Recent new drug approvals

1. Icosapent ethyl (Vascepa)

• Indication: Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. 
• Pharmacology: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).
• Studies suggest that eicosapentaenoic acid reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles.
• Potential mechanisms of action include 
• increased ß-oxidation;
•  inhibition of acyl-CoA:1,2-diacylglycerol acyl­transferase (DGAT); 
• decreased lipogenesis in the liver; and
•  increased plasma lipoprotein lipase activity.

2. Cabozantinib (Cometriq)

• Indication

  :

Treatment of progressive, metastatic medullary thyroid cancer.

• Pharmacology:

• Cabozantinib inhibits the tyrosine kinase activity of RET, MET, VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, and TIE-2. 
• These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

Antibacterial activity of Nigella sativa seed in various germination phases on clinical bacterial strains isolated from human patients

See full text of paper on antimicrobial activity of N. sativa in various germination stages against clinical strains. Nigella sativa is an important spice and flavoring agent which is widely used in various European and Asian cuisines. It harbors an array of medicinal properties as shown by various researches. Germination is a phenomenon during which rapid changes in metabolic activities and the interconversions of metabolites take place. The objective of present study was to evaluate the antibacterial activity of N. sativa seed that are on various germination phases against clinical bacterial strains isolated from pus, urine, ascitic fluid and cerebrospinal fluid of various patients. The minimum inhibitory concentration (MIC) values were determined by using a modified macro-broth dilution technique. The agar well diffusion method was used to test the antimicrobial effects of N. sativa extracts. Some broad spectrum antibiotics were used as positive control. The phytochemical constituents of N. sativa seed were also studied in germination phases. The distilled methanolic extracts of N. sativa showed significant antimicrobial activity against tested clinical strains of Gram-positive Staphylococcus aureus and Gram-negative Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Proteus mirabilis bacteria. Results showed day-dependent and dose-dependent activity and a significant antimicrobial effect was observed as germination proceeded.

Bioethics in India

Knowledge, Attitudes and Practices of Bioethics among Doctors in a Tertiary Care Government Teaching Hospital in India
J Clinic Res Bioeth 2011, 2:118. 0:0, (2011)
http://dx.doi.org/10.4172/2155-9627.1000118

Drugs Update

New drugs approved for marketing in India during November-December 2011

Source: http://cdsco.nic.in

Diazinon Flea Drops Spot on Dogs 30.0% w/w	For dogs infected with fleas.
Cabazitaxel Injection 60mg / 1.5ml	In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.
Trifluridine Eye Drops 1% w/v	For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.
Fosaprepitant (as Dimeglumine) for Injection 150mg.	1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.
Abiraterone Acetate Tablets 250mg	In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.
Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg	For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.
Crizotinib  hard gelatin Capsules 200mg/250mg	For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA-approved test.

Drugs  banned in India in 2011

Source: http://cdsco.nic.in

1.      Gatifloxacin

2.      Tegaserod

3.      Nimesulide for children below 12 years.

4.      Cisapride

5.      Phenyl propanolamine

6.      Human placental extract

7.      Sibutramine

8.      R-Sibutramine

FDA approvals in January 2012

Source: http://drugs.com

1.      Fentanyl Sublingual Spray

Opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.

2.      Glucarpidase Injection

Carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.

3.      Ciclesonide Nasal Aerosol

Corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.

4.      Ingenol mebutate Topical Gel

Inducer of cell death indicated for the topical treatment of actinic keratosis.

5.      Axitinib Tablets        

Kinase inhibitor indicated for the treatment of advanced renal cell carcinoma

6.      Exenatide Extended-Release Injectable Suspension

Glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

7.      Vismodegib Capsules

Hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).

8.      Ivacaftor Tablets

Cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.

Top News From American Heart Association (AHA) 2010 scientific sessions

The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago, Illinois, November 13-17, 2010.
Key trials presented at the sessions include:

• ADVANCE: New LVAD equivalent to HeartMate II, nonrandomized study shows
• RAFT: CRT shows survival benefit for patients with class 2 and 3 HF who have low EF and wide QRS
• EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure
• ASCEND HF: Nesiritide safe but of limited dyspnea benefit in acute HF
• ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority analyses at odds
• CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO closure
• GRAVITAS: No benefit of doubling dose in clopidogrel nonresponders
• P-OM3: Omega-3 PUFA caps don't suppress paroxysmal AF in randomized trial
• BASKET-PROVE: DES as safe as bare-metal stents in larger coronary arteries, with less TVR 
• DEFINE: Large effects on LDL and HDL cholesterol with CETP inhibitor anacetrapib
• SYMPLICITY HTN: Catheter-based renal denervation reduces BP in patients with resistant hypertension
• ASCOT CRP: Analysis fuels debate over JUPITER-based CRP indication for statins
• ACT: No benefit of N-acetylcysteine to reduce contrast-induced nephropathy

