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June 2005

May 2005

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Drug Updates

 

 

Vascular protection with nifedipine

ILAN, Italy

Evidence is growing that the benefits nifedipine GITS (Adalat GITS) offers to hypertensive patients are the result not just of the drug's blood-pressure-lowering but also vascular protective properties.

    In a Bayer HealthCare press conference during the 15th Meeting of the European Society of Hypertension in Milan, Italy, leading experts in hypertension discussed the evidence and trends in the treatment of hypertensive patients. They noted that hypertension is a major risk factor for cardiovascular events, but before cardiovascular events occur, there is subclinical organ damage. "Therapies need to be started early to help prevent subclinical organ damage, and there is good evidence that nifedipine GITS can help in this," said Prof. Giuseppe Mancia of the University of Milan-Bicocca.

    The main evidence that nifedipine GITS can help prevent subclinical organ damage and thus reduce cardiovascular events was seen in recent trials, notably the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT) and A Coronary-disease Trial Investigating Outcome with Nifedipine GITS (ACTION).

    The INSIGHT study showed that nifedipine GITS not only effectively controlled blood pressure but also reduced the risk of cardiovascular events by 50 percent. These improvements are not only related to the blood-pressure-lowering effects, but may also be attributed to the drug's antiatherosclerotic effect, the authors noted. Nifedipine GITS blocks the progression of intima-media thickness (IMT) in the carotid artery, and significantly slows the progression of calcification of the coronary arteries in hypertensive patients.

    In the ACTION trial that involved 7,665 patients with symptomatic stable angina, nifedipine GITS lowered the rate of new overt heart failure by 29 percent during the five-year trial. In a retrospective analysis, the rate of stroke and transient ischemic attacks was reduced by a highly significant 28 percent.

    The hypertensive population in ACTION experienced the greatest benefits from adding nifedipine GITS to their optimal therapy. The analysis of this subgroup showed a 38-percent reduction in new overt heart failure, a 33-percent reduction in debilitating stroke, and a 16-percent reduction in the need for coronary angiography. It also showed a significant 13-percent reduction in the combined rate of death from any cause and cardiovascular events.

    Said Prof. Philip Poole-Wilson of the Imperial College, London: "Physicians now need to install preventative strategies against stroke and heart failure based on the results of recent studies." Bayer HealthCare Press

 


 

Aspirin lowers risk of colon cancer

LEVERKUSEN, Germany

A cetylsalicylic acid (ASA), the active ingredient in aspirin, can lower the risk of redeveloping colorectal cancer based on a recent study presented during the 2005 annual meeting of the American Society of Clinical Oncology.

    The study involved 830 patients with stage-III colon cancer and who were simultaneously taking part in another trial intended to evaluate two different chemotherapeutic regimens. During chemotherapy and six months after treatment, each patient completed questionnaires concerning medication use and lifestyle. Seventy-two patients (8.7 percent) regularly took ASA before and after their cancer treatment. Compared with the group that did not take aspirin, these patients experienced a 48-percent reduction in the risk of disease recurrence and death. The researchers concluded that consistent use of ASA can be associated with improved outcomes for patients with stage-III colon cancer.

    Previous studies have shown that large doses of acetylsalicylic acid can significantly decrease the incidence of colorectal polyps--initially benign tumors that can turn malignant if left untreated. It has also been shown that ASA may prevent precancerous lesions.

    Although colorectal cancer is the second leading cause of cancer-related deaths, the chances of a cure are good if it is diagnosed early. Colon cancer is a malignancy involving both large intestines (colon) and the rectum. Although there is no single cause, certain factors increase the risk of developing the disease, among them, for instance, an unhealthy diet, excessive alcohol consumption, and a lack of exercise. Further risk factors include colorectal polyps, a family history of colorectal cancer, and a history of ulcerative colitis. Bayer HealthCare Press

 


 

Novartis ups malaria-drug output

GENEVA

Swiss pharmaceutical giant Novartis is aiming to quadruple production of a key antimalaria drug next year to tackle a supply shortage. Production of artemether-lumefantrine will be ramped up to 120 million treatment courses in 2006 once a supply of artemisinin--a raw material extracted from the plant Artemisia annua--comes on tap, the company said.

    The drug is the most effective medicine available to treat the deadliest form of the disease. Novartis currently has capacity to produce five million treatment courses a month, but is running at half that rate because of the raw material shortage.

