Evidence with Telmisartan Translated to Real World

Background 

Observational treatment comparisons could be useful for expanding indications for medical products. Real-world database analysis that would support the causal inferences as evident in the well-designed randomized clinical trials (RCTs) is essential to ascertain the efficacy of the drug for such supplemental indications.

Aim

To ascertain whether longitudinal data from a health care database would support the results of an RCT that led to a supplemental indication for telmisartan.

Patient Profile

• Patients with a diagnosis of coronary artery disease, peripheral artery disease, cerebrovascular disease, or diabetes mellitus during the 180 days before cohort entry (n=52739).
• All patients were newly prescribed telmisartan or ramipril users (age ≥55 years).
• The inclusion and exclusion criteria of the Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial (ONTARGET) were replicated in this study.

Method 

Study Design

• A database cohort study.

Outcomes

• A composite of myocardial infarction (MI), stroke, or hospitalization for congestive heart failure (CHF).

Results

• Of the entire study population, 48053 were newly prescribed ramipril users (mean age, 68.29 years; males, 66.5%) and 4665 were newly prescribed telmisartan users (mean age, 69.43 years; males, 51.7%).
• A propensity score match yielded 4665 cases each of newly prescribed telmisartan users (mean age, 69.43 years; males 51.7%), and newly prescribed ramipril users (mean age, 69.36 years; males 50.2%).
• In ONTARGET, the relative risk of the composite outcome of death from CV causes, stroke, MI, and hospitalization for CHF in ONTARGET 1.01, indicating no substantial differences between the two drugs. In the present study, the PS-matched relative risk of composite risk of stroke, MI, and hospitalization for CHF for the 2 medications was also similar (hazard ratio [HR], 0.9).
• Telmisartan was associated with a significant decrease in the risk of angioedema (HR, 0.13) as compared to ramipril in ONTARGET. The incidence of angioedema with telmisartan vs. ramipril was also less in the PS-matched individuals (0.4 events vs. 3.1 events per 100 person years) (HR, 0.4; P = .01).

Conclusions

• Real world data demonstrates that telmisartan is equally effective to ramipril, with fewer incidences of angioedema
• Non-randomized real-world data, if created selectively, might generate evidence in favor of establishing supplemental drug indications

JAMA Intern Med. 2018; 178 (1): 55-63.