Актуальная Медицина

Detailed Overview: MHRA New Drug Risks (2024)

galinadoctor — Sun, 08 Sep 2024 18:47:56 GMT

Detailed Overview: MHRA New Drug Risks (2024)

The Medicines and Healthcare Products Regulatory Agency (MHRA) prioritises drug safety by issuing updates on emerging risks. Here’s a breakdown of some key new risks from 2024:

1️⃣ Fluoroquinolone Antibiotics: Restricted Use

Fluoroquinolones (e.g., ciprofloxacin, levofloxacin), widely prescribed for bacterial infections, are now recommended only when no other antibiotics are appropriate. The MHRA reviewed reports of serious adverse reactions, including:

Tendonitis and tendon rupture
Long-term nerve damage (peripheral neuropathy)
Aortic aneurysm and aortic dissection

These severe side effects are particularly concerning for the elderly, patients with renal impairment, and those using corticosteroids(

GOV.UK

GovDelivery

The MHRA advises extra caution in these high-risk groups and stricter adherence to the use guidelines.

2️⃣ Topiramate (Topamax): Pregnancy Risk

Topiramate, commonly used for epilepsy and migraines, has been flagged by the MHRA for its risks in pregnancy. New safety measures emphasize that Topiramate should not be prescribed to women of childbearing potential unless they are part of a Pregnancy Prevention Programme. The risks to the unborn child include:

Congenital malformations such as cleft palate
Low birth weight
Increased risk of neurodevelopmental disorders like autism and ADHD in children exposed to Topiramate during pregnancy(
GovDelivery

The Pharmaceutical Journal

This update aligns with ongoing efforts to reduce risks associated with teratogenic drugs (drugs that can cause fetal abnormalities).

3️⃣ Valproate: Updated Guidance for Male Patients

Previously known for its severe risks during pregnancy, Valproate (used for epilepsy and bipolar disorder) now has added warnings for male patients. MHRA highlighted recent findings indicating that men taking valproate could also impact future pregnancies, with children at risk of neurodevelopmental disorders. The recommendations for men include using effective contraception during treatment(

The Pharmaceutical Journal

This guidance underscores valproate’s high teratogenic potential, expanding concerns from pregnant women to men of reproductive age.

4️⃣ Topiramate and Valproate Combination: Increased Risk

The combination of Topiramate and Valproate, often used for refractory epilepsy, was also highlighted for its synergistic risk factors. When used together, these drugs pose a heightened risk of fetal harm and neurodevelopmental issues. Healthcare providers are advised to reconsider this combination therapy, especially for women of reproductive age(

The Pharmaceutical Journal

PRAC New Risks from Drugs - September 2024 Update

galinadoctor — Sun, 08 Sep 2024 18:35:55 GMT

PRAC New Risks from Drugs - September 2024 Update

Here’s the latest on emerging drug safety signals identified by the Pharmacovigilance Risk Assessment Committee (PRAC):

1️⃣ Medroxyprogesterone Acetate
PRAC identified a new safety risk with high-dose medroxyprogesterone acetate, commonly used for contraceptive and oncological purposes. Long-term use of high doses has been associated with an increased risk of meningioma (a type of brain tumour). PRAC recommends that patients with a history of meningioma should not use this medication unless it's needed for cancer treatment. Healthcare professionals are advised to closely monitor patients on this medication for symptoms such as headaches, vision changes, or seizures(

European Medicines Agency (EMA)

2️⃣ Metamizole and Agranulocytosis
The use of metamizole, a painkiller, has been linked to agranulocytosis, a potentially life-threatening drop in white blood cells. PRAC advises healthcare professionals to ensure patients are aware of early symptoms like fever, sore throat, and mucosal changes. If agranulocytosis is suspected, treatment must be stopped immediately(

European Medicines Agency (EMA)

3️⃣ 5-Fluorouracil (5-FU) and DPD Deficiency
PRAC also flagged the chemotherapy drug 5-fluorouracil (5-FU), which poses a risk of severe toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for this enzyme deficiency is crucial, but PRAC warns that results should be interpreted cautiously in patients with renal impairment(

European Medicines Agency (EMA)

Лекарственные препараты, которые нельзя смешивать

galinadoctor — Sun, 10 Dec 2017 08:36:44 GMT

Каждый человек хоть раз в жизни сталкивается с ситуацией, когда приходиться принимать разные лекарства в один период. Некоторые медикаменты можно сочетать без вреда, но есть и опасные сочетания лекарств, которые могут привести к летальному исходу.

К сожалению, информация о смертельных сочетаниях лекарств сегодня не очень распространена, хотя каждый человек должен обязательно знать об этом.

Лекарства от кашля и антигистаминные препараты

Многие лекарства от кашля, которые продают без рецепта, например, сиропы и антигистаминные препараты имеют аналогичные вещества в своем составе. Поэтому, принимая их в один период, есть риск передозировки.

Для тех, кто не знает о возможной вялости и сонливости после приема такого микса, напомним, что это огромная опасность, в случае, если человек будет управлять автомобилем или серьезной аппаратурой.

Даже если вы приняли средство от аллергии и лекарство от кашля вечером, перед сном, на утро можете ощущать большую слабость.

Антидепрессанты и обезболивающие

Каждый человек, которому врач выписывает антидепрессанты и обезболивающие препараты, должен знать,что принимать их вместе категорически нельзя. Об этом должен в первую очередь сообщить доктор.

СИОЗС (селективные ингибиторы обратного захвата серотонина, относящиеся к одному из классов антидепрессантов) и нестероидные противовоспалительные средства (НПВС, которые часто используют как обезболивающие и жаропонижающие средства), увеличивают риск развития кровотечения в желудке и пищеводе до 600 %, то есть в 6 раз!

Новое исследование ученых из Голландии доказало, что комбинация из этих двух препаратов еще чаще провоцирует желудочные кровотечения, чем если принимать каждый препарат отдельно.

И СИОЗС, и НПВС— триптаны, которые влияют на уровень серотонина. Если принимать препараты одновременно, это не только повысит риск кровотечения, но и даст неприятные побочные эффекты: повышение температуры, учащенное дыхание и сердцебиение.

Антикоагулянты и аспирин

Во многих странах антикоагулянты, которые применяются для уменьшения тромбов в крови, считаются очень серьезными препаратами и отпускаются только по рецепту.

