title: In a subgroup of high-risk Asians, telmisartan was non-inferior to ramipril and better tolerated in the prevention of cardiovascular events.
abstract: OBJECTIVE
  Results of the recently published ONTARGET study (The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) showed that telmisartan (80 mg/day) was non-inferior to ramipril (10 mg/day) in reducing cardiovascular events. Clinicians in Asia doubt tolerability of these doses for their patients. We therefore analyzed data from this study and a parallel study TRANSCEND (Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease). Our objectives were to compare Asians and non-Asians with respect to the following: 1) Effectiveness of telmisartan vs. ramipril in reducing cardiovascular events;2) Proportions who reached the full dose of telmisartan, ramipril or placebo; and3) Proportions of overall discontinuations, and discontinuations due to adverse effects.
  
  
  METHODS
  The ONTARGET study randomized 25,620 patients at risk of cardiovascular events to ramipril, telmisartan, or their combination. The primary composite endpoint was death caused by cardiovascular disease, acute MI, stroke, and hospitalization because of congestive heart failure. TRANSCEND randomized 5926 high-risk patients with a history of intolerance to ACE-inhibitors to telmisartan or placebo. The primary outcome was the same. In this substudy, we compared Asians and non-Asians as to how well they tolerated telmisartan (given in both studies) and ramipril (given in ONTARGET).
  
  
  RESULTS
  1) Telmisartan was non-inferior to ramipril in lowering the primary endpoint among Asians (RR = 0.92; 95% CI: 0.74, 1.13); 2) more Asians achieved the full dose of either drug; 3) less withdrew (overall); and 4) less withdrew for adverse effects. Furthermore, telmisartan was better tolerated than ramipril. This advantage was greater among Asians.
  
  
  CONCLUSIONS
  Although Asians had lower BMI than non-Asians, Asians tolerated both drugs better. Regulatory agencies require reporting of safety and effectiveness data by ethnicity, but few comply with this requirement. This study shows that safety data in ethnic subgroups can help assess applicability of results to specific populations.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00153101.
authors.affiliation: University of the Philippines College of Medicine, Manila, Philippines. tdans@skybroadband.com.ph
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Dans
authors.forename: Koon
authors.initials: K
authors.lastname: Teo
authors.forename: Peggy
authors.initials: P
authors.lastname: Gao
authors.forename: Jyh-Hong
authors.initials: JH
authors.lastname: Chen
authors.forename: Kim
authors.initials: K
authors.lastname: Jae-Hyung
authors.forename: Khalid
authors.initials: K
authors.lastname: Yusoff
authors.forename: Suphachai
authors.initials: S
authors.lastname: Chaithiraphan
authors.forename: Jun
authors.initials: J
authors.lastname: Zhu
authors.forename: Liu
authors.initials: L
authors.lastname: Lisheng
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D001208:Asia; D001562:Benzimidazoles / Q000627:therapeutic use*; D001565:Benzoates / Q000627:therapeutic use*; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000208:ethnology / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D005006:Ethnicity; D006801:Humans; D010349:Patient Compliance; D010919:Placebos; D017257:Ramipril / Q000627:therapeutic use*; D012306:Risk; D000077333:Telmisartan; D016896:Treatment Outcome
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D001562:Benzimidazoles; D001565:Benzoates; D010919:Placebos; D017257:Ramipril; D000077333:Telmisartan