Soccer is the world’s most popular sport. As the sport has grown, so have the physical demands and the search for ways to edge out the competition with the use of sports science and nutrition. The demands, which include intense training, ≥90 minutes matches, congested fixtures, and travel, lead to increased energy and nutrient requirements, stress on the body, and risk of impaired sleep cycles. Identifying key areas to enhance a player’s performance is an ongoing effort because of individual differences. Moreover, new information is being discovered via research, and advancing technology to measure performance is always evolving. This article focuses on the core nutrition principles known to lay the foundation for a better soccer player. These principles are obvious for some; however, nutrition and hydration are often undervalued, leaving the individual player with the responsibility to eat right. This review addresses the most applicable nutrition-related recommendations for soccer players.

Technical, tactical, and physical skills are key factors in a soccer player’s performance. However, energy demands of matches and training sessions require adequate fuel and hydration to maximize those key factors. Athletes may need to manage carbohydrates, protein, and fat separately to achieve optimal body size and body composition, and to maximize performance.

Nutrition plays a vital role in keeping the player healthy, reducing risk of injuries, speeding up recovery, and enhancing training adaptations. Research has shown what we eat and when we eat can significantly impact skeletal muscle adaptation, inflammation, immune response, and energy metabolism. These are all essential nutrition considerations for soccer players.

ENERGY METABOLISM IN SOCCER

Understanding energy demands will help determine energy requirements: type, amount, and timing of macronutrients and micronutrients. Soccer utilizes both aerobic and anaerobic energy systems. Soccer is an intermittent team-based sport; thus, it contains various high-intensity movements, such as sprinting, jumping, dribbling, and frequent changing of direction performed in between numerous low-intensity slow movements. The high intense movements collectively account for about 30% of match play, whereas 70% is walking, jogging, and standing. Although sprinting and jumping are not a large part of the 90 minutes of match play, they have a huge impact on the outcome of the match. Distance covered in the last 15 minutes of match play decreases by 14% to 45% compared with the first 15 minutes of play.¹ Krustrup and colleagues² found muscles in the quadriceps to be empty or nearly empty of glycogen (stored carbohydrates) after match play. This phenomenon can help explain a significant decrease in sprinting, jumping, and intermittent movements toward the end of a match—energy demands that rely on glycogen as the primary fuel source. Being well-fueled and hydrated and having the ability to delay fatigue can place a team at a performance advantage.

ENERGY EXPENDITURE

Beyond training load or match intensity, a soccer player’s body composition, gender, age, and position can affect energy needs. Position differences in elite soccer players show that the greatest total distance covered is by central midfielders and wide midfielders (~12 km –13 km), whereas central defenders cover the least area of the field players (≤~10 km).^3,4 The environment can also play a role in energy expenditure. To further understand calorie needs, total daily energy expenditure in soccer players has been measured using doubly labeled water and estimated using heart rate, global positioning system, video match analysis, and activity records.^5,6 One study estimated that energy expended during a training day for elite male soccer players is between 3442 kcal and 3824 kcal.⁶ Another study using doubly labeled water concluded that mean energy expenditure of elite male soccer players is 3566 kcal over a 7-day period, which included 5 training days and 2 matches.⁷ In terms of energy expenditure for elite female soccer players, the mean values for match day, training days, and rest days were 2914, 2783, and 2213 calories, respectively.⁸

Continue to: FUELING THE SOCCER PLAYER

 

 

FUELING THE SOCCER PLAYER

Depending on the match fixture, proper fueling can be a challenge due to the number of matches, travel time, and limited recovery time. Macronutrients will provide the mainstay of fuel for a player, specifically carbohydrates and fats. Carbohydrates are the preferred source of fuel for the majority of the calories consumed. Using body weight (kg) is a more current and accurate method of recommending the amount of each macronutrient an individual player should eat as compared to using a percentage of total daily calories.

• Carbohydrates: 5–10 g/kg/day
• Protein: 1.2–2.0 g/kg/day
• Fat: 0.8–1.5 g/kg/day

CARBOHYDRATE AND SOCCER PERFORMANCE

Carbohydrates are a limited supply of fuel compared with fat stores. They are an important fuel source for soccer players, as muscle glycogen is vital to performance during high intense training and match play (Table 1). Yet current research shows that a high carbohydrate intake is not required to be followed every day due to varied energy demands.⁹ This newer strategy is referred to as “training low,” allowing the athlete to train at a low-moderate intensity in a low glycogen state. The glycogen status of the muscle can alter the training adaptations through cellular changes in the mitochondria. Therefore, carbohydrate needs should reflect the work required or demand for optimal performance. However, on high-training load days or 24 hours pre-match, carbohydrate intake should be increased to maximize muscle glycogen stores. Soccer players need to consume up to 8-10 g/kg body weight during the 24 hours before a match.¹⁰ On low or rest days, carbohydrate intake should be reduced to reflect the decreased training load. For example, recent research has demonstrated potential training adaptations when muscle glycogen stores are not consistently high¹¹ or intentionally kept low depending on the training load. Adjusting carbohydrate intake to the physical demands of an athlete is a strategy called nutrition periodization.

However, if glycogen stores are not well supplied before a match >90 minutes, then the muscles and the brain will become fatigued and lead to poor performance. Glycogen depletion contributes to fatigue toward the end of a match.¹⁰ In the early 1970s, Saltin and colleagues¹² showed that players with high muscle glycogen stores (~400 mmol/kg dry wt) achieve higher movement intensities and cover more total distance than those players who start the match with low glycogen stores (~200 mmol/kg dry wt). Another study examined pre-match diets of male soccer players (65% vs 30% daily carbohydrate intake) to determine the effect on performance outcomes and glycogen concentrations. Results showed high-muscle glycogen concentrations in the 65% carbohydrate diet and a significantly higher amount of intense exercise bouts. More acutely, studies have shown a meal containing 200 to 300 grams of carbohydrates 2 to 4 hours before exercise prolongs endurance.^13-15 Ideally, consuming fast-digesting carbohydrate sources during or at half time will help maintain blood glucose concentrations and spare muscle glycogen reserves. The majority of literature shows a 6% to 8% solution of combined fast-digesting carbohydrates (ie, glucose, fructose, sucrose, or maltodextrin) at a rate of 30 to 60 g/h enhances at least 1 aspect of performance in soccer.^16-18 These performance benefits include increased running time, improved time to fatigue, and enhanced technical skills. Regarding recovery, soccer players should begin consuming carbohydrate-rich foods and beverages immediately after exhaustive training or a match to optimize glycogen reloading. Ingesting post-exercise carbohydrates stimulates muscle and liver glycogen synthesis up to tenfold compared with post-intake of no carbohydrates.¹⁹ This recovery period becomes vital when there are <8 hours between training sessions or another match, such as in youth tournaments. The form of carbohydrate, solid or liquid, can be based on preference and tolerance, as long as the source provides a large glycemic and insulin response.

An easy way to adjust daily carbohydrate intake is to schedule carbohydrate-rich foods at meals or snacks around important training sessions or before/during/after on match day. Anderson and colleagues¹⁰ looked at training loads for 1, 2, and 3 matches per week, recommending high carbohydrate intake match day minus 1, on match day, and match day plus 1 for 1 and 2 matches per week and lower carbohydrate intake on the other days. During a 3-match week, lowering carbohydrates any day of that week is not recommended. More research is needed to determine the best strategy for performance regarding carbohydrate periodization in soccer.

PROTEIN AND SOCCER PERFORMANCE

Protein is important to soccer players for muscle tissue repair, strength, bone health, and the immune system (Table 2). The American College of Sports Medicine, the Academy of Nutrition and Dietetics, and the Dietitians of Canada recommend 1.2 to 2.0 g/kg/day.²⁰ Most soccer players meet the daily protein requirements; however, the key to optimizing the total daily amount is focusing on the source/amino acid profile, timing, and amount per feeding. Consuming divided doses of protein (20 g to 40 g) every 3 to 4 hours gives the body a continuous flow of amino acids to support muscle synthesis and recovery. In terms of body size, the recommendation is 0.25 to 0.4 g/kg every 3 to 4 hours, which includes pre-training/match and post-training/match. Protein/amino acids consumed around strength training and high-intensity sessions can promote muscle adaptations, minimize tissue breakdown, and speed recovery. Soccer matches lead to significant muscle damage²¹ especially at 2 sessions/day or multiple matches in a week. Protein is not a priority during training or matches, as its role is not to provide energy, and the primary goal during soccer activities is energy production. Research supports an intake of 30 to 40 g of casein, which is a slow digesting protein, at night before bed when a strength-training session has been performed that day.^22,23

Continue to: FAT AND SOCCER PERFORMANCE

 

 

FAT AND SOCCER PERFORMANCE

Fat is the primary source of energy at rest and at low-training intensities, such as walking or jogging for soccer players (Table 3). Besides providing slow, long-lasting energy, fat helps absorb vitamins A, D, E, and K; produce hormones; protect organs; and support the cell membrane structure. The dietary recommendations of total fat intake for athletes are similar to or slightly greater than those recommended for non-athletes. The total amount required depends on the training demands and the players’ goals. The recommended amount of dietary fat is between 20% and 35% of total daily energy intake.

The key to gaining performance benefits from dietary fat depends on the type of fat selected. Some fats in excess, such as omega-6 fatty acids and saturated fats, may promote inflammation, hinder recovery, and affect brain health. Other types can help reduce inflammation, enhance muscle recovery, and improve brain health. These types include polyunsaturated omega-3 fatty acids, which are essential for the health of the athlete, allowing for a balanced fatty acid profile.²³ Specific omega-3 fatty acids (EPA and DHA) have shown an improvement in the function of the mitochondria, enhancing energy cell metabolism. They also have potential to be highly anti-inflammatory, benefit rehabilitation during soft-tissue injury, and help decrease secondary damage from a concussion.

In addition, research shows that omega-3 may enhance the energy production of the mitochondria, resulting in less oxidative damage to the muscle cell.²⁵ More research is needed on the effects of performance on soccer players. Given the slow digestion and absorption of fats, fat intake must be limited leading up to or during training sessions or matches, which may risk gastrointestinal issues and displacement of carbohydrates. Low to moderate monounsaturated and polyunsaturated fats in a recovery meal have not been shown to inhibit muscle glycogen reloading or muscle protein synthesis.^26,27 In regard to fat intake post-match, fat is not a key nutrient of concern for muscle recovery, as it can be included in the next balanced meal.

MICRONUTRIENTS, VITAMINS, AND MINERALS

Exercise stresses many of the metabolic pathways where vitamins and minerals are required. High-level training demands may also increase the turnover rate of vitamins and minerals. As a result, greater dietary intakes of vitamins and minerals may be warranted. Soccer players at the greatest risk for poor vitamin and mineral levels are those who skip meals, who eliminate ≥1 of the food groups from their diet (such as vegans), or who consume unbalanced and highly processed foods. In soccer players, the micronutrients of concern include iron and vitamin D. In young female soccer players, calcium intake must be assessed along with adequate energy intake for optimal bone density. Vegetarians, vegans, and/or athletes who do not consume meat, eggs, and/or dairy in their diet are at risk for vitamin B12 deficiency. The key to obtaining all the vitamins and minerals an athlete will need is to eat a wide variety of nutrient-dense foods.

IRON

Iron deficiency, with or without anemia, may impair muscle function and limit exercise capacity. Adequate iron intake in athletes with iron deficiencies and/or anemia can improve exercise capacity. Iron depletion is 1 of the most common nutrient deficiencies observed among endurance athletes. Foot strike hemolysis can destroy red blood cells during activities such as running. Research has shown that 30% of professional male soccer players have ferritin levels <30 mcg/L at the end of a soccer season.²⁸ Thus, fatigue and poor recovery time place soccer players at risk of an iron imbalance.^29,30

Continue to: Landahl and colleagues...

Landahl and colleagues³¹ found that iron deficiency and iron deficiency anemia are common in female soccer players at the elite level. In their study of 28 female national soccer players, 57% had iron deficiency and 29% presented with iron deficiency anemia 6 months before the FIFA Women's World Cup. Testing hemoglobin alone is insufficient to detect relative anemia. Regular monitoring of hemoglobin and ferritin concentrations may be necessary to determine appropriate iron needs.

VITAMIN D

Vitamin D is required for optimal bone health, as it helps regulate calcium and phosphorus. Further research shows a link between vitamin D and non–bone-related functions, such as muscle health, immune support, and anti-inflammatory roles, which may be linked to performance. Soccer players with low levels of vitamin D (<30 ng/mL) may be more at risk for musculoskeletal injuries and stress fractures.³⁴ In other sports, vitamin D may enhance muscle strength; however, no association between vitamin D and muscle strength has been found in soccer players.^34,35 The geographic location of an athlete seems to be irrelevant to serum levels, as insufficient levels can be found at various latitudes.^34,36-38

Evidence has shown that vitamin D may improve athletic performance in vitamin D-depleted athletes, thereby improving vertical jumps, lowering risks of muscle injury/strains and stress fractures, and reducing risk of colds/flu. In 2013, researchers showed for the first time a link between vitamin D and muscle aerobic metabolism by studying the energy efficiency of the mitochondria.³² Athletes with low vitamin D levels increased their ATP production within the muscle with vitamin D supplementation over 10 weeks to 12 weeks.³³

CALCIUM

Soccer players present with stronger and denser bones than non-athletes due to running and jumping in their sport. Weight-bearing sites such as lumbar spine, hip, femoral neck, trochanter, intertrochanteric region, and both legs are sensitive to the impact of soccer movements.³⁹ Calcium and vitamin D are also important for muscle contraction.

Given the variation in genetics, sports, and gender, optimal performance requires a healthy eating plan tailored to the individual athlete. A healthy eating plan allows an athlete to train longer and harder, delay the onset of fatigue, and speed recovery. Nutrition supports optimal performance through real food, proper hydration, nutrient timing, and supplementation.

Continue to: FLUID REQUIREMENTS FOR SOCCER PLAYERS

 

 

FLUID REQUIREMENTS FOR SOCCER PLAYERS

Many athletes overlook the importance of hydration on performance, either assuming they are hydrated or they miscalculate fluid and electrolyte needs to actual sweat losses. Numerous factors play a part in optimal hydration such as sweat rate, environment, training intensity, duration, body size, and body composition. Soccer players have fewer breaks to consume fluids during a match compared with basketball, baseball, or American football players. These breaks include a 15-minute half between coming off the pitch to the locker room and back, as well as time spent with coaches reviewing strategies; this short window of time must be maximized to rehydrate. Fluids with a carbohydrate concentration of 4% to 8% at 5 to 10 ounces and breaks every 15 to 20 minutes are optimal to maximize uptake while avoiding gastric intolerance.

Studies have shown that most players do not drink sufficiently during a match to optimize hydration, replacing only ~40% to 45% of their sweat losses.^{40, 41} Maughan and colleagues measured high levels of urine osmolality in some soccer players, thereby indicating that the players started their training session dehydrated.⁴¹ Soccer players must begin training or a match well hydrated due to the limited opportunities after kick-off. The athlete should drink at least 4 hours prior to exercise; if no urine is produced or urine is dark in color, then the athlete should drink again 2 hours prior.

