Monday, 14 July 2014

Sex differences in treatment patterns

Sex differences in treatment patterns of six chronic diseases: an analysis from the German statutory health insurance.


Abstract

OBJECTIVE:

The goal of this study was to investigate gender-specific differences in prevalence, healthcare costs, and treatment patterns in the German Statutory Health Insurance (SHI).

METHODS:

The study analyzed administrative claims data of over 26 million insured with respect to prevalence and cost of illness of six chronic diseases. Insured were identified using the ATC code for medication prescription and ICD-9 code for diagnosis. The influences of gender, age, and comorbidity on cost differences were analyzed via multivariate regression analysis.


RESULTS:

Adjusted for age and comorbidity, gender had a significant influence on both hospital and medication spending. Hospital costs on average were 17.1% (95% CI 14.1; 20.2) higher for men compared with women. Medication spending for men exceeded that for women on average by 13.8% (95% CI 10.9; 16.7). The diagnoses with the highest prevalence were hypertension and heart failure. Women had a higher prevalence of diabetes, coronary artery disease (CAD), heart failure, and hypertension. Medication costs were higher for men in three of five diagnoses and comparable for two diagnoses (diabetes and asthma). Women received more medication prescriptions than men, but on average prescriptions for men were 14%-26% more expensive than prescriptions for women. Regarding treatment patterns men were treated with different drug classes in cardiovascular disease (CVD) compared with women. Total medication spending stratified by diagnosis was highest for diabetes.

CONCLUSIONS:

Gender differences for costs and prescribing patterns for chronic diseases vary disease specifically, but generally men had higher inpatient costs and more expensive medication prescriptions, whereas women had higher numbers of prescriptions

Treatment patterns in disease sclerosis.

Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.


Abstract



BACKGROUND:

Patients with multiple sclerosis (MS) whose disease activity is inadequately controlled with a platform therapy (interferon beta or glatiramer acetate [GA]) may switch to another platform therapy or escalate therapy to natalizumab or fingolimod, which were approved in the US in 2006 and 2010, respectively.

OBJECTIVE:

The objective of this study was to describe treatment patterns in patients with multiple sclerosis (MS) in the United States who were followed for 2 years after initiating a disease-modifying therapy (DMT).

METHODS:

A retrospective observational cohort study was conducted to examine treatment patterns of initial DMT use (on initial therapy for 2 years with and without gaps of ≥ 60 days, medication switching, and discontinuation) among patients with MS who initiated a platform therapy (interferon-β or glatiramer acetate) or natalizumab between January 1, 2007, and September 30, 2009; the first DMT claim was the index. Eligible patients were identified in the MarketScan Commercial and Medicare Supplemental databases based on continuous enrollment for 6 months before (preindex period) and 24 months after their index date, with a diagnosis of MS and no claim for a previous DMT in the 6-month preindex period. Demographics at index and clinical characteristics during the preindex period were also analyzed.


RESULTS:

A total of 6181 MS patients were included, with 5735 (92.8%) starting on platform therapy. Natalizumab initiators were more likely to stay on index therapy (32.3% vs 16.9%, P < 0.001) and have fewer treatment gaps of ≥ 60 days (44.8% vs 55.3%, P < 0.001) compared with platform initiators. In addition, natalizumab initiators were less likely to switch treatment (13.9% vs 19.1%, P = 0.007) and took longer to switch (400.9 days vs 330.7 days, P < 0.001) compared with platform initiators. Nearly 79% of platform initiators who switched went to another platform therapy. Approximately two thirds of patients who switched to a third DMT (n = 130) switched to another platform therapy. A total of 9% of natalizumab and platform initiators discontinued DMT within the 2 years.

CONCLUSIONS:

Most MS patients initiating DMT started on platform therapy. Natalizumab initiators tended to stay on index therapy, have fewer treatment gaps, and switch less than platform initiators in the 2 years after treatment initiation. Switching between platform therapies is common despite evidence that MS patients on platform therapy may benefit from switching to natalizumab.

Treatment patterns for otitis externa.

