A comparative evaluation of safety and efficacy of rosuvastatin, simvastatin, and atorvastatin in patients of type 2 diabetes mellitus with dyslipidemia

Adsule, Samir Maruti; Baig, Mirza Shiraz; Gade, PR; Khandelwal, Priyanka

doi:10.4103/0973-3930.53124

Cited by 9 publications

(2 citation statements)

References 18 publications

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“…Although a growing body of evidence demonstrates the efficacy and safety of atorvastatin in Asian populations of both East Asian31, 32, 33, 34, 35, 36, 37 and South Asian34, 38, 39, 40, 41, 42, 43, 44 origin, many of these previous studies evaluated the safety profile of atorvastatin doses up to 20‐mg over relatively short study durations (6–12 weeks) 31, 33, 35, 36, 41, 42, 43. This current analysis has extended these observations to atorvastatin doses up to 80‐mg and provides strong evidence to support the safety of conventional doses of atorvastatin (10–40‐mg daily) in Asian patients over the short‐ and longer‐term (up to 4.9 years) for intensive lipid lowering.…”

Section: Discussionmentioning

confidence: 99%

Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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SummaryIntroductionData on statin safety in Asian patients are limited compared with evidence from Western populations.AimThis study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials.MethodsData from 52 short‐term trials (median exposure 4–72 weeks) and six long‐term cardiovascular outcomes trials (median exposure 3.1–4.9 years) conducted across the atorvastatin 10–80‐mg dose range were analyzed retrospectively to assess the incidence of safety endpoints.ResultsA total of 77 952 patients were identified (49 974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short‐term trials, the incidence of all‐causality adverse events (AEs) and serious AEs (SAEs) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment‐related AEs/SAEs were infrequent (2.0% across all doses). These observations were confirmed in the long‐term trials. Treatment‐related SAEs were rare (n = 4) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin‐treated Asian patients, and the incidence of myalgia was 1.8% in the short‐term studies and 6.7% in the long‐term trials. Elevations (>3× the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal AEs occurred in <2%.ConclusionThe incidence of AEs/SAEs with atorvastatin 10–40‐mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80‐mg is required owing to the limited number of Asian patients (n = 281; 11.2%) who received this dose.

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Section: Discussionmentioning

confidence: 99%

Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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“…[ 6 ] One study showed that newer statin rosuvastatin and established statin atorvastatin have similar efficacy in reducing low density lipoprotein (LDL) in patients with diabetic dyslipidemia. [ 7 ] Glimepiride is a widely used third-generation sulfonylurea suitable for once daily administration in treatment of type 2 diabetes mellitus. It is completely absorbed after oral administration and is eliminated mainly via metabolism by cytochrome P450 (CYP) 2C9.…”

Section: Introductionmentioning

confidence: 99%

In vivo and In vitro Drug Interactions Study of Glimepride with Atorvastatin and Rosuvastatin

Galani¹,

Vyas²

2010

Journal of Young Pharmacists

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Aim of this investigation was to study the in vivo and in vitro drug interaction of glimepride with atorvastatin and rosuvastatin. In vitro drug interaction of glimepride with atorvastatin and rosuvastatin was studied using human pooled liver microsomes and evaluated using high performance liquid chromatography. In vivo pharmacokinetic drug interaction of glimepride (6 mg/kg) in coadministration with atorvastatin (60 mg/kg) and rosuvastatin (60 mg/kg) were studied in rats and analyzed using liquid chromatography tandem mass spectrometry (LC–MS/MS). In in vitro study, atorvastatin decreased its own metabolism as well as the metabolism of glimepiride. Rosuvastatin coadministration with glimepride reduced the metabolism of glimepride and increased the metabolism of its own. In in vivo study, concentration in plasma, Cmax, AUC(0–t) and AUC(0–∞) (area under the concentration-time curve, AUC) of glimepride was increased significantly in coadministration with atorvastatin whereas there was no significant change was observed in the case of coadministration with rosuvastatin. Half life (T1/2) and volume of distribution (Vd) of glimepride decreased significantly with both atorvastatin and rosuvastatin. Elimination rate constant, Kel of glimepride increased significantly with both atorvastatin and rosuvastatin. Clearance (Cl) of glimepride decreased significantly but the decrease was more with atorvastatin than with rosuvastatin. It is concluded that glimepride metabolism is little affected by rosuvastatin in vitro, which agreed with the negligible interaction in in vivo study. Thus, from safety point of view rosuvastatin is better to prescribe as a coadministration therapy with glimepiride. On the other hand, atorvastatin could cause an increase in the bioavailability of glimepride per oral and also significantly decrease the metabolism of glimerpride in in vitro study. This may pose a positive implication in clinical practice.

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Pharmacokinetic Interaction Between Rosuvastatin and Metformin in Healthy Korean Male Volunteers: A Randomized, Open-label, 3-period, Crossover, Multiple-dose Study

Lee

Roh

Son

et al. 2014

Clinical Therapeutics

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Although the Css,max of rosuvastatin was significantly influenced by coadministration with metformin, the degree of interaction seen was considered clinically insignificant, with no significant interaction observed in the other pharmacokinetic measures between the 2 drugs. These results imply that drug effects of rosuvastatin and metformin will also not be significantly influenced by coadministration of the 2 drugs. All treatments were well tolerated and no serious adverse events occurred. ClinicalTrials.gov identifier: NCT01526317.

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A comparative evaluation of safety and efficacy of rosuvastatin, simvastatin, and atorvastatin in patients of type 2 diabetes mellitus with dyslipidemia

Cited by 9 publications

References 18 publications

Safety of atorvastatin in Asian patients within clinical trials

Safety of atorvastatin in Asian patients within clinical trials

In vivo and In vitro Drug Interactions Study of Glimepride with Atorvastatin and Rosuvastatin

Pharmacokinetic Interaction Between Rosuvastatin and Metformin in Healthy Korean Male Volunteers: A Randomized, Open-label, 3-period, Crossover, Multiple-dose Study

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