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A Glimpse at Avandia (rosiglitazone) Drug Information Resident Ketal Patel Pharm.D. Drug Information Resident
Texas Southern University’s Drug Information Center has a
Rosiglitazone (Avandia®), a thiazolidinedione on the market
new Drug Information Resident for the 2010-2011 year. Dr.
since 1999, is FDA indicated for monotherapy in conjunction
Ketal Patel graduated Cum Laude from Texas Southern University College of Pharmacy and
with diet and exercise as well as combination therapy for the
Health Sciences with a Pharm. D. degree in
treatment of Type II Diabetes Mellitus. It has also been used
May of 2010. Her interests lie in research and
off label for the treatment of Polycystic Ovarian Syndrome.
Rosiglitazone is associated with adverse effects such as
joining the academic team, Dr. Patel hopes to
fractures, and cardiovascular effects such as increased HDL,
bring the Drug Information Center to new
LDL and total cholesterol. Due to the serious nature of the
heights! She looks forward to serving her
cardiovascular related adverse events, rosiglitazone carries a
community and dedicated herself to the ever-growing
black box warning for either initiating or exacerbating
pharmacy profession. Dr. Patel is available at the TSU DIC on M-F from 8:30-4:30 to answer DI questions from health care
congestive heart failure with possible increased risk of
myocardial infarction or angina. Symptoms associated with
congestive heart failure include weight gain, edema and
Rosiglitazone Evaluated for Cardiovascular Outcomes and
Regulation of Glycemia in Diabetes (RECORD) study results
Services Offered by the Drug Information Center
related to increased risk of cardiovascular events to the FDA
for review. In 2007, an additional study showed increased risk
of heart failure with rosiglitazone. At the same time, the FDA
added a black box warning for congestive heart failure to the
Joint Commission Accreditation Assistance
drug while keeping it on the market. A recent re-analysis of the
RECORD study published in January 2010 showed 61 cases
of heart failure events in the rosiglitazone treatment group
versus 29 cases in the control group, approximately a two-fold
increase (P= 0.0010).2 In addition, a final updated meta-
analysis published June 2010 showed results strikingly similar
to previously published studies forcing the FDA to meet
through its advisory committee and decide whether to keep the drug on the market, add restrictions or remove it altogether.
INSIDE THIS ISSUE:
The recently published meta-analysis included all randomized clinical trials with a minimum duration of 24 weeks conducted
till February 2010 which totaled 56 trials with over 35,531
patients of which 19,509 received rosiglitazone while 16,022
Mycophenolate Mofetil for the Treatment of
received control therapy. Data sources included extensive
Chronic Dermatitis: An Open-label Study of 16 Patients
searches on Medline, FDA and GlaxoSmithKline clinical trial registry sites. Trials fell into 3 categories: Group 1 consisting of
5 studies, four of which were published by GSK initially for drug
Chlorhexidine-Alcohol versus Povidone-Iodine
approval, Group 2 consisting of 48 trials listed in the GSK
registry 35 of which were unpublished, and Group 3 consisting
Atorvastatin as a potential anti-malarial drug:
of 3 large prospective trials all of which were published. The
in vitro synergy in com binational therapy with
primary outcomes for myocardial infarction using the Cochrane
quinine against Plasmodium falciparum.
Q statistic were 30.3 (P=0.87) without inclusion of the
RECORD study and 29.7 (P=0.27) with inclusion of the study.
The primary outcomes for cardiovascular mortality were 16.2 (P=0.91) with RECORD and 12.8 (P=0.97) without RECORD.
Using the Peto Odds Ratio (95% CI) the risk for MI including
associated with the procedure. Various reports on the
RECORD was 1.28 compared to 1.39 without. In addition, the
incidence of cyst formation state occurrences of 8 to 53%.