Abstract

BACKGROUND:

Although otitis externa is a common and painful infection of the outer ear canal, there is little specific information available regarding current treatment patterns in the United States. We wanted to examine treatment patterns for otitis externa.

METHODS:

Data were analyzed from the 1993 National Ambulatory Medical Care Survey (NAMCS) and the 1993 National Hospital Ambulatory Medical Care Survey (NHAMCS) for adults and children treated for otitis externa. Data analyses included the reasons for physician visits, concomitant diagnoses, types of physicians seen, sources of payment, medical procedures administered, drugs prescribed, and patient disposition following a physician visit.

RESULTS:

Study results suggested that treatment patterns differ substantially for adults and children, as well as by physician specialty. Although otitis externa is frequently painful, few cases are classified as severe, and the data indicated that less than 20 percent of patients have concomitant diagnoses treatable by medication. Nevertheless, 40 percent of patients received both topical and systemic medication, and many of the oral antibiotics prescribed are not active against Staphylococcus aureus or Pseudomonas aeruginosa, the most common bacterial pathogens in otitis externa.

CONCLUSIONS:

Appropriate treatment of localized otitis externa with topical antibiotics should eliminate the need for systemic medications. Addition of systemic medications can unnecessarily increase treatment costs and the likelihood of side effects, and could reduce the likelihood of patient compliance.


Symptoms of Swimmer's ear / Otitis externa
According to the Centers for Disease Control and Prevention typical symptoms include
  • Persistent itchiness inside the ear
  • Inflammation of the ear
  • Redness of the ear
  • Pain on touching the ear or ear lobe and
  • Formation of pus on the surface of the ear
While swimmers ear can affect anyone, the painful problem is more common in children.

Causes of Swimmer's ear / Otitis externa
Almost all cases of swimmer's ear are caused by bacterial infection and very rarely are caused by fungus or virus. Bacteria found in water and soil is primarily responsible for it. 
Human ear is designed in such a way that it keeps bacteria and foreign objects out. The ear produces a waxy substance called cerumen that prevent water from entering the ear and also ensures foreign material like dirt and dead skin is prevented from finding a way into the ear. Ultimately cerumen is forced out of the ear in the form of what we popularly call as ear wax. Human ear also slopes outward slightly to enable water to flow out. However, during a swim the intake of water can be too heavy for the ear to expel and some amount of water remain. The moisture trapped in the ear makes it good place for bacteria to grow.
In certain cases if there is a scratch or cut in your ear canal region and your skin is exposed, it may lead to bacterial growth. . Sometimes certain hair products or jewelry can also cause such infection.

Risk factors for Swimmer's ear / Otitis externa
Risk for a swimmer’s ear increases when swimming in untreated water like lakes and canals, which have high amount of bacterial growth. The risk of the infection is also high in children as their narrow ear canal prevents water from flowing out. Cleaning your ear with sharp objects also increases the change of rupturing the skin and increasing chances of bacterial infection.

Diagnosis of Swimmer's ear / Otitis externa

According to NewYork-Presbyterian Hospital swimmer's ear is generally diagnosed with a complete medical history and physical examination of the patient. A device called the otoscope maybe used by the doctor which allows the ear canal to be lighted up to ensure proper visibility. This enables easier examination of the ear, says the hospital. An examination of the ear is important as it allows the doctor determine the scope of the infection and the severity of the condition. A doctor may also want to take a culture of the drainage from the ear to help determine proper treatment.

Treatment of Swimmer's ear / Otitis externa
Swimmer’s ear generally heals itself. Most infections get treated on it’s own by keeping the ear dry. However, in certain cases treatment of the infected area becomes necessary. A doctor may recommend ear solution to take care of the infection. These solutions generally contain acidifying and drying agents or both. In some cases steroids also prove beneficial in treatment of swimmer’s ear. 
Ear drops that have antibacterial or antifungal properties are also used. Topical antibiotic solutions such as aminoglycoside, polymyxin or fluoroquinolone are effective in treating swimmer’s ear. For medication to be effective it is important to keep the area clean and remove debris like wax, dead skin, and pus from the ear canal. Sometimes an ear wick is used in cases when medication cannot reach the innermost part of the infection due to ear canal getting blocked due to infection.
Corticosteroids may also be using during this time to reduce itching and inflammation. In cases of fungal infection, antifungal solutions are used for treatment.

