Formulary Watch |

Guidance emerges on specific types of combo therapy for hypertension

With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged.

Head-to-head hypertension study shows olmesartan superior to losartan

New study results show that patients treated with olmesartan medoxomil (Benicar) 40 mg once daily experienced significantly greater blood pressure reductions and higher goal attainment rates than patients treated with losartan potassium (Cozaar) 100 mg once daily, after 8 weeks.

Consensus statement lowers BP goals in blacks to manage hypertension

An updated consensus statement on the management of hypertension among blacks places a major emphasis on a comprehensive assessment and appropriate risk stratification of individual patients with hypertension, according to a report published online Oct. 4, 2010 in Hypertension, HealthDay News reported.

Studies show impact of physician-pharmacist collaboration

A collaborative effort between physicians and pharmacists appears to result in improved blood pressure control in hypertensive patients, and continued education in smoking cessation counseling may help physicians, according to two articles published Oct. 11, 2010 in the Archives of Internal Medicine, HealthDay News reported.

Studies show impact of physician-pharmacist collaboration

A collaborative effort between physicians and pharmacists appears to result in improved blood pressure control in hypertensive patients, and continued education in smoking cessation counseling may help physicians, according to two articles published Oct. 11, 2010 in the Archives of Internal Medicine, HealthDay News reported.

DECISIONS survey study: Americans often make medication decisions without being well-informed

According to the findings of the DECISIONS survey study published in a September/October supplement of Medical Decision Making, Americans frequently find themselves faced with high blood pressure, high cholesterol, and depression medication decisions that they are ill-prepared to make.

Pediatric dosing can be tricky; more awareness needed here and in developing countries

When it comes to pediatric therapy, children ?are not just small adults.? This was one of the dominant messages emerging from the recent National Institutes of Health, Division of AIDS, Forum to Promote TRIUMPH ? TB Research in Underserved Maternal and Pediatric Populations with HIV.

Patients with chronic osteoarthritis of the knee experience reduced pain and improved physical functioning with duloxetine use

In patients with chronic knee pain due to osteoarthritis, 60 mg to 120 mg of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, administered daily, was found to provide both significant pain control and improve physical functioning.

Buprenorphine implants reduce opioid use of opioid-dependent patients

In a new randomized, placebo-controlled clinical trial published in the October 13, 2010 Journal of the American Medical Association, trial investigators demonstrated that the use of buprenorphine implants (Probuphine, Titan Pharmaceuticals) could reduce opioid use over a 24-week study period.

Denosumab effective in reducing skeletal-related events

Amgen of Thousand Oaks, Calif., the maker of denosumab (Prolia) announced at a global conference last month the results of 2 integrated analyses of head-to-head pivotal phase 3 trials comparing the drug to zoledronic acid (Zometa, Novartis Pharmaceuticals), the current standard of care in the prevention of skeletal-related events in patients with advanced malignancies involving bone.

Nonanthracycline regimens for adjuvant treatment of operable breast cancer

Nonanthracycline-containing chemotherapy regimens for the adjuvant treatment of operable stage I to III breast cancer are discussed, including efficacy and toxicity results from recent randomized clinical trials comparing anthracycline to nonanthracycline-containing regimens.

Kombiglyze XR tablets approved for the treatment of type 2 diabetes mellitus in adults

FDA has approved saxagliptin and metformin extended-release (XR) (Kombiglyze XR, AstraZeneca/Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels, fasting plasma glucose, and postprandial glucose

First IV formulation for acetaminophen approved

FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous (IV) formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.

Drug Watch: Multiple sclerosis agents (PDF) (November 2010)

Agents in late-stage development for the treatment of multiple sclerosis.

Formulary Digital Edition November 2010

Attention deficit hyperactivity disorder: More than a child's disorder; Focus on lurasidone; Agents in late-stage development for the treatment of multiple sclerosis

Focus on lurasidone: A new atypical antipsychotic for the treatment of schizophrenia

Lurasidone, a new-generation atypical antipsychotic, has been approved by FDA for the treatment of schizophrenia and is under investigation for the treatment of bipolar disorder. This article will discuss the clinical pharmacology, clinical trials, adverse events, drug interactions, dosing and administration, and formulary considerations.

Attention deficit hyperactivity disorder: More than a child's disease

This article will discuss the diagnosis and treatment of ADHD in adults including stimulant therapy, education and psychosocial intervention, and nonstimulant alternatives.

Aliskiren and amlodipine (Tekamlo): A new combination renin inhibitor and dihydropyridine calcium channel blocker for the treatment of hypertension

New combination: Aliskiren and amlodipine (Tekamlo) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals, in hypertensive patients not adequately controlled with monotherapy, or as a substitute for its individual components.

New agent development crucial in treatment of hepatitis C

The protease inhibitors boceprevir and telaprevir, in phase 3 development, are poised to become a new therapeutic category of medications to be added to the current standard of care to increase sustained virologic response rates and prevent liver disease in patients with hepatitis C.

FDA Actions in Brief November 2010 (Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay)

Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor): A new 3-drug combination product for the treatment of hypertension

New combination: Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals.

Comparative effectiveness research studies will alter methods for assessing the value of new therapies and coverage calculations

PCORI now has a chairman and board representing all stakeholders to take on the daunting task of setting the national CER agenda, developing systems for funding research, establishing standards and methods for comparative studies, and devising programs to disseminate results to practitioners and to the public.

First-time generic approvals November 2010

Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex

FDA Pipeline Preview, November 2010 (Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor)

Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.

FDA issues complete response letter for lorcaserin

FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.

FDA approves Botox for chronic migraine

OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.

FDA approves first once-daily eyedrop for inflammation and pain after cataract surgery

Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

First warfarin replacement approved

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval.

Schizophrenia study stopped early due to success

Because of successfully meeting efficacy criteria at a protocol-specified interim analysis, an independent data monitoring committee (IDMC) has recommended the early termination of Otsuka?s phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

Giving more people statins could cost effectively prevent heart attacks

Giving cholesterol-lowering statin drugs to more people could be a cost-effective way of preventing heart attacks, US researchers said Sept. 27, as reported by Reuters. The study was published in Circulation.