А вот аспирин есть в каждой домашней аптечке и продается без всякого рецепта. Но немногие знают, что он также разжижает кровь. Если принимать эти препараты одновременно, вы рискуете заполучить внутреннее и внешнее кровотечение.

Обезболивающие и успокоительные препараты

Продолжая список опасных сочетаний лекарств, нельзя не сказать о негативном взаимодействии антитревожных препаратов и опиодных обезболивающих( например, кодеина, морфина).

И те, и другие действуют как успокоительное. Если принимать их в одно время, это может значительно уменьшить частоту дыхания и частоту сокращений сердца, причем иногда до смертельного уровня.

Такие препараты обычно выписывают разные врачи, поэтому каждый из медиков не будет знать о назначениях другого. В таком случае человеку нужно быть осторожным и самому проработать данный вопрос. Такая комбинация часто оказывается смертельной из-за ее влияния на дыхательную систему человека.

Ацетаминофен и опиоиды

Несмотря на свою популярность, эти препараты могут быть очень опасны, если их принять в количествах, превышающих рекомендуемую дозу. Часто люди пытаются увеличить эффект ацетаминофена, принимая его с препаратами, которые содержат кодеин. Сочетание этих 2-х лекарств может довольно быстро вызвать серьезное повреждение печени.

Исследование ученых из Сиэтла в 2005 году показало, что у 38% людей развилась острая печеночная недостаточность только потому, что они случайно приняли слишком большую дозу пцетаминофена или более чем один вид таблеток. А у тех, кто одновременно принимал оба вида таблеток, острая печеночная недостаточность развилась в 63% случаев.

Обязательно! Не занимайтесь самолечением, следуйте всем указанием вашего лечащего врача, читайте инструкции, соблюдайте все правила приема лекарственных препаратов. Будьте здоровы!

Секс може продовжити молодість і призупинити розвиток старечої деменції

galinadoctor — Sun, 10 Dec 2017 08:33:31 GMT

Група вчених з Університету Ковентрі й Оксфордського університету встановила, що секс здатен продовжити молодість і зменшити ризики розвитку старечої деменції, а також інших проблем з інтелектом, передає Birmingham Mail. Повний текст дослідження на дану тему оприлюднений у виданні The Journals of Gerontology: Series B, передає Кореспондент. У ході роботи над дослідженням вчені залучили 73 людини (45 жінок і 28 чоловіків), вік яких становив від 50 до 83 років. Всі вони взяли участь в опитуванні, в якому вказали, як часто займалися сексом протягом останніх 12 місяців. Також в ході тестування оцінювалися когнітивні здібності респондентів, в тому числі пам'ять та словниковий запас. У підсумку ті, хто вів більш активне сексуальне життя, показали кращі результати, ніж їхні опоненти.

Liquid Diet, Gradual Reintroduction of Food, Prompts Diabetes Remission

galinadoctor — Sun, 10 Dec 2017 01:53:34 GMT

Lisa Nainggolan

December 05, 2017

ABU DHABI, United Arab Emirates — Patients with type 2 diabetes can reverse the condition if they stick to a very low-calorie liquid diet, of around 850 kcal per day for 3 to 5 months, and then gradually reintroduce food, with ongoing support for maintenance of weight loss that includes strategies to increase physical activity and cognitive behavioral therapy.

This is the message from the 1-year results of the primary-care–led weight management for remission of type 2 diabetes (Diabetes Remission Clinical Tria l[DiRECT]) open-label randomized trial, which were reported today here at the International Diabetes Federation (IDF) Congress 2017 and simultaneously published in the Lancet.

This somewhat controversial study, in almost 250 patients who had had type 2 diabetes for up to 6 years, compared an intensive weight-loss regime using a commercial formula (Cambridge Weight Plan) delivered by practice nurses or dieticians who had received approximately 8 hours of training, with standard best practice for weight loss across 49 primary-care practices in the United Kingdom. The trial is set to continue for at least another 2 years.

Diabetes remission was achieved overall at 1 year in almost half, 68 participants (46%) in the intervention group and six (4%) participants in the control group (odds ratio, 19.7; 95% CI 7.8–49.8; P < .0001).

"This was a clinical trial driven largely by the will of patients, the response to it was very positive," lead author Prof Michael Lean, from the University of Glasgow, Scotland, said in presenting the results here. "Our findings suggest that even if you have had type 2 diabetes for 6 years, putting the disease into remission is feasible."

Noting that bariatric surgery has long been hailed as a "cure" for diabetes, he added that there has been a suggestion that such procedures "have almost magical qualities, but we show this can be done without surgery." Bariatric surgery can achieve remission of diabetes in about three-quarters of people, but it is more expensive and risky and is only available to a small number of patients, he added.

Senior author Prof Roy Taylor from Newcastle University, United Kingdom, told meeting attendees: "The diagnosis of type 2 diabetes is a medical emergency that needs…action. Hopefully this is a watershed in the understanding and management of type 2 diabetes. Short-duration type 2 diabetes can be put into remission by primary-care staff using a structured program."

And the weight-loss goals provided by this program "are achievable for many people," he stressed

Study Results Impressive: Diabetes Diagnosis Is Best Time to Reduce Weight

The present study differs in an important manner from most previous ones in that it was done under real-life conditions, delivered by available local nurses or dietitians rather than by specialist staff, the researchers note. Furthermore, no previous registered study has set remission of type 2 diabetes as a primary outcome

Individuals aged 20 to 65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body mass index of 27 to 45 kg/m², and were not receiving insulin, were invited to participate by letter via their primary-care practice.

The intervention (n = 149) comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet for 3 to 5 months; this was a high-carbohydrate, low-fat, and high-protein diet), followed by stepped food reintroduction (over 2–8 weeks), and structured support for long-term weight-loss maintenance. Participants were given guar fiber supplement to help combat constipation and advised to drink plenty of water.

The remaining 149 patients in the control group received best practice care by guideline.

"A major difference from other studies is that we advised a period of dietary weight loss with no increase in physical activity, but during the long-term follow up increased daily activity is important," Prof Taylor explained.

Meals were reintroduced one at a time, with advice to follow a 50% carbohydrate, 35% fat, and 15% protein diet, and patients were given step counters and encouraged to achieve 15,000 steps per day during this phase.

Overall, one person experienced serious adverse events possibly related to the treatment (biliary colic and abdominal pain) but continued in the trial. Some participants experienced constipation, headache, and dizziness, but all were tolerated by the participants "as no one left the study," Prof Lean stressed.