Prevention of Swimmer's ear / Otitis externa

According to NHS UK if you are a regular swimmer, it is good to get a swimming cap to protect the ears and prevent large amounts of water from entering the ear. Make sure that you ear canals are clear of water after swimming, bathing or showering.


Treatment patterns in patients with advanced breast cancer

Abstract



OBJECTIVE:

The aim of this work was to analyze chemotherapy treatment patterns in patients with advanced breast cancer who had been previously exposed to an anthracycline, a taxane, and capecitabine.

METHODS:

This retrospective cohort study used medical and pharmacy administrative claims with health-plan enrollment data and medical-record review from a large, US-based health insurer database, the HealthCore Integrated Research Database. Women were included if they were aged > or =18 years at the initial breast cancer diagnosis between January 1999 and July 2005 and had received all 3 drug classes of interest, as well as an initial diagnosis of American Joint Committee on Cancer stage I to III breast cancer with metastatic recurrence or an initial diagnosis of stage IV disease. Information about demographics, clinical and pathologic characteristics, survival, and treatments were obtained from computerized data and medical record review. Descriptive analyses were conducted to characterize the treatment patterns.

RESULTS:

One hundred forty-four women with advanced breast cancer were identified. Patients ranged in age from 28 to 76 years, with a mean (SD) age of 48.2 (9.1) years, and with 54 patients (37.5%) aged 40 to 49 years and 48 patients (33.3%) aged 50 to 59 years at the time of initial diagnosis. Ninety-three patients (64.6%) were white, 15 (10.4%) were black, 7 (4.9%) were Hispanic, and 4 (2.8%) were Asian. Overall, 89 patients (61.8%) received > or =1 additional chemotherapy regimen after exposure to all 3 chemotherapy agents of interest; 55 (38.2%) received > or =2 additional regimens. A variety of chemotherapeutic regimens were prescribed; 14 monotherapy regimens and 37 combination therapy regimens were used. The most common regimens (both as single agents and combination therapy) included gemcitabine, vinorelbine, or retreatment with a taxane. Of the 89 patients who received > or =1 retreatment, 7 (7.9%) were retreated with anthracycline, 12 (13.5%) with a taxane, and 9 (10.1%) with capecitabine. For first and second treatment after exposure to all 3 agents of interest, the most common single-agent regimens were gemcitabine (first: 17 patients [19.1%]; second: 9 patients [16.4%]) and vinorelbine (first: 14 patients [15.7%]; second: 9 patients [16.4%]). The most common combination therapies for first retreatment were carboplatin based (6 patients [6.7%]).

CONCLUSIONS:

Of these patients with advanced breast cancer, 61.8% received > or =1 additional chemotherapy regimen after previous treatment with an anthracycline, a taxane, and capecitabine. The variety of agents prescribed suggests a lack of standard of care. Rigorous clinical effectiveness studies of common regimens in heavily pretreated and chemotherapy-resistant populations with breast cancer are warranted.


Breast and Prostate Cancer Data Quality and Patterns of Care (PoC-BP) Study

Started in 2005, the Breast and Prostate Cancer Data Quality and Patterns of Care (PoC-BP) study is the National Program of Cancer Registries' most comprehensive PoC study, involving researchers from CDC and seven states in different geographic areas. The study examines—
  • Patterns of initial (first course) treatment received by prostate cancer and female breast cancer patients.
  • The extent to which that care is concordant with nationally recognized treatment guidelines.
  • How patterns of cancer care vary by patient-, provider-, and health system-level factors.
  • The quality of the cancer data for the study.
The routinely collected registry data were supplemented by re-abstracting hospital records and obtaining information about adjuvant treatment and comorbidity from physicians and outpatient facilities. In addition, the study data were linked with secondary files, including Medicare claims, U.S. Census Bureau socioeconomic status data, and hospital/physician characteristics data.
Several manuscripts providing key results have been published in peer-reviewed literature—

CANCER TYPES

Breast Cancer

Breast cancer usually affects women, but men can get it too. 90% of those who are diagnosed with breast cancer lose their lives to the cancer spreading to the rest of their bodies. People will often have a lump in the breast, which is why mammography and self-exams can help detect the cancer early.

