"Many living with major depressive disorder find that their ongoing antidepressant therapy doesn't offer meaningful relief from the symptoms they experience every day," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "Today's approval of VRAYLAR provides an important new treatment option to meet a critical unmet medical need. AbbVie is committed to driving progress and advancing solutions for patients living with complex neuropsychiatric conditions."

MDD is one of the most common mental disorders in the U.S.; approximately one in five adults will experience this disorder during their lifetime.1 In a large U.S. study of adults with MDD, approximately 50 percent still had depressive symptoms with their first antidepressant.2 If some symptoms of depression persist while on an antidepressant, adding a different type of medication, often referred to as an adjunctive treatment, to the existing regimen may help.

"Patients with inadequate response to standard antidepressant medication are often frustrated by the experience of trying multiple medicines and still suffering from unresolved symptoms. Instead of starting over with another standard antidepressant, VRAYLAR works with an existing treatment and can help build on the progress already made," said Gary Sachs, MD, clinical vice president at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, and lead Phase 3 clinical trial investigator. "For adults living with major depressive disorder, because of inadequate improvement in response to standard antidepressants, VRAYLAR is an efficacious adjunctive treatment option with a well-characterized safety profile."

Cariprazine is marketed as VRAYLAR® in the U.S., and in addition to being approved as an adjunctive therapy to antidepressants for the treatment of MDD in adults, it is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is co-developed by AbbVie and Gedeon Richter Plc. More than 8,000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders.

"When we were in the early stages of development for cariprazine, we focused on designing a compound that covers a range of symptoms for mental health conditions and affects the dopamine D3 receptor," said István Greiner, Ph.D., research and development, director, Gedeon Richter. "While schizophrenia and bipolar manic and mixed episodes were the first indications in the U.S. market, we are thrilled to see the full potential of cariprazine unlocked with approvals in bipolar I depression, and now, as an antidepressant adjunct in major depressive disorder."

Highlights from the clinical program supporting the approval include:

A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day + ADT compared with placebo + ADT. A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the MADRS total score for patients treated with cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) + ADT compared with placebo + ADT.

Cariprazine was generally well tolerated in 6- and 8-week studies. Mean weight change was < 2lbs and ≤ 3% of patients had a weight increase of ≥ 7%.

The starting dosage of VRAYLAR is 1.5 mg once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily on Day 15. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. The maximum recommended dosage is 3 mg once daily.

Most common adverse reactions observed in the adjunctive MDD studies (≥ 5% and at least twice the rate of placebo) were:

Akathisia, nausea, and insomnia at the recommended doses in 6-week, fixed-dose trials

Akathisia, restlessness, fatigue, constipation, nausea, increased appetite, dizziness, insomnia, and extrapyramidal symptoms in one 8-week flexible-dose trial at a titration of less than 14 days.

"W
hat
is Christmas without a feast?" For many the answer would be no Christmas at all. The baking of cakes, the seasoning of meats, mixing of punches and the preparation of a wide variety of meals are normal activities associated with the festive season.

Amidst the celebrations and the preparations, it is important to note that annually food-borne illness outbreaks cost both low- and middle-income economies approximately US$110 billion due to lost in productivity and medical expenses. Also, one out of every five persons who gather for a Christmas feast is likely to get a food-borne illness. Aided by factors such as changes in farming and production practices, climate, as well as mishandling, so far in the year 2022, peanut butter, packaged salads, milk, cheese, oysters, and fish have been named amongst other foods that causes the annual and global incidence of approximately six hundred million cases of food-borne illness and 420,000 deaths.

Major signs and symptoms associated with food-borne illnesses

Food-borne illnesses manifest in a number of ways ranging from fever and diarrhoea to some types of cancers. However, most food-borne illnesses present with gastrointestinal issues such as retching, vomiting and nausea. Illnesses such as ciguatera fish poisoning and botulism are associated with neurological symptoms; listeriosis and hepatitis E infection can lead to spontaneous abortion in pregnant women, while some types of coliforms can cause bloody diarrhoea, renal failure, and death, especially in children.