Changes in body mass, urine color, and thirst offer clues to the need for rehydration. Advanced hydration measurement includes testing urine specific gravity (USG) values. For example, testing pre-training or pre-match can be conducted to determine hydration status and trending changes from day to day. A USG value >1.020 is considered dehydrated in accordance with the NATA position statement.⁴² Calculating a sweat rate is a practical approach to determining individual hydration needs (see Table 4). Sweat rates will vary between soccer players based on their position and intensity of play, along with total match time.³⁹ Soccer players will lose ~1.5 to 4.5 liters during match play.^43-46 In general, athletes, including soccer players, should limit body weight loss to ≤2% to 3% to maintain performance. Studies have shown that >2% body mass loss can hinder soccer-specific performance, such as dribbling skills and intermittent high intensity sprinting.^49-51) Table 5 outlines the detrimental effects dehydration has on performance. Urine-specific gravity values between 1.021 and 1.030 may reflect 3% to 5% change in body weight.

ELECTROLYTES

Sodium is the primary electrolyte lost in sweat. Other electrolytes (potassium, magnesium, and calcium) are lost at much lower levels and typically replaced through diet. Soccer players can lose large amounts of sodium; between 700 and 1500 mg of sodium/L of sweat has been reported in several studies.^42-44 Studies of professional male soccer players have shown potassium losses in the range of 165 mg/L to 234 mg/L.^{42, 51,52} Sodium in a sports drink or in food aids with water uptake from the intestines and enhances the thirst mechanism in the brain, resulting in additional fluid being retained in the body.

REHYDRATION AFTER TRAINING OR COMPETITION

Within 2 hours after training or competition, the rehydration strategy should provide water to restore body fluid status, carbohydrates to replenish glycogen (fuel) stores, and electrolytes to speed rehydration (Table 6). The volume of fluids and type of fluids over the next 24 hours dictate the hydration status prior to the next day’s training session. It is a continuous cycle. Over time, an athlete increases the risk of being in a chronic dehydrated state, resulting in lack of motivation, risk of injury, and illness, fatigue, and poor performance. The current recommendation is to drink ~50% more in volume than the amount of weight lost, such as 22 to 24 ounces/pound lost.⁵²

Soccer is the world’s most popular sport. As the sport has grown, so have the physical demands and the search for ways to edge out the competition with the use of sports science and nutrition. The demands, which include intense training, ≥90 minutes matches, congested fixtures, and travel, lead to increased energy and nutrient requirements, stress on the body, and risk of impaired sleep cycles. Identifying key areas to enhance a player’s performance is an ongoing effort because of individual differences. Moreover, new information is being discovered via research, and advancing technology to measure performance is always evolving. This article focuses on the core nutrition principles known to lay the foundation for a better soccer player. These principles are obvious for some; however, nutrition and hydration are often undervalued, leaving the individual player with the responsibility to eat right. This review addresses the most applicable nutrition-related recommendations for soccer players.

Technical, tactical, and physical skills are key factors in a soccer player’s performance. However, energy demands of matches and training sessions require adequate fuel and hydration to maximize those key factors. Athletes may need to manage carbohydrates, protein, and fat separately to achieve optimal body size and body composition, and to maximize performance.

Nutrition plays a vital role in keeping the player healthy, reducing risk of injuries, speeding up recovery, and enhancing training adaptations. Research has shown what we eat and when we eat can significantly impact skeletal muscle adaptation, inflammation, immune response, and energy metabolism. These are all essential nutrition considerations for soccer players.

ENERGY METABOLISM IN SOCCER

Understanding energy demands will help determine energy requirements: type, amount, and timing of macronutrients and micronutrients. Soccer utilizes both aerobic and anaerobic energy systems. Soccer is an intermittent team-based sport; thus, it contains various high-intensity movements, such as sprinting, jumping, dribbling, and frequent changing of direction performed in between numerous low-intensity slow movements. The high intense movements collectively account for about 30% of match play, whereas 70% is walking, jogging, and standing. Although sprinting and jumping are not a large part of the 90 minutes of match play, they have a huge impact on the outcome of the match. Distance covered in the last 15 minutes of match play decreases by 14% to 45% compared with the first 15 minutes of play.¹ Krustrup and colleagues² found muscles in the quadriceps to be empty or nearly empty of glycogen (stored carbohydrates) after match play. This phenomenon can help explain a significant decrease in sprinting, jumping, and intermittent movements toward the end of a match—energy demands that rely on glycogen as the primary fuel source. Being well-fueled and hydrated and having the ability to delay fatigue can place a team at a performance advantage.

ENERGY EXPENDITURE

Beyond training load or match intensity, a soccer player’s body composition, gender, age, and position can affect energy needs. Position differences in elite soccer players show that the greatest total distance covered is by central midfielders and wide midfielders (~12 km –13 km), whereas central defenders cover the least area of the field players (≤~10 km).^3,4 The environment can also play a role in energy expenditure. To further understand calorie needs, total daily energy expenditure in soccer players has been measured using doubly labeled water and estimated using heart rate, global positioning system, video match analysis, and activity records.^5,6 One study estimated that energy expended during a training day for elite male soccer players is between 3442 kcal and 3824 kcal.⁶ Another study using doubly labeled water concluded that mean energy expenditure of elite male soccer players is 3566 kcal over a 7-day period, which included 5 training days and 2 matches.⁷ In terms of energy expenditure for elite female soccer players, the mean values for match day, training days, and rest days were 2914, 2783, and 2213 calories, respectively.⁸

Continue to: FUELING THE SOCCER PLAYER

 

 

FUELING THE SOCCER PLAYER

Depending on the match fixture, proper fueling can be a challenge due to the number of matches, travel time, and limited recovery time. Macronutrients will provide the mainstay of fuel for a player, specifically carbohydrates and fats. Carbohydrates are the preferred source of fuel for the majority of the calories consumed. Using body weight (kg) is a more current and accurate method of recommending the amount of each macronutrient an individual player should eat as compared to using a percentage of total daily calories.

• Carbohydrates: 5–10 g/kg/day
• Protein: 1.2–2.0 g/kg/day
• Fat: 0.8–1.5 g/kg/day

CARBOHYDRATE AND SOCCER PERFORMANCE

Carbohydrates are a limited supply of fuel compared with fat stores. They are an important fuel source for soccer players, as muscle glycogen is vital to performance during high intense training and match play (Table 1). Yet current research shows that a high carbohydrate intake is not required to be followed every day due to varied energy demands.⁹ This newer strategy is referred to as “training low,” allowing the athlete to train at a low-moderate intensity in a low glycogen state. The glycogen status of the muscle can alter the training adaptations through cellular changes in the mitochondria. Therefore, carbohydrate needs should reflect the work required or demand for optimal performance. However, on high-training load days or 24 hours pre-match, carbohydrate intake should be increased to maximize muscle glycogen stores. Soccer players need to consume up to 8-10 g/kg body weight during the 24 hours before a match.¹⁰ On low or rest days, carbohydrate intake should be reduced to reflect the decreased training load. For example, recent research has demonstrated potential training adaptations when muscle glycogen stores are not consistently high¹¹ or intentionally kept low depending on the training load. Adjusting carbohydrate intake to the physical demands of an athlete is a strategy called nutrition periodization.

However, if glycogen stores are not well supplied before a match >90 minutes, then the muscles and the brain will become fatigued and lead to poor performance. Glycogen depletion contributes to fatigue toward the end of a match.¹⁰ In the early 1970s, Saltin and colleagues¹² showed that players with high muscle glycogen stores (~400 mmol/kg dry wt) achieve higher movement intensities and cover more total distance than those players who start the match with low glycogen stores (~200 mmol/kg dry wt). Another study examined pre-match diets of male soccer players (65% vs 30% daily carbohydrate intake) to determine the effect on performance outcomes and glycogen concentrations. Results showed high-muscle glycogen concentrations in the 65% carbohydrate diet and a significantly higher amount of intense exercise bouts. More acutely, studies have shown a meal containing 200 to 300 grams of carbohydrates 2 to 4 hours before exercise prolongs endurance.^13-15 Ideally, consuming fast-digesting carbohydrate sources during or at half time will help maintain blood glucose concentrations and spare muscle glycogen reserves. The majority of literature shows a 6% to 8% solution of combined fast-digesting carbohydrates (ie, glucose, fructose, sucrose, or maltodextrin) at a rate of 30 to 60 g/h enhances at least 1 aspect of performance in soccer.^16-18 These performance benefits include increased running time, improved time to fatigue, and enhanced technical skills. Regarding recovery, soccer players should begin consuming carbohydrate-rich foods and beverages immediately after exhaustive training or a match to optimize glycogen reloading. Ingesting post-exercise carbohydrates stimulates muscle and liver glycogen synthesis up to tenfold compared with post-intake of no carbohydrates.¹⁹ This recovery period becomes vital when there are <8 hours between training sessions or another match, such as in youth tournaments. The form of carbohydrate, solid or liquid, can be based on preference and tolerance, as long as the source provides a large glycemic and insulin response.

An easy way to adjust daily carbohydrate intake is to schedule carbohydrate-rich foods at meals or snacks around important training sessions or before/during/after on match day. Anderson and colleagues¹⁰ looked at training loads for 1, 2, and 3 matches per week, recommending high carbohydrate intake match day minus 1, on match day, and match day plus 1 for 1 and 2 matches per week and lower carbohydrate intake on the other days. During a 3-match week, lowering carbohydrates any day of that week is not recommended. More research is needed to determine the best strategy for performance regarding carbohydrate periodization in soccer.

PROTEIN AND SOCCER PERFORMANCE

Protein is important to soccer players for muscle tissue repair, strength, bone health, and the immune system (Table 2). The American College of Sports Medicine, the Academy of Nutrition and Dietetics, and the Dietitians of Canada recommend 1.2 to 2.0 g/kg/day.²⁰ Most soccer players meet the daily protein requirements; however, the key to optimizing the total daily amount is focusing on the source/amino acid profile, timing, and amount per feeding. Consuming divided doses of protein (20 g to 40 g) every 3 to 4 hours gives the body a continuous flow of amino acids to support muscle synthesis and recovery. In terms of body size, the recommendation is 0.25 to 0.4 g/kg every 3 to 4 hours, which includes pre-training/match and post-training/match. Protein/amino acids consumed around strength training and high-intensity sessions can promote muscle adaptations, minimize tissue breakdown, and speed recovery. Soccer matches lead to significant muscle damage²¹ especially at 2 sessions/day or multiple matches in a week. Protein is not a priority during training or matches, as its role is not to provide energy, and the primary goal during soccer activities is energy production. Research supports an intake of 30 to 40 g of casein, which is a slow digesting protein, at night before bed when a strength-training session has been performed that day.^22,23

Continue to: FAT AND SOCCER PERFORMANCE

 

 

FAT AND SOCCER PERFORMANCE

Fat is the primary source of energy at rest and at low-training intensities, such as walking or jogging for soccer players (Table 3). Besides providing slow, long-lasting energy, fat helps absorb vitamins A, D, E, and K; produce hormones; protect organs; and support the cell membrane structure. The dietary recommendations of total fat intake for athletes are similar to or slightly greater than those recommended for non-athletes. The total amount required depends on the training demands and the players’ goals. The recommended amount of dietary fat is between 20% and 35% of total daily energy intake.

The key to gaining performance benefits from dietary fat depends on the type of fat selected. Some fats in excess, such as omega-6 fatty acids and saturated fats, may promote inflammation, hinder recovery, and affect brain health. Other types can help reduce inflammation, enhance muscle recovery, and improve brain health. These types include polyunsaturated omega-3 fatty acids, which are essential for the health of the athlete, allowing for a balanced fatty acid profile.²³ Specific omega-3 fatty acids (EPA and DHA) have shown an improvement in the function of the mitochondria, enhancing energy cell metabolism. They also have potential to be highly anti-inflammatory, benefit rehabilitation during soft-tissue injury, and help decrease secondary damage from a concussion.

In addition, research shows that omega-3 may enhance the energy production of the mitochondria, resulting in less oxidative damage to the muscle cell.²⁵ More research is needed on the effects of performance on soccer players. Given the slow digestion and absorption of fats, fat intake must be limited leading up to or during training sessions or matches, which may risk gastrointestinal issues and displacement of carbohydrates. Low to moderate monounsaturated and polyunsaturated fats in a recovery meal have not been shown to inhibit muscle glycogen reloading or muscle protein synthesis.^26,27 In regard to fat intake post-match, fat is not a key nutrient of concern for muscle recovery, as it can be included in the next balanced meal.

MICRONUTRIENTS, VITAMINS, AND MINERALS

Exercise stresses many of the metabolic pathways where vitamins and minerals are required. High-level training demands may also increase the turnover rate of vitamins and minerals. As a result, greater dietary intakes of vitamins and minerals may be warranted. Soccer players at the greatest risk for poor vitamin and mineral levels are those who skip meals, who eliminate ≥1 of the food groups from their diet (such as vegans), or who consume unbalanced and highly processed foods. In soccer players, the micronutrients of concern include iron and vitamin D. In young female soccer players, calcium intake must be assessed along with adequate energy intake for optimal bone density. Vegetarians, vegans, and/or athletes who do not consume meat, eggs, and/or dairy in their diet are at risk for vitamin B12 deficiency. The key to obtaining all the vitamins and minerals an athlete will need is to eat a wide variety of nutrient-dense foods.

IRON

Iron deficiency, with or without anemia, may impair muscle function and limit exercise capacity. Adequate iron intake in athletes with iron deficiencies and/or anemia can improve exercise capacity. Iron depletion is 1 of the most common nutrient deficiencies observed among endurance athletes. Foot strike hemolysis can destroy red blood cells during activities such as running. Research has shown that 30% of professional male soccer players have ferritin levels <30 mcg/L at the end of a soccer season.²⁸ Thus, fatigue and poor recovery time place soccer players at risk of an iron imbalance.^29,30

Continue to: Landahl and colleagues...

Landahl and colleagues³¹ found that iron deficiency and iron deficiency anemia are common in female soccer players at the elite level. In their study of 28 female national soccer players, 57% had iron deficiency and 29% presented with iron deficiency anemia 6 months before the FIFA Women's World Cup. Testing hemoglobin alone is insufficient to detect relative anemia. Regular monitoring of hemoglobin and ferritin concentrations may be necessary to determine appropriate iron needs.

