In December 2020, U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV. The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada. Side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.
Archive for the ‘Uncategorized’ Category
Undocumeneted COVID-19 Infections
In Uncategorized on March 27, 2020 at 3:57 pmMany people feel they have the virus, but for one reason or another they do not, or could not get tested. Those could be transmitting the infection, and may transmitted to others who will have symptoms (some maybe severe) and will be tested.
Hence, the proportion of individuals infected with SARS-CoV-2 who have minimal symptoms is an important determinant of the pathogen’s pandemic potential, as these infections are likely to go undiagnosed. Investigators in China used mathematical modeling to estimate the number of undocumented infections and their contribution to SARS-CoV-2 transmission in China.
Subjects were categorized into two groups: those with symptoms severe enough to elicit care-seeking and a documented COVID-19 diagnosis, and those with undocumented infections. The model also accounted for changes in human mobility between cities based on recent historic data adjusted for the escalating restrictions on such movement.
At the beginning of the epidemic, the estimated basic reproductive number (R0) was 2.38 and the percentage of undocumented infections was 86.0%. Undocumented infections were estimated to cause 86.2% of all infections. Later in the epidemic and with augmented testing, the proportion of undocumented infections fell to 35%, and the R0 dropped to 1.36 and then to 0.99 as restrictions on geographic movement tightened
The Sunscreen in your blood
In Uncategorized on January 23, 2020 at 6:16 pmChemical sunscreen ingredients are systemically absorbed after one application, and some ingredients can stay in the blood for at least 3 weeks, according to an FDA study published in JAMA.
In a lab setting, 48 adults were randomized to receive one of four formulations of chemical sunscreens containing avobenzone (in most sunscreen products) , oxybenzone, octocrylene, homosalate, octisalate, or octinoxate. Sunscreen was applied once on the first day and four times on days 2 through 4. Participants had 34 blood samples collected over 21 days.
The maximum plasma concentration of avobenzone over days 1 through 21 — the primary outcome — was 7.1 ng/mL for lotion, 3.5 ng/mL for aerosol and nonaerosol spray, and 3.3 ng/mL for pump spray. For all six active ingredients, most participants had maximum plasma concentrations that were at or above the FDA’s 0.5 ng/mL threshold (for possibly waiving additional safety studies) for as long as 23 hours after a single application. For homosalate and oxybenzone, over half of participants had above-threshold plasma levels 21 days after application.
The authors say their findings reinforce the need for further studies on sunscreen safety. Editorialists conclude: “In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative.”
Source; Reported NEJM Journal watch, Juanary 22,2020
Comments: Sunscreen, also known as sunblock, is a lotion, spray, gel, foam, stick or other topical product that absorbs or reflects some of the sun’s ultraviolet (UV) radiation and thus helps protect against sunburn. Diligent use of sunscreen can also slow or temporarily prevent the development of wrinkles, dark spots and sagging skin. Depending on the mode of action, sunscreens can be classified into physical sunscreens (i.e., zinc oxide and titanium dioxide, which stay on the surface of the skin and mainly deflect the sunlight) or chemical sunscreens (i.e., UV organic filters, which absorb the UV light). This study emphasizes the preference to using mineral-based sunscreens- BA
Will This Make Me an Addict?
In General Health, Uncategorized on November 22, 2019 at 4:24 pmThe risk of addiction after a short course of opioids for acute pain is poorly understood. To quantify the risk of ongoing opioid use after a single prescription in the emergency department (ED), researchers prospectively enrolled adult opioid-naive patients with new-onset acute pain who were prescribed an opioid and discharged from the ED. Follow-up was performed at 6 months via telephone call, chart review, and review of a statewide prescription database. Among 484 patients enrolled at two EDs, average age was 46 years and the median pain duration was 2 days. Most patients (88%) were low risk for opioid misuse based on the Opioid Risk Tool. Oxycodone-acetaminophen was the most common opioid prescription (77%). Overall, 102 patients (21%) filled at least one additional opioid prescription within 6 months (the primary outcome). “Persistent opioid use,” defined as at least six prescriptions during the 6-month follow up, occurred in five patients (1%). Of patients with persistent opioid use, prescription frequency decreased over the 6-month follow up period.
Citation: Friedman BW et al. Opioid use during the six months after an emergency department visit for acute pain: A prospective cohort study. Ann Emerg Med 2019 Nov 1; [e-pub]. (https://doi.org/10.1016/j.annemergmed.2019.08.446)
Summary appeared in NEJM- Journal Watch
Comments: This question comes up quite often; patients may even endure pain for fear of potential addiction; here is a good, but not great, answer; still 1% met the authors’ definition of persistent opioid use. Patients’ awareness and physician watchful attention are needed to make this practice lower- BA
How much sodium should I eat?
In Uncategorized on May 31, 2016 at 6:02 pmCommon salt is a mineral composed primarily of sodium chloride (NaCl), it is essential to the health of humans and animals, and is one of the five basic taste sensations.Too much or too little salt in the diet can lead to various cramps in the muscle, dizziness, or electrolyte disturbance. This can cause neurological problems, or death. Drinking too much water, with insufficient salt intake, puts a person at risk of water intoxication (hyponatremia).Death can occur by ingestion of large amounts of salt within a short time (about 1 g per kg of body weight).
High sodium excretion is associated with elevated risk for cardiovascular events, but only in people with preexisting hypertension, a Lancet study finds. Meanwhile, low sodium excretion is also associated with increased risk.
The study, which received industry funding, combined patients from four international studies. Over 130,000 participants provided morning fasting urine samples and baseline blood pressure measurements. Nearly half had hypertension at baseline.
After a median follow-up of 4 years, 11% of participants with hypertension and 4% without experienced the primary outcome, a composite of death, myocardial infarction, stroke, and heart failure.
In hypertensive patients, a sodium excretion rate of at least 7 g/day was associated with increased CV risk (adjusted hazard ratio 1.23), relative to 4–4.99 g/day. A low excretion rate (less than 3 g/day) was also associated with increased risk (HR, 1.34). But in non-hypertensive patients, only low sodium excretion was tied to higher risk (HR, 1.26).
Comments: Watch your salt and consider low sodium salt, salt substitutes, and all in moderation and only after a consultation with your physician _always!BA
Source: Journal review – Associations of urinary sodium excretion with cardiovascular events in individuals with and without hypertension: a pooled analysis of data from four studies; Mente A et al. Published online: http://dx.doi.org/10.1016/S0140-6736(16)30467-6
Slim is for Results
In Uncategorized on April 7, 2015 at 3:54 pmAn article in Annals of Internal Medicine review concluded that “weight loss is modest and likely below patients’ expectations.”
Researchers reviewed 45 U.S. trials evaluating 11 programs: Weight Watchers, Jenny Craig, Nutrisystem, Health Management Resources (HMR), Medifast, OPTIFAST, Atkins, The Biggest Loser Club, eDiets, Lose It!, and SlimFast. These programs were compared with controls, which generally provided traditional counseling and education.
At 1 year, only Jenny Craig and Weight Watchers were able to show even modest weight loss compared with controls: 4.9% greater weight loss with Jenny Craig, 2.6% greater with Weight Watchers. Nutrisystem and very low calorie programs (HMR, Medifast, OPTIFAST) resulted in short-term (3–6 months) — but not longer-term — weight loss.
The editorialist writes that the study “highlights something that researchers … have known for decades: Structure and intensity of contact are highly correlated with program success. It is unsurprising that highly structured programs with in-person social support, such as Weight Watchers and Jenny Craig, seem more effective in the long term than less structured interventions.”.
Source : Ann Intern Med. 2015;162(7):501-512. doi:10.7326/M14-2238.
Appeared in NEJM Journal watch on April 7,2015
Note: Leptin: A hormone produced mainly by adipocytes (fat cells) that is involved in the regulation of body fat. Leptin interacts with areas of the brain that control hunger and behavior and signals that the body has had enough to eat, and until one lowers leptin level is not likely that a fast diet will succed at all since it is not able to lower leptin levels as the we shed weight. Antileptin are promising but not here yet.
Sound Medical Bytes 
Summary Appeared in NEJM Journal watch.
Citation: Li R et al. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV2). Science 2020 Mar 16; [e-pub]. (https://doi.org/10.1126/science.abb3221)