Major reasons for food-borne illness outbreaks during the Christmas season

• Guests often bring food to share, which means that these food items could be subject to time and temperature violation; not held hot or cold for extended times, thereby giving bacteria or other germs time to multiply in the food.

• Many people prepare food ahead of an event; foods such as salads, casseroles, seafoods, pies, stews, meats, and meat dishes need to be carefully prepared and kept at the correct temperatures to ensure that the products are safe for human consumption.

Ways to prevent food-borne illness and enjoy the festivity

•Wash hands as often as is necessary using clean running water and a germicidal hand soap. During the preparation of foods, after using the restroom, before serving a meal, before eating, after the hands would have become contaminated are important intervals to be observed regarding hand washing.

•Wearing clean clothes whilst conducting food handling activities can also reduce the risk associated with food-borne illness occurrences.

• Buy foods from reputable suppliers only: Date labels and shelf-life information should be carefully observed as after the expiry date of a food item has passed; it is no longer considered safe for consumption.

• Use safe water for drinking and preparing foods.

•Use clean utensils only, for the preparation of meals and avoid cross contamination by having enough equipment and utensils for food preparation and serving.

•Avoid using bare hands to serve ready to eat foods such hot dogs, pizza, and sandwiches.

•When gloves are worn while serving and preparing meals, ensure that they are changed between tasks and when they would have become contaminated. Ideally, a new pair of gloves should be put on only after the hands would have been properly washed.

• Ham, mutton, chicken, fish, salads, milk, cooked rice, cooked pasta, and eggs are amongst food items which are high risk for causing food-borne illnesses. Hence, mishandling at any stage can lead to a food-borne illness outbreak. Care and adherence to good personal hygiene and food preparation practices is required during preparation and handling of these and other similar food items.

• Do not allow children to consume raw cake batter especially those which have eggs as a main ingredient. Many children are enthusiastic when it is time for baking, this enthusiasm often leads to tasting and adults are sometimes guilty of this action as well. However, tasting or eating raw cake batter or cookie batter can lead to salmonellosis and E coli infections. Eggs are a main source of some types of the salmonella germ and raw flour is known to harbour toxin producing E coli. The illnesses associated with these germs can result in an individual experiencing fever, vomiting, nausea, bloody diarrhoea, and death amongst other symptoms.

•Avoid the consumption of raw egg punches. Only pasteurised eggs should be used to make Guinness punches, strong back, eggnog, tiramisu, hollandaise sauces, Caesar dressings or any other similar food item.

•Do not leave these items to defrost in the sun, in the kitchen sink or on top of the counter. Defrosting of foods especially meats and other high-risk foods are best done ahead of time at the bottom of a properly working refrigerator. The ideal temperature for defrosting foods is one to five degrees Celsius.

• Cold foods such as seasoned or unseasoned beef, pork, chicken, turkey, mutton, seafood, and hams are best kept refrigerated at five degrees Celsius or lower while in storage. Sealed containers or sturdy plastic bags are handy storage options for these types of products.

•Cook foods thoroughly until well done. Meats such as roasted or jerked pork, beef and chicken are normally perfectly cooked when the juices run clear. If any part of these items appears uncooked while being served, it is advisable to recook the item until well done.

•Ensure that fruits such as ackee are mature or fully ripened before being used as a meal. Ackee is not fit for consumption until the pod is fully open and all the arils (yellow part) is fully visible. Consumption of unripe, immature ackee lowers the blood sugar and can also cause jaundice, vomiting, convulsions, coma, and death. Bitter cucumbers, squash, zucchinis, and melons are also not fit for consumption. A bitter taste associated with these foods is a sign that the level of some natural toxins is high in the product and so if consumed, can lead to respiratory and cardiovascular issues.

•For cold foods have enough ice to make ice baths for storage of salads or keep them in the refrigerator at a maximum of five degrees Celsius until the time of consumption.

•Avoid preparing hot meals long ahead of time and if unavoidable, keep the foods on low fire or on a heat source at 60 degrees Celsius or slightly above until time for consumption.