risk for cardiovascular mortality including RECORD was 1.03
Despite the variation in reported incidences of cyst formation,
compared to 1.46 without. The meta-analysis showed
research has clearly associated the occurrence of this adverse
comparative results to those previously found by FDA and
effect with the IVF procedure as a result of the gonadotropin
those found in the unpublished clinical trials by GSK of
agonist employed.2 Gonadotropin agents work by stimulating
increased risk of myocardial infarction with the use of
the development of multiple follicles in women who are
rosiglitazone. Increased cardiovascular mortality with use of
ovulating and are used as part of IVF or assisted reproductive
rosiglitazone was not shown.1 In July 2010, the FDA advisory
technology (ART). In particular these agonists increase the
panel consisting of the Endocrinologic and Metabolic Drugs
effects of follicle stimulating hormone (FSH) and luteinizing
and the Drug Safety and Risk Management advisory
hormone (LH) thereby stimulating the development and
committees, voted 12:10 to remove rosiglitazone from the
maturation of the ovarian follicle and causing ovulation.3
market or keep it with tighter restrictions. The FDA has stated it
Monitoring for the effects of these agents include checking
would take the recommendations by the panel seriously and
serum estradiol concentrations as well as FSH and LH levels
would decide on an appropriate course of action. However, a
throughout the procedure.4 While the mechanism by which
few important key facts to consider are that no large outcomes
these cysts are formed is unknown, researchers partly attribute
clinical trials have been conducted on rosiglitazone. The only
cyst formation to the direct effect of GnRH agonists on ovaries.
available studies are those of non-inferiority trials. Strength of
Ovarian cysts are fluid-filled sacs which reside on the surface
study results should also be taken into consideration. The
of ovaries. They are classified as either functional or non-
previously published study in 2007 and the meta-analysis
functional.5 Functional cysts are those to which increased
follow-up were conducted by Dr. Steven E. Nissen from the
estradiol levels either in the serum or aspirated cyst fluid is
chairman of cardiovascular medicine at the Cleveland Clinic
attributed. They are follicular or luteal in nature. These cysts
who is a paid consultant for pharmaceutical companies
are essentially considered to be normal given that they
including Takeda and GSK.5 As of now the road for
normally self- resolve after a few menstrual cycles. However
rosiglitazone and its impact on pharmacy remains uncertain
they can pose barriers to conception in reproductively
challenged females. Non-functional cysts such as dermoid or endometrial cysts can become abnormal and require close
Nissen SE, Wolski K. Rosiglitazone Revisited: An Updated Meta-
monitoring. Physicians often perform CT scans or MRIs to
Analysis of Risk for Myocardial Infarction and Cardiovascular
detect the presence of ovarian type (or any) cysts.5
Mortality. Arch. Intern. Med. June 2010. E1-E11
Conservative management of functional cysts include the use
Komajda M, McMurray J, Beck-Nielson H, et al. Heart Failure events with rosiglitazone in type 2 diabetes: data from the
of pain medications in complicated cases in which cysts
RECORD clinical trial. Eur Heath J.2010; 31:824-831.
rupture and exhibit profuse and prolonged bleeding. Also
Lexi-Comp Online Web site. http://www.crlonline.com. Accessed
included in this treatment method is laparoscopic surgery to
remove the cysts or the entire ovary in severe instances.
FDA Web site. http://www.fda.gov. Accessed July 12, 2010
Contraceptives have also been employed to prevent the
formation of ovarian cysts though this practice is not fully
http://www.abcnews.go.com. Accessed July 12, 2010.
New approaches to the management of IVF induced ovarian cysts such as aspiration are currently being explored. In one
Treatment of IVF induced
study conducted by Firouzabadi et al, 90 cyst aspirations were performed on infertile women who were under a GnRH-a/HMG
Ovarian Cysts
protocol and experienced formation of functional ovarian cysts
measured at ≥25 mm. Patients were stimulated with GnRH -a
and then with HMG on the 21st day of their menstrual cycles.
In vitro fertilization (IVF) is a protocol used to stimulate and
Transvaginal ultrasonography was conducted every 3 to four
enhance reproduction in women of childbearing age that are
days to detect and diagnose newly formed cysts. This
infertile or experience difficulty conceiving. Agents typically
procedure was then followed by the administration of 10,000
used to enhance ovulation and pregnancy include
units of HCG to promote ovulation. The overall incidence of
gonadotropin releasing hormone agonists (GnRH-a) and
cyst formation in the study was reported to be 20%. From the
human menopausal gonadotropin (HMG). Use of these agents
data obtained it was determined that women undergoing cyst
over a long period of time has been associated with the
aspiration required a significantly higher number of
formation of ovarian cysts which may have negative impacts
gonadotropin injections. While it was determined that there
on the desired outcome of pregnancy. Studies have been
was no significant difference in the number of viable oocytes
conducted to determine treatments for these cysts in order to
selected from the aspiration group (5.6 ± 2.1) compared to the
prevent any mal-effects and ensure positive outcomes. In the
group who received conservative treatment (5.2 ± 1.8), there
United States, the utilization of IVF has increased with the
were more cycle cancellations reported in the aspiration group.
