Diseases Update — The Family Health Guide

Sustained-Release Nifedipine for Raynaud's Disease
Recently, the results of a clinical trial comparing the effects of sustained-release nifedipine with the effects of biofeedback on patients with Raynaud's disease suggest that nifedipine offers a clear benefit over biofeedback therapy.

Participants in the trial reported a minimum of two attacks per day at the start of the trial. After two winters on the sustained-release nifedipine, participants reported a more than 60% reduction in the number of attacks, as well as overall improvement in their symptoms. Although participants in the biofeedback therapy group reported no significant reduction in the number of attacks and no improvement in symptoms, researchers believe further study of this method's effectiveness would be worthwhile. This would be especially true for patients who could not tolerate vasodilators or who prefer nondrug treatments.

Some participants in the trial did report side effects such as rapid heartbeat, swelling, flushing, and headache, though there was a lower incidence of these side effects over time. In addition, the percentage of study volunteers experiencing these side effects from sustained-release nifedipine was significantly lower than for patients in trials looking at immediate-release nifedipine. Participants in previous trials studying immediate-release nifedipine also reported having 50% fewer attacks, but immediate-release nifedipine was found to be less effective over time, while sustained-release nifedipine was found to maintain its effectiveness.

Clonidine for Tamoxifen-Induced Hot Flashes
Hot flashes are a common side effect in postmenopausal women taking tamoxifen for breast cancer. While many of these women are able to keep their hot flashes from interfering with their daily activities, others are not. Even though low doses of megestrol, and other progestational agents, have been found to control hot flashes, doctors are reluctant to prescribe them for women taking tamoxifen because both progestational agents and tamoxifen can cause side effects, including blood clots.

A recent report suggests that clonidine, a nonhormonal drug, appears to be effective in reducing the frequency of hot flashes in this group of women. During this study, participants who took 0.1 mg. of clonidine at bedtime for eight weeks reported a significant reduction in number of hot flashes they experienced and a small beneficial effect on the severity and duration of these episodes. Women in the group taking clonidine had been experiencing an average of eight hot flashes a day at the start of the research. After eight weeks of taking clonidine daily, these women experienced an average of 2.2 fewer hot flashes per day.

While clonidine showed significant benefit for most of the women taking it in the study, it should be noted that some women experienced no benefit. Only one major side effect, difficulty sleeping, was reported by 41% of the women taking clonidine. Though the study did not evaluate clonidine’s long-term benefits, the researchers involved believe that its continued use would prove valuable.

Important Notice: Nationwide Recall of Etodolac Capsules
ESI Lederle, the manufacturer of Etodolac, has recalled one lot number (9991052) of its generic Etodolac (Lodine (R )) Capsules 300 mg. ESI Lederle advises patients who taking Etodolac Capsules 300 mg to stop using them immediately until it is clear that their supply of this drug did not come from the recalled lot. Patients should call their pharmacist immediately in order to determine whether or not their Etodolac Capsules 300 mg came from lot number 9991052. If the lot number cannot be determined, patients should assume that their Etodolac Capsules 300 mg came from the recalled lot and should stop taking them immediately and call their physician without delay.

Etodolac Capsules 300 mg are used by arthritis patients. All Etodolac Capsules mg in every lot produced can be identified by their white color and a red "300" at one end and a red "59911" over a red "3607." The recalled lot of Etodolac Capsules 300 mg may contain acebutolol hydrochlorine, a beta blocker, and can cause serious side effects, and even death, in some patients. Capsules from the lot being recalled were first distributed on October 18, 1999. Patients who have already discontinued taking Etodolac Capsules 300 mg and who have not experienced any side effects should not be concerned. (10.10.00)

To return affected Etodolac Capsules 300 mg to ESI Lederle, call 800-747-7016. Pharmacies and wholesalers have been told to return all Etodolac Capsules 300 mg as well. Health care providers and pharmacists have also been informed of the recall. (10.13.00)

Calcium Carbonate's Effect on the Absorption of Levothyroxine
A recent study has revealed that calcium carbonate may reduce the body's ability to absorb the thyroid medication levothyroxine. The people who are probably most affected by this discovery are postmenopausal women, since they often end taking both levothyroxine and calcium carbonate. However, anyone taking levothyroxine and calcium carbonate concurrently can experience the same effect.

Patients participating in the study ranged in age from 27 to 78 years old and were almost evenly divided between men and women. They all had hypothyroidism (low thyroid function) and were taking levothyroxine. During the study, they were asked to take 1,200 mg of calcium carbonate daily over a three-month period. The majority of patients had significantly lower levels of thyroxine by the end of this period. They were then asked to discontinue taking the calcium carbonate, and their thyroxine levels were measured again after two months. At the end of the two-month period, their thyroxine levels were found to have returned to normal range.

In light of the fact that patients participating in the study were instructed to take the calcium carbonate daily with the levothyroxine on an empty stomach, researchers believe that the acidity level in the stomach may be a factor in how much levothyroxine is absorbed by the body. Researchers have suggested that one way to curb calcium carbonate's effect on levothyroxine is to take the calcium carbonate after a meal in order to optimize the body’s absorption of levothyroxine. They add that if while taking calcium carbonate and levothyroxine concurrently, a patient's thyrotropin level rises, it would be advisable to separate the times at which he or she takes calcium carbonate and levothyroxine on a given day. In some cases, physicians might want to increase the dosage of levothyroxine, to compensate for the effects of calcium carbonate. (10.19.00)

Inhaled Corticosteroids Affect Bone-Mineral Density
While inhaled corticosteroids are effective in controlling asthma, a recent study suggests that long-term use of higher doses of inhaled steroids may predispose both men and women to osteoporosis.