VITAMIN D

Vitamin D is required for optimal bone health, as it helps regulate calcium and phosphorus. Further research shows a link between vitamin D and non–bone-related functions, such as muscle health, immune support, and anti-inflammatory roles, which may be linked to performance. Soccer players with low levels of vitamin D (<30 ng/mL) may be more at risk for musculoskeletal injuries and stress fractures.³⁴ In other sports, vitamin D may enhance muscle strength; however, no association between vitamin D and muscle strength has been found in soccer players.^34,35 The geographic location of an athlete seems to be irrelevant to serum levels, as insufficient levels can be found at various latitudes.^34,36-38

Evidence has shown that vitamin D may improve athletic performance in vitamin D-depleted athletes, thereby improving vertical jumps, lowering risks of muscle injury/strains and stress fractures, and reducing risk of colds/flu. In 2013, researchers showed for the first time a link between vitamin D and muscle aerobic metabolism by studying the energy efficiency of the mitochondria.³² Athletes with low vitamin D levels increased their ATP production within the muscle with vitamin D supplementation over 10 weeks to 12 weeks.³³

CALCIUM

Soccer players present with stronger and denser bones than non-athletes due to running and jumping in their sport. Weight-bearing sites such as lumbar spine, hip, femoral neck, trochanter, intertrochanteric region, and both legs are sensitive to the impact of soccer movements.³⁹ Calcium and vitamin D are also important for muscle contraction.

Given the variation in genetics, sports, and gender, optimal performance requires a healthy eating plan tailored to the individual athlete. A healthy eating plan allows an athlete to train longer and harder, delay the onset of fatigue, and speed recovery. Nutrition supports optimal performance through real food, proper hydration, nutrient timing, and supplementation.

Continue to: FLUID REQUIREMENTS FOR SOCCER PLAYERS

 

 

FLUID REQUIREMENTS FOR SOCCER PLAYERS

Many athletes overlook the importance of hydration on performance, either assuming they are hydrated or they miscalculate fluid and electrolyte needs to actual sweat losses. Numerous factors play a part in optimal hydration such as sweat rate, environment, training intensity, duration, body size, and body composition. Soccer players have fewer breaks to consume fluids during a match compared with basketball, baseball, or American football players. These breaks include a 15-minute half between coming off the pitch to the locker room and back, as well as time spent with coaches reviewing strategies; this short window of time must be maximized to rehydrate. Fluids with a carbohydrate concentration of 4% to 8% at 5 to 10 ounces and breaks every 15 to 20 minutes are optimal to maximize uptake while avoiding gastric intolerance.

Studies have shown that most players do not drink sufficiently during a match to optimize hydration, replacing only ~40% to 45% of their sweat losses.^{40, 41} Maughan and colleagues measured high levels of urine osmolality in some soccer players, thereby indicating that the players started their training session dehydrated.⁴¹ Soccer players must begin training or a match well hydrated due to the limited opportunities after kick-off. The athlete should drink at least 4 hours prior to exercise; if no urine is produced or urine is dark in color, then the athlete should drink again 2 hours prior.

Changes in body mass, urine color, and thirst offer clues to the need for rehydration. Advanced hydration measurement includes testing urine specific gravity (USG) values. For example, testing pre-training or pre-match can be conducted to determine hydration status and trending changes from day to day. A USG value >1.020 is considered dehydrated in accordance with the NATA position statement.⁴² Calculating a sweat rate is a practical approach to determining individual hydration needs (see Table 4). Sweat rates will vary between soccer players based on their position and intensity of play, along with total match time.³⁹ Soccer players will lose ~1.5 to 4.5 liters during match play.^43-46 In general, athletes, including soccer players, should limit body weight loss to ≤2% to 3% to maintain performance. Studies have shown that >2% body mass loss can hinder soccer-specific performance, such as dribbling skills and intermittent high intensity sprinting.^49-51) Table 5 outlines the detrimental effects dehydration has on performance. Urine-specific gravity values between 1.021 and 1.030 may reflect 3% to 5% change in body weight.

ELECTROLYTES

Sodium is the primary electrolyte lost in sweat. Other electrolytes (potassium, magnesium, and calcium) are lost at much lower levels and typically replaced through diet. Soccer players can lose large amounts of sodium; between 700 and 1500 mg of sodium/L of sweat has been reported in several studies.^42-44 Studies of professional male soccer players have shown potassium losses in the range of 165 mg/L to 234 mg/L.^{42, 51,52} Sodium in a sports drink or in food aids with water uptake from the intestines and enhances the thirst mechanism in the brain, resulting in additional fluid being retained in the body.

REHYDRATION AFTER TRAINING OR COMPETITION

Within 2 hours after training or competition, the rehydration strategy should provide water to restore body fluid status, carbohydrates to replenish glycogen (fuel) stores, and electrolytes to speed rehydration (Table 6). The volume of fluids and type of fluids over the next 24 hours dictate the hydration status prior to the next day’s training session. It is a continuous cycle. Over time, an athlete increases the risk of being in a chronic dehydrated state, resulting in lack of motivation, risk of injury, and illness, fatigue, and poor performance. The current recommendation is to drink ~50% more in volume than the amount of weight lost, such as 22 to 24 ounces/pound lost.⁵²

Soccer is the world’s most popular sport. As the sport has grown, so have the physical demands and the search for ways to edge out the competition with the use of sports science and nutrition. The demands, which include intense training, ≥90 minutes matches, congested fixtures, and travel, lead to increased energy and nutrient requirements, stress on the body, and risk of impaired sleep cycles. Identifying key areas to enhance a player’s performance is an ongoing effort because of individual differences. Moreover, new information is being discovered via research, and advancing technology to measure performance is always evolving. This article focuses on the core nutrition principles known to lay the foundation for a better soccer player. These principles are obvious for some; however, nutrition and hydration are often undervalued, leaving the individual player with the responsibility to eat right. This review addresses the most applicable nutrition-related recommendations for soccer players.

Technical, tactical, and physical skills are key factors in a soccer player’s performance. However, energy demands of matches and training sessions require adequate fuel and hydration to maximize those key factors. Athletes may need to manage carbohydrates, protein, and fat separately to achieve optimal body size and body composition, and to maximize performance.

Nutrition plays a vital role in keeping the player healthy, reducing risk of injuries, speeding up recovery, and enhancing training adaptations. Research has shown what we eat and when we eat can significantly impact skeletal muscle adaptation, inflammation, immune response, and energy metabolism. These are all essential nutrition considerations for soccer players.

ENERGY METABOLISM IN SOCCER

Understanding energy demands will help determine energy requirements: type, amount, and timing of macronutrients and micronutrients. Soccer utilizes both aerobic and anaerobic energy systems. Soccer is an intermittent team-based sport; thus, it contains various high-intensity movements, such as sprinting, jumping, dribbling, and frequent changing of direction performed in between numerous low-intensity slow movements. The high intense movements collectively account for about 30% of match play, whereas 70% is walking, jogging, and standing. Although sprinting and jumping are not a large part of the 90 minutes of match play, they have a huge impact on the outcome of the match. Distance covered in the last 15 minutes of match play decreases by 14% to 45% compared with the first 15 minutes of play.¹ Krustrup and colleagues² found muscles in the quadriceps to be empty or nearly empty of glycogen (stored carbohydrates) after match play. This phenomenon can help explain a significant decrease in sprinting, jumping, and intermittent movements toward the end of a match—energy demands that rely on glycogen as the primary fuel source. Being well-fueled and hydrated and having the ability to delay fatigue can place a team at a performance advantage.

ENERGY EXPENDITURE

Beyond training load or match intensity, a soccer player’s body composition, gender, age, and position can affect energy needs. Position differences in elite soccer players show that the greatest total distance covered is by central midfielders and wide midfielders (~12 km –13 km), whereas central defenders cover the least area of the field players (≤~10 km).^3,4 The environment can also play a role in energy expenditure. To further understand calorie needs, total daily energy expenditure in soccer players has been measured using doubly labeled water and estimated using heart rate, global positioning system, video match analysis, and activity records.^5,6 One study estimated that energy expended during a training day for elite male soccer players is between 3442 kcal and 3824 kcal.⁶ Another study using doubly labeled water concluded that mean energy expenditure of elite male soccer players is 3566 kcal over a 7-day period, which included 5 training days and 2 matches.⁷ In terms of energy expenditure for elite female soccer players, the mean values for match day, training days, and rest days were 2914, 2783, and 2213 calories, respectively.⁸

Continue to: FUELING THE SOCCER PLAYER

 

 

FUELING THE SOCCER PLAYER

Depending on the match fixture, proper fueling can be a challenge due to the number of matches, travel time, and limited recovery time. Macronutrients will provide the mainstay of fuel for a player, specifically carbohydrates and fats. Carbohydrates are the preferred source of fuel for the majority of the calories consumed. Using body weight (kg) is a more current and accurate method of recommending the amount of each macronutrient an individual player should eat as compared to using a percentage of total daily calories.

• Carbohydrates: 5–10 g/kg/day
• Protein: 1.2–2.0 g/kg/day
• Fat: 0.8–1.5 g/kg/day

CARBOHYDRATE AND SOCCER PERFORMANCE

Carbohydrates are a limited supply of fuel compared with fat stores. They are an important fuel source for soccer players, as muscle glycogen is vital to performance during high intense training and match play (Table 1). Yet current research shows that a high carbohydrate intake is not required to be followed every day due to varied energy demands.⁹ This newer strategy is referred to as “training low,” allowing the athlete to train at a low-moderate intensity in a low glycogen state. The glycogen status of the muscle can alter the training adaptations through cellular changes in the mitochondria. Therefore, carbohydrate needs should reflect the work required or demand for optimal performance. However, on high-training load days or 24 hours pre-match, carbohydrate intake should be increased to maximize muscle glycogen stores. Soccer players need to consume up to 8-10 g/kg body weight during the 24 hours before a match.¹⁰ On low or rest days, carbohydrate intake should be reduced to reflect the decreased training load. For example, recent research has demonstrated potential training adaptations when muscle glycogen stores are not consistently high¹¹ or intentionally kept low depending on the training load. Adjusting carbohydrate intake to the physical demands of an athlete is a strategy called nutrition periodization.

However, if glycogen stores are not well supplied before a match >90 minutes, then the muscles and the brain will become fatigued and lead to poor performance. Glycogen depletion contributes to fatigue toward the end of a match.¹⁰ In the early 1970s, Saltin and colleagues¹² showed that players with high muscle glycogen stores (~400 mmol/kg dry wt) achieve higher movement intensities and cover more total distance than those players who start the match with low glycogen stores (~200 mmol/kg dry wt). Another study examined pre-match diets of male soccer players (65% vs 30% daily carbohydrate intake) to determine the effect on performance outcomes and glycogen concentrations. Results showed high-muscle glycogen concentrations in the 65% carbohydrate diet and a significantly higher amount of intense exercise bouts. More acutely, studies have shown a meal containing 200 to 300 grams of carbohydrates 2 to 4 hours before exercise prolongs endurance.^13-15 Ideally, consuming fast-digesting carbohydrate sources during or at half time will help maintain blood glucose concentrations and spare muscle glycogen reserves. The majority of literature shows a 6% to 8% solution of combined fast-digesting carbohydrates (ie, glucose, fructose, sucrose, or maltodextrin) at a rate of 30 to 60 g/h enhances at least 1 aspect of performance in soccer.^16-18 These performance benefits include increased running time, improved time to fatigue, and enhanced technical skills. Regarding recovery, soccer players should begin consuming carbohydrate-rich foods and beverages immediately after exhaustive training or a match to optimize glycogen reloading. Ingesting post-exercise carbohydrates stimulates muscle and liver glycogen synthesis up to tenfold compared with post-intake of no carbohydrates.¹⁹ This recovery period becomes vital when there are <8 hours between training sessions or another match, such as in youth tournaments. The form of carbohydrate, solid or liquid, can be based on preference and tolerance, as long as the source provides a large glycemic and insulin response.

An easy way to adjust daily carbohydrate intake is to schedule carbohydrate-rich foods at meals or snacks around important training sessions or before/during/after on match day. Anderson and colleagues¹⁰ looked at training loads for 1, 2, and 3 matches per week, recommending high carbohydrate intake match day minus 1, on match day, and match day plus 1 for 1 and 2 matches per week and lower carbohydrate intake on the other days. During a 3-match week, lowering carbohydrates any day of that week is not recommended. More research is needed to determine the best strategy for performance regarding carbohydrate periodization in soccer.

PROTEIN AND SOCCER PERFORMANCE

Protein is important to soccer players for muscle tissue repair, strength, bone health, and the immune system (Table 2). The American College of Sports Medicine, the Academy of Nutrition and Dietetics, and the Dietitians of Canada recommend 1.2 to 2.0 g/kg/day.²⁰ Most soccer players meet the daily protein requirements; however, the key to optimizing the total daily amount is focusing on the source/amino acid profile, timing, and amount per feeding. Consuming divided doses of protein (20 g to 40 g) every 3 to 4 hours gives the body a continuous flow of amino acids to support muscle synthesis and recovery. In terms of body size, the recommendation is 0.25 to 0.4 g/kg every 3 to 4 hours, which includes pre-training/match and post-training/match. Protein/amino acids consumed around strength training and high-intensity sessions can promote muscle adaptations, minimize tissue breakdown, and speed recovery. Soccer matches lead to significant muscle damage²¹ especially at 2 sessions/day or multiple matches in a week. Protein is not a priority during training or matches, as its role is not to provide energy, and the primary goal during soccer activities is energy production. Research supports an intake of 30 to 40 g of casein, which is a slow digesting protein, at night before bed when a strength-training session has been performed that day.^22,23

Continue to: FAT AND SOCCER PERFORMANCE

 

 

FAT AND SOCCER PERFORMANCE

Fat is the primary source of energy at rest and at low-training intensities, such as walking or jogging for soccer players (Table 3). Besides providing slow, long-lasting energy, fat helps absorb vitamins A, D, E, and K; produce hormones; protect organs; and support the cell membrane structure. The dietary recommendations of total fat intake for athletes are similar to or slightly greater than those recommended for non-athletes. The total amount required depends on the training demands and the players’ goals. The recommended amount of dietary fat is between 20% and 35% of total daily energy intake.

The key to gaining performance benefits from dietary fat depends on the type of fat selected. Some fats in excess, such as omega-6 fatty acids and saturated fats, may promote inflammation, hinder recovery, and affect brain health. Other types can help reduce inflammation, enhance muscle recovery, and improve brain health. These types include polyunsaturated omega-3 fatty acids, which are essential for the health of the athlete, allowing for a balanced fatty acid profile.²³ Specific omega-3 fatty acids (EPA and DHA) have shown an improvement in the function of the mitochondria, enhancing energy cell metabolism. They also have potential to be highly anti-inflammatory, benefit rehabilitation during soft-tissue injury, and help decrease secondary damage from a concussion.

In addition, research shows that omega-3 may enhance the energy production of the mitochondria, resulting in less oxidative damage to the muscle cell.²⁵ More research is needed on the effects of performance on soccer players. Given the slow digestion and absorption of fats, fat intake must be limited leading up to or during training sessions or matches, which may risk gastrointestinal issues and displacement of carbohydrates. Low to moderate monounsaturated and polyunsaturated fats in a recovery meal have not been shown to inhibit muscle glycogen reloading or muscle protein synthesis.^26,27 In regard to fat intake post-match, fat is not a key nutrient of concern for muscle recovery, as it can be included in the next balanced meal.