availability of physicians that perform the procedure as well as
The pregnancy rate (although not statistically significant)
with extended insurance policies that provide coverage.1 Along
reported for the aspiration group was 10.3% in comparison to
with the increase in utilization is the consequent increased
14.9% for the conservative treatment group. Consistently,
observation of adverse effects, namely cyst formation,
similar studies in this field such as that conducted by Segal et
al indicate a 24% pregnancy rate in aspiration groups
the prevention of surgical site infection. Recently, a study was
compared to 41% in non-aspiration groups.6 Furthermore, it
published in the New England Journal of Medicine (NEJM) that
was reported that the rate of implantation and the incidence of
compared the efficacy of chlorhexidine-alcohol with povidone-
pregnancy were lower for patients with cyst aspiration.
iodine for prevention of surgical site infections. This was a
Additionally, in a study conducted by Qublan et al, a 9.7%
prospective, randomized clinical trial that was done between
pregnancy rate was reported for patients undergoing cyst
the time period of April 2004 and May 2008 at six university-
aspiration in comparison to 29.7% in patients receiving no
affiliated hospitals in the US. The inclusion criteria for the study
intervention.7 In accordance with the aforementioned studies,
included patients who were 18 years of age or older and
is the reporting of factors that attribute to the formation of
undergoing clean-contaminated surgery (procedures that are
functional ovarian cysts. These include patient age, agonist
done under controlled conditions without significant spillage or
used for stimulation, stimulation protocol administered and the
unusual contamination). Patients were assigned in a 1:1 ratio
presence of residual ovarian tissues from previous surgeries.
to have the skin at surgical site be preoperatively scrubbed
Furthermore these studies agree that elevated serum estradiol
with 2% chlorhexidine gluconate and 70% isopropyl alcohol or
levels in aspirated fluids are linked to a higher rate of ovarian
an aqueous solution of 10% povidone-iodine. There were a
cysts. Overall, the results from the more recent study
total of 849 patients, who qualified for the intention-to-treat
conducted by Firouzabadi et al indicate that cyst aspiration
analysis. Out of these patients, 409 patients were given
offers no significant therapeutic advantage over conservative
chlorhexidine alcohol and 440 received povidone-iodine. The
treatment methods. Moreover, the aspiration technique may
primary outcome for the study was the occurrence of any
negatively impact the desired outcome and further complicate
surgical site infection within 30 days after surgery. Secondary
the reproductive ability of fertility challenged women.
outcomes assessed individual types of surgical site infections. The results showed that the rate of surgical site infection was
Hammond AO, Gibson M, Stanford J, White G, Carrell DT,
lower with chlorhexidine-alcohol compared to povidone- iodine
Peterson M. In vitro fertilization availability and utilization in the
(9.5% vs. 16.1%; p=0.004). Chlorhexidine alcohol patients had
United States: a study of demographic, social, and economic
lesser superficial incisional infections (4.2% vs. 8.6%; p=0.008)
factors. Fertil and Steril. 2009; 91 (5): 1630–1635.
Firouzabadi RD, Sekhavat L, Javedanii M. The effect of ovarian
and deep incisional infections (1% vs. 3%; p=0.05). There were
cyst aspiration on IVF treatment with GnRH. Arch Gynecol
no major differences between chlorhexidine alcohol and
povidone iodine group for the risk of organ space infection or
Lexi-Comp [computer program]. Lexi-Comp; July 14, 2010.
sepsis from surgical site infection. Three of the patients from
Advanced Fertility; http://www.advancedfertility.com/ivf; July 14,
each study group had an adverse event such as pruritus,
erythema or both around the surgical wound.3Some other
studies that support the NEJM study included an earlier study.
http://www.nlm.nih.gov/medlineplus/ency/article/007279.htm.
It was done to compare chlorhexidine based solution with
Segal S, Shifren JL, Isaacson KB et al. Effect of a baseline
alcohol based povidone iodine to find out the rate of catheter
ovarian cyst on the outcome of in vitro fertilization-embryo
colonization and blood stream infection. This study confirmed
transfer. Fertil Steril. 2009; 71(2): 274-277.
that alcohol based povidone iodine must be replaced with
Qublan HS, Amarin Z, Tahat YA et al. Ovarian cyst formation
chlorhexidine based solution to stop catheter related
following GnRH agonist administration in IVF cycles: incidence
infections.4Another study confirmed that washing patients with
and impact. Hum Reprod. 2006; 21(3): 640-644.
