PHARMACOTHERAPY REVIEW CNS STIMULANTS for treatment of ...

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EXCEL(Expanded Clinical Evaluation of Lovastatin)• Randomized, double-blind, 8245 patients, lovastatin at various dosages and times (20mg withevening meal, 40 mg q evening, 20 mg bid morning and evening meal, and 40 mg bid, andplacebo)• The increase in receptor mediated removal of LDL from the plasma accounts for the largereductions in LDL cholesterol level achieved with lovastatin.• This study treated patients with moderate hypercholesterolemia.• 40% of patients had HTN, 92% white, 59% men, 29% had CHD, 30% overweight• 47 patients had transaminase levels >3 times ULN. 32 had elevated ALT only and 14 hadelevated ALT and AST levels, and one had elevated AST only• The elevations in transaminase levels confirms the need to monitor patients during the firstyear of therapy• Muscle symptoms with a CK level elevated >10 times the ULN were observed in 5 patients• The most reported adverse effects were constipation, palpitations and insomnia• Patients at higher risk may require larger doses of lovastatin and in some instances mayrequire the addition of a second drug to reach LDL cholesterol levels recommended by theNCEP guidelines• We concluded that Lovastatin, when added after an adequate trial of a prudent diet, is ahighly effective and generally well-tolerated drug for the treatment of patients with moderatehypercholesterolemiaVariable Placebo 20mg q pm 40mg q pm 20mg bid 40mg bidLDL +0.4 -24 -30 -34 -40HDL +2.0 +6.6 +7.2 +8.6 +9.5Total +0.7 -17 -22 -24 -29Triglycerides +3.6 -10 -14 -16 -1921
MRC/BHF Heart Protection Study• Simvastatin 40 mg, randomized, 20,536 patients (15,454 men and 5,082 women) withcoronary disease, other occlusive diseases, or diabetes.Simvastatin PlaceboDeath 1328 1507Coronary deaths 587 707Other vascular causes of death 194 230Non-fatal or fatal stroke 444 585Non-fatal MI 898 1212Non-vascular death 547 570Myopathy (Rhabdomyolysis) 5 3Any Cancer/GI Cancer(most common)814/ 228 802/ 223• The study states that five years of simvastatin would prevent about 70-100 people per 1000from suffering from at least one of these major vascular events, and longer treatment shouldproduce further benefit.• Simvastatin produced a risk reduction of 25%• The size of risk reduction produced by lowering LDL can be determined more by anindividual’s overall risk of cardiovascular disease rather than just their initial blood lipidconcentration.• There was no significant difference in the number of patients with elevated ALT 2-4 x ULN(139 vs. 131 placebo) or CK 4-10 x ULN (19 vs. 13 placebo).• This trial suggests that there is no need for routine liver functional test when using thisregimen or other statin regimens except to monitor patients with pre-existing liver disease.• Patients with LDL below 100 mg/dL still benefited from a reduction in their LDL.Simvastatin safely reduced some patient’s LDL to 65 mg/dL and produced as great of areduction found in patients with higher risk.22
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