drug adverse effects of angiotensin II receptor antagonists
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Adverse effects
- well tolerated
- similar to placebo
- reduced incidence of cough relative to ACE inhibitors
- urticaria & angioedema (rare)
- no increased risk of cancer; refs[2] report RR = 1.1-1.2; but FDA concludes no excess risk of cancer with ARBs[4]
- no increased cardiovascular risk[3]
- risk of contrast nephropathy[5]
- may decrease GFR & increase serum creatinine in patients with renal perfusion maintained by increased angiotensin-2[6]
- associated with increased risk of hospitalization with acute renal failure[7]
- increases in serum creatinine after the start of ACE inhibitor or ARB is associated with adverse cardiorenal outcomes, even below the guideline recommended threshold of a 30% increase for stopping treatment[8]
- <2% with serum creatinine increases of >=30% after starting ARB
- these patients with increased risk for
- end-stage renal disease (RR=3.4)
- myocardial infarction (RR=1.5)
- heart failure (RR=1.4)
- all-cause mortality (RR=1.8)[8]
- these patients with increased risk for
- increase in adverse events seen (hospitalizations & emergency department visits) after switching from brand name to generic drug (17%)[9]
* nitrosamines NDEA & NMBA found in certain lots of losartan & valsartan (2018)
* FDA list nitrosamine-free ARBs[10]
More general terms
References
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, Update 9/99
- ↑ 2.0 2.1 Sipahi I et al Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials The Lancet Oncology, Early Online Publication, 14 June 2010 PMID: https://www.ncbi.nlm.nih.gov/pubmed/20542468 Free PMC article. doi:10.1016/S1470-2045(10)70106-6 http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2810%2970106-6/abstract
- ↑ 3.0 3.1 Bangalore S et al. Angiotensin receptor blockers and risk of myocardial infarction: Meta-analyses and trial sequential analyses of 147 020 patients from randomised trials. BMJ 2011 Apr 26; 342:d2234 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21521728
Julius S et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: The VALUE randomised trial. Lancet 2004 Jun 19; 363:2022-31. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15207952 - ↑ 4.0 4.1 FDA Drug Safety Communication: 06/02/2011 No increase in risk of cancer with certain blood pressure drugs- Angiotensin Receptor Blockers (ARBs) http://www.fda.gov/Drugs/DrugSafety/ucm257516.htm
Bhaskaran K et al. Angiotensin receptor blockers and risk of cancer: Cohort study among people receiving antihypertensive drugs in UK General Practice Research Database. BMJ 2012 Apr 24; 344:e2697 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22531797 - ↑ 5.0 5.1 Rim MY et al. The effect of renin-angiotensin-aldosterone system blockade on contrast-induced acute kidney injury: A propensity-matched study. Am J Kidney Dis 2012 Oct; 60:576. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22658321
- ↑ 6.0 6.1 Medical Knowledge Self Assessment Program (MKSAP) 16, American College of Physicians, Philadelphia 2012
- ↑ 7.0 7.1 Tomlinson LA et al ACE Inhibitor and Angiotensin Receptor-II Antagonist Prescribing and Hospital Admissions with Acute Kidney Injury: A Longitudinal Ecological Study. PLoS ONE. 2013 8(11): e78465 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24223154 <Internet> http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0078465
- ↑ 8.0 8.1 8.2 Schmidt M et al Serum creatinine elevation after renin-angiotensin system blockade and long term cardiorenal risks: cohort study. BMJ 2017;356:j791 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28279964 Free full text <Internet> http://www.bmj.com/content/356/bmj.j791
- ↑ 9.0 9.1 Leclerc J, Blais C, Rochette L, Hamel D, Guenette L, Poirier P. Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada. A Population-Based Time Series Analysis. Circulation: Cardiovascular Quality and Outcomes. 2017; 10:e003891. Published October 3, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28974512 <Internet> http://circoutcomes.ahajournals.org/content/10/10/e003891
Alter DA When Do We Decide That Generic and Brand-Name Drugs Are Clinically Equivalent? Perfecting Decisions With Imperfect Evidence. Circulation: Cardiovascular Quality and Outcomes. 2017; 10:e004158. Published October 3, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28974513 <Internet> http://circoutcomes.ahajournals.org/content/10/10/e004158 - ↑ 10.0 10.1 FDA Statement. April 4, 2019 Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency's list of known nitrosamine-free valsartan and ARB class medicines, as part of agency's ongoing efforts to resolve ongoing safety issue. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635251.htm
FDA Drug Safety and Availability. FDA's Assessment of Currently Marketed ARB drug product. https://www.fda.gov/Drugs/DrugSafety/ucm634620.htm