•When travelling from one place to another, it is best to take your own water for drinking or purchase purified water. Avoid drinking water directly from rivers, streams, springs, or any other similar untreated source.

•Sanitise fruits and vegetables before peeling, eating, cutting, or cooking. Using a solution of half cup distilled white vinegar to two cups water and leaving the items to soak for five minutes will remove most common contaminants which are normally associated with food-borne illness outbreaks relating to fruits and vegetables. Prior to consumption the sanitised produce should be rinsed thoroughly with clean water.

•When transporting foods to another location, insulated carriers such as igloos, iceboxes and thermoses work well for temperature control. Ice packs or shaved ice in an igloo are also extremely useful in maintaining cold food temperatures.

•Cover foods whilst in storage or during preparation as flies and other pest are carriers of many types of disease-causing germs. Dust and other environmental contaminants can also be the source of several types of bacteria that cause food-borne illnesses.

•Foods such as peanuts and tree nuts, seafood, eggs, soy, milk, honey, and wheat are common food allergens that should be carefully managed to avoid contact with other foods which are non-allergens. Food allergies result in hives, skin rashes, and shortness of breath, respiratory distress and even death.

•When eating out, ensure that hot foods are kept and served hot and that cold foods kept cold and severed cold. Hot foods such as meat, pies, salads, patty, soup, cooked rice, cooked pasta, and other similar items left out without temperature control and require reheating before consumption are to be avoided as they are likely to result in a food-borne illness of rapid onset.

•When hot food items are pre-prepared for later use, ensure that these foods are cooled quickly; once the steam stops, place the item into sealed containers and refrigerate at five degrees Celsius or lower. Leftover food items are to be handled in the same manner, cooled quickly and then refrigerate.

•Reheat leftover foods by ensuring that the heat is spread evenly throughout the item before consumption. Do not consume reheated foods with cold spots.

Food-borne illnesses are preventable

The occurrence of food-borne illnesses is a growing public health concern as they contribute significantly to the global burden of disease and mortality annually while putting strain on families, health-care systems, and the wider society. Control of food-borne illnesses is based on avoidance of contaminated food, destruction of contaminants, and preventing the spread of contaminants. Purchasing foods from reputable sources, selecting, and using safe raw ingredients in meal preparation, adhering to proper preparation and handling techniques as well as employing good personal hygiene guarantees the prevention of food-borne illnesses so that the celebratory and festive events remain as a pleasant memory.

Karlene Atkinson is a public health specialist and lecturer at the School of Public Health, University of Technology Jamaica.

For most patients who suffer cardiac arrest the problem is that of cardiac arrhythmia. The vast majority of these are rapid heart rhythms that arise from the bottom chambers of the heart (ventricular tachycardia and ventricular fibrillation). These rhythms are amenable to what is known as defibrillation in which an electric current is sent through the heart muscle. This depolarises all the heart muscle at the same time and in most scenarios will lead to a normal heart rhythm. The ability to rapidly recognise and treat these abnormal heart rhythms is the major reason good outcomes can be obtained with cardiac arrest in the coronary care unit. In contrast, when these events occur outside of monitored health-care settings it is often not possible for defibrillation to take place within minutes resulting in a worsening of morbidity and risk of death. Decades of research have found that if blood flow to the heart and the brain can be sustained when the patient is in cardiac arrest, then the time window for successful defibrillation can be extended and the chance for successful outcome increased. This is accomplished by cardiopulmonary resuscitation or CPR which involves breathing for a patient and compressing the chest to support the delivery of blood and oxygen to the brain, the heart and other vital organs of the body. CPR is a skill which most lay persons can acquire quickly, for example, by doing a day course in basic life support.

In the United States, the American Heart Association (AHA) has developed programmes to try to improve the outcome of patients who suffer cardiac arrest. They have described what is known as the Chain of Survival where each link in this "chain" plays a significant role in decreasing mortality and morbidity. There are six parts to this chain:

1) Recognition of cardiac arrest and activation of the emergency response system.

