title: Efficacy and safety of a single-pill fixed-dose combination of high-dose telmisartan/hydrochlorothiazide in patients with uncontrolled hypertension.
abstract: OBJECTIVE
  Many patients still have high blood pressure (BP) after treatment with high-dose angiotensin II type 1 receptor blockers (ARBs) or Preminent® (medium-dose of losartan (50 mg/day)/hydrochlorothiazide (HCTZ) (12.5 mg/day)). Therefore, we analyzed whether Micombi®BP (high-dose telmisartan (80 mg/day)/HCTZ (12.5 mg/day)) could provide better results with regard to efficacy and safety for patients with uncontrolled hypertension.
  
  
  METHODS
  In total, 44 hypertensive patients (22 males, age 71±14 years) who showed uncontrolled BP despite the use of high-dose ARBs or Preminent® were enrolled in this study. We used a changeover design in which the patients were switched from high-dose ARBs or Preminent® to Micombi®BP. We analyzed BP, heart rate (HR), and biochemical parameters before and after treatment for 3 months.
  
  
  RESULTS
  Systolic BP and diastolic BP significantly decreased (125±15/69±11 mmHg) and 85% of the patients achieved their target BP at 3 months after changeover. Patients who switched from ARBs and those who switched from Preminent® showed similar BP-lowering effects. In addition, the reductions in BP after 3 months in patients with or without chronic kidney disease and in those with or without metabolic syndrome (MetS) were also similar. There were no significant changes in HR during the study period. Although blood levels of potassium, hemoglobin A1c and uric acid (UA) significantly increased after 3 months for all of the patients, none of the patients showed serious adverse effects.
  
  
  CONCLUSIONS
  High-dose telmisartan/HCTZ therapy was associated with a significant reduction in BP and helped patients achieve their target BP.
authors.affiliation: Department of Cardiology, Fukuoka University School of Medicine, Japan.
authors.forename: Yuhei
authors.initials: Y
authors.lastname: Shiga
authors.forename: Shin-ichiro
authors.initials: S
authors.lastname: Miura
authors.forename: Ryoko
authors.initials: R
authors.lastname: Mitsutake
authors.forename: Kenji
authors.initials: K
authors.lastname: Norimatsu
authors.forename: Itsuki
authors.initials: I
authors.lastname: Nagata
authors.forename: Tadaaki
authors.initials: T
authors.lastname: Arimura
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Shimizu
authors.forename: Joji
authors.initials: J
authors.lastname: Morii
authors.forename: Takashi
authors.initials: T
authors.lastname: Kuwano
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Uehara
authors.forename: Asao
authors.initials: A
authors.lastname: Inoue
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Shirotani
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Fujisawa
authors.forename: Eiyu
authors.initials: E
authors.lastname: Matsunaga
authors.forename: Keijiro
authors.initials: K
authors.lastname: Saku
mesh_terms: D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000494:pharmacology / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D001565:Benzoates / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006442:Glycated Hemoglobin / Q000378:metabolism; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D006973:Hypertension / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000188:drug therapy; D011188:Potassium / Q000097:blood; D000077333:Telmisartan; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D004304:Dosage Forms; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D006852:Hydrochlorothiazide; D011188:Potassium; D000077333:Telmisartan; D014527:Uric Acid; C436283:telmisartan, hydrochlorothiazide drug combination