Pharmacy Drugs
Recent Posts
- Democrats Push Medical Device Liability Bill
- FDA Investigates Heparin Link in Two Delaware Deaths
- Conflict Of Interest Reported In 29 Percent Of Cancer Studies
- Interim Results Of Abbott’s PROGRESS Study Show Rapid Viral Decline In Dual-Therapy Regimen Of Kaletra(R) (lopinavir/ritonavir) And Raltegravir
- Survival For Prostate Cancer Patients Younger Than 50 Improved By Surgery
Random Posts
- Pharmacy Bodies Respond To EC Proposals On Prescription Medicines
- The Lives Of Pancreatic Cancer Patients Prolonged By New Drug Candidate
- SNM's Clinical Trials Network Expands European Membership Of PET Biomarker Manufacturers
- FDA Okays Drug for Maintenance Therapy in Advanced NSCLC
- RISPERDAL CONSTA (risperidone) Long-Acting Treatment May Improve Health Outcomes And Reduce Hospitalizations In Patients With Schizophrenia
- New Software To Improve Clinical Trial Performance
- Growing Retail Clinic Trend Makes Few Inroads In Poor, Underserved Areas
- Measurements Fail To Identify TB Patients Who Could Benefit From Shorter Treatment Course
- FDA Requires New Warnings for Testosterone Gels
- Cardiovascular Systems Announces First Patient Enrolled In COMPLIANCE 360° Clinical Trial
FDA Okays Antihypertensive Combo for First-Line Therapy
Posted by: admin in Pharmacy Drugs on November 22nd, 2009
LITTLE FALLS, N.J., May 13 — A combination pill containing amlodipine and olmesartan medoxomil — marketed as Azor — has received FDA approval as initial treatment for hypertensive patients likely to need multiple medications to reach blood pressure goals, the maker of the drug announced.
Daiichi Sankyo’s product, combining a calcium channel blocker and an angiotensin II receptor blocker, was originally approved in September 2007 for use alone or with other agents, but the indication for first-line therapy was recently added.
The approval was made on the basis of data from a phase III trial comparing the combination treatment with amlodipine or olmesartan medoxomil (Benicar) monotherapy and placebo in patients with mild-to-severe hypertension. (See ASH: More Proves Better in Treating Hypertension)
Through eight weeks, the combination yielded greater reductions in seated blood pressure and brought a greater percentage of patients to their blood pressure targets.
The benefits were seen in patients regardless of whether they had received antihypertensives before the study.
The only adverse reaction that occurred more with the active treatment than with placebo was edema.
Other adverse reactions included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.
The drug’s label contains a boxed warning about the risk of injury or death to a developing fetus if used in the second or third trimesters of pregnancy.
Initial therapy with the combination is not recommended for patients 75 and older or those with liver problems, according to the company.
Related Article(s):
No Comments »
No comments yet.
RSS feed for comments on this post. TrackBack URL
Leave a comment
You must be logged in to post a comment.
| Copyright 2009 |online pharmacy ambien no prescription buy xanax online no prescription online tramadol buying xanax online buy soma