2) Early cardiopulmonary resuscitation (CPR) with an emphasis on chest compressions.

3) Rapid defibrillation.

4) Advanced resuscitation by emergency medical services and other health-care providers.

5) Post-cardiac arrest care.

6) Recovery (including additional treatment, observation, rehabilitation, and psychological support).

It should be noted that the first three links in the chain of survival are dependent on educated and trained lay people who are able to deliver care in an emergency.

Recognition of cardiac arrest and activation of the emergency response system

From the perspective of identifying a cardiac arrest, an adult who is witnessed to collapse or who is found unresponsive needs to have an assessment of whether they are breathing spontaneously and whether they have a pulse. If a patient is without a pulse and not breathing, then the emergency medical services should be activated by calling 110 and CPR should begin. Checking for a pulse and the presence of spontaneous breathing is a skill that most adults can master. If as a bystander, you are unsure as to whether a pulse exists the safest approach to take is to commence CPR.

Early cardiopulmonary resuscitation (CPR) with an emphasis on chest compressions

It is important to note that the sooner that CPR begins after a patient is in cardiac arrest, the better the potential outcome. CPR allows for the resumption of blood flow to the heart and brain. This helps to keep the cells of these organs alive until the heart is restarted. It should be noted that for most bystanders who are not medically trained, CPR with chest compressions only that is, without rescue breathing is a reasonable course of action to take. This avoids the risk of exchange of body fluids with a person whose health status and medical history is unknown. Studies have shown that early in the CPR process enough oxygen remains in the blood stream so that similar outcomes are observed with traditional and compression only CPR.

Rapid defibrillation

Probably the most important link in the chain of survival is the rapid delivery of an electric shock to the muscle of the heart. Unfortunately, this requires the availability of an automatic external defibrillator (AEDs). These devices are different from the machines that we often see in medical dramas, in that they have pads which are attached to the chest and are much simpler to operate. A bystander need only turn the device on, attach the pads to the patient (usually following the diagram on the pads) and press a button to deliver the shock. Most of these devices made today have verbal instructions to guide use once they are turned on. Ideally these devices should be available in places where the public gather such as sports arenas, stadiums, schools, malls. The Heart Institute of the Caribbean (HIC) and HIC Foundation have been strong advocates for the acquisition of AEDs in public spaces.

After defibrillation care

The first three steps outlined above are the areas in which the lay public can act to improve the outcome in the cardiac arrest patient. Learning to recognise the patient in cardiac arrest and how to do CPR are skills that are easily acquired and the more people in our population who have these skills, the higher the chance that we give these patients to survive. The widespread availability of AED's is important as well and we could look to our large corporations and government agencies to try and fill the void that currently exists. The remaining steps in the chain of survival are primarily the responsibility of the health-care sector and the Government. There is a need for a properly equipped, trained, and maintained emergency medical service who can service as much of our island as possible. These personnel provide advanced resuscitation techniques to support the patient beyond simple defibrillation. These techniques include obtaining and maintaining an airway for breathing, starting IVs, giving drugs, obtaining electrocardiograms, etc. In many countries the emergency medical services are in communication with emergency rooms so that physician input can be obtained prior to the patient reaching the hospital.

Post-arrest cardiac care is a large topic that is beyond the scope of this article. Suffice it to say that every society needs facilities like HIC that can quickly and comprehensively manage critically ill patients with severe cardiac disease. Otherwise, the initial gains with successful CPR are lost. There is often a need for assessment of cardiac function, of the blood flow to the heart muscle, management in a cardiac intensive care unit, mechanical ventilation, introduction of techniques that have been shown to improve outcome such as hypothermia and physicians with expertise in protecting the brain and other organs after cardiac arrest. Lastly for patients that survive and leave the hospital, there is often the need for rehabilitation and long-term care.