    Chief executive Daniel Vasella said the company had "significantly increased" its investments in the drug and cultivation of the Artemisia plant. "We are confident that we will succeed in increasing the available volumes to 30 million treatments by the end of the year and to 120 million treatments in 2006," he added. AFP

 


 

Alfuzosin-Cialis combo is safe

PARIS

Concomitant use of alfuzosin (ALFUCIA) to treat symptoms of benign prostate hyperplasia (BPH) and tadalafil (Cialis) for erectile dysfunction has been found safe, "with no clinically significant hemodynamic interaction."

    Results of the Alfuzosin and Cialis (ALFUCIA) study recently presented at the 20th European Association of Urology congress in Istanbul, Turkey, suggest that uroselective alpha1-blocker alfuzosin 10 mg once daily could be safely associated with the phosphodiesterase-5 (PDE-5) inhibitor tadalafil 20 mg.

    ALFUCIA was double-blind, placebo-controlled crossover study involving 18 healthy volunteers 40 to 65 years old. They were given alfuzosin 10 mg daily for seven days and then randomized to receive tadalafil 20 mg or placebo four hours after the last dose of alfuzosin 10 mg. Blood pressure (BP) was recorded at baseline and for 24 hours after medication to evaluate potential hemodynamic interaction between the two drugs.

    The results showed that tadalafil produced marginal blood pressure changes (mean maximal decrease of 4.3 mm Hg systolic and 3.5 mm Hg systolic BP) versus placebo. Analysis of outliners on alfuzosin 10 mg (the number of patients with clinically important BP effects v. baseline BP) was low and similar between tadalafil and placebo. In both arms of the study, no patient had a drop in BP greater than 30 mm Hg (systolic) or 20 mm Hg (diastolic).

    Commented Dr. Francois Giuliano of the Academic Hospital of Bicetre, Medical University of Paris: "The ALFUCIA study demonstrates that alfuzosin 10 mg shows no clinically significant hemodynamic interaction with tadalafil 20 mg. These results are an import-ant finding as they comfort the physician that both drugs could be associated if patients already treated for LUTS suggestive of BPH…requir[e] a specific treatment for sexual dysfuntion."

    BPH affects 50 percent of men 60 years or older. Seven out of 10 men with BPH report its symptoms to be bothersome.

    Recent studies have shown that sexual dysfunction and reduced ejaculation are common among men with lower-urinary-tract symptoms (LUTS). This association between LUTS and sexual dysfunction is independent of age and other comorbid conditions such as diabetes and hypertension. Experts say this high level of burden implies that sexual function should be carefully assessed before treating LUTS as some treatment options may further cause impairment.

    "Because alfuzosin has no deleterious effect on sexual function and…is well tolerated in association with a PDE inhibitor such as tadalafil, it is likely to be the alpha-blocker of choice in BPH patients complaining of LUTS and sexual dysfunction" said Dr. Steve Kaplan, vice chair of the College of Physicians and Surgeons at Columbia University, New York. Sanofi-Aventis Corporate Communications

 


 

Westmont launches Omepron

 

 

Amid the raging political crisis, Westmont Pharmaceuticals cooked up an atmosphere nothing short of a Philippine fiesta to launch Omepron, its version of omeprazole, July 5 at the NBC Tent inside the former Fort Bonifacio in Taguig. Recording artists Rico J. Puno, Hajji Alejandro, Nonoy Zuñiga, Marco Sison, Janine Desiderio, and Verni Varga took turns entertaining the audience with songs from the 1970s and 1980s.

    Omepron para sa Pilipinong Mag-anak was the theme of the launch, with Westmont general manager Constante Calubaquib stressing that making available essential medicines like Omepron at an affordable cost is Westmont's way of helping Filipino families cope with economic difficulties.

     "Omepron is 50-percent cheaper than the other brands of omeprazole in the market," he said, adding that effective medicines don't have to be expensive. He said omeprazole has been the gold standard among proton-pump inhibitors (PPIs) in the market.

    Omepron is available in 20 mg capsules for the treatment of duodenal and gastric ulcer, gastroesophageal reflux, erosive esophagitis, pathological hypersecretory conditions, and for eradication of H. pylori (in combination with antibiotics), and in 40 mg powder formulation for IV injection for those who cannot take oral medication.

    Omeprazole is as a potent inhibitor of gastric-acid secretion. It reduces gastric-acid secretion by inhibiting the parietal cell H+-K+-ATPase (proton pump) in gastric parietal cells.

    Omeprazole is rapidly absorbed, with peak plasma concentrations occurring within 30 minutes to three-and-a-half hours. Unlike antacids and antisecretory agents, it is completely metabolized once taken. About 20 percent of the administered dose is excreted in the feces and the remaining 80 percent is excreted in the urine as metabolites. A. Mendoza

 

 

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