The primary outcomes were weight loss of 15 kg or more and remission of diabetes, which was defined as HbA_1c level of less than 6.5%, off all medications.

At 1 year, mean body weight fell by 10.0 kg in the intervention group and 1.0 kg in the control group (adjusted difference –8.8 kg; P < .0001).

The primary outcome of weight loss of 15 kg or more was achieved in 36 (24%) participants in the intervention group and no participants in the control group (P < .0001).

As well as the 46% of patients who achieved remission overall in the intervention group, when the analysis was confined to those who lost 10 kg or more, 73% achieved remission of diabetes.

Writing in an accompanying comment, Prof Matti Uusitupa, from the University of Eastern Finland, Kuopio, said: "These results are impressive and strongly support the view that type 2 diabetes is tightly associated with excessive fat mass in the body."

"The DiRECT study indicates that the time of diabetes diagnosis is the best point to start weight reduction and lifestyle changes because motivation of a patient is usually high and can be enhanced by the professional healthcare providers," he adds, noting that 86% of participants in the intervention group and 99% of those in the control group attended the 12-month study assessment.

Results Should Pave Way to Try This Approach, but Weight Maintenance is Key

Asked whether he thought these results would lead to any changes in guidelines, Prof Lean said he doubted it. "One study for 1 year is unlikely to lead to any major changes in guidelines," although he noted that other interventions for type 2 diabetes have been recommended with lesser evidence.

Therefore, "our results should pave the way for this type of intervention to be considered in the routine care of patients with type 2 diabetes who wish to attain diabetes remission," he and his coauthors stress.

Prof Uusitupa agrees: "In view of the results of the DiRECT trial, a nonpharmacological approach should be revived," he writes.

However, Prof Lean and colleagues are also cognizant of the fact that maintenance of weight loss is a key factor of success, and so they appreciate that longer-term results of their trial will be keenly anticipated.

"It's relatively easy to lose weight, but patients struggle to maintain the weight loss, and there is very little research funding into maintenance," Prof Lean told the congress.

Prof Taylor said: "The big challenge is long-term avoidance of weight regain. Follow-up of DiRECT will continue for 4 years and reveal whether weight loss and remission are achievable in the long term."

Prof Uusitupa says: "Long-term results from the study would be extremely important because postintervention weight regain has been reported in most weight-management studies in nondiabetic patients and in patients with type 2 diabetes."

Lancet. Published online December 5, 2017.

Is garcinia a safe and effective dietary supplement for patients hoping to lose weight?

galinadoctor — Sun, 10 Dec 2017 01:47:04 GMT

Is garcinia a safe and effective dietary supplement for patients hoping to lose weight?

Response from Gayle N. Scott, PharmD
Assistant Professor, Department of Physiological Sciences, Eastern Virginia Medical School, Norfolk, Virginia

Garcinia became a rock star in the dietary supplement world after a 2012 endorsement by television host Dr Mehmet Oz, who called it a "revolutionary fat buster." (The endorsement was removed from the Dr Oz website following a Senate hearing on questionable weight loss products.^[1]) Described as the "Oz effect," Dr Oz's endorsement of a dietary supplement usually has a substantial impact on product sales,^[2,3,4] even when scientific evidence is not favorable.

Garcinia (Garcinia gummi-gutta, formerly known as Garcinia cambogia) is a small- to medium-sized tree native to India, Nepal, and Sri Lanka. Other common names include brindleberry, Malabar tamarind, and kudam puli (pot tamarind).^[2] In the United States, garcinia products derived from the fruit are available as dietary supplements that are often promoted for weight loss. The major organic acid in the fruit is hydroxycitric acid (HCA), which is thought to account for the pharmacologic effects of garcinia. Animal research suggests that HCA may inhibit enzymes that synthesize fatty acids.^[2]

A 2011 meta-analysis^[3] reviewed nine clinical trials of garcinia extract (HCA) for weight loss; little research has been published since. The meta-analysis revealed a small yet statistically significant difference in weight loss in favor of HCA over placebo (mean difference: -0.88 kg; 95% confidence interval, -1.75 to -0.00, P < .05). This corresponds to about a 1% body weight loss in the HCA group compared with placebo,^[3] in contrast to an average 3% weight loss in patients taking orlistat compared with placebo.^[4] The study design showed considerable heterogeneity, and the duration of treatment and the dose of HCA used in the different trials varied widely. Two of the studies lasted 12 weeks, and the rest lasted 2-8 weeks. The persistence of weight loss and long-term safety with garcinia are unknown.^[3]

The most common adverse effects reported were headache, nausea, and upper respiratory and gastrointestinal tract symptoms, but most of the trials reported no significant differences in adverse events between HCA and placebo.^[3]

However, multiple case reports have implicated HCA-containing products in serious adverse reactions.^[5] Hepatitis and hepatic failure requiring transplantation have been described in several case reports.^[6,7,8] Serotonin toxicity in a 35-year-old woman who was also taking escitalopram has been reported.^[9] Animal research suggests that HCA may increase serotonin levels.^[10] Mania in patients with and without a history of psychiatric illness has been reported.^[11]

The dietary supplements associated with these adverse effects often contained multiple ingredients, including HCA. For example, previous formulations of the combination weight loss product Hydroxycut® contained HCA along with various other supplements. Hydroxycut products that contained HCA have been associated with mania,^[12] rhabdomyolysis,^[13]hepatotoxicity, and other adverse effects.^[14,15] Whether HCA or another Hydroxycut ingredient was responsible for the toxicities is unknown.^[5]

Currently, not enough research is available to recommend garcinia or HCA-containing products for weight loss.

Currently, not enough research is available to recommend garcinia or HCA-containing products for weight loss. If garcinia or HCA-containing products are beneficial, the effects appear to be modest. Rare but serious adverse effects have been reported, and long-term toxicity is unknown. No published studies have lasted beyond 3 months.

Patients taking medications that affect serotonin (eg, dextromethorphan, selective serotonin reuptake inhibitors, tramadol) should avoid HCA. Given the reports of hepatic toxicity, patients with liver disease or patients taking potentially hepatotoxic drugs (eg, carbamazepine, isoniazid) should not take HCA.