MICRONUTRIENTS, VITAMINS, AND MINERALS

Exercise stresses many of the metabolic pathways where vitamins and minerals are required. High-level training demands may also increase the turnover rate of vitamins and minerals. As a result, greater dietary intakes of vitamins and minerals may be warranted. Soccer players at the greatest risk for poor vitamin and mineral levels are those who skip meals, who eliminate ≥1 of the food groups from their diet (such as vegans), or who consume unbalanced and highly processed foods. In soccer players, the micronutrients of concern include iron and vitamin D. In young female soccer players, calcium intake must be assessed along with adequate energy intake for optimal bone density. Vegetarians, vegans, and/or athletes who do not consume meat, eggs, and/or dairy in their diet are at risk for vitamin B12 deficiency. The key to obtaining all the vitamins and minerals an athlete will need is to eat a wide variety of nutrient-dense foods.

IRON

Iron deficiency, with or without anemia, may impair muscle function and limit exercise capacity. Adequate iron intake in athletes with iron deficiencies and/or anemia can improve exercise capacity. Iron depletion is 1 of the most common nutrient deficiencies observed among endurance athletes. Foot strike hemolysis can destroy red blood cells during activities such as running. Research has shown that 30% of professional male soccer players have ferritin levels <30 mcg/L at the end of a soccer season.²⁸ Thus, fatigue and poor recovery time place soccer players at risk of an iron imbalance.^29,30

Continue to: Landahl and colleagues...

Landahl and colleagues³¹ found that iron deficiency and iron deficiency anemia are common in female soccer players at the elite level. In their study of 28 female national soccer players, 57% had iron deficiency and 29% presented with iron deficiency anemia 6 months before the FIFA Women's World Cup. Testing hemoglobin alone is insufficient to detect relative anemia. Regular monitoring of hemoglobin and ferritin concentrations may be necessary to determine appropriate iron needs.

VITAMIN D

Vitamin D is required for optimal bone health, as it helps regulate calcium and phosphorus. Further research shows a link between vitamin D and non–bone-related functions, such as muscle health, immune support, and anti-inflammatory roles, which may be linked to performance. Soccer players with low levels of vitamin D (<30 ng/mL) may be more at risk for musculoskeletal injuries and stress fractures.³⁴ In other sports, vitamin D may enhance muscle strength; however, no association between vitamin D and muscle strength has been found in soccer players.^34,35 The geographic location of an athlete seems to be irrelevant to serum levels, as insufficient levels can be found at various latitudes.^34,36-38

Evidence has shown that vitamin D may improve athletic performance in vitamin D-depleted athletes, thereby improving vertical jumps, lowering risks of muscle injury/strains and stress fractures, and reducing risk of colds/flu. In 2013, researchers showed for the first time a link between vitamin D and muscle aerobic metabolism by studying the energy efficiency of the mitochondria.³² Athletes with low vitamin D levels increased their ATP production within the muscle with vitamin D supplementation over 10 weeks to 12 weeks.³³

CALCIUM

Soccer players present with stronger and denser bones than non-athletes due to running and jumping in their sport. Weight-bearing sites such as lumbar spine, hip, femoral neck, trochanter, intertrochanteric region, and both legs are sensitive to the impact of soccer movements.³⁹ Calcium and vitamin D are also important for muscle contraction.

Given the variation in genetics, sports, and gender, optimal performance requires a healthy eating plan tailored to the individual athlete. A healthy eating plan allows an athlete to train longer and harder, delay the onset of fatigue, and speed recovery. Nutrition supports optimal performance through real food, proper hydration, nutrient timing, and supplementation.

Continue to: FLUID REQUIREMENTS FOR SOCCER PLAYERS

 

 

FLUID REQUIREMENTS FOR SOCCER PLAYERS

Many athletes overlook the importance of hydration on performance, either assuming they are hydrated or they miscalculate fluid and electrolyte needs to actual sweat losses. Numerous factors play a part in optimal hydration such as sweat rate, environment, training intensity, duration, body size, and body composition. Soccer players have fewer breaks to consume fluids during a match compared with basketball, baseball, or American football players. These breaks include a 15-minute half between coming off the pitch to the locker room and back, as well as time spent with coaches reviewing strategies; this short window of time must be maximized to rehydrate. Fluids with a carbohydrate concentration of 4% to 8% at 5 to 10 ounces and breaks every 15 to 20 minutes are optimal to maximize uptake while avoiding gastric intolerance.

Studies have shown that most players do not drink sufficiently during a match to optimize hydration, replacing only ~40% to 45% of their sweat losses.^{40, 41} Maughan and colleagues measured high levels of urine osmolality in some soccer players, thereby indicating that the players started their training session dehydrated.⁴¹ Soccer players must begin training or a match well hydrated due to the limited opportunities after kick-off. The athlete should drink at least 4 hours prior to exercise; if no urine is produced or urine is dark in color, then the athlete should drink again 2 hours prior.

Changes in body mass, urine color, and thirst offer clues to the need for rehydration. Advanced hydration measurement includes testing urine specific gravity (USG) values. For example, testing pre-training or pre-match can be conducted to determine hydration status and trending changes from day to day. A USG value >1.020 is considered dehydrated in accordance with the NATA position statement.⁴² Calculating a sweat rate is a practical approach to determining individual hydration needs (see Table 4). Sweat rates will vary between soccer players based on their position and intensity of play, along with total match time.³⁹ Soccer players will lose ~1.5 to 4.5 liters during match play.^43-46 In general, athletes, including soccer players, should limit body weight loss to ≤2% to 3% to maintain performance. Studies have shown that >2% body mass loss can hinder soccer-specific performance, such as dribbling skills and intermittent high intensity sprinting.^49-51) Table 5 outlines the detrimental effects dehydration has on performance. Urine-specific gravity values between 1.021 and 1.030 may reflect 3% to 5% change in body weight.

ELECTROLYTES

Sodium is the primary electrolyte lost in sweat. Other electrolytes (potassium, magnesium, and calcium) are lost at much lower levels and typically replaced through diet. Soccer players can lose large amounts of sodium; between 700 and 1500 mg of sodium/L of sweat has been reported in several studies.^42-44 Studies of professional male soccer players have shown potassium losses in the range of 165 mg/L to 234 mg/L.^{42, 51,52} Sodium in a sports drink or in food aids with water uptake from the intestines and enhances the thirst mechanism in the brain, resulting in additional fluid being retained in the body.

REHYDRATION AFTER TRAINING OR COMPETITION

Within 2 hours after training or competition, the rehydration strategy should provide water to restore body fluid status, carbohydrates to replenish glycogen (fuel) stores, and electrolytes to speed rehydration (Table 6). The volume of fluids and type of fluids over the next 24 hours dictate the hydration status prior to the next day’s training session. It is a continuous cycle. Over time, an athlete increases the risk of being in a chronic dehydrated state, resulting in lack of motivation, risk of injury, and illness, fatigue, and poor performance. The current recommendation is to drink ~50% more in volume than the amount of weight lost, such as 22 to 24 ounces/pound lost.⁵²

Patients were more likely to use branded topical medications for treatment of rosacea, and almost a quarter used a combination of topical therapies, according to a retrospective analysis of claims data published in the Journal of the American Academy of Dermatology.

“We found the mean annual cost of topical therapy for branded medications per person was nearly twice the cost of generics, despite the rise in generic drug costs,” Hadar Lev-Tov, MD, from the department of dermatology and cutaneous surgery at the University of Miami and his colleagues wrote in their study, published as a letter to the editor. “Thus, there is an opportunity to save healthcare costs, nearly $7.5 million annually, for this cohort.”

Dr. Lev-Tov and his colleagues performed an analysis of the MarketScan Commercial Claims and Encounters database to determine real-world costs and usage of rosacea medication and identified 72,173 adults with two or more claims for rosacea who visited a primary care provider, dermatologist, or ophthalmologist over 18 months, from January 2005 through December 2014. The majority of these patients – 62,074 (86%) – received topical medication therapy, while 4,463 (6%) of patients received oral therapy only. Of the patients who received topical therapy, 47,035 (75.8%) received single agent topical therapy and 15,039 (24.2%) patients used combination topical therapy. Metronidazole and azelaic acid were the most common combination used.

The researchers noted that this was “an important proportion” of patients who used combination topical therapy, despite it not being discussed in most guidelines. In addition, they added, “these medications are thought to work by similar mechanisms (anti-inflammatory, antioxidant, and KLK5 modulation) and to our knowledge have not been studied together.”

More patients were treated with branded topical medications (50,334) than with generics (39,621). With regard to price (calculated as the sum of insurance payments, copay, and deductible for each medication over 1 year), the mean annual cost of the branded topical medication was $308.02, compared with $160.37 for generic medications (P less than .0001). The researchers noted switching to a generic medication for treatment of rosacea would potentially save $147.65 per patient a year. (Costs were reported in 2015 US dollars.)

The researchers said their study was limited by lack of Medicare and Medicaid claims data, the retrospective study design, and dependence on an ICD-9 code only for diagnosis of rosacea, but they noted that 92% of patients received a diagnosis from a dermatologist. In addition, they recommended more studies be conducted on the cost-effectiveness of rosacea therapy when comparing systemic medications and topical therapies.

This study was funded in part by a grant from the American Acne and Rosacea Society. The authors report no relevant conflicts of interest.

SOURCE: Lev-Tov H et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.09.039.

Patients were more likely to use branded topical medications for treatment of rosacea, and almost a quarter used a combination of topical therapies, according to a retrospective analysis of claims data published in the Journal of the American Academy of Dermatology.

“We found the mean annual cost of topical therapy for branded medications per person was nearly twice the cost of generics, despite the rise in generic drug costs,” Hadar Lev-Tov, MD, from the department of dermatology and cutaneous surgery at the University of Miami and his colleagues wrote in their study, published as a letter to the editor. “Thus, there is an opportunity to save healthcare costs, nearly $7.5 million annually, for this cohort.”

Dr. Lev-Tov and his colleagues performed an analysis of the MarketScan Commercial Claims and Encounters database to determine real-world costs and usage of rosacea medication and identified 72,173 adults with two or more claims for rosacea who visited a primary care provider, dermatologist, or ophthalmologist over 18 months, from January 2005 through December 2014. The majority of these patients – 62,074 (86%) – received topical medication therapy, while 4,463 (6%) of patients received oral therapy only. Of the patients who received topical therapy, 47,035 (75.8%) received single agent topical therapy and 15,039 (24.2%) patients used combination topical therapy. Metronidazole and azelaic acid were the most common combination used.

The researchers noted that this was “an important proportion” of patients who used combination topical therapy, despite it not being discussed in most guidelines. In addition, they added, “these medications are thought to work by similar mechanisms (anti-inflammatory, antioxidant, and KLK5 modulation) and to our knowledge have not been studied together.”

More patients were treated with branded topical medications (50,334) than with generics (39,621). With regard to price (calculated as the sum of insurance payments, copay, and deductible for each medication over 1 year), the mean annual cost of the branded topical medication was $308.02, compared with $160.37 for generic medications (P less than .0001). The researchers noted switching to a generic medication for treatment of rosacea would potentially save $147.65 per patient a year. (Costs were reported in 2015 US dollars.)

The researchers said their study was limited by lack of Medicare and Medicaid claims data, the retrospective study design, and dependence on an ICD-9 code only for diagnosis of rosacea, but they noted that 92% of patients received a diagnosis from a dermatologist. In addition, they recommended more studies be conducted on the cost-effectiveness of rosacea therapy when comparing systemic medications and topical therapies.

This study was funded in part by a grant from the American Acne and Rosacea Society. The authors report no relevant conflicts of interest.

SOURCE: Lev-Tov H et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.09.039.

Patients were more likely to use branded topical medications for treatment of rosacea, and almost a quarter used a combination of topical therapies, according to a retrospective analysis of claims data published in the Journal of the American Academy of Dermatology.

“We found the mean annual cost of topical therapy for branded medications per person was nearly twice the cost of generics, despite the rise in generic drug costs,” Hadar Lev-Tov, MD, from the department of dermatology and cutaneous surgery at the University of Miami and his colleagues wrote in their study, published as a letter to the editor. “Thus, there is an opportunity to save healthcare costs, nearly $7.5 million annually, for this cohort.”

Dr. Lev-Tov and his colleagues performed an analysis of the MarketScan Commercial Claims and Encounters database to determine real-world costs and usage of rosacea medication and identified 72,173 adults with two or more claims for rosacea who visited a primary care provider, dermatologist, or ophthalmologist over 18 months, from January 2005 through December 2014. The majority of these patients – 62,074 (86%) – received topical medication therapy, while 4,463 (6%) of patients received oral therapy only. Of the patients who received topical therapy, 47,035 (75.8%) received single agent topical therapy and 15,039 (24.2%) patients used combination topical therapy. Metronidazole and azelaic acid were the most common combination used.

The researchers noted that this was “an important proportion” of patients who used combination topical therapy, despite it not being discussed in most guidelines. In addition, they added, “these medications are thought to work by similar mechanisms (anti-inflammatory, antioxidant, and KLK5 modulation) and to our knowledge have not been studied together.”

More patients were treated with branded topical medications (50,334) than with generics (39,621). With regard to price (calculated as the sum of insurance payments, copay, and deductible for each medication over 1 year), the mean annual cost of the branded topical medication was $308.02, compared with $160.37 for generic medications (P less than .0001). The researchers noted switching to a generic medication for treatment of rosacea would potentially save $147.65 per patient a year. (Costs were reported in 2015 US dollars.)

The researchers said their study was limited by lack of Medicare and Medicaid claims data, the retrospective study design, and dependence on an ICD-9 code only for diagnosis of rosacea, but they noted that 92% of patients received a diagnosis from a dermatologist. In addition, they recommended more studies be conducted on the cost-effectiveness of rosacea therapy when comparing systemic medications and topical therapies.

This study was funded in part by a grant from the American Acne and Rosacea Society. The authors report no relevant conflicts of interest.

SOURCE: Lev-Tov H et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.09.039.

Vitamin D levels measured in maternal sera during gestation and in umbilical cord blood were not predictive of the prevalence of eczema, food allergy, asthma and allergic rhinitis in children at ages 2 years and 5 years, according to study results published in the journal Allergy.

copyright istock/Thinkstock

Áine Hennessy, PhD, from the School of Food and Nutritional Sciences at the University College Cork (Ireland), and her colleagues performed a prospective cohort study of 1,537 women in the Cork BASELINE Birth Cohort Study who underwent measurement of serum 25-hydroxyvitamin D (25[OH]D) from maternal sera followed by measurement of 25(OH)D in umbilical cord blood (1,050 cases). They then measured the prevalence of eczema, food allergy, allergic rhinitis, and asthma in infants at aged 2 and 5 years.

The researchers found at 2 years old, 5% of infants had persistent eczema, 4% of infants had a food allergy and 8% of infants had aeroallergen sensitization. At age 5 years, 15% of infants had asthma, while 5% had allergic rhinitis. Mothers whose children went on to have atopy did not differ in their 25(OH)D levels at 15 weeks’ gestation (mean 58.4 nmol/L vs. 58.5 nmol/L) or in the levels in umbilical cord blood (mean 35.2 nmol/L and 35.4 nmol/L).

