The special drug use-results survey on long-term use of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed dose combination tablets in Patients with Hypertension in Japan (Japanese Micatrio PMS, long term)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, prospective, observational, single arm

Study drug and medical condition

• Medicinal product name, other:
  Micatrio® Combination Tablets
• Study drug International non-proprietary name (INN) or common name:
  TELMISARTAN

  AMLODIPINE

  HYDROCHLOROTHIAZIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (C09DX08) telmisartan, amlodipine and hydrochlorothiazide

  telmisartan, amlodipine and hydrochlorothiazide
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  Patients who diagnosed with hypertension based upon the most recent JSH guideline.; Inclusion criteria; - Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert; - Patients who have never been treated with Micatrio® Combination Tablets before enrolment
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  500

Study design details

• Study design:
  Non-interventional study based on newly collected data. The study consisted of a baseline visit and follow up visits at Weeks 4, 8, 12, 24, 36, and 52 for patients who had newly initiated Micatrio® Combination Tablets. The patients were followed up until discontinuation of Micatrio® Combination Tabs
• Main study objective:
  Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
• Outcomes:
  The frequency of patients with any suspected adverse drug reactions (ADRs), change from baseline in blood pressure at Week 52.
• Data analysis plan:
  Descriptive statistics will be summarized for safety and efficacy. Incidence of adverse drug reactions.Change from baseline in blood pressure at Week 52.Subgroup analyses.
• Summary results:
  Adverse Drug Reactions; The overall incidence of ADRs reported during the course of this PMS (4.76% [32/672 patients]) was lower than that described in the Japanese package insert of Micatrio® Combination Tablets (14.4% [40/278]). Most ; ADRs reported in the PMS were the same as those listed in the Japanese package insert of Micatrio® Combination Tablets, suggesting no remarkable changes were found on the safety profiles from the time of Micatrio® Combination Tablets approval on 28 September 2016.; Effectiveness (Change from baseline in clinic DBP and SBP)[mmHg] at Week 52); No remarkable change was found in clinic DBP and SBP at Week 52, indicating that patients’ blood pressures were well controlled and maintained. From the results for change in blood pressure at Week 52, consistent effectiveness profile was found for long-term use of Micatrio® Combination Tablets as same as the results which were obtained from clinical trials at the time of Micatrio® Combination Tablets approval on 28 September 2016.; No remarkable change was noted in DBP and SBP at each time point, as well as proportion of patients with clinic DBP <90 mmHg and/or SBP <140 mmHg, indicating that patients’ blood pressures were well controlled and maintained.; Appropriate use of Micatrio® Combination Tablets; The majority of patients (490 patients, 97.03%) used Micatrio® Combination Tablets appropriately.; ; In conclusion, the PMS results raised no new concerns on the safety and effectiveness profile, and appropriate use of Micatrio® Combination Tablets in long-term daily use in Japanese patients with hypertension.