NFCR RESEARCH

Detection
  • MOST BREAST CANCER HAS A SPECIFIC MARKER THAT COULD BE USED TO IDENTIFY THE CANCER, BUT OUR TECHNOLOGY CAN’T SEE THESE MARKERS.  NFCR IS WORKING TO MAKE CURRENT IMAGING TECHNOLOGY MUCH MORE SENSITIVE SO THAT IT CAN FIND THE MARKERS AND DETECT BREAST CANCER IN ITS EARLIEST STAGE.   
Treatment

  • ONE CURRENT THERAPY TO SLOW CANCER GROWTH IS USED FOR A THIRD OF BREAST CANCER PATIENTS, BUT WAS THOUGHT TO BE INEFFECTIVE FOR THE OTHERS.  NFCR IS CONDUCTING CLINICAL TRIALS OF A NEW TREATMENT THAT COMBINES THE EXISTING THERAPY WITH A NEW TECHNIQUE AND CHEMOTHERAPY AND COULD BE USED FOR ALL PATIENTS.  INITIAL RESULTS HAVE SHOWN REDUCED TUMOR SIZE AND COULD LEAD TO A NEW TREATMENT THAT WILL REACH MORE PEOPLE.
  • NFCR IS DESIGNING A NEW ANTI-CANCER DRUG THAT WILL TARGET CANCER PROTEINS THAT PREVENT HEALTHY PROTEINS FROM STOPPING CANCER GROWTH.  THIS NEW TECHNOLOGY HAS MAJOR IMPLICATIONS FOR THE POSSIBILITY OF STOPPING THE SPREAD OF CANCER.
  • A COMMON CHEMOTHERAPY DRUG (TAXOL) DOES NOT WORK ON EVERYONE. NFCR IS DEVELOPING A TEST THAT WILL SHOW IF THE DRUG WILL WORK OR NOT, BEFORE TREATMENT IS STARTED.  THIS WILL AVOID WASTING TIME ON A TREATMENT THAT WON’T WORK.
  • NFCR IS DEVELOPING A WAY TO KILL CERTAIN BREAST CANCER CELLS THAT ARE RESISTANT TO TREATMENT. INSTEAD OF DYING, THESE CELLS SEEM TO DISAPPEAR, BUT BRING THE CANCER BACK YEARS LATER.
  • NFCR IS RESEARCHING THE SPREAD OF CANCER, WHICH IS WHAT MAKES CANCERS EVEN MORE DANGEROUS. WE ARE WORKING ON A NEW TREATMENT THAT COPIES THE INTERACTION BETWEEN GENES AND PROTEINS THAT SLOW THE SPREAD OF CANCER AND COULD PREVENT IT FROM SPREADING ALL TOGETHER.
  • ANOTHER WAY NFCR IS TRYING TO STOP THE SPREAD OF CANCER IS BY IDENTIFYING THE GENES THAT ALLOW CANCER CELLS TO MOVE THROUGHOUT THE BODY. ONCE THESE GENES ARE IDENTIFIED, WE WILL CREATE A TECHNIQUE TO STOP THE GROWTH OF CANCER IN HEALTHY AREAS AND TO PREVENT THE CANCER CELLS FROM MOVING TO BEGIN WITH.
  • NFCR MANAGES THE TISSUE BANK CONSORTIUM IN ASIA, A TISSUE SAMPLE PREPARATION AND STORAGE FACILITY THAT SERVES AS AN EXTENSIVE DATA HUB TO SUPPORT RESEARCH. SO FAR, THE TISSUE BANK HAS IMPROVED THE CLASSIFICATION OF BREAST CANCER, CREATED TESTS TO DIAGNOSE CANCER, AND LED TO BETTER THERAPIES.