chlorhexidine-cloths is an effective way to reduce VRE from
spreading to patient’s skin, environment and employee.5 Aqueous povidone-iodine is the most commonly used skin
Chlorhexidine-Alcohol
antisepsis in the US. The study that was published in NEJM proved that the chlorhexidine alcohol lessened the risk of
versus Povidone-Iodine for
surgical site infection by 41% compared to povidone iodine. Both of the drugs have broad-spectrum antimicrobial activity
Surgical-Site Antisepsis
but chlorhexidine alcohol has more protection against infections. Potential reasons for this superiority include a rapid
onset of action and continual activity even after being exposed
to bodily fluids and lasting effect. Two thirds of surgical site
According to Centers for Disease Control and Prevention
infections are limited to the incision so optimizing skin
(CDC), an average of 27 million surgeries are done every year
antisepsis before surgery will be very beneficial to patients.3
in the United States (US). Surgical site infections (SSIs) usually happen within 30 days at the site of surgery. Infection
Center for Disease Control Website: CDC.
can also occur within a year if a foreign body is inserted during
http://www.cdc.gov/ncidod/dhqp/FAQ_SSI.html. Accessed on July 12, 2010
the surgery. Seventy percent of SSIs are superficial infections,
Digison MB. A review of antiseptic agents for pre-operative skin
which mean it involves skin only. Other infections are more
preparation. Plastic Surgical Nursing. 2007;27:185-189
serious and involve tissues under the skin, organs or implanted
Darouiche RO, Wall MJ, Itani KMF, et al. Chlorhexidine-Alcohol
material. Many SSIs do not become fatal.1 Some of the
versus Povidone-Iodine for Surgical Site Antisepsis. NEJM.
examples of antiseptic pre-operative skin products include
povidone iodine, iodophor, chlorhexidine gluconate with
Mimoz O, Villeminey S, Ragot S, et al. Chlorhexidine-based
alcohol etc.2 There have been studies done before to compare
antiseptic solution vs. alcohol based povidone iodine for central
efficacy of different types or doses of systemic antibiotics for
venous catheter care. Arch Intern Med. 2007;167(19):2066-2072
Vernon MO, Hayden MK, Trick WE, et al. Chlorhexidine gluconate
AVA 80 mg daily, the differences in QN IC50 were found to be
to cleanse patients in a medical intensive care unit. Arch Intern
very significant (p < 0.009). The QN IC50 reductions in the
presence of AVA did not significantly correlate with the QN
IC50 alone (r= 0.22, P=0.3288) or the AVA IC50 alone (r=0.03, P=0.8946). The QN IC50 response in the presence of AVA
Atorvastatin as a potential
0.1µM was reduced by 5% (0% to 15%; 95%CI: 1%-8%). In the presence of AVA 0.5 µM, there was a 10% (3% to 23%;
anti-malarial drug
95%CI: 7%-14%) reduction. There was a 22% (14% to 40%; 95%CI: 19%-25%) reduction in the QN IC50 response with
AVA 1.0µM group. Of the P. falciparum parasites analyzed,
86% showed potentiation activity of AVA with QN.
Nearly 500 million people are afflicted with malaria annually,
Furthermore, it was shown that a maximum dose of AVA 120
with roughly 2 million succumbing to this tropical disease.1 Risk
mg daily could be administered with limited side effects
estimates for contracting malaria have been placed at
reported. Adverse events such rhabdomyolysis were not
approximately 40% of the world’s population, giving malaria the
induced in patients who were administered 120 mg daily. This
dubious distinction of being the world’s most destructive
study showed promising results of the synergistic effects of
parasitic infection.2 Pregnant women, children younger than 5
AVA with QN. The results of in vitro responses (IC50) and
years of age, and immunocompromised individuals are
polymorphisms in the pfcrt and pfmrp genes showed results
especially susceptible to this parasitic infection.1 A major health
that were highly significant. Polymorphism in the pfcrt gene
risk still exists in the aforementioned sections of the population
(codons 75, 76 and 220) were significant (P<0.0022) as well as
in highly endemic areas.2 Malaria is transmitted through
with the pfmrp gene (codons 191 and 437, P= 0.0008). An
various avenues, including blood transfusions, sharing of
additional study was conducted to determine the potential for
needles, and congenitally, but the primary means of
HMG-CoA reductase inhibitors as adjuvant anti-malarial
transmission is from person to person through the bite of
therapy.4 Results from this study showed that although
infected Anopheline mosquitoes.1 Four species of intracellular
atorvastatin exhibited more potency than rosuvastatin, it
protozoa of the genus Plasmodium are responsible for causing
demonstrated weak synergistic activity with chloroquine and
human malaria: P. falciparum, P. vivax, P. ovale, and P.
dihydroartemisinin. Atorvastatin showed inhibition of growth of
malariae. P. falciparum is responsible for causing the most
P.falciparum in vitro, but studies need to be conducted to
serious infections. Sporozites, injected into the human host by
further evaluate the synergistic effects of statins and
the mosquitoes, invade hepatocytes and develop into
conventional antimalarial agents. Urban developments, proper
schizonts. Following the rupture of the hepatocytes, merozoites
water management, novel agricultural and animal husbandry
are released into circulation. The parasites develop in the red
practices have all led to a steady decline in the incidences of
blood cells and this cycle is repeated every 48 (P. falciparum,
malaria after the mid-19th century. By the mid-20th century,
P. vivax, P. ovale) or 72 (P. malariae) hours ultimately resulting
transmission was drastically reduced. In malaria-endemic
in fevers, sweats, chills, and myriad symptoms of the disease.
areas, however, resistance to anti-malarial agents continues to
An emerging resistance of some strains of P. falciparum to
be an emerging concern. Studies are ongoing to assess the
some anti-malarial agents has warranted studies that hope to
use of these cholesterol-lowering drugs as potential additions
identify and isolate ways to combat the emergence of
to a growing arsenal of anti-malarial agents.
treatment failure. One such study investigated atorvastatin (AVA) for potential inclusion in a malarial treatment protocol in
Shapiro Theresa A, Goldberg Daniel E, "Chapter 39. Chemotherapy of Protozoal Infections: Malaria" (Chapter).
response to quinine (QN) resistance.3 HMG-CoA reductase
Brunton LL, Lazo JS, Parker KL: Goodman & Gilman's The
inhibitors, specifically AVA, have demonstrated ten-fold more
Pharmacological Basis of Therapeutics, 11e:
activity against P. falciparum strains. A potential link between
http://www.accessmedicine.com/content.aspx?aID=946964.
the presence of reductase enzymes in the protozoa may
Fairhurst RM, Wellems TE. Plasmodium Species (Malaria). Mandell: Mandell, Douglas, and Bennett’s Principles and Practice
explain why AVA demonstrates some activity against these
of Infectious Diseases. 7th ed. Accessed July 13, 2010.
organisms. The objectives of the study were to analyze in vitro
Parquet V, Henry M, Wurtz N, et al. Atorvastatin as a potential
synergism with AVA in combination with QN and to investigate
anti-malarial drug: in vitro synergy in combinational therapy with
polymorphisms in the P. falciparum sodium/hydrogen
quinine against Plasmodium falciparum. Malar J. 2010;9:139.
Wong RP, Timothy ME. Statins as Potential Antimalarial Drugs:
exchanger (pfnhe), P. falciparum chloroquine resistance
Low Relative Potency and Lack of Synergy with Conventional
transporter (pfcrt), and P. falciparum MDR-like protein (pfmrp,
Antimalarial Drugs. Antimicrob. Agents Chemother. May 2009;
pfmdr) genes. Twenty-one strains of P. falciparum were
isolated from several countries and an in vitro study was
conducted assessing the potentiation effects of AVA with QN against these strains.3 Twenty-five microliters of AVA and 200
Mycophenolate Mofetil for
µL of a parasitized red blood cell suspension were placed in each of 96-well plates containing concentrations of QN.
the Treatment of Chronic
Following three independent experiments assessing evidence
Dermatitis
of potentiation for each of the 21 strains, findings showed a 50% inhibition of parasitic growth (IC50). Variations in QN IC50
between AVA groups were accounted for with ANOVA statistical analysis. At plasma concentrations correlating to
Denisha Thomas Pharm. D. Candidate
Chronic dermatitis is a critical, relapsing inflammatory condition
Jackson J, Fowler J, Callen J, et al. Mycophenolate mofetil for
in which genetics, environmental stimuli, epidermal
the treatment of chronic dermatitis: an open-label study of 16
abnormalities, and immune dysregulation leads to pruitis,
patients. Journal of Drugs in Dermatology. 2010; 9(4): 356-362.
lichenification, and severe eczema.1 In immunity, T cells
van Velsen S, Haeck I, Bruijnzeel-Koomen C, et al. First
function to eradicate body cells that are infected from viral
experience with enteric-coated mycophenolate sodium (Myfortic®)
pathogens. In response to foreign invasion, B cells produce
in severe recalcitrant adult atopic dermatitis: an open label study.
antibodies that attach to antigens on the surface of pathogens
to aid in destruction.2 Collectively, these along with a host of other bodily defenses work simultaneously to aid the body in
fighting infection. Mycophenolate Mofetil, commonly referred to
Editor: Ketal Patel PharmD
as MMF, is an immunosuppressive agent. It is primarily used
Reviewer: Uche Anadu Ndefo, PharmD, BCPS
for the prevention of organ transplant rejections. MMF works
by inhibition of de novo synthesis of purines for the production
of precursors for RNA and DNA. Ultimately, MMF impedes the
proliferation of T cells and B cells; delaying the process of immunity.An open-label study evaluated the use of
If you have any comments, questions or
mycophenolate mofetil in sixteen patients with recalcitrant
suggestions please feel to call or email us today!
eczema. The investigator-initiated study took place over 34
weeks; 28 weeks of therapy and a follow-up assessment six
weeks after completion. The sixteen subjects were divided into
three cohorts. In cohort one, once patients received 1g/day safely without therapeutic benefits, enrollment into cohort two took place with an upward dose of 1.5 g/day. Similarly, once patients in cohort two achieved a dosage of 1.5 g/day safely without any therapeutic benefit, enrollment into cohort three took place with a maximum dose of 2 g/day. Upon termination of the study, results were reviewed from both the investigators and the enrolled subjects. The grading rubric for improvement was as follows: worse, no change, mild improvement, marked improvement, or completely clear. By investigator assessment, out of the 14 patients who displayed improvement; three patients were completely cleared, six showed marked improvement, one showed moderate improvement, and four displayed mild improvement. In the patient assessment, within the 12 patients who demonstrated improvement; three were completely cleared, six had marked improvement, two showed moderate improvement, and one had mild improvement. In both analysis among investigators and patients, therapeutic benefits were significantly greater in cohort three in which patients received 2 g/day in comparison to only 1 gram daily in cohort one (P<0.0001.) 3 There was one unfavorable adverse
event in which a patient developed pancreatic cancer at week
12. However, prior to entrance into the study, the patient noted
Texas Southern University
epigastric pain which was previously diagnosed as chronic reflux. With such, this episode is not considered as an adverse
College of Pharmacy and Health Sciences
event from MMF therapy. Other reported adverse events
DRUG INFORMATION CENTER
included insomnia and transient nausea. Previous studies have
Texas Medical Center
been carried out for assessment of the usage of MMF in the
John P. McGovern Campus
management of chronic dermatitis. In a 12 week pilot study
2450 Holcombe Blvd, Houston, TX 77021
involving ten patients from ages 29-47; there was a 68%
713-313-1242
decrease in disease severity. A subsequent study including
713-313-1243
ten patients with severe atopic dermatitis exhibited a median
improvement of more than 55%. Altogether, based on the
M-F 8:30 AM – 4:30 PM
referenced studies, one could conclude that mycophenolate mofetil is indeed effective in the treatment of chronic dermatitis.
Because MMF has the capability to increase a patient’s overall
risk of infection as well as gastrointestinal discomfort, further
research is warranted for the management of such adverse
events. MMF is positioned as a viable option for enhancement
of the quality of life in patients suffering from chronic dermatitis. 1.
Akhavan A, Rudikoff D. Atopic dermatitis: systemic immunosuppressive therapy. Semin Cutan Med Surg. 2008; 27:151-155.
The Immune System – In More Detail; Nobelprize.org; http://nobelprize.org/educational/medicine/immunity/immune-detail.html; 2010; Accessed July 14, 2010.
Linagliptin recommended for approval in the treatment of type 2 diabetes in Europe Boehringer Ingelheim and Eli Lilly and Company’s DPP-4 inhibitor received on 23rd June 2011 a positive opinion from the European Medicines Agency’s (EMA) medicinal committee Ingelheim, Germany, 23 June, 2011 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) received on 23rd June 2011 a positive op
La vacatio legis è: • la carenza di disciplina normativa in una particolare materia • il periodo che intercorre tra la pubblicazione e l’entrata in vigore di una legge • il periodo che intercorre tra l’emanazione di un decreto legge e la conversione dello st esso in legge Da chi sono nominati i componenti della Giunta Comunale? • dal Consiglio Comunale • da