Efficacy and Safety of Ezetimibe and Rosuvastatin Combination Therapy Versus Those of Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Kim, Woohyeun; Yoon, Yeonyee E.; Shin, Sung Hee; Bae, Jang Whan; Hong, Bum Kee; Hong, Soon Jun; Sung, Ki Chul; Han, Seung Hwan; Kim, Weon; Rhee, Moo Yong; Kim, Sang Hyun; Lee, Sang Eun; Hyon, Min Su; Hwang, Gyo Seung; Son, Jang Won; Kim, Jang Young; Kim, Min Kyu; Kim, Sang Wook; Park, Jae‐Hyeong; Shin, Jin Ho; Park, Chang Gyu

doi:10.1016/j.clinthera.2018.04.015

Cited by 21 publications

(28 citation statements)

References 35 publications

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“…In previous studies performed in Korean population, the values ranged from 42.9% to 52.0%. 6 7 8 9 10 The LDL-C target achievement rate in our study was 75.0%–77.1%. In previous studies in Korea, the target achievement rate was relatively variable and ranged from 67.5% to 94.0%.…”

Section: Discussionmentioning

confidence: 46%

“…In previous studies in Korea, the target achievement rate was relatively variable and ranged from 67.5% to 94.0%. 7 8 9 10 The cardiovascular risk status and baseline LDL-C of study populations varied in the studies, and the differences in the target achievement rates might be associated with these factors. Although studies analyzing the effect of generic rosuvastatin have not been common, one report from West Asia has showed that the generic one was efficacious and safe.…”

Section: Discussionmentioning

confidence: 99%

“… 6 8 9 In addition, the incidence of drug-related serious adverse events has been very low and ranged from 0% to 1.5% in Korean studies. 9 10 14 An increase in liver enzyme by > 3 times the upper limit of normal after rosuvastatin use was rare, with 0.5%–1.3%. 6 7 Conversely, an increase in creatine kinase by >5 or 10 times the upper limit of normal was observed in nearly none or 2.6% of Korean study populations.…”

Section: Discussionmentioning

confidence: 99%

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Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin

Kim

Park

Choi

et al. 2020

J Lipid Atheroscler

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Objective The aim of this study was to investigate whether a new generic rosuvastatin is non-inferior to a proprietary one in terms of lipid-lowering efficacy. We also evaluated its non-lipid effects including adverse events. Methods One-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened. After a 4-week run-in period, 126 individuals who met the lipid criteria for drug therapy were randomly assigned to receive the new generic or proprietary rosuvastatin 10 mg daily for 8 weeks. The primary outcome variables were low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement. Hematological and biochemical parameters and adverse events were assessed. Results After 8 weeks of drug treatment, the mean percentage change in LDL-C was not different between the groups (−45.5%±19.9% and −45.1%±19.0% for generic and proprietary rosuvastatin, respectively; p =0.38). The LDL-C target achievement rate was similar between the groups (75.0% and 77.1% for generic and proprietary rosuvastatin, respectively; p =0.79). The percentage change in the other lipid profiles was not significantly different. Although generic- and proprietary rosuvastatins modestly affected creatine kinase and blood pressure, respectively, the changes were all within normal ranges. Incidence of adverse events did not differ between the receivers of the 2 formulations. Conclusion The new generic rosuvastatin was non-inferior to the proprietary rosuvastatin in terms of lipid-lowering efficacy. The rosuvastatin formulations did not exhibit clinically significant non-lipid effects with good safety profiles. Our study provides comprehensive data regarding 2 rosuvastatin formulations in East Asian subjects. Trial Registration ClinicalTrials.gov Identifier: NCT03949374

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Section: Discussionmentioning

confidence: 46%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin

Kim

Park

Choi

et al. 2020

J Lipid Atheroscler

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“…Comparison of the outcomes found here with studies of the use of single-agent rosuvastatin in patients with metabolic syndrome or type 2 diabetes, although this specific assessment was not part of the initial study hypothesis, suggests that adding ezetimibe to rosuvastatin could represent an efficient strategy for a more intense lipid level reduction recommended in these patient populations. 41 , 42 , 43 …”

Section: Discussionmentioning

confidence: 99%

Efficacy and Tolerability of a Fixed-Dose Combination of Rosuvastatin and Ezetimibe Compared with a Fixed-Dose Combination of Simvastatin and Ezetimibe in Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized Trial