Researchers studied a group of men and women between the ages of 20 and 40 year old. All had mild asthma and had been using a steroid inhaler for an average of six years. Because the study did not include patients with severe asthma, decreased growth and physical activity in childhood would most likely not be a contributing factor to patients' decrease in bone-mineral density. In addition, fewer than 10% of the participants had used a steroid inhaler before the age of 15. Most participants (80%) had been using beclometasone dipropionate, though the results for participants using budesonide and fluticasone propionate were the same.

What researchers found was that long-term exposure to high doses of an inhaled corticosteroid produces a significant decrease in bone-mineral density at the spine and femur. Such a decrease in bone-mineral density is associated with a doubling of the risk for fracture. Researchers also discovered that the length of time a patient used a steroid inhaler was similar to the patient's cumulative dose in its effect on the patient's bone-mineral density. Researchers also concluded that participants who had taken an inhaled steroids long term and in high doses would enter their 50s and 60s with lower bone-mineral densities than those participants who had taken an inhaled corticosteroid in low doses.

People with asthma who need to use a high dose steroid inhaler over an extended period of time should consult their doctor about the best measures they can take to prevent osteoporosis. (10.19.00)

Side Effect Warnings for New Arthritis Drug Enbrel
Individuals taking Enbrel, a new rheumatoid arthritis medication, should be advised of the following. Among patients taking Enbrel, there have been 10 cases of low blood-cell counts, including reductions in red and white blood cells and platelets — which leave patients vulnerable to infection. Five of the individuals who developed this serious side effect died. Patients taking Enbrel are advised to seek medical care if they experience any of the following symptoms: persistent fever, bruising, bleeding, or paleness. If blood tests show significant abnormalities, they should consider discontinuing the drug. It should be noted that the Food and Drug Administration has stated that there is no proof that Enbrel causes dangerous anemia.

In patients with multiple sclerosis (MS) who also take Enbrel for their rheumatoid arthritis, the drug may increase MS symptoms. Among people who do not have MS, but have been taking Enbrel, there have been 11 cases of patients acquiring certain demyelinating diseases, a specific type of nerve disorder that includes MS. New cases of MS in Enbrel users are rare, however, and, in fact, there is no evidence that MS strikes Enbrel users more often than it strikes the general population. However, since Enbrel might increase MS symptoms in users who already have this condition, individuals with MS should consider these reports when evaluating treatment options rheumatoid arthritis. (10.19.00)

Renal-Artery Stenosis Related High Blood Pressure: Angioplasty vs. Medication
For many people with difficult to control high blood pressure, the problem really begins with (or is made worse by) narrowing of the arteries that supply the kidneys (renal stenosis). One way to manage the resulting elevations in blood pressure is with antihypertensive medications. Another way is balloon angioplasty — the same procedure used to clear narrowed or blocked coronary arteries, but applied to the renal arteries. A study conducted in the Netherlands compared the effects of balloon angioplasty with that of medical therapy (medication) on high blood pressure caused by renal stenosis.

Patients in this study had similar blood pressure levels and took similar doses of high blood pressure drugs at the beginning of the trial. Researchers then randomly assigned these volunteers to two groups. One group continued the two-drug regimen they had been taking, but could take a higher dose of a drug or add a drug, as needed; the other group continued to take a two-drug regimen and were also assigned to undergo balloon angioplasty.

The blood pressure of study participants was measured at three months and at 12 months. At three months, there was no significant difference in blood pressure between the two groups of patients. Also at three months, nearly half of the patients in the drug-therapy group had received balloon angioplasty either because drug therapy failed to adequately reduce blood pressure or because they showed signs of worsening kidney function. Nevertheless, the patients who only received drug therapy did not have higher blood pressure than those who underwent balloon angioplasty did.

Researchers concluded that, compared with antihypertensive drugs, balloon angioplasty does not always result in better blood pressure control for patients with renal stenosis. In patients whose high blood pressure cannot be controlled even when they take three or more medications or those for whom the renal artery blockages worsen, balloon angioplasty serves only to lower blood pressure to the level that can be achieved by drug therapy in other patients. In only a very few cases did balloon angioplasty cure hypertension. (10.19.00)

Ramipril for Diabetics with Heart Disease
The incidence of heart disease in the general population has been dropping. This is good news of course, but for individuals with diabetes, the statistics are not so promising. In fact, men with type 2 diabetes have experienced only a modest decline in heart disease rates, while women with diabetes have actually experienced an increase.

Heart disease accounts for 70% of deaths in people with diabetes. So, the outcome of a recent study, which demonstrated that the angiotensin-converting enzyme (ACE) inhibitor, ramipril, significantly lowered the incidence of heart disease, stroke, and death in people with diabetes who had a history of heart disease and hypertension, should be welcome news.

The Heart Outcomes Prevention Evaluation (HOPE) study included people with and without diabetes. More than one third of the participants had diabetes. Of the participants with diabetes, the average age was a little over 65 years old, and one third were women. All had a history of heart disease and half had a history of high blood pressure as well. All study volunteers were randomly assigned to either ramipril or a placebo. While ramipril did not lower the blood pressure of participants much — as it was originally intended to do — it did lower their risk for heart attack by 22%, their risk for heart disease by 37%, and their risk for stroke by 33%. Other studies conducted to evaluate the effects of ACE inhibitors on blood pressure in people with diabetes have had similar outcomes. (10.30.00)