Improving outcome in patients with cardiac arrest requires input from many segments of the society. For the lay population, the larger the percentage of the population that can provide basic life support the more likely it is that a patient who has a cardiac arrest can be assisted. It may help to think selfishly about this issue as the person that you aid may be a family member or a friend. Our entire health care system, public and private, have roles to play including continuing education of both the professional class and lay public about this critical issue, providing training in basic life support and laying the groundwork for post-cardiac arrest care.

Of importance is the diagnosis and treatment of patients who have heart disease that puts them at risk for cardiac arrest. Often medical treatment, surgical or percutaneous procedures or implantation of implantable cardiac defibrillators will reduce risk in these patients. Corporate Jamaica and our large State agencies should ensure that the public spaces that they manage have AEDs available and clear directions on where to find and access these devices. Our Government and Ministry of Health should play a key role in ensuring facilitated recruitment of qualified and experienced health-care workers from the global marketplace, especially in the post-COVID era when countries around the world are aggressively recruiting talent from Jamaica and elsewhere to protect the lives of their citizens. A policy and regulatory framework from the Ministry of Health will provide guidance and direction to other agencies and parastatals to ensure that they embrace a common purpose and the noble 'One Health' initiative that has been championed by the Minister of Health Dr Christopher Tufton. This will create the enabling environment to facilitate efforts in reducing the scourge that is sudden cardiac death.

While it is not likely that we can improve the outcome of patients with out of hospital cardiac arrest to the level of a patient who has an arrest in a monitored health-care setting, there is the opportunity to significantly change the chance of survival of these patients especially if we have facilities with appropriate infrastructure and necessary human capital to provide post cardiac arrest care.

Dr Ernest Madu, MD, FACC and Dr Paul Edwards, MD, FACC are consultant cardiologists for Heart Institute of the Caribbean (HIC) and HIC Heart Hospital. HIC is the regional centre of excellence for cardiovascular care in the English-speaking Caribbean and has pioneered a transformation in the way cardiovascular care is delivered in the region. HIC Heart Hospital is registered by the Ministry of Health and Wellness and is the only heart hospital in Jamaica. Correspondence to info@caribbeanheart.com or call 876-906-2107

a total of 330 patients who were randomized in a 1:1 ratio between Linzess or placebo.In the study, Linzess reportedly demonstrated an improvement in stool consistency and 12-week spontaneous bowel

Without an elevation in thrombotic events, the reported decline in aspirin consumption was also correlated with declines in bleeding outcomes, reported the authors.

The study's lead author, Geoffrey D. Barnes, MD, MSc, Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, asserted that these results "emphasize the need for improved aspirin administration among patients on warfarin for anticoagulation."

"Our effective intervention across numerous health systems, with diverse patient populations and clinical structures, could serve as a national paradigm for lowering excess aspirin use," the authors wrote.

A possible therapy benefit of adding aspirin (acetylsalicylic acid) while taking warfarin for some people is an increase in bleeding risk. The use of aspirin less frequently may lead to better clinical results.

In order to evaluate changes in aspirin use, bleeding, and thrombosis event rates among individuals using warfarin, the authors conducted their study.

6738 adults who were taking warfarin for atrial fibrillation and/or venous thromboembolism without an obvious indication for concurrent aspirin participated in this pre-post observational quality improvement study between January 1, 2010, and December 31, 2019, at a 6-center quality improvement collaborative in Michigan. From November 26, 2020 to June 14, 2021, statistical analysis was done. If a continuous regimen of aspirin and warfarin was necessary for patients who took aspirin, primary care physicians were questioned about this. In that case, the supervising clinician gave his or her clearance for the aspirin to be stopped. In both the primary and secondary analyses, outcomes were evaluated prior to and following the intervention (i.e., when rates of aspirin use first started to decline) and prior to and following 24 months prior to the intervention. The rate of aspirin use, hemorrhage, and thrombotic events were among the outcomes. An interrupted time series analysis evaluated the evolution of cumulative monthly event rates.

