PHARMACOTHERAPY REVIEW CNS STIMULANTS for treatment of ...

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