Is Pitavastatin as Effective as Other Agents for Lowering Cholesterol?

Is Pitavastatin as Effective as Other Agents for Lowering Cholesterol?

I. Introduction/Background

1. Disease overview: (a. Condition and b. general Characteristics)

Pitavastatin is used in the treatment of both hyperlipidemia and dyslipidemia (Gotto, et al, 2010; Baker, et al, 2011). Dyslipidemia is caused by the elevation in the plasma cholesterol levels, triglycerides, or low density lipoprotein levels, it leads to atherosclerosis and cardiovascular diseases such as coronary heart disease. Hyperlipidemia is an assembly of disorders characterized by over production of lipids in the blood stream. Primary hyperlipidemia is caused by genetic factors, while secondary hyperlipidemia is caused by diseases such as diabetes, thyroid disease, liver and renal disorders, obesity, Cushing's syndrome, and alcohol consumption. Signs and symptoms of the disease include hypercholesterolemia, hypertriglyceridemia (2000mg/dL), hyperlipoproteinemia, dyslipidemia, and high serum cholesterol. The diagnosis required using the measurement of plasma levels of and triglycerides.

2. Drug overview: (a. Type of Drug and b. role of drug in treatment of disease)

Pitavastatin is an oral tablet that completely hinders 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase during the synthesis of hepatic cholesterol. Pitavastatin reduces LDL levels and increases HDL levels. Increase of LDL-C receptors in the liver results in increasing the rate of LDL cholesterol elimination from blood (Bersot, 20111). After oral administration, pitavastatin gets absorbed and distributed in blood. Pitavastatin is 51% bioavailable and its concentration and plasma levels increases with the amount of drug and administration time, while concentration decrease with the high fat meal (Bersot, 20111). Metabolic route of the drug is hepatic glucuronidation and route of elimination is through fecal execution, 15% excreted through urine (Hudson, 2013).

3. Standard of care practice guidelines

Dose is 1to 4mg for adults, administered orally at any time of the day, it reduces cholesterol level by 20%-30%. In conditions with fibric acid or enzyme inhibitors the dose should be reduced (Budinski et al, 2009). Some of the adverse effects of pitavastatin include diarrhea, back pain, and myalgia. Taking gemfibrozil with pitavastatin therapy should be avoided because it reduces clearance and raises blood concentrations.

II. Literature Evaluation (summary and critique of trial)

A. Study methods

Saku et al, (2011) conducted trial for the head to head comparison of Pitavastatin, Atorvastatin, and Rosuvastatin for Safety and Efficacy (Quantity and Quality of LDL) PATROL, in patients with hypercholesterolemia. According to this trial Atorvastatin, rosuvastatin and pitavastatin are effective drugs for the treatment of low-density lipoprotein cholesterol (LDL-C)-lowering therapy in clinical practice. The study design is provided in the Appendix in which 327 patients were selected for screening visit, out of which 302 were enrolled on the basis of receiving lipid lowering drugs. The patients with lipid lowering drugs were washed out for four weeks. The design was randomized, controlled, parallel and multi-center clinical trial (Saku et al, 2011). Each participant signed content form and the protocol was explained to them. Usual diet was followed during the trial. The patients were randomly divided into three groups on the basis of administering atorvastatin, rosuvastatin and ...