Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: IV. Additional perspectives on the tolerability of lovastatin

Article Abstract:

A report is presented from a large-scale, randomized study involving 8,245 patients with moderately high levels of blood cholesterol (between 240 and 300 milligrams per deciliter) and levels of low-density lipoprotein (LDL) cholesterol (the ''bad'' cholesterol) that were 160 milligrams per deciliter or higher. Subjects were randomly assigned to receive one of four doses of lovastatin, a drug approved for lowering cholesterol levels, or a placebo drug. This article focuses on the side effects associated with lovastatin use, with particular concern for effects on liver or muscle. An elevation of liver enzymes in the blood to three times the normal upper limit was taken as indicative of possible liver toxicity. This occurred equally often in patients who received the lower dose of lovastatin (20 milligrams per day) and in those who received the placebo drug (0.1 percent), but was more frequent in patients who took the higher doses of lovastatin (40 milligrams per day and 80 milligrams per day). Symptoms of abnormal liver function were not noted and enzyme levels returned to normal when the drug was discontinued. Elevations in the enzyme creatine kinase (CK), which could indicate muscle abnormalities, were seen in many patients, regardless of whether treatment had been with lovastatin or placebo. However, CK levels that were very high (as much as 10 times the normal upper limit) were noted in five lovastatin patients and in none of the placebo patients. The affected patients experienced symptoms such as muscle weakness, abdominal or chest pain, nausea, and fatigue, and an elevation of this magnitude is regarded as evidence of muscle damage (myopathy). Treatment was stopped for the three patients who did not have preexisting conditions associated with CK elevations and levels returned to normal within 30 days. The results of the study indicate that liver function should be monitored in patients treated with lovastatin, particularly during the first 15 months of therapy. While routine measurement of CK is of little value, clinicians who prescribe lovastatin should be aware of the possibility of muscle abnormalities. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia

Article Abstract:

A specific goal of the National Cholesterol Education Program (NCEP) is to help people achieve a blood level of low-density lipoprotein cholesterol (LDL cholesterol, the ''bad'' cholesterol) lower than 160 milligrams per deciliter in the absence of coronary artery disease (CAD) and lower than 130 milligrams per deciliter if CAD or certain CAD risk factors are present. The effectiveness of lovastatin, a drug approved for treating high LDL cholesterol levels, was evaluated in a multicenter, controlled study of 8,245 patients. The patients had moderate hypercholesterolemia (blood cholesterol levels between 240 and 300 milligrams per deciliter) and LDL cholesterol levels above 160 milligrams per deciliter. They were placed on special diets and were randomly assigned to receive one of four different dosages of lovastatin or a placebo drug for 48 weeks. Most patients without CAD or two CAD risk factors who took lovastatin met the study's LDL cholesterol goal (160 milligrams per deciliter): 81 percent of those on the lower dose of lovastatin, and 96 percent of those on the higher dose, were successful. Only 22 percent of the patients treated with the placebo were able to meet this goal. Patients with CAD or two or more CAD risk factors also benefited from lovastatin: 38 percent of those who received the lower dose met the goal, and 83 percent of those on the higher dose were successful. Only 4 percent of these patients who received the placebo lowered their LDL cholesterol levels to the level of the goal. Levels of high-density lipoprotein cholesterol (the ''good'' cholesterol) and triglycerides (another form in which fats are carried in the blood) were also affected positively by lovastatin. The results indicate that this drug is very effective in reducing the level of fats in the blood when used in combination with an appropriate diet. (Consumer Summary produced by Reliance Medical Information, Inc.)

Blood cholesterol, Lipoproteins, Blood lipoproteins

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Spectrum of dysautonomia in mitral valvular prolapse

Article Abstract:

Mitral valve prolapse (MVP) is a common valvular disorder in which the mitral valve, which separates the left atrium and left ventricle of the heart, sags into the ventricle. This study evaluated the suggestion that the same alterations to the involuntary heart muscles found in patients with MVP may also occur in patients with other disorders, such as a disease called dysautonomia (a childhood disease characterized by problems such as defective secretion of tears, incoordination of muscles, weakened reflexes and a total absence of pain sensation). The authors evaluated the cardiovascular responses to autonomic (independent) stimuli in a group of patients with symptoms of dysautonomia, some of whom had MVP, some of whom did not to see if unique patterns of responses distinguished patients in one subgroup from the other subgroup. Both groups were studied under the following conditions: standing, forcibly trying to exhale against a closed throat (a maneuver causing an increase in interthoracic pressure, which interferes with venous return to the heart), immersion of their faces in ice water, and administration of various drugs. In addition, these measurements were also taken from a group of patients with MVP who did not have symptoms of dysautonomia, and from a group of normal volunteers. Constitutional, cardiovascular and neuropsychiatric symptoms occurred with similar frequency in the two symptomatic patient groups. No consistent pattern of abnormality was noted in any of the patient subgroups. These findings suggest that abnormal cardiovascular responses to autonomic stimuli may occur in any patient with symptoms of autonomic nervous system dysfunction regardless of absence or presence of MVP.

Abnormalities, Complications and side effects, Heart valve diseases, Nervous system, Autonomic, Autonomic nervous system, Dysautonomia

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