Of the women in the cohort, 74% ranged in age from 25 to 34 years; 49% reported a personal history of allergy and 37% reported a paternal allergy. The mean birth weight of the infants was 3,458 g; infants were breastfed for mean 11.9 weeks, 73% of infants were breastfeeding by the time they left the hospital and 45% of infants were breastfeeding by age 2 months.

Limitations of the study included that parental atopy status was self-reported and that the researchers noted they did not examine genetic variants of immunoglobulin E synthesis or vitamin D receptor polymorphisms.

“To fully characterize relationships between intrauterine vitamin D exposure and allergic disease, analysis of well‐constructed, large‐scale prospective cohorts of maternal‐infant dyads, which take due consideration of an individual’s inherited risk, early‐life exposures and environmental confounders, is still needed,” Dr. Hennessy and her colleagues wrote.

The study was funded by grants from the European Commission, Ireland Health Research Board, National Children’s Research Centre, Food Standards Agency and Science Foundation Ireland. The authors report no relevant conflicts of interest.

SOURCE: Hennessy A et al. Allergy. 2018 Aug 7. doi: 10.1111/all.13590.

Vitamin D levels measured in maternal sera during gestation and in umbilical cord blood were not predictive of the prevalence of eczema, food allergy, asthma and allergic rhinitis in children at ages 2 years and 5 years, according to study results published in the journal Allergy.

copyright istock/Thinkstock

Áine Hennessy, PhD, from the School of Food and Nutritional Sciences at the University College Cork (Ireland), and her colleagues performed a prospective cohort study of 1,537 women in the Cork BASELINE Birth Cohort Study who underwent measurement of serum 25-hydroxyvitamin D (25[OH]D) from maternal sera followed by measurement of 25(OH)D in umbilical cord blood (1,050 cases). They then measured the prevalence of eczema, food allergy, allergic rhinitis, and asthma in infants at aged 2 and 5 years.

The researchers found at 2 years old, 5% of infants had persistent eczema, 4% of infants had a food allergy and 8% of infants had aeroallergen sensitization. At age 5 years, 15% of infants had asthma, while 5% had allergic rhinitis. Mothers whose children went on to have atopy did not differ in their 25(OH)D levels at 15 weeks’ gestation (mean 58.4 nmol/L vs. 58.5 nmol/L) or in the levels in umbilical cord blood (mean 35.2 nmol/L and 35.4 nmol/L).

Of the women in the cohort, 74% ranged in age from 25 to 34 years; 49% reported a personal history of allergy and 37% reported a paternal allergy. The mean birth weight of the infants was 3,458 g; infants were breastfed for mean 11.9 weeks, 73% of infants were breastfeeding by the time they left the hospital and 45% of infants were breastfeeding by age 2 months.

Limitations of the study included that parental atopy status was self-reported and that the researchers noted they did not examine genetic variants of immunoglobulin E synthesis or vitamin D receptor polymorphisms.

“To fully characterize relationships between intrauterine vitamin D exposure and allergic disease, analysis of well‐constructed, large‐scale prospective cohorts of maternal‐infant dyads, which take due consideration of an individual’s inherited risk, early‐life exposures and environmental confounders, is still needed,” Dr. Hennessy and her colleagues wrote.

The study was funded by grants from the European Commission, Ireland Health Research Board, National Children’s Research Centre, Food Standards Agency and Science Foundation Ireland. The authors report no relevant conflicts of interest.

SOURCE: Hennessy A et al. Allergy. 2018 Aug 7. doi: 10.1111/all.13590.

Vitamin D levels measured in maternal sera during gestation and in umbilical cord blood were not predictive of the prevalence of eczema, food allergy, asthma and allergic rhinitis in children at ages 2 years and 5 years, according to study results published in the journal Allergy.

copyright istock/Thinkstock

Áine Hennessy, PhD, from the School of Food and Nutritional Sciences at the University College Cork (Ireland), and her colleagues performed a prospective cohort study of 1,537 women in the Cork BASELINE Birth Cohort Study who underwent measurement of serum 25-hydroxyvitamin D (25[OH]D) from maternal sera followed by measurement of 25(OH)D in umbilical cord blood (1,050 cases). They then measured the prevalence of eczema, food allergy, allergic rhinitis, and asthma in infants at aged 2 and 5 years.

The researchers found at 2 years old, 5% of infants had persistent eczema, 4% of infants had a food allergy and 8% of infants had aeroallergen sensitization. At age 5 years, 15% of infants had asthma, while 5% had allergic rhinitis. Mothers whose children went on to have atopy did not differ in their 25(OH)D levels at 15 weeks’ gestation (mean 58.4 nmol/L vs. 58.5 nmol/L) or in the levels in umbilical cord blood (mean 35.2 nmol/L and 35.4 nmol/L).

Of the women in the cohort, 74% ranged in age from 25 to 34 years; 49% reported a personal history of allergy and 37% reported a paternal allergy. The mean birth weight of the infants was 3,458 g; infants were breastfed for mean 11.9 weeks, 73% of infants were breastfeeding by the time they left the hospital and 45% of infants were breastfeeding by age 2 months.

Limitations of the study included that parental atopy status was self-reported and that the researchers noted they did not examine genetic variants of immunoglobulin E synthesis or vitamin D receptor polymorphisms.

“To fully characterize relationships between intrauterine vitamin D exposure and allergic disease, analysis of well‐constructed, large‐scale prospective cohorts of maternal‐infant dyads, which take due consideration of an individual’s inherited risk, early‐life exposures and environmental confounders, is still needed,” Dr. Hennessy and her colleagues wrote.

The study was funded by grants from the European Commission, Ireland Health Research Board, National Children’s Research Centre, Food Standards Agency and Science Foundation Ireland. The authors report no relevant conflicts of interest.

SOURCE: Hennessy A et al. Allergy. 2018 Aug 7. doi: 10.1111/all.13590.

The single-item sleep quality scale (SQS) produced favorable results comparable to other complex, time-intensive assessment tools, according to findings published in the Journal of Clinical Sleep Medicine.

Silvia Jansen/iStockphoto

In a study of 70 insomnia patients and 651 depression patients, concurrent criterion validity analysis yielded strong correlations between the SQS and the morning-questionnaire insomnia (MQI) and Pittsburgh Sleep Quality Index (PSQI) in patients with insomnia and depression, respectively. The investigators wrote, “The single-item format enables a patient-reported rating of sleep quality over a 7-day recall period without greatly increasing the patient’s burden. The use of a discretizing visual analog scale (VAS) increases the potential for a more sensitive measurement.” The SQS is a quick but accurate self-reported assessment of sleep quality.

The SQS was validated based on two studies. Eligible patients in the 4-week, randomized, multicenter insomnia study were aged 30-75 years and were receiving a Food and Drug Administration–approved hypnotic agent as usual treatment for insomnia based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The MQI was used daily for the duration of the study, wrote Ellen Snyder, PhD, of Merck & Co., in Kenilworth, N.J., and her coauthors.

The depression study was a randomized, double-blind, parallel-group, 12-month international trial evaluating the safety of the substance P antagonist aprepitant, compared with paroxetine hydrochloride. Patients were aged 18 years or older, with a DSM-IV diagnosis of major depressive disorder. Patients completed the SQS and PSQI at baseline, week 1, and week 8.

In insomnia patients, a Pearson correlation of –.76 was found at week 1 for the SQS in relation to the MQI.

In patients with depression, Goodman-Kruskal correlation coefficients for the SQS in relation to the Pittsburgh Sleep Quality Index (PSQI) were –.87, –.88, and –.92 at baseline, week 1, and week 8, respectively.

Correlations were negative because “better sleep quality is associated with a lower score on the MQI and PSQI, but a higher score on the SQS,” the authors noted.

The results support the use of the SQS as a “practical sleep measure that can effectively gauge sleep quality without significantly increasing the burden of clinical trial participants,” compared with lengthier assessments such as the MQI and PSQI, they added.

Funding for the study was provided by Merck Sharp & Dohme.

SOURCE: Snyder E et al. J Clin Sleep Med. 2018;14(11):1849-57.

The single-item sleep quality scale (SQS) produced favorable results comparable to other complex, time-intensive assessment tools, according to findings published in the Journal of Clinical Sleep Medicine.

Silvia Jansen/iStockphoto

In a study of 70 insomnia patients and 651 depression patients, concurrent criterion validity analysis yielded strong correlations between the SQS and the morning-questionnaire insomnia (MQI) and Pittsburgh Sleep Quality Index (PSQI) in patients with insomnia and depression, respectively. The investigators wrote, “The single-item format enables a patient-reported rating of sleep quality over a 7-day recall period without greatly increasing the patient’s burden. The use of a discretizing visual analog scale (VAS) increases the potential for a more sensitive measurement.” The SQS is a quick but accurate self-reported assessment of sleep quality.

The SQS was validated based on two studies. Eligible patients in the 4-week, randomized, multicenter insomnia study were aged 30-75 years and were receiving a Food and Drug Administration–approved hypnotic agent as usual treatment for insomnia based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The MQI was used daily for the duration of the study, wrote Ellen Snyder, PhD, of Merck & Co., in Kenilworth, N.J., and her coauthors.

The depression study was a randomized, double-blind, parallel-group, 12-month international trial evaluating the safety of the substance P antagonist aprepitant, compared with paroxetine hydrochloride. Patients were aged 18 years or older, with a DSM-IV diagnosis of major depressive disorder. Patients completed the SQS and PSQI at baseline, week 1, and week 8.

In insomnia patients, a Pearson correlation of –.76 was found at week 1 for the SQS in relation to the MQI.

In patients with depression, Goodman-Kruskal correlation coefficients for the SQS in relation to the Pittsburgh Sleep Quality Index (PSQI) were –.87, –.88, and –.92 at baseline, week 1, and week 8, respectively.

Correlations were negative because “better sleep quality is associated with a lower score on the MQI and PSQI, but a higher score on the SQS,” the authors noted.

The results support the use of the SQS as a “practical sleep measure that can effectively gauge sleep quality without significantly increasing the burden of clinical trial participants,” compared with lengthier assessments such as the MQI and PSQI, they added.

Funding for the study was provided by Merck Sharp & Dohme.

SOURCE: Snyder E et al. J Clin Sleep Med. 2018;14(11):1849-57.

The single-item sleep quality scale (SQS) produced favorable results comparable to other complex, time-intensive assessment tools, according to findings published in the Journal of Clinical Sleep Medicine.

Silvia Jansen/iStockphoto

In a study of 70 insomnia patients and 651 depression patients, concurrent criterion validity analysis yielded strong correlations between the SQS and the morning-questionnaire insomnia (MQI) and Pittsburgh Sleep Quality Index (PSQI) in patients with insomnia and depression, respectively. The investigators wrote, “The single-item format enables a patient-reported rating of sleep quality over a 7-day recall period without greatly increasing the patient’s burden. The use of a discretizing visual analog scale (VAS) increases the potential for a more sensitive measurement.” The SQS is a quick but accurate self-reported assessment of sleep quality.

The SQS was validated based on two studies. Eligible patients in the 4-week, randomized, multicenter insomnia study were aged 30-75 years and were receiving a Food and Drug Administration–approved hypnotic agent as usual treatment for insomnia based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The MQI was used daily for the duration of the study, wrote Ellen Snyder, PhD, of Merck & Co., in Kenilworth, N.J., and her coauthors.

The depression study was a randomized, double-blind, parallel-group, 12-month international trial evaluating the safety of the substance P antagonist aprepitant, compared with paroxetine hydrochloride. Patients were aged 18 years or older, with a DSM-IV diagnosis of major depressive disorder. Patients completed the SQS and PSQI at baseline, week 1, and week 8.

In insomnia patients, a Pearson correlation of –.76 was found at week 1 for the SQS in relation to the MQI.

In patients with depression, Goodman-Kruskal correlation coefficients for the SQS in relation to the Pittsburgh Sleep Quality Index (PSQI) were –.87, –.88, and –.92 at baseline, week 1, and week 8, respectively.

Correlations were negative because “better sleep quality is associated with a lower score on the MQI and PSQI, but a higher score on the SQS,” the authors noted.

The results support the use of the SQS as a “practical sleep measure that can effectively gauge sleep quality without significantly increasing the burden of clinical trial participants,” compared with lengthier assessments such as the MQI and PSQI, they added.

Funding for the study was provided by Merck Sharp & Dohme.

SOURCE: Snyder E et al. J Clin Sleep Med. 2018;14(11):1849-57.

Acute flaccid myelitis (AFM) activity in the United States appears to have peaked for the year, according to the Centers for Disease Control and Prevention.

Through Nov. 30, 134 cases of AFM in 33 states have been confirmed out of the 299 reported to the CDC. That represents “an increase of 18 confirmed cases from the previous week, but most of the latest confirmed AFM cases occurred in September and October,” the CDC reported Dec. 3.

There has been a pattern of increased AFM cases every other year for the previous 4 years: 120 cases in 2014, 22 cases in 2015, 149 cases in 2016, and 33 cases in 2017. “Most cases are reported between August and October, and a marked reduction in cases is seen in November. That pattern appears to be repeating in 2018 because states have reported fewer [persons under investigation] over the past couple of weeks. CDC expects this decline to continue,” the statement said.

The 16 confirmed cases in Texas are the most for any state this year, followed by Colorado with 15; Ohio with 10; and Illinois, New Jersey, and Washington with 9 each. California and Florida have not had any confirmed cases as of Nov. 30. Since 2014, over 90% of all confirmed AFM cases have occurred in children, the CDC noted.

More information on AFM is available at a CDC website for health care professionals.

rfranki@mdedge.com

Acute flaccid myelitis (AFM) activity in the United States appears to have peaked for the year, according to the Centers for Disease Control and Prevention.

Through Nov. 30, 134 cases of AFM in 33 states have been confirmed out of the 299 reported to the CDC. That represents “an increase of 18 confirmed cases from the previous week, but most of the latest confirmed AFM cases occurred in September and October,” the CDC reported Dec. 3.

There has been a pattern of increased AFM cases every other year for the previous 4 years: 120 cases in 2014, 22 cases in 2015, 149 cases in 2016, and 33 cases in 2017. “Most cases are reported between August and October, and a marked reduction in cases is seen in November. That pattern appears to be repeating in 2018 because states have reported fewer [persons under investigation] over the past couple of weeks. CDC expects this decline to continue,” the statement said.

The 16 confirmed cases in Texas are the most for any state this year, followed by Colorado with 15; Ohio with 10; and Illinois, New Jersey, and Washington with 9 each. California and Florida have not had any confirmed cases as of Nov. 30. Since 2014, over 90% of all confirmed AFM cases have occurred in children, the CDC noted.

More information on AFM is available at a CDC website for health care professionals.

rfranki@mdedge.com

Acute flaccid myelitis (AFM) activity in the United States appears to have peaked for the year, according to the Centers for Disease Control and Prevention.

