Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

HMG-CoA REDUCTASE INHIBITORS: NHLBI PILOT STUDY will assess the short-term safety and efficacy of the cholesterol-lowering agent in men and women aged 65 and older. In January, the National Heart, Lung and Blood Institute will begin recruiting a total of 500 patients at five centers. The 12-18 month, $2.5 mil. pilot study is part of NHLBI's Cholesterol Reduction in Seniors Program (CRISP). Participants must have an LDL cholesterol level between 160 and 220 mg/dl at entry that remains over 120 mg/dl after the introduction of a cholesterol-lowering diet. Subjects will be randomized to receive either placebo; low-dose HMG-CoA, i.e., 20 mg lovastatin (Merck's Mevacor), 20 mg pravastatin (Bristol-Myers Squibb's Pravachol) or 10 mg simvastatin (Merck's Zocor); or high-dose HMG-CoA -- 40 mg lovastatin, 40 mg pravastatin or 20 mg simvastatin. Neither Pravachol nor Zocor has been approved for marketing in the U.S. Pravachol is scheduled to be reviewed by FDA's Endocrinologic and Metabolic Drugs Advisory Committee during the second day of its Oct. 22-23 meeting ("The Pink Sheet" Oct. 8, p. 9). A full-scale trial involving 5,000 to 6,000 subjects may be initiated after the pilot study is completed in June 1992. The primary endpoints of the full-scale trial will be coronary heart disease and other cardiovascular morbidity and mortality. The pilot study will monitor those endpoints, but NHLBI noted that the sample size and duration of the study are inadequate to determine the impact of cholesterol-lowering drugs on the endpoints. The CRISP study was discussed at an Oct. 9-10 NHLBI conference on diseases associated with low blood cholesterol. The risk of coronary heart disease has been shown to decrease with a decline in blood cholesterol levels. However, David Jacobs, PhD, University of Minnesota, pointed out that data from observational studies and clinical trials indicate that lowering blood cholesterol may be associated with increased risk of hemorrhagic stroke and noncardiovascular diseases. Jacobs presented a meta-analysis of 18 studies. The analysis showed that in people aged 35-69 who are free of coronary heart disease at baseline, death rates due to noncardiovascular, noncancer causes are elevated at low blood total cholesterol levels and that total cancer deaths are similarly elevated in men. Conference participants noted that a causal relationship between low blood cholesterol and mortality has not been established. Jacobs said a number of plausible biological mechanisms have been proposed to explain the observations of increased disease rates at low blood cholesterol levels. In addition, he said confounding factors may play a role, such as disease conditions and behaviors that may lower blood cholesterol.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts