Telmisartan, amlodipine, rosuvastatin: Triple threat against hypertension, dyslipidaemia
The three-drug combination of telmisartan, amlodipine and rosuvastatin yields significant reductions in blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels in patients with hypertension and dyslipidaemia while having a good safety profile and tolerability, according to data from the J-TAROS* trial.
“Hypertension is a well-known risk factor for cardiovascular diseases (CVDs), whose prevalence is gradually increasing with dyslipidaemia,” the investigators noted. “Patients with multiple risk factors … need to take several medications to control BP and LDL-C, especially in elderly patients who have multiple comorbidities.”
However, polypharmacy and regimen complexity are the two most recognized reasons for medication nonadherence, which in a major cause of treatment failure, they added.
“Thus, administration of antihypertensive and lipid-lowering therapy via fixed-dose combinations could improve adherence by reducing the pill burden,” they said.
The phase III J-TAROS trial randomized 144 patients (68.06 percent male) to receive one of the following combinations: telmisartan 80 mg/amlodipine 10 mg/rosuvastatin 20 mg (n=47; mean age 67.96 years), telmisartan 80 mg/amlodipine 10 mg (n=49; mean age 66.63 years) or telmisartan 80 mg/rosuvastatin 20 mg (n=48; mean age 65.88 years) for 8 weeks.
By the end of treatment, results for the primary efficacy endpoints were more favourable in the triple therapy arm than in the two-drug combination arms. Specifically, triple therapy improved mean sitting systolic blood pressure by –24.41 mm Hg vs –9.31 mm Hg with the telmisartan/rosuvastatin combo, as well as mean LDL-C by −57.59 percent vs 6.08 percent with the telmisartan/amlodipine combo. [Clin Ther 2019;doi:10.1016/j.clinthera.2018.12.008]
Additionally, significantly more patients in the triple therapy arm achieved the target BP (87.2 percent vs 50.0 percent in the telmisartan/rosuvastatin arm; p<0.001) and target LDL-C (97.87 percent vs 6.12percent in the telmisartan/amlodipine arm; p<0.0001) at week 8.
In terms of safety, the incidence of overall adverse events (AEs), adverse drug reactions and serious AEs were similar in the three treatment arms.
According to the investigators, while the present data demonstrate the efficacy of a fixed-dose combination of telmisartan, amlodipine and rosuvastatin, the the polypill strategy may be limited by the inconvenience of dose adjustments.
When therapeutic target is not reached, fine-tuning with the polypill strategy may be difficult, they continued. Moreover, patients who experience an AE with any of the drug components is bound to discontinue use of all drugs.
“Nonetheless, the long-term studies found better risk factor control by better adherence to the polypill strategy. Actually, fixed-dose combinations improve … adherence by 20–24 percent compared with free-equivalent combination regimen, thereby contributing to higher target goal achievement and fewer complications,” they said. [Am J Med 2007;120:713-719;
*Jeil Telmisartan, Amlodipine and Rosuvastatin