Through Nov. 30, 134 cases of AFM in 33 states have been confirmed out of the 299 reported to the CDC. That represents “an increase of 18 confirmed cases from the previous week, but most of the latest confirmed AFM cases occurred in September and October,” the CDC reported Dec. 3.

There has been a pattern of increased AFM cases every other year for the previous 4 years: 120 cases in 2014, 22 cases in 2015, 149 cases in 2016, and 33 cases in 2017. “Most cases are reported between August and October, and a marked reduction in cases is seen in November. That pattern appears to be repeating in 2018 because states have reported fewer [persons under investigation] over the past couple of weeks. CDC expects this decline to continue,” the statement said.

The 16 confirmed cases in Texas are the most for any state this year, followed by Colorado with 15; Ohio with 10; and Illinois, New Jersey, and Washington with 9 each. California and Florida have not had any confirmed cases as of Nov. 30. Since 2014, over 90% of all confirmed AFM cases have occurred in children, the CDC noted.

More information on AFM is available at a CDC website for health care professionals.

rfranki@mdedge.com

LAS VEGAS – Patients like cold packs for pain control after laparoscopic hysterectomy, according to a small trial from Cleveland Clinic Florida (Weston).

M. Alexander Otto/MDedge News

Cold packs have been shown to reduce pain in other types of surgery, so investigators at the clinic wanted to try them out for the procedure, said study lead Pamela Frazzini Padilla, MD, an ob.gyn. at the clinic.

Twenty-eight women were randomized to get packs right after surgery, and told to use them – before turning to oxycodone tabs – every 6 hours for 72 hours – and then as needed. Twenty-eight other women were randomized to the control group. Surgery was for benign indications, most often uterine bleeding secondary to fibroids. Besides the cold packs, there were no differences between the groups in analgesia protocols.

The differences in pain control, assessed on a 10-point scale over the phone, weren’t statistically significant, but they di move in the right direction. At 24 hours, women who were cold pack users reported a median pain score of 4, versus 4.5 among controls. At 72 hours, they reported a median score of 2, versus 2.5 in the control group.

At 2 weeks postoperatively, women who were cold pack users had used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = .143).

While not significantly different, overall numbers of opioid tabs consumed and morphine equivalents “demonstrated lower use in the study group,” Dr. Frazzini Padilla noted at the meeting sponsored by AAGL.

Also, 89% of women said that cold packs helped reduce their pain, and 92% said they’d use them again after an operation. “In a day when everything is driven by patient satisfaction, patients’ perception of their recovery” is important. Because cold packs are cheap, harmless, and seemed to help with patient perceptions, “we do recommend that people use” them. “It’s just another added measure that we give” at Cleveland Clinic Florida, she said.

The study team also found that 86% of the women in the trial used 10 or fewer oxycodone tabs after surgery. Across the country, women are prescribed about 25 tabs after a laparoscopic hysterectomy; the study suggests it’s overkill, as an audience member noted, especially given the current climate.

The two arms of the study were well balanced. The mean age was 46 years, and mean body mass index 30.4 kg/m².

There was no outside funding, and the investigators didn’t have any disclosures.

aotto@mdedge.com

SOURCE: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.

LAS VEGAS – Patients like cold packs for pain control after laparoscopic hysterectomy, according to a small trial from Cleveland Clinic Florida (Weston).

M. Alexander Otto/MDedge News

Cold packs have been shown to reduce pain in other types of surgery, so investigators at the clinic wanted to try them out for the procedure, said study lead Pamela Frazzini Padilla, MD, an ob.gyn. at the clinic.

Twenty-eight women were randomized to get packs right after surgery, and told to use them – before turning to oxycodone tabs – every 6 hours for 72 hours – and then as needed. Twenty-eight other women were randomized to the control group. Surgery was for benign indications, most often uterine bleeding secondary to fibroids. Besides the cold packs, there were no differences between the groups in analgesia protocols.

The differences in pain control, assessed on a 10-point scale over the phone, weren’t statistically significant, but they di move in the right direction. At 24 hours, women who were cold pack users reported a median pain score of 4, versus 4.5 among controls. At 72 hours, they reported a median score of 2, versus 2.5 in the control group.

At 2 weeks postoperatively, women who were cold pack users had used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = .143).

While not significantly different, overall numbers of opioid tabs consumed and morphine equivalents “demonstrated lower use in the study group,” Dr. Frazzini Padilla noted at the meeting sponsored by AAGL.

Also, 89% of women said that cold packs helped reduce their pain, and 92% said they’d use them again after an operation. “In a day when everything is driven by patient satisfaction, patients’ perception of their recovery” is important. Because cold packs are cheap, harmless, and seemed to help with patient perceptions, “we do recommend that people use” them. “It’s just another added measure that we give” at Cleveland Clinic Florida, she said.

The study team also found that 86% of the women in the trial used 10 or fewer oxycodone tabs after surgery. Across the country, women are prescribed about 25 tabs after a laparoscopic hysterectomy; the study suggests it’s overkill, as an audience member noted, especially given the current climate.

The two arms of the study were well balanced. The mean age was 46 years, and mean body mass index 30.4 kg/m².

There was no outside funding, and the investigators didn’t have any disclosures.

aotto@mdedge.com

SOURCE: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.

LAS VEGAS – Patients like cold packs for pain control after laparoscopic hysterectomy, according to a small trial from Cleveland Clinic Florida (Weston).

M. Alexander Otto/MDedge News

Cold packs have been shown to reduce pain in other types of surgery, so investigators at the clinic wanted to try them out for the procedure, said study lead Pamela Frazzini Padilla, MD, an ob.gyn. at the clinic.

Twenty-eight women were randomized to get packs right after surgery, and told to use them – before turning to oxycodone tabs – every 6 hours for 72 hours – and then as needed. Twenty-eight other women were randomized to the control group. Surgery was for benign indications, most often uterine bleeding secondary to fibroids. Besides the cold packs, there were no differences between the groups in analgesia protocols.

The differences in pain control, assessed on a 10-point scale over the phone, weren’t statistically significant, but they di move in the right direction. At 24 hours, women who were cold pack users reported a median pain score of 4, versus 4.5 among controls. At 72 hours, they reported a median score of 2, versus 2.5 in the control group.

At 2 weeks postoperatively, women who were cold pack users had used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = .143).

While not significantly different, overall numbers of opioid tabs consumed and morphine equivalents “demonstrated lower use in the study group,” Dr. Frazzini Padilla noted at the meeting sponsored by AAGL.

Also, 89% of women said that cold packs helped reduce their pain, and 92% said they’d use them again after an operation. “In a day when everything is driven by patient satisfaction, patients’ perception of their recovery” is important. Because cold packs are cheap, harmless, and seemed to help with patient perceptions, “we do recommend that people use” them. “It’s just another added measure that we give” at Cleveland Clinic Florida, she said.

The study team also found that 86% of the women in the trial used 10 or fewer oxycodone tabs after surgery. Across the country, women are prescribed about 25 tabs after a laparoscopic hysterectomy; the study suggests it’s overkill, as an audience member noted, especially given the current climate.

The two arms of the study were well balanced. The mean age was 46 years, and mean body mass index 30.4 kg/m².

There was no outside funding, and the investigators didn’t have any disclosures.

aotto@mdedge.com

SOURCE: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.

CHICAGO – Both methotrexate and canakinumab are anti-inflammatory drugs, but only canakinumab cut the incidence of cardiovascular disease events in a major clinical trial, CANTOS. A second big trial designed to parallel CANTOS tested methotrexate in roughly the same way and found it produced no cardiovascular disease benefit among high-risk patients.

Mitchel L. Zoler/MDedge News

The CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcome Study) results with canakinumab and the new results with methotrexate “demonstrate that inflammation inhibition [with canakinumab] can significantly reduce cardiovascular event rates independent of lipid lowering and blood pressure reduction,” Paul M. Ridker, MD, said at the American Heart Association scientific sessions. But, “inhibition of the IL [interleukin]–1 beta to IL-6 to CRP [C-reactive protein] pathway of innate immunity appears to be important for atheroprotection,” and was something methotrexate couldn’t deliver, concluded Dr. Ridker, a professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston.

The new results he reported showed that weekly treatment with a single, oral, 15- to 20-mg dose of methotrexate not only had no effect on cardiovascular events but also had no discernible impact on serum levels of IL-1beta (IL-1B), IL-6, or high sensitivity (hs) CRP, in contrast to canakinumab, which Dr. Ridker took as evidence that this inflammatory pathway links to the pathophysiology of atherosclerotic cardiovascular disease.

CIRT (Cardiovascular Inflammation Reduction Trial) randomized 4,786 patients at 417 centers in the United States or Canada. Enrolled patients had to have a history of an MI or documented multivessel coronary disease, and also had to have type 2 diabetes, metabolic syndrome, or both. All patients were maintained on optimized dosages of a statin, aspirin, a beta-blocker, and an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker. All patients also received 1 mg folate daily. Randomization assigned patients to either receive 15-20 mg methotrexate orally once a week or placebo.


CIRT stopped prematurely because of futility after a median follow-up of 2.3 years. At that time, the incidence of one of two primary endpoints, the combination of cardiovascular death, nonfatal MI, and nonfatal stroke was 3.46/100 person-years with methotrexate treatment and 3.43/100 person-years with placebo, a difference that was not statistically significant. The incidence of the second primary endpoint, which combined the first three types of events plus hospitalization for unstable angina that led to urgent coronary revascularization, occurred in 4.13/100 person-years with methotrexate and 4.31/100 person years with placebo, also a difference that was not statistically significant. Concurrently with this report, the results were published online (N Engl J Med. 2018 Nov 10. doi: 10.1056/NEJMoa1809798).

Analysis of inflammatory markers in the blood after 8 months on treatment showed that methotrexate had no effect on levels of IL-1B, IL-6, and hsCRP. Methotrexate’s lack of an effect on these markers as well as the absence of an effect on cardiovascular disease events contrasted sharply with results that Dr. Ridker and his associates reported a little more than a year earlier in CANTOS. The study’s investigators randomized 10,061 patients with a history of an MI and an elevated serum level of hsCRP, at least 2.0 mg/L. After a median follow-up of 3.7 years, treatment with 150 mg of canakinumab injected subcutaneously once every 3 months produced a 15% relative risk reduction in the combined rate of cardiovascular death, nonfatal MI, and nonfatal stroke, compared with patients treated with placebo, a statistically significant between-group difference (N Engl J Med. 2017 Sep 21;377[12]:1119-31). Canakinumab had no impact on LDL cholesterol levels, but lowered hsCRP levels by more than a third. Dr. Ridker and his associates designed the CIRT and CANTOS trials “in parallel,” he said, and the CIRT results using methotrexate provided a “neutral control” to complement the positive results from canakinumab in CANTOS,

Given its high cost, canakinumab (Ilaris) is not an obviously practical option for treating patients similar to those enrolled in CANTOS, so other candidate agents that inhibit the IL-1B, IL-6, CRP inflammatory pathway are now under study, Dr. Ridker said in an interview. The mechanism of methotrexate’s inhibition of inflammation is unknown, but clearly does not involve this pathway; it may be mediated by adenosine, Dr. Ridker suggested. Canakinumab has Food and Drug Administration approval for treating systemic juvenile idiopathic arthritis and a handful of additional, low-prevalence diseases. Novartis, the company that markets canakinumab, made a submission to the Food and Drug Administration seeking an indication for prevention of cardiovascular disease based on the CANTOS results, and the company said in October 2018 that the FDA denied this request.

The CIRT results also showed a previously unseen signal of a possible safety issue with the tested methotrexate regimen. The incidence of non–basal cell skin cancer was 0.65/100 person-years with methotrexate, compared with 0.24/100 person-years with placebo, a statistically significant difference. Until now, no one had reported a link like this and it requires further analysis, Dr. Ridker said.

CIRT received no commercial funding. Dr. Ridker has been a consultant to Corvidia, Inflazome, and Novartis; he has received research funding from Kowa and Novartis; and his work led to a patent held by Brigham and Women’s Hospital for inflammatory biomarkers licensed to Siemens and AstraZeneca.

mzoler@mdedge.com

SOURCE: Ridker P et al. AHA scientific sessions, Abstract 17778.

CHICAGO – Both methotrexate and canakinumab are anti-inflammatory drugs, but only canakinumab cut the incidence of cardiovascular disease events in a major clinical trial, CANTOS. A second big trial designed to parallel CANTOS tested methotrexate in roughly the same way and found it produced no cardiovascular disease benefit among high-risk patients.

Mitchel L. Zoler/MDedge News

The CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcome Study) results with canakinumab and the new results with methotrexate “demonstrate that inflammation inhibition [with canakinumab] can significantly reduce cardiovascular event rates independent of lipid lowering and blood pressure reduction,” Paul M. Ridker, MD, said at the American Heart Association scientific sessions. But, “inhibition of the IL [interleukin]–1 beta to IL-6 to CRP [C-reactive protein] pathway of innate immunity appears to be important for atheroprotection,” and was something methotrexate couldn’t deliver, concluded Dr. Ridker, a professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston.

The new results he reported showed that weekly treatment with a single, oral, 15- to 20-mg dose of methotrexate not only had no effect on cardiovascular events but also had no discernible impact on serum levels of IL-1beta (IL-1B), IL-6, or high sensitivity (hs) CRP, in contrast to canakinumab, which Dr. Ridker took as evidence that this inflammatory pathway links to the pathophysiology of atherosclerotic cardiovascular disease.

CIRT (Cardiovascular Inflammation Reduction Trial) randomized 4,786 patients at 417 centers in the United States or Canada. Enrolled patients had to have a history of an MI or documented multivessel coronary disease, and also had to have type 2 diabetes, metabolic syndrome, or both. All patients were maintained on optimized dosages of a statin, aspirin, a beta-blocker, and an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker. All patients also received 1 mg folate daily. Randomization assigned patients to either receive 15-20 mg methotrexate orally once a week or placebo.


CIRT stopped prematurely because of futility after a median follow-up of 2.3 years. At that time, the incidence of one of two primary endpoints, the combination of cardiovascular death, nonfatal MI, and nonfatal stroke was 3.46/100 person-years with methotrexate treatment and 3.43/100 person-years with placebo, a difference that was not statistically significant. The incidence of the second primary endpoint, which combined the first three types of events plus hospitalization for unstable angina that led to urgent coronary revascularization, occurred in 4.13/100 person-years with methotrexate and 4.31/100 person years with placebo, also a difference that was not statistically significant. Concurrently with this report, the results were published online (N Engl J Med. 2018 Nov 10. doi: 10.1056/NEJMoa1809798).

