title: Comparative effect of fixed-dose combination tablets of candesartan cilexetil/amlodipine versus olmesartan medoxomil/azelnidipine on laboratory parameters in patients with hypertension: a retrospective cohort study.
abstract: We conducted a retrospective cohort study to evaluate and compare the long-term effects of two single-pill fixed-dose combinations (FDCs), candesartan/amlodipine and olmesartan/azelnidipine, on laboratory parameters in patients in routine clinical practice. We identified an equal number of new users (n = 182) of a candesartan/amlodipine (8/5 mg/day) FDC tablet (CAN/AML users) and a propensity-score matched cohort (n = 182) receiving an olmesartan/azelnidipine (20/16 mg/day) FDC tablet (OLM/AZ users). Generalized estimating equations were used to estimate and compare the effects of the drugs on serum levels of creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), uric acid, sodium, potassium, aspartate aminotransferase, and alanine aminotransferase levels up to 12 months after the start of study drug administration. There was a significant increase of serum creatinine level and a significant decrease of eGFR from the baseline period to during the exposure period in both CAN/AML and OLM/AZ users, and a significant increase of BUN level in CAN/AML users. However, there were no significant differences in the mean changes of laboratory parameters between CAN/AML and OLM/AZ users. Our findings suggested that the effects of CAN/AML and OLM/AZ on laboratory parameters, including an unfavorable effect on renal function, were similar at least during 1 year of administration.
authors.affiliation: a Division of Genomic Epidemiology and Clinical Trials , Clinical Trials Research Center, Nihon University School of Medicine , Tokyo , Japan .
authors.forename: Norio
authors.initials: N
authors.lastname: Susa
authors.affiliation: a Division of Genomic Epidemiology and Clinical Trials , Clinical Trials Research Center, Nihon University School of Medicine , Tokyo , Japan .
authors.forename: Yayoi
authors.initials: Y
authors.lastname: Nishida
authors.affiliation: b Division of Pharmacology , Department of Biomedical Sciences, Nihon University School of Medicine , Tokyo , Japan .
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Yada
authors.affiliation: c Division of Laboratory Medicine , Department of Pathology and Microbiology, Nihon University School of Medicine , Tokyo , Japan , and.|d Division of Companion Diagnosis , Department of Pathology of Microbiology, Nihon University School of Medicine , Tokyo , Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nakayama
authors.affiliation: b Division of Pharmacology , Department of Biomedical Sciences, Nihon University School of Medicine , Tokyo , Japan .
authors.forename: Satoshi
authors.initials: S
authors.lastname: Asai
authors.affiliation: a Division of Genomic Epidemiology and Clinical Trials , Clinical Trials Research Center, Nihon University School of Medicine , Tokyo , Japan .|d Division of Companion Diagnosis , Department of Pathology of Microbiology, Nihon University School of Medicine , Tokyo , Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Takahashi
mesh_terms: D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D017311:Amlodipine / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001383:Azetidinecarboxylic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000627:therapeutic use*; D001806:Blood Urea Nitrogen; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D004095:Dihydropyridines / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil / Q000627:therapeutic use*; D011188:Potassium / Q000097:blood; D057216:Propensity Score; D012189:Retrospective Studies; D012964:Sodium / Q000097:blood; D013777:Tetrazoles / Q000627:therapeutic use*; D014527:Uric Acid / Q000097:blood
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D004095:Dihydropyridines; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine; D014527:Uric Acid; D001383:Azetidinecarboxylic Acid; D000068557:Olmesartan Medoxomil; D012964:Sodium; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; C061679:azelnidipine; C077793:candesartan cilexetil; D011188:Potassium
keywords: Candesartan/amlodipine; fixed-dose combination; laboratory parameter; olmesartan/azelnidipine; propensity-score matching; single-pill combination