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. Warfarin was approved in 1954.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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-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.
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
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.
Agents in late-stage development for the treatment of multiple sclerosis.
Attention deficit hyperactivity disorder: More than a child's disorder; Focus on lurasidone; Agents in late-stage development for the treatment of multiple sclerosis
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.
This article will discuss the diagnosis and treatment of ADHD in adults including stimulant therapy, education and psychosocial intervention, and nonstimulant alternatives.
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.
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.
Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay
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.
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.
Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex
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 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.