Analysis of inflammatory markers in the blood after 8 months on treatment showed that methotrexate had no effect on levels of IL-1B, IL-6, and hsCRP. Methotrexate’s lack of an effect on these markers as well as the absence of an effect on cardiovascular disease events contrasted sharply with results that Dr. Ridker and his associates reported a little more than a year earlier in CANTOS. The study’s investigators randomized 10,061 patients with a history of an MI and an elevated serum level of hsCRP, at least 2.0 mg/L. After a median follow-up of 3.7 years, treatment with 150 mg of canakinumab injected subcutaneously once every 3 months produced a 15% relative risk reduction in the combined rate of cardiovascular death, nonfatal MI, and nonfatal stroke, compared with patients treated with placebo, a statistically significant between-group difference (N Engl J Med. 2017 Sep 21;377[12]:1119-31). Canakinumab had no impact on LDL cholesterol levels, but lowered hsCRP levels by more than a third. Dr. Ridker and his associates designed the CIRT and CANTOS trials “in parallel,” he said, and the CIRT results using methotrexate provided a “neutral control” to complement the positive results from canakinumab in CANTOS,

Given its high cost, canakinumab (Ilaris) is not an obviously practical option for treating patients similar to those enrolled in CANTOS, so other candidate agents that inhibit the IL-1B, IL-6, CRP inflammatory pathway are now under study, Dr. Ridker said in an interview. The mechanism of methotrexate’s inhibition of inflammation is unknown, but clearly does not involve this pathway; it may be mediated by adenosine, Dr. Ridker suggested. Canakinumab has Food and Drug Administration approval for treating systemic juvenile idiopathic arthritis and a handful of additional, low-prevalence diseases. Novartis, the company that markets canakinumab, made a submission to the Food and Drug Administration seeking an indication for prevention of cardiovascular disease based on the CANTOS results, and the company said in October 2018 that the FDA denied this request.

The CIRT results also showed a previously unseen signal of a possible safety issue with the tested methotrexate regimen. The incidence of non–basal cell skin cancer was 0.65/100 person-years with methotrexate, compared with 0.24/100 person-years with placebo, a statistically significant difference. Until now, no one had reported a link like this and it requires further analysis, Dr. Ridker said.

CIRT received no commercial funding. Dr. Ridker has been a consultant to Corvidia, Inflazome, and Novartis; he has received research funding from Kowa and Novartis; and his work led to a patent held by Brigham and Women’s Hospital for inflammatory biomarkers licensed to Siemens and AstraZeneca.

mzoler@mdedge.com

SOURCE: Ridker P et al. AHA scientific sessions, Abstract 17778.

CHICAGO – Both methotrexate and canakinumab are anti-inflammatory drugs, but only canakinumab cut the incidence of cardiovascular disease events in a major clinical trial, CANTOS. A second big trial designed to parallel CANTOS tested methotrexate in roughly the same way and found it produced no cardiovascular disease benefit among high-risk patients.

Mitchel L. Zoler/MDedge News

The CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcome Study) results with canakinumab and the new results with methotrexate “demonstrate that inflammation inhibition [with canakinumab] can significantly reduce cardiovascular event rates independent of lipid lowering and blood pressure reduction,” Paul M. Ridker, MD, said at the American Heart Association scientific sessions. But, “inhibition of the IL [interleukin]–1 beta to IL-6 to CRP [C-reactive protein] pathway of innate immunity appears to be important for atheroprotection,” and was something methotrexate couldn’t deliver, concluded Dr. Ridker, a professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston.

The new results he reported showed that weekly treatment with a single, oral, 15- to 20-mg dose of methotrexate not only had no effect on cardiovascular events but also had no discernible impact on serum levels of IL-1beta (IL-1B), IL-6, or high sensitivity (hs) CRP, in contrast to canakinumab, which Dr. Ridker took as evidence that this inflammatory pathway links to the pathophysiology of atherosclerotic cardiovascular disease.

CIRT (Cardiovascular Inflammation Reduction Trial) randomized 4,786 patients at 417 centers in the United States or Canada. Enrolled patients had to have a history of an MI or documented multivessel coronary disease, and also had to have type 2 diabetes, metabolic syndrome, or both. All patients were maintained on optimized dosages of a statin, aspirin, a beta-blocker, and an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker. All patients also received 1 mg folate daily. Randomization assigned patients to either receive 15-20 mg methotrexate orally once a week or placebo.


CIRT stopped prematurely because of futility after a median follow-up of 2.3 years. At that time, the incidence of one of two primary endpoints, the combination of cardiovascular death, nonfatal MI, and nonfatal stroke was 3.46/100 person-years with methotrexate treatment and 3.43/100 person-years with placebo, a difference that was not statistically significant. The incidence of the second primary endpoint, which combined the first three types of events plus hospitalization for unstable angina that led to urgent coronary revascularization, occurred in 4.13/100 person-years with methotrexate and 4.31/100 person years with placebo, also a difference that was not statistically significant. Concurrently with this report, the results were published online (N Engl J Med. 2018 Nov 10. doi: 10.1056/NEJMoa1809798).

Analysis of inflammatory markers in the blood after 8 months on treatment showed that methotrexate had no effect on levels of IL-1B, IL-6, and hsCRP. Methotrexate’s lack of an effect on these markers as well as the absence of an effect on cardiovascular disease events contrasted sharply with results that Dr. Ridker and his associates reported a little more than a year earlier in CANTOS. The study’s investigators randomized 10,061 patients with a history of an MI and an elevated serum level of hsCRP, at least 2.0 mg/L. After a median follow-up of 3.7 years, treatment with 150 mg of canakinumab injected subcutaneously once every 3 months produced a 15% relative risk reduction in the combined rate of cardiovascular death, nonfatal MI, and nonfatal stroke, compared with patients treated with placebo, a statistically significant between-group difference (N Engl J Med. 2017 Sep 21;377[12]:1119-31). Canakinumab had no impact on LDL cholesterol levels, but lowered hsCRP levels by more than a third. Dr. Ridker and his associates designed the CIRT and CANTOS trials “in parallel,” he said, and the CIRT results using methotrexate provided a “neutral control” to complement the positive results from canakinumab in CANTOS,

Given its high cost, canakinumab (Ilaris) is not an obviously practical option for treating patients similar to those enrolled in CANTOS, so other candidate agents that inhibit the IL-1B, IL-6, CRP inflammatory pathway are now under study, Dr. Ridker said in an interview. The mechanism of methotrexate’s inhibition of inflammation is unknown, but clearly does not involve this pathway; it may be mediated by adenosine, Dr. Ridker suggested. Canakinumab has Food and Drug Administration approval for treating systemic juvenile idiopathic arthritis and a handful of additional, low-prevalence diseases. Novartis, the company that markets canakinumab, made a submission to the Food and Drug Administration seeking an indication for prevention of cardiovascular disease based on the CANTOS results, and the company said in October 2018 that the FDA denied this request.

The CIRT results also showed a previously unseen signal of a possible safety issue with the tested methotrexate regimen. The incidence of non–basal cell skin cancer was 0.65/100 person-years with methotrexate, compared with 0.24/100 person-years with placebo, a statistically significant difference. Until now, no one had reported a link like this and it requires further analysis, Dr. Ridker said.

CIRT received no commercial funding. Dr. Ridker has been a consultant to Corvidia, Inflazome, and Novartis; he has received research funding from Kowa and Novartis; and his work led to a patent held by Brigham and Women’s Hospital for inflammatory biomarkers licensed to Siemens and AstraZeneca.

mzoler@mdedge.com

SOURCE: Ridker P et al. AHA scientific sessions, Abstract 17778.

CHICAGO – The selective Janus kinase 1 inhibitor filgotinib showed efficacy and safety for patients with rheumatoid arthritis in a phase 3 trial, and efficacy and safety for treating patients with psoriatic arthritis in results from a phase 2 study in two separate reports at the annual meeting of the American College of Rheumatology.

Mitchel L. Zoler/MDedge News

In the phase 3 study, treatment with filgotinib at an oral dosage of 200 mg once daily led to a 66% incidence of American College of Rheumatology 20 (ACR20) responses after 16 weeks of treatment in 147 patients with moderately to severely active rheumatoid arthritis (RA), compared with a 31% rate among 148 patients randomized to receive placebo, a statistically significant improvement for the study’s primary efficacy endpoint, Mark C. Genovese, MD, reported in a poster at the meeting. The rate of ACR20 responses among the 153 RA patients who received 100 mg/day filgotinib was 58%, reported Dr. Genovese, professor of medicine and director of the rheumatology clinic at Stanford (Calif.) University.

After 24 weeks of daily treatment, the longest duration studied in the trial, ACR20 rates were 69%, 55%, and 35% in the 200-mg, 100-mg, and placebo patients, respectively. Dr. Genovese also reported that after 24 weeks on treatment, the rates of patients achieving low disease activity measured by their disease activity score based on 28 joints and C-reactive protein level (DAS28-CRP) were 48%, 38%, and 21%, respectively, and the percentages of patients achieving complete remission at 24 weeks based on their DAS28-CRP scores were 31%, 26%, and 12%, respectively.

“We were incredibly fortunate to see such positive results. The drug worked very well in very-challenging-to-treat patients,” Dr. Genovese said in an interview. All of the RA patients enrolled in the study had not previously responded to or were intolerant of prior treatment with at least one biologic disease-modifying antirheumatic drug (DMARD), and almost a quarter of enrolled patients had failed prior treatment with at least three different biologic DMARDs. The number of biologic DMARDs a patient had previously received showed no relationship to how well patients responded to filgotinib, he noted.

Dr. Genovese also highlighted the relatively high percentage of patients who achieved low disease activity and remission. The 48% and 31% rates, respectively, of low disease activity and remission among patients treated with the higher filgotinib dosage for 24 weeks “is fairly impressive in patients who did not previously respond to a biologic DMARD,” the researcher said. These findings are similar to data previously reported for upadacitinib, another Janus kinase (JAK) inhibitor that, like filgotinib, is selective for the JAK1 receptor, noted Dr. Genovese, who also was the lead investigator for a phase 3 study of upadacitinib in RA patients (Lancet. 2018 June 23;391[10139]:2513-24).

The filgotinib data he presented came from the FINCH 2 (Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drug[s] Treatment) trial, which was run at 104 sites in 15 countries, including the United States. The results also showed a “favorable safety profile and stable laboratory parameters,” Dr. Genovese reported. Results from two additional phase 3 trials in RA patients are expected in 2019, he said.

Filgotinib studied in psoriatic arthritis

The separate, phase 2 study of filgotinib in patients with psoriatic arthritis (PsA) reported during the meeting showed safety “in line with previous reports without new safety signals” in a multicenter trial with 131 patients randomized to receive oral filgotinib 200 mg daily for 16 weeks or placebo, Philip J. Mease, MD, reported in a talk at the meeting. For the primary endpoint of achievement of ACR20 response after 16 weeks, the rate was 80% of the filgotinib-treated patients and 33% of patients in the placebo group, a statistically significant difference, said Dr. Mease, a rheumatologist at Swedish Medical Center in Seattle.

Mitchel L. Zoler/MDedge News

EQUATOR (A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis) enrolled patients at sites in seven European countries who had “very active” PsA and either a history of or current plaque psoriasis. All patients had to have a history of either insufficient response to or intolerance of at least one conventional synthetic DMARD. The enrollment criteria had no specifications for prior use of an anti–tumor necrosis factor drug, and about 15% of patients had used least one of these drugs. At entry, about three-quarters of patients were on treatment with a conventional synthetic DMARD and about a quarter received treatment with a glucocorticoid.

The results showed statistically significant benefits from filgotinib, compared with placebo, for several other measures of arthritis activity, as well as measures of psoriasis, enthesitis, and pain, Dr. Mease reported. He also highlighted a “lack of meaningful changes in hemoglobin” or other laboratory measures that, along with the efficacy findings, make filgotinib “a promising first step” for patients with PsA. Dr. Mease also noted that roughly concurrently with his report, a separate group of researchers published results from a phase 2 study of filgotinib in patients with ankylosing spondylitis that also found evidence for efficacy and safety during 12 weeks of treating 116 randomized patients (Lancet. 2018 Oct 22. doi: 10.1016/S0140-6736[18]32463-2).

FINCH 2 was sponsored by Galapagos and Gilead, the two companies developing filgotinib. Dr. Genovese has had financial relationships with Galapagos and Gilead and also with AbbVie, Lilly, and Pfizer. Dr. Mease has had financial relationships with Galapagos and Gilead and a dozen other companies.

mzoler@mdedge.com

SOURCES: Genovese M et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract L06; Mease P et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 1821.

CHICAGO – The selective Janus kinase 1 inhibitor filgotinib showed efficacy and safety for patients with rheumatoid arthritis in a phase 3 trial, and efficacy and safety for treating patients with psoriatic arthritis in results from a phase 2 study in two separate reports at the annual meeting of the American College of Rheumatology.

Mitchel L. Zoler/MDedge News

In the phase 3 study, treatment with filgotinib at an oral dosage of 200 mg once daily led to a 66% incidence of American College of Rheumatology 20 (ACR20) responses after 16 weeks of treatment in 147 patients with moderately to severely active rheumatoid arthritis (RA), compared with a 31% rate among 148 patients randomized to receive placebo, a statistically significant improvement for the study’s primary efficacy endpoint, Mark C. Genovese, MD, reported in a poster at the meeting. The rate of ACR20 responses among the 153 RA patients who received 100 mg/day filgotinib was 58%, reported Dr. Genovese, professor of medicine and director of the rheumatology clinic at Stanford (Calif.) University.

After 24 weeks of daily treatment, the longest duration studied in the trial, ACR20 rates were 69%, 55%, and 35% in the 200-mg, 100-mg, and placebo patients, respectively. Dr. Genovese also reported that after 24 weeks on treatment, the rates of patients achieving low disease activity measured by their disease activity score based on 28 joints and C-reactive protein level (DAS28-CRP) were 48%, 38%, and 21%, respectively, and the percentages of patients achieving complete remission at 24 weeks based on their DAS28-CRP scores were 31%, 26%, and 12%, respectively.

“We were incredibly fortunate to see such positive results. The drug worked very well in very-challenging-to-treat patients,” Dr. Genovese said in an interview. All of the RA patients enrolled in the study had not previously responded to or were intolerant of prior treatment with at least one biologic disease-modifying antirheumatic drug (DMARD), and almost a quarter of enrolled patients had failed prior treatment with at least three different biologic DMARDs. The number of biologic DMARDs a patient had previously received showed no relationship to how well patients responded to filgotinib, he noted.

Dr. Genovese also highlighted the relatively high percentage of patients who achieved low disease activity and remission. The 48% and 31% rates, respectively, of low disease activity and remission among patients treated with the higher filgotinib dosage for 24 weeks “is fairly impressive in patients who did not previously respond to a biologic DMARD,” the researcher said. These findings are similar to data previously reported for upadacitinib, another Janus kinase (JAK) inhibitor that, like filgotinib, is selective for the JAK1 receptor, noted Dr. Genovese, who also was the lead investigator for a phase 3 study of upadacitinib in RA patients (Lancet. 2018 June 23;391[10139]:2513-24).

The filgotinib data he presented came from the FINCH 2 (Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drug[s] Treatment) trial, which was run at 104 sites in 15 countries, including the United States. The results also showed a “favorable safety profile and stable laboratory parameters,” Dr. Genovese reported. Results from two additional phase 3 trials in RA patients are expected in 2019, he said.

