New Drugs and Devices 1999

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Agenerase (Amprenavir)

This new protease inhibitor is the most recent addition to the drugs used to combat the HIV virus (AIDS-producing). It major advantage is that it can be give two times a day. Thus, if taken with other AIDS drugs also given two times a day, patient adherance to therapy should be improved. Adverse effects include diarrhea, vomiting and perioral numbness. Occasionally, a severe life-threatning rash may occur in 1% of patients treated with Agenerase. The cost is between Crixivan and Viracept, the other two more commonly used protease inhibitors.

Antagon (Ganirelix)

This injectable drug is used to increase the liklihood of successful multiple oocyte formation and harvesting in women undergoing in vitro fertilization. It acts by suppressing the surge in lutenizing hormone (LH) associated with stimulation of gonadotropin-releasing hormone. This surge results in the expulsion of the oocyte from the ovary which is not wanted.

Avandia (Rosiglitazone)

This new oral antidiabetic drug is indicated in the management of Type 2 (non-insulin dependent) diabetes. Avandia acts by increasing the sensitivity to circulating insulin and by decreasing the formation of glucose in the liver. Avandia is the second drug in this unique class of antidiabetic drugs. Unlike its predessor, Rezulin, Avandia does not appear to produce severe liver damage. Other side effects appear to be minimal. When used in combination with metformin (Glucophage) there was an increase in patients who had anemia.

Comtan (Entacapone)

Comtan is used for the treatment of Parkinson's Disease. It acts by inhibiting the enzyme catechol-O-methyltransferase which metabolizes l-DOPA. Inhibition of this enzyme will increase the blood levels of levodopa. This may lead to more constant dopaminergic stimulation in the brain and better control of the disease. It is likely that co-administration with l-DOPA will require a reduction in l-dopa dose.

Ellence (Epirubicin)

This new drug indicated for the treatment of breast cancer which has lymph node involvement. Clinical studies compared the long term result of epirubicin in combination with fluorouracil and cyclophosphamide to the previous standard cyclophosphamide-methotrexate-fluorouracil (CMF). The regimen containing Ellence produced a significantly greater relapse-free 5-year survival rate of 62% vs. 53% observed with the CMF protocol. However, there were also significantly more side effects, particularly cardic toxicity which could result in congestive heart failure.

Exemestane (Aromasin)

This new drug is indicated for metastatic breast cancer in postmenopausal women. It acts by inhibiting the enzyme, aromatase. There are two other similar drugs available with that pharmacology, Arimidex and Femara. It may have and advantage in producing more complete estrogen depletion than the other drugs.

Keppra (Levetiracetam)

UCB Pharma- this is a new addition to antiepileptic drugs used to treat seizure disorders. It is indicated for partial onset seizures where 35-40% of patients responded with a 50% reduction of episodes compared with 7% on placebo. Side effects include: weakness (15%), change in behavior (13%), motor coordination difficulties (4%) drowsiness (2%), and minor decreases in white blood cells (3%). Note: Keppra will not be available in pharmacies until April-May 2000 and is not available inder a compassionate release program.

Levulan

This innovative drug was approved for use as photodynamic treatment of actinic keratosis, a premalignant shin condition found in aging adults. Following the application of Levulan as a topical solution, and blue light there was a 86% clearing of lesions after one application and a 94% clearing after a second application.

Lidoderm (Lidocaine Patch 5%)

Lidoderm is indicated for the relief of pain associated with postherpetic neuralgia, a complication of shingles. When applied topically over the area of pain, significant pain relief occurred lasting for 8-12 hours. Side effects of local erythem and edema at the application site were generally mild and transient. Available Sept.-Oct.,1999.

Lotronex

Lotronex was withdrawn by the FDA in December 2000. An alternative drug Zelmac should be available in Europe and USA.

Ontak (Denileukin Diftitox)

This drug has been approved for the treatnent of persistant or recurrent T-cell lymphoma whose cells express an IL-2 recerptor. Ontak is a fusion protein which adheres to the interleukin-2 receptor on the malignant cell thus affecting producing cell death.

Penlac (Ciclopirox)

Recently the FDA approved this innovative topical preparation for the treatment of fingernail and toenail fungasl infections. Penlac must be applied daily for 7 days at which time the lacquer is removed and the applications repeated. It may take up to 48 weeks to completely eradicate the fungus but the topical administration does avoid the side effects of systemic antifungal agents.

