Drug Pipeline

In a prospective, observational study, exposure to protease inhibitors (PIs) was associated with an increased risk of myocardial infarction (MI). The authors stated that this association is partly explained by dyslipidemia.

In this multicenter, randomized, open-label trial, it was demonstrated that among patients whose diabetes was not well controlled with either a sulfonylurea or metformin alone, the addition of rosiglitazone (n=2,220) did not increase the risk of cardiac-related hospitalization or death compared with patients who received metformin plus a sulfonylurea (n=2,227).

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals, August 2007

The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135

Amlodipine/valsartan, a combination of calcium-channel blocker and angiotensin II receptor antagonist is now approved by FDA for the treatment of hypertension

Pregabalin, an anticonvulsant agent, is now approved by FDA for the management of fibromyalgia.

Ambrisentan, an endothelin-receptor antagonist is now approved by FDA for the treatment of PAH

First-time generic drug approval: amlodipine/benazepril capsules

In a nested case-control study, the use of low-to-moderate doses of aspirin (ASA) in women was associated with a significant reduction in all-cause mortality.

New research presented at the Digestive Disease Week 2007 regarding the effect of statins on hepatitis C infection.

In the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) study, initial treatment of hypertension with a fixed-dose, dual-drug combination demonstrated "unprecedented" levels of control at 18 months.

Nebivolol is associated with long-term control of blood pressure and is as effective in obese patients as in nonobese patients with hypertension, according to the results of a 9-month extension study and a post-hoc analysis that were presented at the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition.

In a randomized, controlled trial, telmisartan demonstrated a greater antiproteinuric effect than losartan in hypertensive patients with type 2 diabetes and chronic kidney disease.

Rituximab, which is currently FDA-approved for the treatment of certain B-cell lymphomas and moderate-to-severe rheumatoid arthritis, demonstrated benefit in the treatment of relapsing-remitting multiple sclerosis (RRMS) in 2 early-phase experimental trials.

Hemostatic treatment with recombinant activated factor vIIa (rFVIIa) failed to reduce death or disability in a phase 3 trial of patients with intracerebral hemorrhage (ICH), according to results presented during the AAN 59th annual meeting.

Immediate initiation of interferon beta-1b in patients with a first event suggestive of multiple sclerosis (MS) significantly reduces the risk of permanent neurologic impairment compared with delayed initiation, according to findings from the BENEFIT study presented during the AAN's 59th annual meeting.

In a large cohort study, aprotinin was not associated with an increased risk of cerebrovascular events or myocardial infarction (MI) in patients undergoing cardiothoracic surgery.

Chronic hepatitis B is a common disease worldwide with significant morbidity and mortality. Early diagnosis is essential but difficult, as most patients with chronic hepatitis B do not have specific symptoms until the symptoms of advanced disease occur. The main goal of therapy is to prevent cirrhosis and hepatocellular carcinoma by suppressing hepatitis B virus (HBV) DNA levels. The decision to treat and the choice of therapy require careful consideration of both patient and drug characteristics, as stated in both an expert panel consensus recommendation and the American Association for the Study of Liver Diseases (AASLD) treatment guidelines. Lamivudine, once the mainstay of oral antiviral treatment, has been supplanted by newer agents such as adefovir, entecavir, and telbivudine, which produce less drug resistance overall; these oral agents often require long-term treatment. Pegylated interferon alfa-2a, which has a predefined treatment course but is often poorly tolerated, is now the main option in..

Rosiglitazone is associated with an increased risk of myocardial infarction [MI] and death from cardiovascular causes, according to findings of a meta analysis.

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic drug approval: amlodipine/benazepril capsules

The latest FDA action (through July 2007) related to tramadol (Labopharm), SPD465 (Shire), continuous erythropoiesis receptor activator (Roche), fosaprepitant (Merck), ACAM2000 smallpox vaccine (Acambis), repository corticotropin injection (Questcor), rimonabant (Sanofi-Aventis), tamibarotene (Innovive), mycophenolate (Aspreva), romidepsin (Gloucester), aripiprazole (Otsuka/Bristol-Myers Squibb), AMT 011 (Amsterdam Molecular Therapeutics), aminolevulinic acid (Dusa), cyclosporine A (Novagali), and ARD-07 (Ardana)

Temsirolimus is now approved by FDA as an antineoplastic agent for the treatment of advanced renal cell carcinoma.

Rotigotine transdermal system is now approved by FDA as a nonergoline dopamine agonist for the treatment of for the treatment of signs and symptoms of early-stage idiopathic Parkinson disease.

Doxorubicin liposome injection, an anthracycline topoisomerase inhibitor, is approved by FDA in combination with bortezomib for the treatment of multiple myeloma

A new formulation/dosing regimen for levonorgestrel 90 mcg/ethinyl estradiol 20 mcg, a continuous-use combination oral contraceptive approved by FDA for the prevention of pregnancy.

A summary of case management adherence guidelines and online-based case management systems.

The investigational vasopressin receptor antagonist tolvaptan had no long-term impact on clinical events in patients hospitalized with acute decompensated heart failure (ADHF), but the agent did improve symptoms and volume status over the short term, according to results presented at the 56th annual ACC scientific session.

Succinobuccol, an investigational monosuccinic acid ester of probucol, was not associated with a reduction in a composite end point of major cardiovascular events in patients diagnosed with acute coronary syndrome (ACS), but use of the agent did result in improvements on certain secondary end points.