints and safety were assessed in all randomised patients (intention to treat). The study was registered with Clinicaltrials.gov, NCT03071263.FINDINGSBetween Feb 13, 2017, and Aug 20, 2018, we screened 574 patients. 295 (51%) of 574 patients met all inclusion criteria and were randomly assigned to spironolactone in addition to double-blind treatment with either placebo (n=148) or patiromer (n=147). At week 12, 98 (66%) of 148 patients in the placebo group and 126 (86%) of 147 patients in the patiromer group remained on spironolactone (between-group difference 19·5%, 95% CI 10·0-29·0; p<0·0001). Adverse events were mostly mild or moderate in severity and occurred in 79 (53%) of 148 patients in the placebo group and 82 (56%) of 147 patients in the patiromer group.INTERPRETATIONIn patients with resistant hypertension and chronic kidney disease, patiromer enabled more patients to continue treatment with spironolactone with less hyperkalaemia. Persistent spironolactone enablement in this population of patients has clinical relevance for the treatment of resistant hypertension.FUNDINGRelypsa, a Vifor Pharma Group Company.

2019-06-01·Journal of Managed Care & Specialty Pharmacy4区 · 医学

Prescription Drug Spending and Medication Adherence Among Medicare Beneficiaries with Heart Failure

4区 · 医学

Article

作者: Phillips, Victoria ; McGee, Blake Tyler ; Higgins, Melinda K. ; Butler, Javed

BACKGROUNDEvidence suggests that cost sharing adversely affects appropriate prescription drug use for chronic disorders. However, few studies have evaluated this effect in heart failure (HF), the most common cause of hospitalization in Medicare.OBJECTIVETo determine whether spending on HF pharmacotherapy by Medicare Part D enrollees was associated with prescription refill adherence.METHODSThis correlational study used pooled data from the 2010-2012 Medicare Current Beneficiary Survey (MCBS). The analysis sample consisted of community-dwelling MCBS participants with self-reported HF and continuous Part D coverage during the year of participation. 3 drug classes were analyzed independently: beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers (ARBs). 1,448 weighted participant-year records (derived from 964 individuals) met the inclusion criteria, of which 846 (58%) were included for beta-blockers, 633 (44%) for ACE inhibitors, and 229 (16%) for ARBs. Spending was measured by average out-of-pocket payment for the relevant prescription, standardized to a 30-day supply, as a percentage of average monthly income. Adherence was measured by the medication possession ratio (MPR): total days supplied for all but the last refill divided by number of days between the first and last fills of the year.RESULTSAccounting for sampling weights, the median (interquartile range) monthly income was $1,472 ($949-$2,466), and average percentage of monthly income spent on a 30-day medication supply was 0.22% for beta-blockers, 0.19% for ACE inhibitors, and 0.90% for ARBs. Mean MPR was 88.9% for beta-blockers, 88.5% for ACE inhibitors, and 90.4% for ARBs. Risk-adjusted models showed that percentage of income spent on a beta-blocker prescription was directly associated with odds of nonadherence (MPR < 80%), odds ratio = 1.38, 95% CI = 1.01-1.89, P = 0.045, and inversely associated with beta-blocker MPR, B = -4.17, SE = 1.23, P = 0.001. No such association was observed for ACE inhibitors or ARBs.CONCLUSIONSPrice sensitivity was evident for beta-blockers but not for antiangiotensin drugs, despite very low out-of-pocket costs and high adherence. This study is relevant to value-based pricing of HF management drugs in Part D plans.DISCLOSURESNo outside funding supported this study. Butler has served as a paid consultant or advisor on unrelated projects for Amgen, Array, Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CVRx, G3, Innolife, Janssen, Medtronic, Merck, Novartis, Relypsa, Stealth Peptide, SC Pharma, Vifor, and ZS Pharma. The other authors have no potential conflicts of interest to declare. An early version of this paper was presented as a poster at Sigma Theta Tau International's 28th Nursing Research Congress; July 27-31, 2017; Dublin, Ireland.

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