The Effects of Rosuvastatin on the Serum Cortisol, Serum Lipid, and Serum Mevalonic Acid Levels in the Healthy Indian Male Population

Abstract

Abstract.In this open-label, balanced, randomized, placebo-controlled, parallel study, healthy male volunteers were randomly divided into two groups. Each group received either a single oral dose of rosuvastatin 20 mg or placebo. Estimations were done at predose on day 1 of dosing (baseline) and 24 h postdose after days 7 and 14. Serum cortisol and serum lipid levels were estimated using enzyme-linked immunosorbent assay kits and serum mevalonic acid (MVA) levels were measured using validated liquid chromatography-tandem mass spectrometry method. Rosuvastatin produced a statistically significant (P<0.05) decrease in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and triglycerides. However, the increase in high-density lipoprotein cholesterol and decrease in cortisol and MVA were not statistically significant when compared to the placebo-treated group. The study showed that rosuvastatin at a dose of 20 mg/day for a period of 14 days was very potent as cholesterol-lowering agent, without any significant change in serum cortisol level in the healthy Indian male population.

An ultrasensitive enzymatic method for measuring mevalonic acid in serum

“…Until now, however, the use of enzymatic spectrophotometric methodology has been precluded by the extremely low levels of MVA in human plasma and serum. The normal range of MVA concentration has been reported to be 1.0-11.2 ng/ml (6.7-75.6 nmol/l) in plasma ( 9 ) and 12.28 ± 2.54 ng/ml (82.9 ± 17.1 nmol/l) in serum ( 11 ). In the present study, we describe a simple, precise, and ultrasensitive enzymatic method for measuring MVA in serum .…”

“…These include a radioenzyme assay ( 2 ), enzyme immunoassay ( 3 ), GC-MS assay ( 4-7 ), and LC-MS/MS assay (8)(9)(10)(11)(12)(13). Until now, however, the use of enzymatic spectrophotometric methodology has been precluded by the extremely low levels of MVA in human plasma and serum.…”

Effects of Evolocumab on Vitamin E and Steroid Hormone Levels

“…35,36 The impact of statins on adrenal function has been studied in multiple populations with a wide variety of statins. 23,[25][26][27][28][29]31,32,[37][38][39][40][41][42][43][44][45] None of these studies showed clinically relevant impairment of adrenal function, secondary to statin therapy. Patients with heterozygous or homozygous familial hypercholesterolemia could also theoretically be at increased risk of adrenal dysfunction because of their reduced capacity to use LDL receptor-mediated cholesterol uptake.…”

“…49 Two studies of adrenal function in patients treated with rosuvastatin did not find any impairment in adrenal function despite lowering LDL-C to a mean of 1.5 mmol/L (59 mg/dL) and 1.6 mmol/L (61 mg/dL), respectively. 27,31 In another study of patients selected on the basis of LDL-C <1.8 mmol/L (70 mg/dL), with a mean LDL-C of 1.5 mmol/L (58 mg/dL), adrenal function was also normal. 50 In our study, we observed no evidence of hypoadrenalism (decreased cortisol, increased ACTH, or a decreased cortisol:ACTH ratio) in evolocumab-treated patients, even in those achieving very low LDL-C.…”

“…[23][24][25][26][27][28][29][30][31][32] Some of this concern was based on studies in isolated patients with abetalipoproteinemia and homozygous hypobetaliproteinemia showing mildly raised ACTH levels, normal cortisol levels, and a blunted response to prolonged ACTH stimulation. 33,34 Further studies of abetalipoproteinemic patients have not always confirmed these early observations, although the endocrine evaluations undertaken have varied substantially.…”