News From The Annals Of Internal Medicine, May 6, 2008

Main Category: Bones / Orthopaedics
Also Included In: Clinical Trials / Drug Trials;  Cholesterol;  Cancer / Oncology
Article Date: 06 May 2008 - 4:00 PDT

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Study Finds Little Difference in Osteoporosis Drugs for Preventing Fractures

A study of pharmacy records of 43,135 people who began to take osteoporosis drugs between 2000 and 2005 found 1,051 nonvertebral fractures within 12 months and no large differences in fracture risk between those who took risedronate, raloxifene, and alendronate (Article, p. 637). Those who took nasal calcitonin had more nonvertebral fractures than those who took alendronate.

A study like this one, which uses existing administrative data to compare drugs directly, has important shortcomings: The researchers did not know if patients actually took the medications, could not measure side effects, and did not know why physicians prescribed one medication over another.

An editorial writer says that this study is an attempt to solve a problem in the U.S. drug approval process, which specifies that a new drug be tested against placebo but not against existing drugs (Editorial, p. 702). So we have several drugs for osteoporosis but no head-to-head trials to guide use. "I propose that we devise an ethical way to prospectively randomly assign patients to different (and apparently equivalent) drug regimens and measure the outcomes of treatment, potential adverse events, drug interactions and costs," the writer says.

How Often Should Cholesterol Levels Be Monitored After Therapy Begins?

Although cholesterol-lowering drugs have become some of the most widely used and expensive pharmaceuticals, guidelines on how often to monitor cholesterol levels while on treatment vary widely, from every four months, to annually, or as necessary (Article, p. 656).

Changes in a person's cholesterol level could be due to random fluctuations (noise) or a long-term effect of the drug (signal). A new study involved more than 9,000 people with past heart disease whose cholesterol levels were measured at regular intervals for five years. Researchers found that for the first four years of treatment, the noise was greater than the signal, making it difficult to accurately identify someone who needed a change in dose.

The results suggest that frequent testing of cholesterol levels while on treatment will often be misleading. "Current guidelines that recommend annual or more frequent monitoring (of cholesterol levels) should be reconsidered," the authors say.

Hydroxyurea Reduces Frequency of Pain and Hospitalizations for Sickle Cell Disease

A review for a consensus conference on hydroxyurea for treatment of adults with sickle cell disease found the drug increases fetal hemoglobin, reduces frequency of extreme pain crises, reduces frequency and/or length of hospital admissions, and reduces the need for transfusions. Hydroxyurea is a chemotherapy agent that affects the bone marrow. Approved by the FDA in 1998 for treatment of adults with sickle cell disease, hydroxyurea remains the only approved disease-modifying therapy.

Note: This article will be posted online at http://www.annals.org/ along with the May 6, 2008, issue of Annals of Internal Medicine. It will appear in the June 17, 2008, print edition of the journal.

High Insurance Deductibles Change Use of Some Cancer Screening Tests

A study of payment records of HMO patients who moved from a standard insurance plan into a high-deductible insurance plan found that patients did not change use of recommended breast or cervical cancer screening (which were fully covered by the new plan) but had fewer screenings for colorectal cancer with colonoscopies (which were not covered until the patient had met the high deductible) (Article, p. 647). The authors say that high-deductible health plans should fully cover mammography, Pap tests, and colonoscopy, because, in the case of colonoscopy, an adequate substitute does not exist.

Editorial writers say, "Cost-sharing is a blunt tool. … [E]ven small amounts of cost-sharing reduce the use of effective services. However, cost sharing also reduces costs and provides disincentives to choose services that do not improve health or are possibly harmful" (Editorial, p. 704).

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Article adapted by Medical News Today from original press release.
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Annals of Internal Medicine is published by the American College of Physicians.

Source: Susan Anderson
American College of Physicians