Vattimo¹,

Fonseca

Morais³

et al. 2020

Current Therapeutic Research

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Background: The addition of ezetimibe to statin therapy has been reported to result in increased efficacy for reduction of LDL-C levels and achievement of lipid targets, compared with monotherapy. Objective: This study was designed to demonstrate the noninferiority of therapy with fixed-dose rosuvastatin plus ezetimibe formulations versus fixed dose simvastatin and ezetimibe formulations for reduction of LDL-C levels in Brazilian patients with hypercholesterolemia or mixed dyslipidemia. Methods: Phase III, multicenter, randomized, parallel, open-label, noninferiority study that included male and female participants (aged 21–80 years) with hypercholesterolemia or mixed dyslipidemia. After a 1-week screening period with washout of lipid-lowering medications when needed, patients were treated with simvastatin 20 mg/d for 5 weeks. Participants with LDL-C levels ≥100 mg/dL after the initial treatment were submitted to a 1-week washout period, and then randomized 1:1 to receive either combined rosuvastatin 10 mg + ezetimibe 10 mg (R/E) or simvastatin 20 mg + ezetimibe 10 mg (S/E) for 4 weeks and, if they still did not achieve the stipulated target, doses were readjusted to rosuvastatin 20 mg + ezetimibe 10 mg or simvastatin 40 mg + ezetimibe 10 mg, respectively, for 4 weeks. Results: One hundred twenty-nine participants were enrolled, including 66 in R/E and 63 in S/E. At the end of simvastatin 20 mg treatment period, mean LDL-C values were 124.79 mg/dL and 121.27 mg/dL for participants randomized to R/E and S/E arms, respectively. After 4 weeks of R/E 10 mg + 10 mg or S/E 20 mg + 10 mg combined treatments, adjusted mean LDL-C values were 74.21 mg/dL and 85.58 mg/dL, respectively ( P = 0.0005), and after 9 weeks, with dose adjustment to R/E 20 mg + 10 mg in 6 patients and to S/E 40 mg +10 mg in 19 patients, LDL-C adjusted mean values were 75.29 mg/dL and 86.62 mg/dL, respectively ( P = 0.0006). There was a statistically significant difference between the association R/E and S/E ( P = 0.0013) in percentage change of LDL-C after 9 weeks of combined treatments. The adjusted mean difference was estimated at –10.32% (95% CI, –16.94% to –3.70%). The LDL-C <100 mg/dL target was achieved in a significantly greater proportion of participants at week 4 in the R/E compared with the S/E arm (84.8% vs 68.2%; P = .0257), and at week 9, the proportion was 81.2% versus 73.0%, respectively ( P = 0.23). LDLC <70 mg/dL was achieved at a significantly greater proportion in the R/E arm, both at week 4 (45.4% vs 15.9%; P = 0.003) and week 9 (40.9% vs 15.9%; P = 0.0017). A statistically significant difference at week 9 ( P = 0.0106) was observed in fasting blood glucose in the R/E arm, but the overall incidence of adverse events was not significantly different between groups. Conclusions: Rosuvastatin and ezeti...

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“…The primary evaluation variable was the achieved percentage of expected LDL-C reduction. The expected LDL-C reduction was calculated using different doses of statins determined from previous studies and reviews (Table 1) [23][24][25][26][27][28][29] . Other evaluation variables included the percentage LDL-C reduction and achievement rate of an LDL-C target of < 70 mg/dL.…”

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confidence: 99%

GENetic characteristics and REsponse to lipid-lowering therapy in familial hypercholesterolemia: GENRE-FH study

Kim

Park

Pak

et al. 2020

Sci Rep

Self Cite

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Among the 146 patients enrolled in the Korean FH registry, 83 patients who had undergone appropriate LLT escalation and were followed-up for ≥ 6 months were analyzed for pathogenic variants (PVs). The achieved percentage of expected low-density lipoprotein-cholesterol (LDL-C) reduction (primary variable) and achievement rates of LDL-C < 70 mg/dL were assessed. The correlations between the treatment response and the characteristics of PVs, and the weighted 4 SNP-based score were evaluated. The primary variables were significantly lower in the PV-positive patients than in the PV-negative patients (p = 0.007). However, the type of PV did not significantly correlate with the primary variable. The achievement rates of LDL-C < 70 mg/dL was very low, regardless of the PV characteristics. Patients with a higher 4-SNP score showed a lower primary variable (R2 = 0.045, p = 0.048). Among evolocumab users, PV-negative patients or those with only defective PVs revealed higher primary variable, whereas patients with at least one null PV showed lower primary variables. The adjusted response of patients with FH to LLT showed significant associations with PV positivity and 4-SNP score. These results may be helpful in managing FH patients with diverse genetic backgrounds.

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Efficacy and Safety of Ezetimibe and Rosuvastatin Combination Therapy Versus Those of Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Cited by 21 publications

References 35 publications

Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin

Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin

Efficacy and Tolerability of a Fixed-Dose Combination of Rosuvastatin and Ezetimibe Compared with a Fixed-Dose Combination of Simvastatin and Ezetimibe in Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized Trial

GENetic characteristics and REsponse to lipid-lowering therapy in familial hypercholesterolemia: GENRE-FH study

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