Olmesartan-amlodipine single-pill + rosuvastatin reduces SBP, LDL-C in concomitant hypertension, dyslipidaemia

Treatment with a single-pill combination (SPC) drug, composed of olmesartan and amlodipine, plus a separate dose of rosuvastatin led to significantly reduced systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) levels in patients with concomitant hypertension and dyslipidaemia, according to the LEISURE* trial.

“The final study purpose was to develop a triple SPC with these three drugs [comprising olmesartan and amlodipine and rosuvastatin] … Our data confirmed the efficacy of the triple combination of antihypertensive and antidyslipidaemia drugs,” said the researchers.

This phase III, multicentre, double-blind trial involved 265 patients (aged 20–80 years) with concomitant hypertension and dyslipidaemia who were recruited from 36 tertiary hospitals in Korea. The participants were randomized to receive olmesartan 40 mg and amlodipine 10 mg as an SPC drug + rosuvastatin 20 mg (n=106), olmesartan 40 mg + rosuvastatin 20 mg (n=106), or the SPC drug only (n=53) for 8 weeks. [J Clin Med 2022 Jan;11:350]

At week 8, patients who received the SPC drug + rosuvastatin had a significantly greater reduction in sitting SBP (sitSBP) than those who received olmesartan + rosuvastatin (mean change from baseline, -24.30 vs -9.72 mm Hg; p<0.0001).

Patients in the SPC drug + rosuvastatin arm also achieved significantly reduced LDL-C levels compared with those in the SPC drug-only arm at week 8 (mean change from baseline, -52.31 percent vs -2.98 percent; p<0.0001).

In the per-protocol population comprising the 224 patients who completed the study, the SPC drug + rosuvastatin recipients (n=94) also achieved significantly reduced sitSBP and LDL-C with mean reductions of -24.60 mm Hg and -52.92 percent, respectively, from baseline (p<0.0001 for both).

Significantly more patients in the SPC drug + rosuvastatin arm attained target BP vs the olmesartan + rosuvastatin arm (84.76 percent vs 47.06; p<0.0001) as well as target LDL-C levels vs the SPC drug-only arm (84.76 percent vs 15.38 percent; p<0.0001).

All treatment arms showed no significant difference in the total rate of adverse events (10.48, 5.66, and 3.7 percent for SPC drug + rosuvastatin, olmesartan + rosuvastatin, and SPC drug-only, respectively), with no serious adverse events reported.

The drug adherence rates were also similar in all treatment arms (97.01, 98.24, and 96.65 percent in the SPC drug + rosuvastatin, olmesartan + rosuvastatin, and SPC drug-only groups, respectively).

“Olmesartan/amlodipine single pill + rosuvastatin combination treatment … is safe and effective in reducing BP and LDL-C … as compared to either olmesartan + rosuvastatin or olmesartan + amlodipine [single-pill] treatment,” noted the researchers.

“[As] this phase III trial was performed to develop the triple SPC drug, … our results clearly …  provide the rationale for developing a triple combination of olmesartan/amlodipine/rosuvastatin for treatment of hypertension and dyslipidaemia … [which] will help to improve drug compliance in patients with comorbidity,” they concluded.

“[T]he result is meaningful because it can provide physicians with efficacy and safety data for this SPC of antihypertensive and antidyslipidaemia drugs and can help to treat patients with combined risks ... Future studies investigating whether this combination could increase the adherence rate and improve clinical outcomes are warranted,” they added.

*LEISURE: A clinical trial to evaluate the efficacy and safety of olmesartan/amlodipine/rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia