PHARMACY

Study shows Avodart/Flomax combo more effective on enlarged prostate problems

BY Drew Buono

PHILADELPHIA A new study that will be published in the Journal of Urology shows that men with enlarged prostates who took a combination of two medications, Avodart and tamsulosin hydrochloride, the generic version of the Astellas Pharma/Boehringer Ingelheim drug Flomax, experienced greater improvements in urinary symptoms than men prescribed either medication alone, according to published reports.

Over time, Avodart (dutasteride) shrinks the prostate, improves symptoms and arrests the enlarged prostate disease process. Tamsulosin is an alpha-blocker that relaxes the muscles in the bladder and prostate.

The study, entitled The Combination of Avodart and Tamsulosin, looked at male patients with moderate-to-severe enlarged prostate symptoms received a placebo for four weeks and then were randomized to receive Avodart and tamsulosin as combination therapy, for the remaining 24 months of the study.

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Study shows positive results from adding Lipitor early to blood pressure treatment

BY Drew Buono

NEW YORK According to a new study, when Lipitor was added as an early treatment to lower blood pressure, the drug showed a 36 percent reduction in the risk of fatal or non-fatal heart attacks over five years.

The study, entitled Anglo-Scandinavian Cardiac Outcomes Trial, was conducted over a five-year period in Europe with over 19,000 patients, with the first three years being dedicated to comparing Lipitor, a Pfizer product, with a placebo. The additional two years were used for post-study follow up. At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease.

“This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk,” according to Bryan Williams, chairman of the British Hypertension Society Guideline working party and professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom.

Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels, were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or a placebo at the outset of the trial.

At the end of the follow-up period, LDL-C or bad cholesterol levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.

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Taro submits Flo-Pred application to FDA in new PLR format

BY Adam Kraemer

WASHINGTON Taro Pharmaceuticals applied Thursday to the Food and Drug Administration seeking approval for its new oral solution, Flo-Pred.

Flo-Pred (prednisolone acetate oral suspension) is an anti-inflammatory or immunosuppressive agent indicated for a variety of diseases and conditions, including allergic, dermatologic, gastrointestinal and hematologic. 

The medication also enjoys the distinction of—pending approval—being the first oral steroid label in the FDA’s new physician labeling rule format. The PLR format, which went into effect June 19, requires new content, new structure and new highlights information, as compared to the former structured product labeling.

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