Treatment patterns for hair loss in men/women surgical treament

If hair loss is caused by an infection or a condition such as anaemia, treating the infection or condition may prevent further hair loss. In some cases, including after cancer treatment, your hair may start to grow again.

Male-pattern baldness

There are two medicines that are known to be effective in treating male-pattern baldness: finasteride and minoxidil.

Finasteride

Finasteride works by preventing the hormone testosterone being converted to the hormone dihydrotestosterone (DHT). DHT causes the hair follicles to shrink, so blocking its production allows the hair follicles to regain their normal size.
Although more research is needed, studies suggest that two-thirds of men who take finasteride, experience some hair regrowth. In the remaining third, there is no hair regrowth, but most do not experience any further hair loss. It normally takes at least four months of using finasteride before any effect is seen, and the balding process will normally resume if treatment is stopped.
Finasteride is not available on the NHS, but is available on private prescription from your GP. It comes as a tablet that you take every day. Side effects are uncommon, although about two in 100 men who use it experience a loss of sex drive.

Minoxidil

Minoxidil is available as a lotion that you rub on your scalp every day. It is available from pharmacies without prescription. It is not clear how minoxidil works, but studies suggest that the balding process will slow in about half of those men who use it, and that about 15% of those who use it will experience hair regrowth. However, about a third of men who use minoxidil will not see any change in their hair loss.
Like finasteride, minoxidil normally needs at least four months of use before any effect is seen, and the balding process will normally resume if treatment is stopped. Any new hair that does regrow will fall out two months after treatment is stopped. Side effects are uncommon.

Female-pattern baldness

Currently, the only medicine available to treat female-pattern baldness is minoxidil. Minoxidil lotion may help hair to grow in 20-25% of women who use it, and in the majority it may slow or stop the loss of hair.
Other treatments for hair loss include wigs, hair transplants (taking hair from the sides and back of the head) and plastic surgery, such as scalp reduction, where the bald area is removed and the bit with hair on is stretched forward.

Alopecia areata

There is no completely effective treatment for alopecia areata.
However, in about eight out of 10 cases, the hair grows back after about a year without any treatment, so sometimes ‘watchful waiting’ is best, especially if you just have a few small patches.
When treatments are necessary, they tend to have variable results (see below). 

Steroid injections

Steroid injections appear to be the most effective treatment for small patches of alopecia. A steroid solution is injected several times into the bald areas of skin. This stops the immune system from attacking the hair follicles, and it can stimulate hair to grow again in those patches after about four weeks. Injections are repeated every few months. Alopecia may return when injections are stopped.

Topical steroids and steroid tablets

Topical steroids (creams and ointments) are widely prescribed for alopecia areata, but their long-term benefits are not known. There is some evidence that they can make hair regrow.

Steroids can also be taken as tablets, but alopecia often returns when the tablets are stopped, and after a while of taking them they can produce serious side effects, such as diabetes and stomach ulcers. Other possible side effects are itching or hair growth in other areas. 

Minoxidil lotion

Minoxidil lotion is applied to the scalp and can stimulate hair regrowth after two to three months. It is not recommended for those under the age of 16 and is not available on the NHS, but can be prescribed privately or bought over the counter. It can take up to a year for a maximum response.

Immunotherapy

Immunotherapy appears to be the most effective treatment for extensive or total hair loss. A chemical solution called diphencyprone (DPCP) is applied to a small area of bald skin. This is repeated every week, using a stronger amount each time. Eventually, the DPCP causes an allergic reaction and the skin develops mild eczema (dermatitis). With many people, after about 12 weeks, hair then starts to regrow.
A possible side effect is a severe skin reaction, although this can be avoided by increasing the DPCP concentration gradually. Less common side effects include a rash and patchy-coloured skin (vitiligo). In many cases, if treatment is stopped, the hair falls out again, therefore treatment needs to be maintained. Immunotherapy is only available in specialised centres.