Pletal (Cilostazol)

This drug is indicated for the treatment of intermittent claudication, a painful condition where the legs do not get enough blood supply for brief periods of time. The mechanism of action may be to affect platelet aggregation thus making it less likely that blood flow will be interrupted and that intermittent claudication will occur. It will also produce dilation of small arteries which may also help to maintain blood flow. Pletal is contraindicated in congestive heart failure. Headache is the most common side effect, followed by diarrhea.

Rapamune (Sirolimus)

This drug is indicated for the prevention of transplant rejection. When used together with cyclosporin and corticosteroids, the incidence of rejection was 15-19% compared with 32% for a similar treatment using azathioprine (Immuran). Side effects include: anemia, decreased white blood cells (leukopenia), low blod potassium, fever, diarrhea, and a decreased blood platelet count (thrombocytopenia).

Relenza (Zanamivir)

This drug is the first drug approved for the treatment of influenza A and B. It is inhaled and for maximum effectiveness, it must be used in the first 48 hrs. Following onset of symptoms. Use requires the use of a special mouthpiece with the medication in powder form added to the device. Relenza should be used with great caution in asthmatics.

Sonata (Zaleplon)

This drug is indicated for the treatment of insomnia. It differs from those currently on the market in that it has a very short duration of action of 4 hours. For that reason it may be of value for those who need to take medication midway through the night and who do not want the morning "hangover" characteristic of longer acting sedatives. Side effects are minimal however, as with other similar drugs, use with alcohol will potentiate its depressent effects and should be avoided.

Synercid (Quinupristin/dalfopristin)

This injectable newly approved drug combines two semi-synthetic derviatives of a naturally occurring drug, pristinamycin. It acts by inhibiting bacterial protein synthesis. It is indicated for the treatment of bacterial infections, particularily those due to Enterococcus, which are resistant to other currently available antibiotics. It can also be used to treat skin and soft tissue infections due to streptococcus and staphylococcus which are resistant to other antibiotics. Side effects are relatively mild with rash (1%) and nausea (0.8%) being the most common.

Targretin (Bexarotene)

This orally administered drug represents a new class of agents derived from vitamin A. It is indicated for the treatment of cutaneous T-cell lymphoma who no longer respond to at least one course of systemic chemotherapy. Although only 2% of patient had a complete response, an additional 30% had a partial response. Targretin is containdicated in pregnancy. Side effects include elevated blood lipids, itching, and edema of extremities.

Temodar (Temozolomide)

This newly approved drug is indicated for the treatment of refractory anaplastic astrocytoma, a brain tumor which does not respond well to chemotherapy. Temodar produced a 22% remission rate (complete 9%) with a mean duration of responders of 64 weeks. Significant side effects include bone marrow suppression which limited the highest dose that could be given. Other side effects include nausea (53%), vomiting (42%), headache (41%), fatigue (34%) and constipation (33%).

Tikosyn (Dofetilide)

This newly approved drug is an antiarrhythmic indicated for the maintenance and conversion of atrial fibrillation and flutter to normal sinus rhythm (NSR). It is also valuable in maintaining normal sinus rhythm in patients electrically cardioverted from atrial fibrillation-flutter to NSR. Ths drug will not be available until early 2000.

Vioxx (Rofecoxib)

Vioxx is the second of a class of antiinflammatory drugs called the COX-2 inhibitors. Inhibition of the COX-2 enzyme reduces a cascade which leads to inflammation and the resultant pain. It, unlike the other COX-2 inhibitor, Celebrex, is approved for pain as well as for osteoarthritis. It, unlike, Celebrex is not approved for rheumatoid arthritis. Side effects are generally mild and occur in <5% of patients. They include: fatigue, lower extremity edema, increased blood pressure, heartburn, nausea, and an increased incidence of bronchitis. This class of antiinflammatory drugs has a much lower incidence of gastrointestinal bleeding than drugs like ibuprofen and naproxan.

Xenical (Orlistat)

This is the first non-controlled drug released for the treatment of obesity. It acts by complexing fat in the intestine thus reducing fat absorption by 30-40%. Weight loss begins in two weeks and continues for 6-12 months. The average loss is 12-15 lbs. Side effects include: diarrhea, flatulence (gas), and oily stools.