Filgotinib studied in psoriatic arthritis

The separate, phase 2 study of filgotinib in patients with psoriatic arthritis (PsA) reported during the meeting showed safety “in line with previous reports without new safety signals” in a multicenter trial with 131 patients randomized to receive oral filgotinib 200 mg daily for 16 weeks or placebo, Philip J. Mease, MD, reported in a talk at the meeting. For the primary endpoint of achievement of ACR20 response after 16 weeks, the rate was 80% of the filgotinib-treated patients and 33% of patients in the placebo group, a statistically significant difference, said Dr. Mease, a rheumatologist at Swedish Medical Center in Seattle.

Mitchel L. Zoler/MDedge News

EQUATOR (A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis) enrolled patients at sites in seven European countries who had “very active” PsA and either a history of or current plaque psoriasis. All patients had to have a history of either insufficient response to or intolerance of at least one conventional synthetic DMARD. The enrollment criteria had no specifications for prior use of an anti–tumor necrosis factor drug, and about 15% of patients had used least one of these drugs. At entry, about three-quarters of patients were on treatment with a conventional synthetic DMARD and about a quarter received treatment with a glucocorticoid.

The results showed statistically significant benefits from filgotinib, compared with placebo, for several other measures of arthritis activity, as well as measures of psoriasis, enthesitis, and pain, Dr. Mease reported. He also highlighted a “lack of meaningful changes in hemoglobin” or other laboratory measures that, along with the efficacy findings, make filgotinib “a promising first step” for patients with PsA. Dr. Mease also noted that roughly concurrently with his report, a separate group of researchers published results from a phase 2 study of filgotinib in patients with ankylosing spondylitis that also found evidence for efficacy and safety during 12 weeks of treating 116 randomized patients (Lancet. 2018 Oct 22. doi: 10.1016/S0140-6736[18]32463-2).

FINCH 2 was sponsored by Galapagos and Gilead, the two companies developing filgotinib. Dr. Genovese has had financial relationships with Galapagos and Gilead and also with AbbVie, Lilly, and Pfizer. Dr. Mease has had financial relationships with Galapagos and Gilead and a dozen other companies.

mzoler@mdedge.com

SOURCES: Genovese M et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract L06; Mease P et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 1821.

CHICAGO – The selective Janus kinase 1 inhibitor filgotinib showed efficacy and safety for patients with rheumatoid arthritis in a phase 3 trial, and efficacy and safety for treating patients with psoriatic arthritis in results from a phase 2 study in two separate reports at the annual meeting of the American College of Rheumatology.

Mitchel L. Zoler/MDedge News

In the phase 3 study, treatment with filgotinib at an oral dosage of 200 mg once daily led to a 66% incidence of American College of Rheumatology 20 (ACR20) responses after 16 weeks of treatment in 147 patients with moderately to severely active rheumatoid arthritis (RA), compared with a 31% rate among 148 patients randomized to receive placebo, a statistically significant improvement for the study’s primary efficacy endpoint, Mark C. Genovese, MD, reported in a poster at the meeting. The rate of ACR20 responses among the 153 RA patients who received 100 mg/day filgotinib was 58%, reported Dr. Genovese, professor of medicine and director of the rheumatology clinic at Stanford (Calif.) University.

After 24 weeks of daily treatment, the longest duration studied in the trial, ACR20 rates were 69%, 55%, and 35% in the 200-mg, 100-mg, and placebo patients, respectively. Dr. Genovese also reported that after 24 weeks on treatment, the rates of patients achieving low disease activity measured by their disease activity score based on 28 joints and C-reactive protein level (DAS28-CRP) were 48%, 38%, and 21%, respectively, and the percentages of patients achieving complete remission at 24 weeks based on their DAS28-CRP scores were 31%, 26%, and 12%, respectively.

“We were incredibly fortunate to see such positive results. The drug worked very well in very-challenging-to-treat patients,” Dr. Genovese said in an interview. All of the RA patients enrolled in the study had not previously responded to or were intolerant of prior treatment with at least one biologic disease-modifying antirheumatic drug (DMARD), and almost a quarter of enrolled patients had failed prior treatment with at least three different biologic DMARDs. The number of biologic DMARDs a patient had previously received showed no relationship to how well patients responded to filgotinib, he noted.

Dr. Genovese also highlighted the relatively high percentage of patients who achieved low disease activity and remission. The 48% and 31% rates, respectively, of low disease activity and remission among patients treated with the higher filgotinib dosage for 24 weeks “is fairly impressive in patients who did not previously respond to a biologic DMARD,” the researcher said. These findings are similar to data previously reported for upadacitinib, another Janus kinase (JAK) inhibitor that, like filgotinib, is selective for the JAK1 receptor, noted Dr. Genovese, who also was the lead investigator for a phase 3 study of upadacitinib in RA patients (Lancet. 2018 June 23;391[10139]:2513-24).

The filgotinib data he presented came from the FINCH 2 (Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drug[s] Treatment) trial, which was run at 104 sites in 15 countries, including the United States. The results also showed a “favorable safety profile and stable laboratory parameters,” Dr. Genovese reported. Results from two additional phase 3 trials in RA patients are expected in 2019, he said.

Filgotinib studied in psoriatic arthritis

The separate, phase 2 study of filgotinib in patients with psoriatic arthritis (PsA) reported during the meeting showed safety “in line with previous reports without new safety signals” in a multicenter trial with 131 patients randomized to receive oral filgotinib 200 mg daily for 16 weeks or placebo, Philip J. Mease, MD, reported in a talk at the meeting. For the primary endpoint of achievement of ACR20 response after 16 weeks, the rate was 80% of the filgotinib-treated patients and 33% of patients in the placebo group, a statistically significant difference, said Dr. Mease, a rheumatologist at Swedish Medical Center in Seattle.

Mitchel L. Zoler/MDedge News

EQUATOR (A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis) enrolled patients at sites in seven European countries who had “very active” PsA and either a history of or current plaque psoriasis. All patients had to have a history of either insufficient response to or intolerance of at least one conventional synthetic DMARD. The enrollment criteria had no specifications for prior use of an anti–tumor necrosis factor drug, and about 15% of patients had used least one of these drugs. At entry, about three-quarters of patients were on treatment with a conventional synthetic DMARD and about a quarter received treatment with a glucocorticoid.

The results showed statistically significant benefits from filgotinib, compared with placebo, for several other measures of arthritis activity, as well as measures of psoriasis, enthesitis, and pain, Dr. Mease reported. He also highlighted a “lack of meaningful changes in hemoglobin” or other laboratory measures that, along with the efficacy findings, make filgotinib “a promising first step” for patients with PsA. Dr. Mease also noted that roughly concurrently with his report, a separate group of researchers published results from a phase 2 study of filgotinib in patients with ankylosing spondylitis that also found evidence for efficacy and safety during 12 weeks of treating 116 randomized patients (Lancet. 2018 Oct 22. doi: 10.1016/S0140-6736[18]32463-2).

FINCH 2 was sponsored by Galapagos and Gilead, the two companies developing filgotinib. Dr. Genovese has had financial relationships with Galapagos and Gilead and also with AbbVie, Lilly, and Pfizer. Dr. Mease has had financial relationships with Galapagos and Gilead and a dozen other companies.

mzoler@mdedge.com

SOURCES: Genovese M et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract L06; Mease P et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 1821.

The Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery trial is an observational, prospective cohort study of patients receiving mechanical ventilation during robotic surgery.

The trial will assess the incidence of postoperative pulmonary complications in patients who receive mechanical ventilation while under general anesthesia during robotic surgery to characterize current ventilation practices and evaluate any association between ventilator parameters and postoperative pulmonary complications.

Patients will be included if they are at least 18 years old and had their robotic surgical procedure done under general anesthesia. Exclusion criteria include being pregnant during surgery and having their procedure done outside an operating room.

The primary outcome measure is incidence of postoperative pulmonary complications within 5 days of the procedure or hospital discharge. Secondary outcomes include intraoperative mechanical ventilation practice, mechanical ventilation practice, and postoperative pulmonary complications within 5 days of the procedure or hospital discharge, intraoperative surgical positioning and ventilation, preoperative risk for postoperative pulmonary complications, and intraoperative mechanical ventilation practice and complications.

The estimated primary completion date is March 1, 2019, and the estimated study completion date is May 1, 2019. About 500 patients are estimated to be enrolled.

Find more information on the study at Clinicaltrials.gov.

lfranki@mdedge.com

The Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery trial is an observational, prospective cohort study of patients receiving mechanical ventilation during robotic surgery.

The trial will assess the incidence of postoperative pulmonary complications in patients who receive mechanical ventilation while under general anesthesia during robotic surgery to characterize current ventilation practices and evaluate any association between ventilator parameters and postoperative pulmonary complications.

Patients will be included if they are at least 18 years old and had their robotic surgical procedure done under general anesthesia. Exclusion criteria include being pregnant during surgery and having their procedure done outside an operating room.

The primary outcome measure is incidence of postoperative pulmonary complications within 5 days of the procedure or hospital discharge. Secondary outcomes include intraoperative mechanical ventilation practice, mechanical ventilation practice, and postoperative pulmonary complications within 5 days of the procedure or hospital discharge, intraoperative surgical positioning and ventilation, preoperative risk for postoperative pulmonary complications, and intraoperative mechanical ventilation practice and complications.

The estimated primary completion date is March 1, 2019, and the estimated study completion date is May 1, 2019. About 500 patients are estimated to be enrolled.

Find more information on the study at Clinicaltrials.gov.

lfranki@mdedge.com

The Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery trial is an observational, prospective cohort study of patients receiving mechanical ventilation during robotic surgery.

The trial will assess the incidence of postoperative pulmonary complications in patients who receive mechanical ventilation while under general anesthesia during robotic surgery to characterize current ventilation practices and evaluate any association between ventilator parameters and postoperative pulmonary complications.

Patients will be included if they are at least 18 years old and had their robotic surgical procedure done under general anesthesia. Exclusion criteria include being pregnant during surgery and having their procedure done outside an operating room.

The primary outcome measure is incidence of postoperative pulmonary complications within 5 days of the procedure or hospital discharge. Secondary outcomes include intraoperative mechanical ventilation practice, mechanical ventilation practice, and postoperative pulmonary complications within 5 days of the procedure or hospital discharge, intraoperative surgical positioning and ventilation, preoperative risk for postoperative pulmonary complications, and intraoperative mechanical ventilation practice and complications.

The estimated primary completion date is March 1, 2019, and the estimated study completion date is May 1, 2019. About 500 patients are estimated to be enrolled.

Find more information on the study at Clinicaltrials.gov.

lfranki@mdedge.com

The Treating Sleep Apnea in Women Veterans study is an interventional, randomized, controlled trial for woman veterans recently diagnosed with sleep apnea and prescribed positive airway pressure (PAP) treatment with at least one risk factor for sleep-disordered breathing (SDB).

The trial will compare the efficacy of two different programs combining patient education with behavioral techniques to improve adherence to PAP therapy in women veterans. The recommended first-line treatment for SDB is PAP therapy, but women have been shown to have lower adherence to men, especially in woman veterans, who experience significant sleep disturbance and other consequences of sleep disorders. No study has tested possible interventions to increase PAP adherence in this population.

Among inclusion criteria are being a woman veteran aged at least 18 years, having received care from a Veterans Affairs facility, and having been diagnosed with sleep apnea with an apnea-hypopnea index of 5 or greater. Patients will be excluded if they are currently using a sleep apnea treatment, are pregnant, are an active substance user or started recovery in the past 90 days, are too ill to participate, do not have transportation, cannot self-consent, have unstable housing, have another sleep disorder that accounts for sleep disturbance, or have no sleep complaints or symptoms.

The primary outcome measures are PAP adherence 3 months post PAP initiation and sleep quality by patient-reported sleep questionnaire 3 months after randomizations. In addition, remote PAP usage data will be collected for 12 months post PAP initiation.

The estimated primary completion date is Dec. 21, 2021, and the estimated study completion date is Jan. 31, 2022. About 300 patients are estimated to be recruited.

Find more information on the study page at Clinicaltrials.gov.

lfranki@mdedge.com

The Treating Sleep Apnea in Women Veterans study is an interventional, randomized, controlled trial for woman veterans recently diagnosed with sleep apnea and prescribed positive airway pressure (PAP) treatment with at least one risk factor for sleep-disordered breathing (SDB).

The trial will compare the efficacy of two different programs combining patient education with behavioral techniques to improve adherence to PAP therapy in women veterans. The recommended first-line treatment for SDB is PAP therapy, but women have been shown to have lower adherence to men, especially in woman veterans, who experience significant sleep disturbance and other consequences of sleep disorders. No study has tested possible interventions to increase PAP adherence in this population.

Among inclusion criteria are being a woman veteran aged at least 18 years, having received care from a Veterans Affairs facility, and having been diagnosed with sleep apnea with an apnea-hypopnea index of 5 or greater. Patients will be excluded if they are currently using a sleep apnea treatment, are pregnant, are an active substance user or started recovery in the past 90 days, are too ill to participate, do not have transportation, cannot self-consent, have unstable housing, have another sleep disorder that accounts for sleep disturbance, or have no sleep complaints or symptoms.

The primary outcome measures are PAP adherence 3 months post PAP initiation and sleep quality by patient-reported sleep questionnaire 3 months after randomizations. In addition, remote PAP usage data will be collected for 12 months post PAP initiation.

The estimated primary completion date is Dec. 21, 2021, and the estimated study completion date is Jan. 31, 2022. About 300 patients are estimated to be recruited.

Find more information on the study page at Clinicaltrials.gov.

lfranki@mdedge.com

The Treating Sleep Apnea in Women Veterans study is an interventional, randomized, controlled trial for woman veterans recently diagnosed with sleep apnea and prescribed positive airway pressure (PAP) treatment with at least one risk factor for sleep-disordered breathing (SDB).

The trial will compare the efficacy of two different programs combining patient education with behavioral techniques to improve adherence to PAP therapy in women veterans. The recommended first-line treatment for SDB is PAP therapy, but women have been shown to have lower adherence to men, especially in woman veterans, who experience significant sleep disturbance and other consequences of sleep disorders. No study has tested possible interventions to increase PAP adherence in this population.

Among inclusion criteria are being a woman veteran aged at least 18 years, having received care from a Veterans Affairs facility, and having been diagnosed with sleep apnea with an apnea-hypopnea index of 5 or greater. Patients will be excluded if they are currently using a sleep apnea treatment, are pregnant, are an active substance user or started recovery in the past 90 days, are too ill to participate, do not have transportation, cannot self-consent, have unstable housing, have another sleep disorder that accounts for sleep disturbance, or have no sleep complaints or symptoms.

The primary outcome measures are PAP adherence 3 months post PAP initiation and sleep quality by patient-reported sleep questionnaire 3 months after randomizations. In addition, remote PAP usage data will be collected for 12 months post PAP initiation.

The estimated primary completion date is Dec. 21, 2021, and the estimated study completion date is Jan. 31, 2022. About 300 patients are estimated to be recruited.

Find more information on the study page at Clinicaltrials.gov.

lfranki@mdedge.com