Conclusive points of the study:

• The pre-intervention period, which was 24 months before the intervention, revealed a marginal decline in aspirin use from the baseline mean use of 29.4% (95% CI, 28.9% - 29.9%) to 27.1% (95% CI, 26.1% - 28.0%).
• At a mean use of 15.7% (95% CI, 14.8% - 16.5%), there was a noticeably faster decline in aspirin use.
• The number of major bleeding events per month declined substantially (0.31% vs 0.21%; P =.03 for difference in slope between before and after intervention). The average patient percentage who experienced a thrombotic event did not alter much (0.21% vs. 0.24%; P =.34 for difference in slope).
• In additional analyses, a fall in aspirin use (24 months prior to intervention) was linked to a drop in the mean proportion of patients experiencing any bleeding incident (2.3% vs 1.5%; P =.02) or significant bleeding event (0.31% vs 0.25%; P =.001).

Given that aspirin is not a prescription drug, the researchers hypothesized that "doctors might not always be aware that patients are taking aspirin, which would be a hurdle to efforts to deprescribe aspirin".

The authors concluded that among patients receiving warfarin for atrial fibrillation and/or venous thromboembolism without a clear justification for aspirin therapy, this quality improvement intervention was linked to an acceleration of a preexisting drop in aspirin use.

REFERENCE

Schaefer JK, Errickson J, Gu X, et al. Assessment of an Intervention to Reduce Aspirin Prescribing for Patients Receiving Warfarin for Anticoagulation. JAMA Netw Open. 2022;5(9):e2231973. doi:10.1001/jamanetworkopen.2022.31973

We are also readying another listening party with Mrs. Pharmalot (the rotation will include this, this and this) and will stop to observe some ancient rituals (sufganiyot, anyone?). And what about you? Holidays are nearing, but there is still time to squeeze in a visit to a nearby temple of consumption. You could also plan a much-needed getaway. Or work on your list of resolutions for the next year — if so, we wish you much luck. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon….

AbbVie is leaving several major industry groups representing its interests in Washington, D.C., STAT reports. The company is leaving the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, the two prominent pharmaceutical trade associations, according to the groups. AbbVie is also leaving the Business Roundtable, a group comprising the chief executives of the largest U.S. companies. The decision comes as regulators begin to implement the drug-pricing provisions of the Inflation Reduction Act that drugmakers spent millions in lobbying to defeat.

Continue to STAT+ to read the full story…

AbbVie, which for years has fought off competition for its blockbuster autoimmune drug Humira — the world’s top-selling medicine before Pfizer’s Covid-19 vaccine hit the market — has been the target of congressional hearings and legislation aimed at so-called patent thickets that can stall rival products.

Continue to STAT+ to read the full story…

release in 2023 alongside a deluge of other Humira biosimilars.Idacio (adalimumab-aacf, Fresenius Kabi) is a citrate-free biosimilar to the world’s top-selling Humira (adalimumab, AbbVie), a TNF inhibitor approved to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.“This is another important

By Anesta Henry

Executive Chairman of the Queen Elizabeth Hospital (QEH) Dr Juliette Bynoe-Sutherland has given the assurance that even though a cyber security incident affected a number of the hospital’s services on Tuesday, swift measures were implemented to protect patient privacy.

Bynoe-Sutherland said the disruption caused the suspension of all internet-dependent services which she described as extensive.

“The IT [Information Technology] experts have taken all precautions to protect the integrity of our system and the privacy of all of our patients. We do apologise for the inconvenience that may be experienced by all of our users, but rest assured we will continue to keep the public informed as we seek to restore services here at the hospital,” Bynoe-Sutherland said.

MIST (Ministry of Industry, Innovation Science and Technology) and cyber security specialists have been working with the QEH’s IT department to rectify the issue. 

In addition to the temporary precautions being taken to protect the integrity of systems and patient privacy, the hospital chief indicated that the Ambulance Service continues to function as normal, the Blood Collecting Centre continues to welcome blood donations. Members seeking further information have been encouraged to contact the Patient Liason Service (Help Desk), at 536-4800.

The Executive Chairman told Barbados TODAY she could not say exactly when the matter will be resolved. 

anestahenry@barbadostoday.bb

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