Acceptability and safety profile of oral and sublingual misoprostol for uterine evacuation following early fetal demise

Background: It has been established that sublingual (SL) route of misoprostol has a great potential to be developed for medical abortion, but there is dearth of evidence to reveal satisfaction rate and safety profile among patients of oral and SL routes. Thus, this study was conducted to provide an insight into the acceptability and safety profile of the same.
Materials and Methods: A randomized controlled trial was carried out by giving 200 mg mifepristone orally, followed by administration of 600 ΅g misoprostol orally to 50 women and sublingually to 50 women. The primary endpoints of study were measurements of acceptability and safety profile parameters (average blood loss, nausea, vomiting, diarrhea, hot flushes, fever) of both the groups. The secondary endpoints of the study were number of doses required for complete abortion, success rate and the induction to evacuation interval in both the groups.
Results: SL route of administration was more acceptable than the oral route (P = 0.009). Average blood loss was higher in the oral group than in the SL group (P = 0.001). Amongst the side effects, 34% in the SL group and 52% in the oral group had nausea (P = 0.264), 22% in the SL group and 44% in the oral group had vomiting (P = 0.031), 48% in the SL group and 86% in the oral group had diarrhea (P < 0.05), hot flushes were presented by 24% in the SL group and 50% in the oral group (P < 0.05), fever was presented by 20% in the SL group and 44% in the oral group (P < 0.05), and the number of cases aborted with only one dose was higher (86%) in the SL group as compared to 63% in the oral group (P = 0.004). The evacuation (success) rates were 92% in the SL group and 84% in the oral group (P = 0.218) and the mean ± SD induction to evacuation intervals in the SL and oral groups were 5.6 ± 4.54 hours and 9.44 ± 5.61 hours, respectively (P = 0.0002).Conclusion: The SL route had fewer undesirable effects, was more satisfactory, required less number of doses and was more acceptable to the patient compared to the oral route.


Kushwah DS, Kushwah B, Salman MT, Verma VK. Acceptability and safety profile of oral and sublingual misoprostol for uterine evacuation following early fetal demise. Indian J Pharmacol [serial online] 2011 [cited 2011 May 24];43:306-10. Available from: http://www.ijp-online.com/text.asp?2011/43/3/306/81513

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Promising Therapies in Diabetes Mellitus

Diabetes mellitus (DM) results from defects in insulin secretion (type 1) or insulin resistance (type 2). Insulin is used to manage type 1 DM, and oral hypoglycemic agents are used to manage type 2 DM. These therapies are inconsistent in maintaining glycemic control and cause some severe adverse effects such as undue weight gain and hypoglycemia. New and appropriate therapies are needed to overcome these problems. Drugs that are in the pipeline include oral insulins for type 1 DM and incretin mimetics, incretin enhancers, gastric inhibitory peptides, amylin analogues, peroxisome proliferator-activated receptor-α/γ ligands, sodium-dependent glucose transporter inhibitors, and fructose 1,6-bisphosphatase inhibitors for type 2 DM.

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Measures of Obesity

There are several measures of obesity. Each  has its own strengths and limitations. The gold standard is dual-energy X-ray absorption (DEXA). Body mass index (BMI) is calculated as mass (kg) per height² (m²). Waist circumference is widely thought to be a better indicator of cardiovascular risk than BMI, although some studies have shown them to be equally predictive. Other measures include the waist-to-hip ratio (WHR) and the waist-to-hip-to-height index, which have both been forwarded as potentially better measures of obesity than BMI. Using measurements of hip circumference and height, the new body adiposity index (BAI) can be used to reflect percentage of body fat for adult men and women of differing ethnicities, without numerical correction or assessment of weight. BAI, calculated as (hip circumference/height^1.5)–18, is a good predictor of percent fat and works for men and women.  The BAI also yields the percentage of fat itself, rather than just a correlate (or index) of it, which is what the BMI does. Body fat percentage is estimated from three skinfold thicknesses (biceps, triceps, and subscapular).