US Senate Committee on Commerce, Science, & Transportation. Protecting consumers from false and deceptive advertising of weight-loss products. June 17, 2014. https://www.commerce.senate.gov/public/index.cfm/2014/6/commerce-committee-announces-subcommittee-hearing-on-false-and-deceptive-marketing-of-weight-loss-products Accessed August 11, 2017.
Semwal RB, Semwal DK, Vermaak I, Viljoen A. A comprehensive scientific overview of Garcinia cambogia. Fitoterapia. 2015;102:134-148.
Onakpoya I, Hung SK, Perry R, Wider B, Ernst E. The use of Garcinia extract (hydroxycitric acid) as a weight loss supplement: a systematic review and meta-analysis of randomised clinical trials. J Obes. 2011;2011:509038.
Rucker D, Padwal R, Li SK, Curioni C, Lau DC. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ. 2007;335:1194-1199.
Chuah LO, Yeap SK, Ho WY, Beh BK, Alitheen NB. In vitro and in vivo toxicity of garcinia or hydroxycitric acid: a review. Evid Based Complement Alternat Med. 2012;2012:197920.
Corey R, Werner KT, Singer A, et al. Acute liver failure associated with Garcinia cambogia use. Ann Hepatol. 2016;15:123-126.
Melendez-Rosado J, Snipelisky D, Matcha G, Stancampiano F. Acute hepatitis induced by pure Garcinia cambogia. J Clin Gastroenterol. 2015;49:449-450.
Lunsford KE, Bodzin AS, Reino DC, Wang HL, Busuttil RW. Dangerous dietary supplements: Garcinia cambogia-associated hepatic failure requiring transplantation. World J Gastroenterol. 2016;22:10071-10076.
Lopez AM, Kornegay J, Hendrickson RG. Serotonin toxicity associated with Garcinia cambogia over-the-counter supplement. J Med Toxicol. 2014;10:399-401.
Ohia SE, Awe SO, LeDay AM, Opere CA, Bagchi D. Effect of hydroxycitric acid on serotonin release from isolated rat brain cortex. Res Commun Mol Pathol Pharmacol. 2001;109:210-216.
Hendrickson BP, Shaikh N, Occhiogrosso M, Penzner JB. Mania induced by Garcinia cambogia: a case series. Prim Care Companion CNS Disord. 2016;18.
Narasimha A, Shetty PH, Nanjundaswamy MH, Viswanath B, Bada Math S. Hydroxycut - dietary supplements for weight loss: can they induce mania? Aust N Z J Psychiatry. 2013;47:1205-1206.
Dehoney S, Wellein M. Rhabdomyolysis associated with the nutritional supplement Hydroxycut. Am J Health Syst Pharm. 2009;66:142-148.
Stevens T, Qadri A, Zein NN. Two patients with acute liver injury associated with use of the herbal weight-loss supplement hydroxycut. Ann Intern Med. 2005;142:477-478.
Vitalone A, Menniti-Ippolito F, Moro PA, Firenzuoli F, Raschetti R, Mazzanti G. Suspected adverse reactions associated with herbal products used for weight loss: a case series reported to the Italian National Institute of Health. Eur J Clin Pharmacol. 2011;67:215-224.
Cite this article: Garcinia for Weight Loss: Modest Effect With Safety Caveats - Medscape - Nov 21, 2017.

Proton Pump Inhibitors, Nephropathy, and Cardiovascular Disease in Type 2 Diabetes

galinadoctor — Sun, 10 Dec 2017 01:23:32 GMT

Proton Pump Inhibitors, Nephropathy, and Cardiovascular Disease in Type 2 Diabetes

The Fremantle Diabetes Study Timothy M. E. Davis; Jocelyn Drinkwater; Wendy A. Davis DISCLOSURES J Clin Endocrinol Metab. 2017;102(8):2985-2993