Dithranol cream

Similar to immunotherapy, dithranol cream is applied regularly to the scalp and then washed off. It causes a skin reaction, followed by hair regrowth in some cases. It is not as effective as immunotherapy, it can cause itchiness and scaling of the skin, and it can stain the scalp and hair. For these reasons, dithranol is not widely used.

UV light treatment

Two to three sessions of light therapy are given every week in hospital, where the skin is exposed to UVA rays. It can take up to a year to produce maximum results. Responses vary and there is a high relapse rate. Side effects include nausea, pigment changes, and an increased risk of skin cancer, so it is often not a recommended treatment.

Tattooing

Eyebrows can be tattooed over a few hourly sessions. This is known as dermatography, and it generally produces good results.

Wigs

Synthetic wigs:
The cheapest wigs are made from acrylic, and they cost anywhere between £60 and £200. As of April 2008, an NHS stock acrylic wig costs £59.20. An acrylic wig lasts for six to nine months and is easier to look after than a wig made of real hair (it does not need styling). However, it can be itchy and hot, and it needs to be replaced more often than a real-hair wig. You may be entitled to receive a free acrylic wig every six months on the NHS (see box).
Real-hair wigs:
Some people prefer the look and feel of a real-hair wig, even though it is more expensive - it costs anywhere between £200 and £2,000. As of April 2008, an NHS human-hair wig that is made to order costs £229.05. The wig lasts for three to four years, but is harder to maintain because it may need to be set and styled by a hairdresser, and professionally cleaned. A human-hair wig is only available on the NHS if you are allergic to acrylic, or have a skin condition made worse by acrylic. You may wish to buy your wig privately.
See the ‘Useful links’ section for more information on wigs, including tips for wearing a wig and getting one fitted.

Complementary therapy

Aromatherapy, acupuncture and massage are often used for alopecia, but there is not enough evidence to support their use as an effective treatment

Thursday, 5 June 2014

FDA Approves Synribo for treament of Drug-Resistant Leukemia

SYNRIBO

(omacetaxine )


Synribo is the semisynthetic version of a Chinese herbal extract derived from an Asian conifer known as the Cowtail Pine or Japanese Plum Yew. This extract, called homoharringtonine or HHT, was considered the most CML-effective treatment, short of bone marrow transplant, back when standard treatments failed for patients in the days before TKIs.)


 The FDA has approved Teva's Synribo (omacetaxine mepesuccinate) for the treatment of adults with chronic myelogenousleukemia (CML).
The fast-track approval is for people for whom at least two of the most common treatments have failed. These treatments, tyrosine kinase inhibitors or TKIs, include Gleevec (imatinib), Sprycel (dasatinib), and Tasigna(nilotinib).
Although these drugs help most patients, they sometimes fail because of the emergence of drug-resistant CML, or rapidly progressing disease.
"From our perspective, it is another option for patients that might be running out of options," says Hildy Dillon, MPH, senior vice president of patient services for the Leukemia and Lymphoma Society. "I think it will be very meaningful for those who don't do well on the TKIs. With this drug, there is a chance they might respond."
Synribo can have very serious, life-threatening side effects. Some of these side effects, including bone-marrow suppression and bleeding, have been fatal. Other serious side effects include high blood sugar and low blood levels of platelets, red blood cells, and white blood cells.
Common side effects include diarrheanauseafatiguefever, and injection site reactions.
Treatment patterns
Synribo is given by under-the-skin injections twice daily for two weeks until white blood cells -- needed to fight infection -- normalize. It's then given for seven consecutive days over a 28-day cycle as long as patients continue to benefit.
Synribo is the semisynthetic version of a Chinese herbal extract derived from an Asian conifer known as the Cowtail Pine or Japanese Plum Yew. This extract, called homoharringtonine or HHT, was considered the most CML-effective treatment, short of bone marrow transplant, back when standard treatments failed for patients in the days before TKIs.