Abstract and Introduction . Abstract Context: There is emerging evidence of various adverse effects of chronic proton pump inhibitor (PPI) therapy. Objective: To assess the impact of PPI use on nephropathy and cardiovascular disease (CVD) risk in type 2 diabetes. Design: Longitudinal observational study. Setting: Urban-dwelling community. Patients: Patients with type 2 diabetes from the Fremantle Diabetes Study Phase II and on stable renin-angiotensin system blocking therapy were divided into those remaining untreated with a PPI (group 1, n = 686), on PPI therapy throughout (group 2, n = 174), and commencing (group 3, n = 109) or discontinuing regular PPI therapy (group 4, n = 67) during the 2 years between assessments. Main Outcome Measures: Changes (Δ) in urinary albumin/creatinine ratio (uACR), estimated glomerular filtration rate (eGFR), and predicted 5-year CVD risk. Results: There were no statistically significant differences in ΔuACR between groups [analysis of variance (ANOVA), P = 0.36], but ΔeGFR was different (ANOVA, P = 0.002), with group 3 exhibiting a greater reduction than group 1 [adjusted mean difference (95% confidence interval), −2.7 (−4.5 to −0.8) mL/min/1.73 m2; P = 0.005]. The Δ5-year CVD risk showed a similar pattern (ANOVA, P < 0.001), with group 3 having a greater increase than group 1 [adjusted mean difference (95% confidence interval), 1.7% (0.6% to 2.8%); P = 0.002]. Conclusions: Although PPI use was not associated with a sustained adverse effect on uACR, the association between PPI initiation and both worsening nephropathy and increasing 5-year CVD risk has potential clinical implications in type 2 diabetes. Introduction A recent in vitro study found that prolonged exposure to the proton pump inhibitor (PPI) esomeprazole impaired endothelial function and accelerated human endothelial senescence by reducing telomere length.[1] The authors postulated that irreversible endothelial damage associated with long-term PPI use could be a unifying mechanism underlying the observation that the PPI class of drugs is associated with cardiovascular disease (CVD), cognitive decline, and renal impairment in administrative database and pharmacovigilance studies.[2–5] Diabetes is a disease characterized by endothelial dysfunction and premature vascular aging,[6] and the adverse endothelial effects of PPIs[1] could accelerate diabetes-associated angiopathy and contribute to complications and death. Albuminuria is considered to reflect widespread endothelial damage[7,8] and could be used as an in vivo marker of PPI effects on the vasculature.[9] It can be hypothesized, therefore, that patients with type 2 diabetes initiating PPI therapy will manifest a subsequent increase in urinary albumin excretion that will persist after withdrawal of treatment. We have examined this hypothesis and also assessed PPI effects on renal function and cardiovascular risk by using longitudinal observational data from the representative community-based Fremantle Diabetes Study Phase II (FDS2). Materials and Methods Patients and Approvals The FDS2 is a prospective cohort study of 1732 participants recruited between 2008 and 2011 from a postcode-defined urban population of 157,000 in the Australian state of Western Australia.[10] Of these, 1551 (89.5%) had type 2 diabetes [mean±standard deviation (SD) age 65.7±11.6 years, 51.9% males]. Details of recruitment, characterization of diabetes type, and nonrecruited patients (who were similar to recruits in age, sex distribution, and diabetes type) have been published.[10] The FDS2 protocol was approved by the South Metropolitan Area Health Service Human Research Ethics Committee. Written informed consent was obtained from each participant. Clinical Procedures Each patient underwent a detailed assessment at study entry that comprised a comprehensive questionnaire, physical examination, and fasting biochemical and hematologic tests conducted in a single nationally accredited laboratory (PathWest Laboratory Medicine, Fremantle Hospital). Similar biennial face-to-face assessments interspersed with biennial postal questionnaires are continuing with all patients having been scheduled for at least two biennial (years 2 and 4) reviews. Details of all medications are recorded at each assessment. Chronic complications are ascertained using standard criteria, and CVD events are ascertained by self-report and validated linkage with government morbidity and mortality databases.[10] Albumin and creatinine concentrations were measured in serum and first-morning urine samples using an Architect ci8200 (Abbott Laboratories, Abbott Park, IL) with betweenday coefficients of variation of <5.0%.[11] The estimated glomerular filtration rate (eGFR) was determined using the Chronic Kidney Disease Epidemiology Collaboration equation.[12] The urinary albumin/creatinine ratio (uACR) was calculated from the respective urinary concentrations. Data Analysis We analyzed data from FDS2 patients who 1) remained off PPI therapy throughout follow-up (group 1), 2) remained on PPI therapy throughout follow-up (group 2), 3) commenced regular therapy with a PPI and who had a biennial assessment either side of this therapeutic change (group 3) with an average of duration of therapy of 12 months if the time of initiation was random during the follow-up period, or 4) were taking a PPI and had discontinued the medication at the next face-to-face review (group 4) with an average of duration off therapy of 12 months if the time of cessation was random during follow-up (see Figure 1). In the case of groups 1 and 2, comparisons were between baseline and year 2 data. Group 3 comparisons were made between either baseline and year 2 or between year 2 and year 4 depending on when the PPI was initiated. Similarly, group 4 comparisons were made between either baseline and year 2 or between year 2 and year 4 depending on when the PPI was stopped. Groups 3 and 4 contained a small number of patients who restarted after stopping or who stopped after starting (see Figure 1). We excluded[1] patients who did not have valid biochemical testing at both assessments and, because angiotensin-converting enzyme inhibitor and angiotensin receptor blocker therapies can influence both uACR and eGFR,[13,14] and[2] those whose angiotensin-converting enzyme inhibitor/angiotensin receptor blocker treatment status changed between time-points (i.e., who started or stopped these medications). Click to zoom (Enlarge Image) Figure 1. Consort diagram showing the numbers of the patients recruited to the FDS2 and those selected for the present subgroup analyses. ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; T2DM, type 2 diabetes mellitus. The computer package IBM SPSS Statistics 22 (IBM Corp., Armonk, NY) was used for statistical analysis. Data are presented as proportions, mean ± SD, geometric mean (SD range), or, in the case of variables that did not conform to a normal or lognormal distribution, median and interquartile range. For independent samples, two-way comparisons for proportions were by Fisher's exact test, for normally distributed variables by Student t test, and for nonnormally distributed variables by Mann-Whitney U test. Multiple logistic regression with forward conditional variable selection (P < 0.05 for entry, P > 0.10 for removal) of clinically plausible variables with bivariate P<0.20 was used to identify independent associates of PPI use. A validated prediction equation based on outcome data from the Fremantle Diabetes Study Phase I[15] was used to estimate the 5-year risk of a major adverse CVD event (myocardial infarction, stroke, or CVD death) using the baseline variables age, sex, race/ethnicity (Aboriginal or Southern European), hemoglobin A1c, serum high-density lipoprotein cholesterol, uACR, and a history of CVD. Changes in normally distributed variables and in logtransformed (ln) variables, including uACR and CVD risk, were assessed using the paired t test. Mean changes in untransformed variables over time were compared by PPI group using analysis of variance (ANOVA) and multiple linear regression with group 1 as reference. Initial parsimonious models were obtained by comparing clinically plausible baseline confounding variables by PPI group and considering those with bivariate P < 0.20 for entry into forward stepwise multiple linear regression models (P < 0.05 for entry, P > 0.10 for removal). Mean changes were then compared by PPI group with group 1 as reference after adjusting for the respective most parsimonious models. In addition, between-group differences in uACR were assessed after adjustment for all baseline variables that differed across the PPI groups at P<0.20 and not just those in each individual most parsimonious model. Results The characteristics of FDS2 participants with type 2 diabetes are summarized in Table 1, categorized by PPI treatment status at study entry. There were 342 taking a PPI at baseline (esomeprazole, 36.7%; pantoprazole, 24.9%; omeprazole, 21.1%; rabeprazole, 12.6%; and others, 4.7%). Those taking a PPI were older at diagnosis and study entry, and they had a longer duration of diabetes than the 1209 who were not. They were more likely to be obese and treated for hypertension but had better glycemic control. They had better serum lipid profiles in the presence of more frequent lipid-lowering therapy. There was no statistically significant betweengroup difference in uACR or albuminuria category, but the patients on a PPI were more likely to have at least stage 2 renal impairment. They were also more likely to have evidence of CVD and to be treated with a nonsteroidal anti-inflammatory drug. These bivariate differences were consistent with the independent associates of PPI use in logistic regression analysis. Variables inversely associated with PPI use were an eGFR ≥90 mL/min/1.73 m2 [odds ratio (OR) and 95% confidence interval, 0.60 (0.45 to 0.80); P < 0.001], hemoglobin A1c [0.84 (0.76 to 0.94) for an increase of 1% or 11mmol/mol; P = 0.002], male sex [0.71 (0.55 to 0.92); P = 0.009], education beyond primary level [0.66 (0.47 to 0.94); P = 0.019], and an Aboriginal racial background [0.40 (0.18 to 0.91); P = 0.028]. Variables positively associated with PPI use were cerebrovascular disease [2.12 (1.42 to 3.16); P < 0.001], coronary heart disease [1.62 (1.23 to 2.13); P = 0.001], nonsteroidal anti-inflammatory drug therapy [1.60 (1.11 to 2.30); P = 0.011], and lipidmodifying treatment [1.42 (1.06 to 1.92); P = 0.021]. There were 1016 participants eligible for the longitudinal study (20 were counted twice due to commencement of a PPI at year 2 and then discontinuation at year 4 or vice versa). Their characteristics at FDS2 entry are summarized by PPI treatment status in Supplemental Table 1. They were not statistically significantly different from the 535 ineligible participants by age at FDS2 entry, sex, or PPI use (P > 0.06) but had shorter diabetes duration [median (interquartile range) 8.0 (2.0 to 15.3) vs 10.0 (3.0 to 17.0) years; P = 0.001] and were less likely to have died during follow-up to the end of year 4 (8.2%vs 20.4%; P<0.001). The baseline characteristic of the four groups of eligible participants are summarized in Table 2. Those in group 1 tended to be younger and to have a shorter diabetes duration than participants in the other three groups. They also tended to be less intensively treated with antihypertensive and lipid-modifying therapies and to have a higher eGFR, consistent with a less frequent history of CVD and a lower 5-year CVD risk score. The overall mean ± SD time between the two FDS2 assessments was 2.1±0.3 years. The variables of interest at baseline and follow-up are summarized in Table 3, together with the temporal changes after adjustment in parsimonious models in which variables in Table 2 that differed across the four groups with P < 0.20 were considered for entry. There was no temporal change in geometric mean uACR in groups 1 and 2 (P ≥ 0.47). There was a trend to an increase in group 3 (P = 0.056) and a statistically significant decrease in group 4 (P = 0.015). Compared with group 1 (reference), the adjusted mean changes from baseline (ΔuACR) in each of groups 2, 3, and 4 were not statistically significantly different (P ≥ 0.15; see Supplemental Figure 1). The between-group differences in uACR were similar after adjustment for all baseline variables that differed across the PPI groups except that the increase in group 4 vs group 1 patients was statistically significant (see Supplemental Table 3). In a parallel analysis of eGFR, there was a statistically significant temporal reduction in eGFR in groups 1, 2, and 3 (P < 0.001 in each case) but no change in those who stopped PPI therapy (group 4; P = 0.45). In the case of ΔeGFR, there were statistically significant differences between the groups (P = 0.002 by ANOVA), with those who initiated a PPI (group 3) exhibiting a statistically significantly greater adjusted mean reduction compared with group 1 (−2.7 mL/min/1.73 m2; P = 0.005; see Supplemental Figure 1). This patternwas also seen in a model that adjusted for all baseline variables that differed across all PPI groups at P < 0.20 (see Supplemental Table 3). There was a statistically significant increase in composite 5-year CVD risk score in each of the four groups during the mean 2.1 years of follow-up (P < 0.001; see Table 3 and Supplemental Table 2 for group-specific changes in individual CVD risk factors). The Δ5-year CVD risk score was statistically significantly different between the four groups (P < 0.001 by ANOVA), with those who initiated a PPI (group 3) exhibiting a greater adjusted mean increase compared with group 1 (1.7%; P = 0.002; see Supplemental Figure 1). These findings parallel preliminary analysis of largely self-reported CVD events (coronary heart disease, cerebrovascular disease, or CVD death) between the two FDS2 biennial assessments in the four groups of patients (2.8%, 5.2%, 9.2%, and 4.5% in groups 1 through 4, respectively; P = 0.012). After adjustment for age, sex, and diabetes duration, and using group 1 as reference, only group 3 had a statistically significant OR (95% confidence interval) for CVD[3.67 (1.63 to 8.23), P = 0.002 vs 2.02 (0.88–4.60) and 1.71 (0.49–5.97) for groups 2 and 4, respectively;P>0.10 in each case]. The adjusted between-group differences in 5-year CVD risk score were similar after adjustment for all baseline variables that differed across all PPI groups at P<0.020 (see Supplemental Table 3). Discussion The present real-life longitudinal data suggest that initiation of a PPI in community-based patients with type 2 diabetes during an average 2.1-year period of follow-up does not result in a clinically significant and sustained increase in uACR relative to that in other patients. However, PPI initiation may accelerate the diabetesassociated decline in renal function and increase 5-year CVD risk over the same time. Data from our patients who stopped PPI therapy during follow-up provide evidence that the deleterious effects associated with this group of drugs do not persist. These data, which are, to our knowledge, the first that address the potential adverse effects of PPI therapy in diabetes, may have implications for the management of type 2 diabetes outside glycemia and nonglycemic CVD risk factors. The patients taking a PPI at FDS2 entry had better glycemic control (lower fasting serum glucose and hemoglobin A1c) than those who were not despite similar blood glucose-lowering therapies. This finding is in accord with a range of other studies showing that PPIs improve glycemia in diabetes, probably through the trophic effects of increased circulating gastrin concentrations on the pancreatic β-cell mass.[16] Consistent with general population studies,[17,18] baseline PPI use in the current study was more frequent in those with limited education and with greater cardiovascular comorbidity and its treatment, including lipid-lowering therapy. This could also reflect use of PPIs to reduce the risk of gastrointestinal hemorrhage associated with use of aspirin and other nonsteroidal anti-inflammatory drugs.[19] The association between abdominal obesity and increased risk of gastroesophageal reflux disease and thus PPI use is well recognized.[20] We postulate that the inverse association between Aboriginal racial background and PPI use indicates access issues consistent with continued socioeconomic disadvantage.[11] We interpret the lack of a statistically significant influence of initiation of a PPI and of chronic PPI use on uACR as suggesting that the permanent and marked deleterious effects of this group of drugs on endothelial function found in in vitro studies[1] are not replicated in vivo. This is consistent with the results of a short-term study of 21 adults without diabetes, approximately half of whom had CVD.[21] Nonsignificant trends in the present uACR data suggested that those initiating a PPI (group 3) had the greatest temporal increase in uACR but that those on chronic PPI therapy (group 2) had similar ΔuACR as those who remained untreated (group 1), whereas the mean ΔuACR in those stopping the medication (group 4) was negative (a finding that became significant after adjustment for all baseline variables that differed across the PPI groups). Although these findings parallel the more pronounced temporal changes in eGFR, overall they suggest that there is no clinically significant chronic progressive change in endothelial function when PPIs are prescribed in patients with type 2 diabetes. There was a strong independent inverse association between PPI use and renal function at study entry in our patients. This is likely to represent a nephropathic effect of PPIs that has been found in a number of large-scale administrative database and pharmacovigilance studies[3,22–24] and is also consistent with the changes across the present four groups during follow-up. Group 3 patients had the greatest decline in eGFRover the mean 2.1 years of follow-up, a mean fall that was approaching three times that in untreated group 1 patients. The fact that group 2 patients had a similar ΔeGFR to that in group 1 might suggest that chronic use is associated with an adaptive response, and it is of relevance that there was evidence of an attenuation of the adverse effect of PPI therapy of more than 2 years' duration in a recent meta-analysis.[22] It could also represent patient selection with those experiencing adverse (including renal) effects on PPIs having withdrawn from treatment before FDS2 entry. Nevertheless, group 4 patients had a slower rate of eGFR decline than would be expected for patients with type 2 diabetes, suggesting potential reversibility on cessation of therapy. The PPI group of drugs is known to cause acute interstitial nephritis, which can progress subclinically to chronic interstitial nephritis.[3] Most cases of acute interstitial nephritis are reversible, but the development of fibrosis may herald an irreversible progression to endstage renal disease,[25] a situation that emphasizes the importance of an awareness of the nephrotoxic effects of PPIs, especially in a vulnerable population such as patients with type 2 diabetes. One animal study has, by contrast, shown that lansoprazole is associated with renoprotection,[26] an effect attributed to the antiinflammatory and antioxidant properties of PPIs,[27] but the relevance to human disease is uncertain given the present and other data. Because uACR is strongly associated with incident CVD[7–9] and a variable in our validated FDS CVD risk equation,[15] and because PPIs may have effects on glycemia,[16] we assessed 5-year CVD risk in the same way as uACR and eGFR. Patients in group 3 had the greatest increase in the predicted risk of an incident CVD event, a result that tallied with the between-group differences in ORs for largely self-reported incidence of CVDevents during the approximate 2 years of follow-up. As with eGFR, we cannot rule out selection or survivor bias resulting in temporal changes in CVD risk in chronically treated group 2 patients that were no different from those on no PPI therapy or withdrawing from a PPI during follow-up. The significant increase in 5-year CVD risk in group 3 patients persisted after adjustment for potentially confounding variables and accords with the association between PPIs and CVD end points found in other studies.[4,5] Evidence of mitigating pleiotropic anti-inflammatory and antioxidant properties[27] has not been confirmed in all studies,[28] whereas PPI effects on the absorption of micronutrients such as magnesium[29] may have adverse consequences for CVD independent of direct drug effects.[30] The FDS2 is a prospective study with ongoing collection of morbidity and mortality data that should allow a future assessment of the relationship between PPI use and CVD events and death in type 2 diabetes. The current study had limitations. We examined associations between PPI use over at least 2 years and key outcomes, but the data cannot be used to infer causality. Although our findings do not suggest, as preempted by preclinical evidence,[1] that there is a large permanent effect of PPI on endothelial function in patients with type 2 diabetes, a small but clinically significant change may have been detected with a larger patient sample followed for a longer period, especially those in group 4 who stopped PPI therapy during follow-up. We did not have measurements of key variables between FDS2 assessments, including at the time of initiation or cessation of PPI therapy in groups 3 and 4, respectively. As acknowledged, selection and survival bias may have influenced the results, especially for those in group 2 on chronic PPI therapy. We had relatively small numbers of CVD outcomes, but accumulation of more robust and complete data is in progress through validated linkage. The strength of the current study is its access to near-complete prospective data froma large wellcharacterized community-based sample. The PPI group of drugs has radically changed the management of acid-related diseases in recent decades, but these drugs are expensive and associated with adverse effects when used for prolonged periods.[31] The present data provide a note of caution in the context of type 2 diabetes. Regular assessment of their appropriateness as part of chronic pharmacotherapy, as well as regular monitoring of renal function during chronic use, appears important, and there is an argument that CVD risk factor management should be optimized if PPIs are prescribed given the present association with CVD risk after their initiation. Acknowledgments We are grateful to the FDS2 participants for their involvement and FDS2 staff for help with collecting and recording clinical information. We thank the Biochemistry Departments at Fremantle Hospital and Health Service and PathWest Laboratory Medicine, Sir Charles Gairdner Hospital, for performing laboratory tests. Abbreviations ANOVA, analysis of variance; CVD, cardiovascular disease; eGFR, estimated glomerular filtration rate; FDS2, Fremantle Diabetes Study Phase II; OR, odds ratio; PPI, proton pump inhibitor; SD, standard deviation; uACR, urinary albumin/creatinine ratio. J Clin Endocrinol Metab. 2017;102(8):2985-2993.

Study Confirms Higher Breast Cancer Risk With Hormone-based Contraception

galinadoctor — Sun, 10 Dec 2017 01:14:36 GMT

By Gene Emery December 08, 2017 Reuters Health) - Women who currently use or recently used hormone-based contraception face a 20% higher risk of breast cancer, although the overall risk for most women is relatively low, a new study of 1.8 million women in Denmark has concluded. Older contraceptives were known to carry a higher risk of breast cancer, but doctors had hoped that the newer lower-estrogen formulations might pose a lower risk. The new findings, reported online December 6 in The New England Journal of Medicine, show that they do not, and the longer the products were used, the greater the danger. The researchers calculated that hormone contraception produced one extra case of breast cancer for every 7,690 women each year. That's a lot of cancers, given that 140 million use hormonal contraception worldwide – or about 13% of women ages 15 to 49. Breast cancer strikes about 255,000 U.S. women each year and kills about 41,000, according to the American Cancer Society. The study shows that "the search for an oral contraceptive that does not elevate the risk of breast cancer needs to continue," said Dr. David Hunter of the University of Oxford in a Journal editorial. Beyond the fact that they provide an effective means of contraception and may benefit women with menstrual cramping or abnormal menstrual bleeding, "the use of oral contraceptives is associated with substantial reductions in the risks of ovarian, endometrial, and colorectal cancers later in life. Indeed, some calculations have suggested that the net effect of the use of oral contraceptives for 5 years or longer is a slight reduction in the total risk of cancer," Hunter said. But as women get into their 40s, non-hormonal alternatives such as IUDs might be better, he said. Most cases of breast cancer were seen in women using oral contraceptives in their 40s. I don't think anyone's going to say stop taking oral contraceptives. That's not necessary and not supported by the data," said Dr. Roshni Rao, chief of breast surgery at New York - Presbyterian/Columbia University Medical Center in New York City, who was not involved with the study. "But it does show an increased risk, so for people who don't have a great reason for taking oral contraceptives, or are amenable to alternatives, perhaps they should think about it." Such alternatives include a copper IUD, condoms or, if women are done having children, tubal ligation. The new study looked at all women in Denmark ages 15 to 49 who had not had cancer, clots in their veins, or treatment for infertility. The women were followed for nearly 11 years. The 20% increase in breast cancer risk varied by age and how long the women used hormone-based contraceptives, including pills, contraceptive patches, vaginal rings, progestin-only implants, and injections. The risk was 9% higher with less than one year of use and 38% higher with more than 10 years of use. "Another thing that has not been clear before is that after discontinuation, if you have used this product for more than 5 years, the risk seems to be increased, even after 5 years of discontinuation of the drugs," chief author Dr. Lina Morch, a senior researcher at Copenhagen University Hospital told Reuters Health by phone. On the other hand, among women who used hormonal contraceptives for short periods, the excess risk of breast cancer disappeared rapidly after use was stopped, the researchers said. IUDs infused with hormones also appear to pose a risk, Morch said, so "so there's a lot of things to take into account when deciding what type of contraception to use. Contraception itself is a benefit, of course, but this study indicates it might be worth considering an alternative to hormone contraception, like the copper intrauterine device or barrier methods like condoms." "If you compare this to other risks, such as obesity and being overweight, there's more of a risk with obesity than if you take a few years of oral contraceptives," Rao told Reuters Health by phone. "There's no need to panic based on these results," said Morch, "We don't want women dropping their contraception without having something different to go to. And there are alternatives." SOURCE: http://bit.ly/2jUGTHR N Engl J Med 2017.

Statins May Up Breast Cancer–Specific and Overall Survival

galinadoctor — Sun, 10 Dec 2017 01:10:31 GMT

Statins May Up Breast Cancer–Specific and Overall Survival Pam Harrison December 08, 2017 AN ANTONIO — Overall survival and, more intriguingly, breast cancer–specific survival are significantly enhanced by statin therapy when used both in the prediagnostic and the postdiagnostic setting compared with no statin use, suggests a Swedish nationwide study reported here at the San Antonio Breast Cancer Symposium (SABCS) 2017. "I don't think any of us were surprised that it was beneficial for women to be on a statin in terms of overall survival because statins have a lot of beneficial effects on cardiovascular disease prevention," lead investigator, Signe Borgquist, MD, PhD, professor of oncology, Aarhus University Hospital, Denmark, told Medscape Medical News. "But when we look at breast cancer–related death, which is a more interesting endpoint than overall survival when it comes to treatment as exposure, we see that both prediagnostic use and postdiagnostic use is beneficial for women in terms of breast cancer–related death, where we saw significantly lower hazard ratios if women were using a statin in either setting. If women were regular users, they had more benefit than if they were not regular users," she added. Data were collected from a nationwide retrospective cohort study involving 20,559 Swedish women diagnosed with breast cancer from July 2005 through 2008. Statin use was identified through the Swedish Prescription Registry, while breast cancer–specific death was identified from the national cause-of-death registry through the end of 2012. "During follow-up, a total of 4678 patients died, whereof 2669 were considered breast cancer–specific deaths," the investigators observed. Compared with women not receiving statins at all, women who took a statin regularly before their diagnosis had a 23% lower relative risk of dying from breast cancer (hazard ratio [HR], 0.77; P = .014). After their diagnosis, women who had been exposed to any statin use had a 17% lower relative risk of dying from breast cancer (HR, 0.83; P = .001). The benefit of taking a statin before diagnosis also did not seem to be influenced by the statin dose, Dr Borgquist added. For example, women who took an intermediate statin dose had a 26% lower relative risk for a breast cancer–related death (HR, 0.74; P = .019). In comparison, women who took high-dose statin therapy before diagnosis had a 16% lower risk of reaching the same endpoint, she added. Nor did the type of statin taken in the postdiagnostic setting affect the risk of dying from breast cancer: The relative risk was identical at an HR of 0.93 for both statin types (P < .001 and P = .002 for lipophilic and hydrophilic statins, respectively). "The main take-home message from this study is that all the Scandinavian studies are showing more or less the same beneficial effect in breast cancer, even though studies from the United Kingdom have not depicted as good an effect as we have," Dr Borgquist observed. What we would like to do now is conduct a large adjuvant trial to show that this holds true in a trial setting, which would hopefully enable us to identify robust predictive markers as to which women might benefit from a statin and which might not, because I am sure that not all breast tumors are equally susceptible to statin treatment," she added. HMG-CoA Reductase Target As Dr Borgquist explained, extrahepatic function of the statins may affect the mevalonate pathway in cancer cells by targeting 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. "HMG-CoA reductase is differentially expressed in breast tumors," she noted, with some tumors having high levels of HMG-CoA reductase expression and others, much lower levels of expression. In early clinical work, Swedish investigators observed that high levels of HMG-CoA reductase expression was associated with better outcomes in breast cancer.

Разработана методика "перекрашивания" глаз лазером.

galinadoctor — Sun, 06 Nov 2011 12:15:04 GMT

Американская компания разработала методику смены цвета глаз с карего на голубой, сообщает CBS News.
Как пояснил сотрудник калифорнийской фирмы Stroma Medical Грег Хоумер (Gregg Homer), процедура проводится специально настроенным лазером, который разрушает в радужной оболочке глаза пигмент меланин, ответственный за темную окраску тканей.
Сама процедура занимает около 20 секунд, а смена цвета происходит постепенно в течение двух-трех недель. После этого глаза остаются голубыми навсегда.
Хоумер заявил, что он убежден в безопасности новой методики. Однако представитель Американского колледжа офтальмологии Элмер Ту (Elmer Tu) отметил, что высвобождение меланина во внутриглазную жидкость в ходе процедуры теоретически может повысить риск развития пигментной глаукомы – тяжелого заболевания, чреватого слепотой.
Подтвердить или опровергнуть эти опасения должны дальнейшие испытания методики, которые продлятся не менее года. В случае их успеха новый прибор окажется на мировом рынке уже через 18 месяцев. Предполагаемая стоимость процедуры – около пяти тысяч долларов.
Исполнительный директор Stroma Medical Дауг Дэниэлс (Doug Daniels) пояснил, что "перекрашивание" глаз лазером избавлено от недостатков цветных контактных линз. В частности, светлые линзы на темных глазах смотрятся неестественно и мешают зрению. Кроме того, их постоянное ношение может привести к развитию инфекции.